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Behaviour Research and Therapy 44 (2006) 317337

www.elsevier.com/locate/brat

Prediction of treatment outcome among patients with irritable

bowel syndrome treated with group cognitive therapy
Edward B. Blancharda,, Jeffrey M. Lacknerb, Rebecca Gusmanoa,
Gregory D. Gudleskib, Kathryn Sandersa, Laurie Keefera, Susan Krasnerc
a
Department of Psyhology, Center for Stress and Anxiety Disorders, University of Albany-SUNY,
1400 Washington Avenue, Albany, NY 12222 0001, USA
b
Department of Medicine, Behavioral Medicine Clinic, University at Buffalo School of Medicine and Biomedical Sciences,
Buffalo, NY, USA
c
Department of Anesthesiology, University at Buffalo School of Medicine and Biomedical Sciences, Buffalo, NY, USA

Received 8 December 2004; received in revised form 8 December 2004; accepted 10 January 2005

Abstract

Using a sample of over 125 patients with irritable bowel syndrome (IBS) who were treated with cognitive
therapy administered in small groups, we sought to predict end of treatment and 3-month follow-up
improvement in two changes indices of gastrointestinal (GI) symptoms (Pain/Discomfort Index which
assessed change in abdominal pain, abdominal tenderness and bloating and Bowel Regularity Index which
assessed change in diarrhea and constipation). We also sought to predict scores on IBS specic quality of
life (QOL) and overall level of psychological distress using the Global Severity Index (GSI) of the Brief
Symptom Inventory (BSI). Signicant, but modest, levels of prediction were found for prediction of
improvement in GI symptoms (415% of variance). Stronger signicant prediction was obtained for the
QOL and global psychological distress measure with R2 s ranging from 0.36 to 0.50. A wide variety of
demographic, GI symptom, psychological status and psychiatric status variables entered the nal
prediction equations.
r 2005 Published by Elsevier Ltd.

Keywords: Irritable bowel syndrome (IBS); Cognitive behavioral therapy (CBT); Prediction of treatment outcome

Corresponding author. Tel.: +1 518 674 0524.

E-mail address: ceblanchard@earthlink.net (E.B. Blanchard).

0005-7967/$ - see front matter r 2005 Published by Elsevier Ltd.

doi:10.1016/j.brat.2005.01.003
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318 E.B. Blanchard et al. / Behaviour Research and Therapy 44 (2006) 317337

Introduction

Irritable bowel syndrome (IBS) is a functional disorder of the lower gastrointestinal tract that
affects 10% or more of the adult population in the United States (Drossman, Li, Andruzzi et al.,
1993). It is estimated to cost American society billions of dollars in direct medical care (Levy et al.,
2001) as well as in lost work time or reduced productivity (Hahn, Yan, & Strassels, 1999). At
present, there are no universally accepted pharmacological treatments (for a review see Mertz,
2003) for the full range of symptoms. This has led to a growing literature exploring the efcacy of
psychological treatments including several recent relatively large scale randomized controlled
trials (RCTs) (Drossman et al., 2003; Creed et al., 2003; Boyce, Talley, Balaam, Koloski, &
Gruman, 2003; and a large-scale effectiveness study of hypnotherapy (Gonsalkorale, Houghton,
& Whorwell, 2002).
Recent detailed qualitative reviews of this literature are available in Blanchard and Scharff
(2002) and Blanchard (2005), with a quantitative review (meta-analysis) available in Lackner,
Morley, Dowzer, Mesmer, and Hamilton (in press). A conclusion that emerges from these reviews
is that the various psychological treatments (hypnotherapy, brief psychodynamic or interpersonal
psychotherapy, various combinations of cognitive and behavioral techniques) lead to noticeable
improvement in some, but not all, IBS sufferers. Therefore, there is a need to identify patient
characteristics that can help predict who will benet from which type of treatment.
In the next section of this paper, which centers on Table 1, the available published information
(to the best of our knowledge) on prediction of response to psychological treatment of IBS is
summarized as a way of setting the stage for the empirical portion of this paper.
As Table 1 indicates, one can see contributions from the three primary psychological treatments
of IBS, hypnotherapy as initially described by Whorwell, Prior, and Faragher (1984), brief
psychodynamic psychotherapy as initially described by Guthrie, Creed, Dawson, and Tomenson
(1991), renamed as interpersonal therapy in Creed et al. (2003), and various combinations of
cognitive and behavioral techniques, termed CBT. Several themes seem apparent in these results.

Psychological disturbance

For hypnotherapy, there are two reports of an inverse relation between pre-treatment degree of
overall psychological distress (Whorwell, Prior, & Colgan, 1987, Harvey, Hinton, Gunary, &
Barry, 1989) and degree of GI symptom improvement with a partial replication in female patients
only with regards to depression in Gonsalkorale et al. (2002). Galovski and Blanchard (1998),
using the same hypnotherapy protocol, reported the opposite results (presence of more Axis I
disorders is associated with greater GI symptom relief).
There are other conicting reports on this potential predictor: Guthrie et al. (1991) also report
better outcome (higher percent of patients improved) with the presence of pre-treatment anxiety
or depression when brief psychodynamic psychotherapy is used, agreeing with Galovski and
Blanchards (1998) hypnotherapy trial. On the other side, Blanchard, Schwarz, Neff, and Gerardi
(1988) reported an inverse relation between STAI trait anxiety and a composite IBS symptom
reduction score (CPSR score) derived from patients diaries. In a report on a separate sample
using the same CBT protocol, Blanchard et al (1992a, b) reported lower likelihood of success with
the presence of one or more Axis I disorders. Drossman et al. (2003) reported that their variety of
Table 1
Summary of research on prediction of outcome from psychological treatments of IBS

Authors Sample % female Treatment How outcome Signicant predictors

size assessed

Whorwell et al. (1987) 50 88 Hypnotherapy Patient daily diary 95% of classical cases respond vs. 43% of
atypical cases (intractable abdominal pain with
little bloating or bowel habit disturbance) vs.
60% with signicant psychopathology (GHQ
score of 14+) 25% of patients over age 50
respond vs. 100% of classical cases under
age 50
Harvey et al. (1989) 33 75 Hypnotherapy Patient daily diary Presence of more psychological problems
(GHQ score of 5+) associated with poorer
outcome: percent with psychological problems
who are: unimproved-38%, improved-33%,
symptom-free-0%
Galovski & Blanchard 12 83 Hypnotherapy Patient daily diary Signicant correlation (r :59) between
(1998) number Axis I diagnoses and CPSR scores
indicating better response with less pathology.
No correlation between hypnotic susceptibility
and improvement
Guthrie et al. (1991) 43 85 Brief dynamic Physician global Presence of anxiety or depression predicts
psychother. rating better outcome, 65% vs. 25% success
Presence of constant pain predicts poorer
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outcome, 23% vs. 75% success

Presence of abdominal pain from stressful
events predicts better outcome, 65% vs. 17%
success
Longer duration of symptoms predicts poorer
outcome, 2 years (successes) vs. 4.5 years
More lost time from work predicts poorer
outcome 2 weeks (successes) vs. 6.5 weeks
E.B. Blanchard et al. / Behaviour Research and Therapy 44 (2006) 317337

Blanchard et al. (1988) 45a 73 CBT Patient daily diary Higher STAI trait anxiety score predicts
poorer outcome (CPSR) (r
:39)
Female gender predicts poorer outcome:
female successes50%, males70%
More symptom-free days in 2 weeks baseline
predicts better outcome (r :32)
319
 320

Table 1 (continued )

Authors Sample % female Treatment How outcome Signicant predictors

size assessed

Blanchard et al (1992) 90b 67 CBT Patient daily diary Presence of Axis I diagnosis predicts poorer
Study 2 outcome (CPSR): 64% success with no Axis I,
29% success with at least one Axis I diagnoses
Gonsalkorale et al. 250 80 Hypnotherapy Patient global Greater improvement in overall IBS symptoms
(2002) rating in females (52%) than males (33%); males with
diarrhea predominant IBS do less well than all
other groups on IBS ratings, other physical
symptoms, anxiety and depression; females
who are less depressed have greater IBS
symptom improvement
Creed et al. (2003) 85 80 Brief dynamic Change in SF-36 History of sexual abuse, unemployed, baseline
psychotherapy physical SF-36 physical component (total R2 36.1%)
component (QOL)
86 Paroxetine Same Baseline SF-36 physical component;
unemployed (total R2 21.4%)
Drossman et al. (2003) 321 100 CBT Satisfaction with History of abuse, moderate IBS severity, non-
treatment, depressed predict DES4placebo, non-
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depressed (BDIp16) predict

CBT4psychoeducational
Desipramine Global rating of
(DES) well-being
a
Patients from Neff and Blanchard (1987); Blanchard and Schwarz (1987); Blanchard et al. (1992), Study 1 treated with CBT.
b
Patients from Blanchard et al (1992), Study 2, treated with CBT or attention control condition GHQGeneral Health Questionnaire (Goldberg,
1972); STAIState Trait Anxiety Inventory (Spielberger, 1983); CPSRComposite Primary Symptom Reduction Scores (Blanchard et al., 1988),
E.B. Blanchard et al. / Behaviour Research and Therapy 44 (2006) 317337

(BDI)Beck Depression Inventory (Beck, Ward, Mendelson, Mock, & Erbaugh, 1961); SF-36 (SF-36 Health Survey, Ware, 1993).
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E.B. Blanchard et al. / Behaviour Research and Therapy 44 (2006) 317337 321

CBT was better than a psychological control, on a composite measure comprised of quality of life
(QOL) and patient satisfaction measures with less depressed (Beck Depression Inventory [BDI]
o16) patients but not different with more depressed patients. Clearly, there is some agreement
that the level of psychological distress, either measured dimensionally (e.g., trait anxiety,
depression on BDI) or categorically (presence of Axis I disorders) predicts outcome, but the
direction seems to depend on the particular treatment.

Demographic variables

Demographic variables such as gender and age have also been identied as treatment
predictors. Whorwell et al. (1987) found older patients (over 50 of age) responded less well to
hypnotherapy. Blanchard et al. (1988) reported better response on their CPSR measure of GI
symptom reduction by males treated with CBT than females; on the other hand, Gonsalkorale et
al. (2002) found males whose IBS was diarrhea predominant responded less well to hypnotherapy
than males with different bowel habits and all females. Again, we have conicting prediction
depending upon type of therapy. To the best of our knowledge, ethnicity has not been examined.

Illness characteristics

Characteristics of the IBS itself also predict treatment outcome. Whorwell et al. (1987), using
hypnotherapy, and Guthrie et al (1991), using psychodynamic psychotherapy, found intractable
or constant abdominal pain predicted poorer outcome with hypnotherapy or psychodynamic
psychotherapy, respectively. Blanchard et al. (1988), using CBT, had a similar nding that more
symptom free (and hence pain-free) days predicted better outcome (greater reduction in CPSR).
The duration of GI symptoms predicted poorer response for Guthrie et al. (1991). Whether the
illness led to unemployment predicted poorer response (Creed et al., 2003), in patients undergoing
an interpersonal psychotherapy developed by using the same therapy as Guthrie et al. (1991).
Finally, a history of sexual abuse predicted better response on a QOL measure to interpersonal
therapy by Creed et al. (2003) and to the drug desipramine in Drossman et al. (2003). It thus seems
clear that there are a range of possible predictor variables that have appeared in previous research,
some with conicting directions depending upon the treatment program. It also seems clear that a
variety of outcome or criterion measures have been used including GI symptom relief (as
measured by daily diary, or by physician rating or by patient global report), improvement in QOL
or global ratings of psychological well-being.
We (Blanchard et al., manuscript under review) have recently completed a moderate sized, two-
site study comparing group-based cognitive therapy to a psychoeducational support group and a
daily GI symptom and daily stressor monitoring control. Results showed group cognitive therapy
was consistently statistically superior in IBS symptom reduction and psychological distress
reduction to the symptom monitoring control. Psychoeducational support groups were less
consistently superior to the control. The two active treatments did not differ signicantly on any
dependent variable.
Because the symptom monitoring controls were subsequently crossed over to group cognitive
therapy, we have a fairly large (n 132) sample who completed group cognitive therapy and for
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322 E.B. Blanchard et al. / Behaviour Research and Therapy 44 (2006) 317337

whom 3-month follow-up data (n 127) are available. For these reasons this paper focuses on
predicting outcome from group cognitive therapy.

Aim of present study

In the study to be described below we sought to predict three classes of criterion variables: (1)
reduction in GI symptoms of distress (pain, tenderness, bloating) and (1a) reduction in GI
symptoms of bowel habit regularity (diarrhea, constipation) measured by a daily symptom diary;
(2) improvement in quality of life as measured by an IBS specic QOL scale (Patrick et al., 1998);
and (3) improvement in psychological distress as measured by the global severity index (GSI) of
the Brief Symptom Inventory (Derogatis, 1993). We used a wide array of potential predictors that
had been restricted statistically to predictors which were individually signicant. These predictions
were calculated at end of treatment and for a 3-month follow-up assessment.

Methods

Participants

Participants were recruited in each of the two sites, through referral of local physicians, local
media coverage and advertising. A total of 1298 individuals were screened for possible IBS by
telephone, 427 attended an initial assessment appointment. Three-hundred and twenty
participants completed the initial assessment and started the 4-week GI symptom monitoring
phase; 83 dropped out during this phase. In all, 195 participants were randomized to one of the
three treatment conditions: 14 dropped out of cognitive therapy, 6 from the psychoeducational
support groups, and 5 from the symptom monitoring wait-list control, for a total dropout rate of
12.8%. We had to exclude 5 participants because of missing data on the Daily Stress Inventory
(see below).

Inclusion and exclusion criteria

Inclusion criteria required a Rome II (Drossman, Corazziari, Talley, Thompson, & Whitehead,
2000) diagnosis that was conrmed by a board certied gastroenterologist who conducted a
history, medical examination, and needed laboratory tests to exclude organic GI disease (these
costs were covered by the project). A minimum age of 18 was also used. The oldest participant was
75. We excluded participants based on presence of organic GI disease (inammatory bowel
disease or lactose malabsorption syndrome), very low baseline diary pain ratings (fewer than 12 of
28 days with a minimum pain rating), and presence of a psychotic disorder, bipolar disorder, or
current major depression with moderate to severe suicidal ideation as determined by the SCID
(see below).

Gastroenterologists global ratings

In the study gastroenterologists made independent ratings of the frequency and severity of
overall IBS symptoms, abdominal pain, diarrhea and constipation, and bloating. The overall
severity of IBS symptoms (0 absent, 1 mild, 2 moderate, 3 severe, or 4 very severe)
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rated in a manner comparable to prior IBS research (Drossman et al., 2003) yielded 3% who
classied as mild, 35% as moderate, 53% as severe, and 9% as very severe.

Assessment procedures

At the initial assessment, a structured interview (Blanchard, 2001) was administered to gather a
detailed description of present GI symptoms and their history in order to make a tentative Rome
II (Thompson et al., 1999) diagnosis of IBS. We also obtained information on current
psychosocial functioning. We administered structured psychiatric interviews, the Structured
Clinical Interview for DSM-IV (SCID) (First, Spitzer, Gibbon, & Williams, 1996a) and SCID-II
(First, Spitzer, Gibbon, Williams, & Benjamin, 1996b) to make DSM-IV (American Psychiatric
Association (APA), 1994) diagnoses on Axis I and Axis II (personality disorders): 37 had no Axis
I disorder, 52 (38.2%) met criteria for one Axis I disorder, whereas 47 (34.5%) met criteria for 2
or more Axis I disorders. A written summary of this information was prepared and made
available to the therapist. The interviews were conducted in part by doctoral level personnel and
in part by advanced doctoral students in clinical psychology who had been trained by the site PIs.
This assessment would typically be spread over two clinic visits. From this part of the assessment
we gathered information on possible demographic and illness history predictors as well as
psychiatric diagnosis (current and life time) predictors.

GI symptoms
The GI symptom diary (Blanchard, 2001) was explained and patients were asked to begin
recording with it. In the GI symptom diary, participants rated the severity of each of 8 GI
symptoms (abdominal pain, abdominal tenderness, bloating, diarrhea, constipation, belching,
atulence, and nausea) each day on a four point scale where 0 absent, 1 mild, 2 moderate,
3 severe, 4 debilitating. Values derived from this diary have been shown to be sensitive to
treatment effects described on patients global ratings (Blanchard, 2001). Patients returned after 2
weeks to have the diary checked (and to complete the interview and psychological tests). If the
diary was apparently not completed appropriately, the patient was asked to start over. Four
weeks of pre-treatment GI symptom diary data were collected. Baseline values for primary IBS
symptoms as well as number of days (out of 28) that symptoms occurred were available as
potential predictors of outcome. Patients also indicated their overall level of abdominal pain using
the short form of the McGill Pain Questionnaire (Melzack, 1987) before and after treatment. At
the completion of treatment we obtained global ratings from patients on degree of overall changes
(improvement or worsening) in their IBS symptom picture as well as specic change in pain and
change in bowel regularity (diarrhea and/or constipation).

Psychological distress
(i) We obtained patient ratings of depressive symptoms using the Beck Depression Inventory
(BDI) (Beck et al., 1961) a 21-item scale with well established reliability and validity that is
probably the most widely used depression inventory (Beck, Steer, & Garbin, 1988). (ii) The State-
Trait Anxiety Inventory (STAI) (Spielberger, 1983) contains a 20-item scale to measure current or
state anxiety and another 20-item scale that measures relatively enduring, or trait anxiety. It has
well-established reliability and validity (Spielberger, 1983). (iii) Given the high rate of anxiety
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324 E.B. Blanchard et al. / Behaviour Research and Therapy 44 (2006) 317337

disorders in general and Generalized Anxiety Disorder (GAD) in specic among IBS patients (see
Blanchard, 2001 for a summary), we also assessed pathological worry using the Penn State Worry
Questionnaire (PSWQ) (Meyer, Miller, Metzger, & Borkovec, 1990), a 16-item questionnaire with
good reliability and validity. (iv) Finally, as a measure of overall psychological distress we used
the Brief Symptom Inventory (BSI) (Derogatis, 1993), a 53-item inventory that yields scores on
nine primary symptom dimensions as well as an overall measure of distress, the Global Severity
Index (GSI). Scores on each of these measures were available as potential predictors. We selected
the post-treatment and 3-month follow-up values of the GSI as our one psychological distress
criterion variable.

Quality of life
We obtained scores on a widely used (including Creed et al., 2003) generic measure of QOL, the
SF-36 Health Survey (Ware, 1993). Following the advice of the measure developer, we scored all
eight subscales, rather than composite subscales as reported by others. In addition we used an IBS
specic QOL measure developed by Patrick et al. (1988). Patients also made a global rating of
change in overall well-being. All of the pre-treatment scores were available as potential predictors.
For our QOL criterion variable, we used the post-treatment scores on the IBS-QOL scale.

Life stress
Because a premise of the cognitive therapy is that IBS sufferers are not dealing effectively with
ongoing stressful life circumstances, we obtained three classes of measures of life stress. Major life
events over the previous year were assessed with Sarason, Johnson, and Siegels (1978) Life
Experience Scale. We also obtained responses to the Hassles Scale (Kanner, Coyne, Schaefer, &
Lazarus, 1981) as a retrospective measure of the frequency and intensity of minor life events
(hassles) over the 30 days prior to the initial assessment. Finally, participants completed the Daily
Stress Inventory (Brantley & Jones, 1989) on a daily basis, along with GI symptom diary. This
measure inquires about the occurrence of 65 possible daily hassles and the impact their occurrence
has on the respondent. From this measure we obtained frequency, daily impact and a ratio of
impact to frequency measures. Averages from this measure from baseline were also available as
potential predictors.

Cognitive measures
Since this was a study of cognitive therapy we also included two measures of pre-treatment
maladaptive cognitive activity commonly used in research on cognitive therapy, the Dysfunctional
Attitude Scale (DAS) (Weissman & Beck, 1978) and the Automatic Thoughts Questionnaire
(ATQ) (Hollon & Kendall, 1980).

Post-treatment assessment
Participants were interviewed by someone other than the treating therapist (independent
evaluator) approximately 2 weeks after the nal treatment session. Status of psychiatric disorders
was assessed by re-administering appropriate SCID modules as well as screening questions.
Change in global status of GI symptoms and overall functioning was also assessed. Participants
completed the psychological tests and returned the 2 weeks of GI symptom diaries. Participants
from the Symptom Monitoring Condition were given appointments to begin treatment with the
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E.B. Blanchard et al. / Behaviour Research and Therapy 44 (2006) 317337 325

next available cognitive-therapy group. Participants had a brief examination by study

gastroenterologists at which the physician ratings were repeated.

Three-month follow-up assessment

At the 3-month point, all of the procedures for the post-treatment assessment, except the
patient global ratings and physician global ratings, were completed. The group members had a
short reunion meeting with the therapist and were reminded to continue to apply the procedures
they had learned during the formal phase of treatment. They had been sent 2 weeks of GI
Symptom Diaries to complete prior to assessment.

Treatment

Both treatment conditions were applied in small groups of 36 participants for ten weekly 90-
min sessions. In Albany, the therapists were either Dr. Annette Payne, a very experienced doctoral
level clinician, who helped to develop the cognitive therapy protocol and who was responsible for
developing the psychoeducational support protocol, or by one of the three different post-doctoral
fellows who had been trained in the procedures by Dr. Payne. In Buffalo, the majority of groups
were run by one of two experienced doctoral level clinicians, JML and SK, who each had several
years of experience treating chronic pain patients with cognitive and behavioral techniques. A
post-doctoral fellow treated a portion of the Buffalo patients.

Cognitive therapy
The cognitive therapy was manualized and is available in Blanchard (2001). In essence it begins
with explaining the possible role of stress in IBS symptoms. Participants are taught to become
progressively more astute observers of their cognitions by keeping diaries. The initial focus is on
becoming aware of self-talk (Meichenbaum, 1977) and learning to alter it. Next, attention is
directed to Becks (1976) ideas of cognitive fallacies (such as all or nothing thinking) and how they
are applicable to participants. From here the treatment addressed underlying schema and helps
patients change maladaptive ones. Attention is also paid to teaching patients problem solving
strategies for coping with realistic stressors that aggravate IBS symptoms and related distress.
Participants kept diaries of self-talk and various encounters with stressful situations as part of
their homework along with details of efforts to change or counter cognitions.

Psychoeducational support
This condition is also manualized and available in Blanchard (2001).

Treatment integrity and process data collection

To monitor implementation of both conditions, facilitate consistency of treatment quality and
delivery, and prevent therapist drift during the study, a doctoral student in clinical psychology
sat in on all groups as an observer (not a co-therapist). This individual was responsible for
gathering GI symptom diaries and a set of weekly process measures that are not a part of this
report. He or she also recorded whether certain tasks and topics, scheduled for that session by the
manual, were completed or not. This was our measure of treatment integrity. There was no
evidence of compromised treatment delivery.
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Results

Participants

One-hundred and thirty-seven IBS patients completed group cognitive therapy out of 151 who
started the treatment. There were 111 females and 26 males (19%) of average age 49.0 (SD 13.1)
years who had suffered from IBS for an average of 18.1 (SD 15.7) years. Two-thirds were
treated in Buffalo. Over 94% were White; average level of education was 14.9 (SD 3.0) years; 89
(65.4%) were married or cohabiting, with the remaining 47 participants single, divorced or
widowed. With respect to primary bowel habit disturbance 49 (35.8%) were characterized as
diarrhea predominant IBS, 31 (22.6%) constipation predominant, and 57 (41.6%) had an
alternating type of IBS.

Calculation of GI Symptom Diary Distress Index and Bowel Regularity Index

To reduce the number of criterion variables related to GI symptom change to a manageable

number, and following a convention in the eld (Blanchard, 2001), we have calculated two GI
symptom indices: the Distress Index and the Bowel Regularity Index. For the Distress Index, the
following formula was used:
End of Treatment Distress Index
Sum of pre-treatment 28 days Sum of post-treatment 14 days
averages for abdominal pain
averages for abdominal pain
abdominal tenderness bloating abdominal tenderness bloating
.
Sum of pre-treatment 28 days averages for
abdominal pain abdominal tenderness bloating

It thus would represent a percent improvement score if multiplied by 100. For the Bowel
Regularity Index, the value from the GI symptom diary ratings for diarrhea and constipation
were substituted. For the 3-month values, the pre-treatment symptom diary ratings (28 days) and
the 14 days of values collected at the follow-up point were used.
In Table 2 are the intercorrelations among our criterion variables at end of treatment and at the
3-month follow-up point.
Examining the values in Table 2, one can see that the diary-based measure of degree of
improvement in GI pain and discomfort (Discomfort Index) and the similar diary-based measure
of degree of improvement in bowel regularity are essentially unrelated at end of treatment but
signicantly correlated by the 3-month follow-up point. The zero-order correlation justies
developing separate prediction equations for the two diary-based GI symptom indices.
The post-treatment QOL measure is signicantly (po.001) related to improvement in lower GI
distress but not to improvement in bowel regularity. A higher score on the IBS-QOL scale
indicates poorer quality of life. Finally, the correlation between the two subjective measures, IBS-
QOL and GSI have by far the strongest relation accounting for 32% of variance in each other.
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E.B. Blanchard et al. / Behaviour Research and Therapy 44 (2006) 317337 327

Table 2
Intercorrelations of IBS criterion variables at end of treatment and at the 3-month follow-up point

Variables

Variables Symptom diary Symptom diary IBS QOL scale Global severity index
distress index bowel regularity (BSI)
index

Symptom Diary 0.16
.34***
.20*

Distress Index
Symptom Diary
.08
.22*
Bowel Regularity
Index
IBS-QOL Scale 0.55***
3-month follow-up
Symptom Diary .48*** .31***
.23**
.19
Distress Index
Symptom Diary .46***
.02
.05
Regularity Index
IBS-QOL Scale .75*** .35***
Global Severity .69***
Index (BSI)

Note: *po.05, **po.01, ***po.001.Values in boxes are correlation of end of treatment and 3-month follow-up values
for criterion variables.

At the 3-month follow-up point a different picture emerges. The two diary-based symptom
improvement indices are now signicantly (po:001) correlated. Interestingly, the global measure
of psychological distress (GSI) is unrelated to degree of GI symptom improvement at 3 months.
Moreover, IBS-QOL continues to be signicantly related to improvement in lower GI distress
symptoms. The strongest (but somewhat diminished) relation is between the two subjective
measures (IBS-QOL and GSI).
In the lower half of the table are the correlations for each criterion variable between the end of
treatment value and 3-month follow-up value. These show a moderate degree of relation and
stability between the time points for the diary-based GI symptom reduction indices (2123% of
explained variance) and much higher degree of stability in the subjective measures of QOL (57%
of common variance) and subjective distress (48% of common variance).

Prediction of end of treatment outcome

Univariate predictors1
In order to protect against spuriously inated multivariate prediction equations, following the
advice of Jaccard and Becker (2002), we have taken the initial step of examining the univariate
1
In the interest of conserving space the table of individual signicant predictors for the 3-month outcome are not
presented nor is the matrix of correlations among the predictors. Both are available from the rst author at the address
in the authors note.
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328 E.B. Blanchard et al. / Behaviour Research and Therapy 44 (2006) 317337

predictors and retained only those that correlated signicantly (po:05) with the criterion (thus
insuring that spuriously low predictors are not included). These individual predictors are
presented in Table 3 and are the potential predictors to be used in the multivariate prediction
equations for end of treatment outcome.
Two points are obvious from the results in Table 3: rst, there were very few signicant
univariate predictors for the two GI symptom improvement indices. Second, there are a very large
number of potential predictors for post-treatment QOL status and the post-treatment subjective
distress indicator, with a fair degree of overlap (17 potential predictors) between the predictors of
the two subjective outcome measures.
The univariate correlation matrix, tolerance values and VIF values were examined to screen for
multicollinearity among potential predictors. None of the correlations among predictors reached
.90, all tolerance values were greater than 1, and VIF values were all lower than 10 indicating
multicollinearity was not problematic (Tabachnick & Fidell, 2001).

Gi symptom improvement
In Table 4 are the nal multivariate prediction equations for post-treatment Pain/Discomfort
Index and post-treatment Bowel Regularity Index.
Examining the prediction of the Discomfort Index (our measure of degree of improvement in
abdominal pain and tenderness and in bloating), we nd that we can account for only about 12%
of the variance (multiple R 0:348) in this measure with two variables: the total number of
current Axis I disorders at pre-treatment (the more disorders the less improvement), and the
baseline DSI Impact to Event ratio (the higher the score [more stress experienced per event]), the
less improvement).
For prediction of the Bowel Regularity Index (our measure of degree of improvement in
diarrhea and constipation), we can account for only 4.6% of the variance (multiple R 0:214).
Only one predictor loads signicantly: SF-36 Physical Functioning subscale (the higher one rated
ones overall physical functioning at pre-treatment, the more improvement in bowel regularity).

Improvement in quality of life

The nal multivariate prediction equation for post-treatment IBS-QOL is in Table 5. Because
of the high correlation between pre- and post-treatment scores on the IBS-QOL measure, and
because the SF-36 subscales are conceptually related to the IBS-QOL scale, we conducted these
analyses in what is essentially a hierarchical stepwise fashion. First we forced the 16 predictors
related to demographics, baseline GI symptoms and psychological tests on the rst step. Within
this step variables were retained by a stepwise multiple regression program. On the second
conceptual step we allowed the SF-36 pre-treatment scores to enter, again using stepwise multiple
regression. On the third and nal step we entered the pre-treatment IBS-QOL score. The nal
equation accounted for 46% of the variance in post-treatment IBS-QOL scores and was highly
signicant (po:001).
When we repeated the analysis as purely a stepwise multiple regression (that is, not forcing any
certain block of variables before others), we could account 49.5% of variance. There was a fair
degree of overlap between the predictor variables identied by the two methods. Both contained
pre-treatment IBS-QOL score, race, baseline diarrhea, and pre-treatment state anxiety score. Our
preferred equation (Table 5) also included baseline pain and tenderness, pre-treatment Beck
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Table 3
Individual univariate predictors of four criterion values at post-treatment

Predictor Criterion variables

Symptom diary Symptom diary IBS-QOL Global severity

distress index bowel regularity index (BSI)
index

Age
.181*
Race (0 minority, 1 caucasian)
.24**
Overall degree of interference in social .19*
or family life
Presence of GAD (0 absent,
.17* .22**
1 present)
Total # Current Axis I Disorders
.21* .17* .23**
Total # Current Anxiety Disorder
.20* .22*
Presence of Any Current Anxiety
.19* .22*
(0 absent, 1 present)
Presence of Any Current Mood .18*
Disorder (0 absent, 1 present)
Past History of Any Axis I Disorders .28*
(0 absent, 1 present)
Average baseline pain and tenderness .35*** .22*
Average baseline diarrhea .30***
Average baseline constipation .18** .23**
Average baseline bloating .30*** .22**
Average baseline atulence .21** .19*
Average baseline nausea .25** .23**
Pre-treatment state anxiety .28** .45***
Pre-treatment trait anxiety .25** .54***
Pre-treatment PSWQ .33***
Pre-treatment BDI .32*** .45***
Pre-treatment GSI .29*** .57***
SF-36 general health
.32***
.24**
Vitality
.24*
.18*
Physical functioning .214*
.23**
Role physical .18*
.31***
Social functioning
.47***
.24**
Mental health
.21*
.35***
Bodily pain
.20*
Pre-treatment IBS-QOL
.23** .56*** .21*
McGill pain questionnaire .17*
Pre-treatment hassles-intensity .30*** .33***
Baseline DSI no. stressful events .23** .33***
Baseline DSI impact/event ratio
.30*** .26** .22*
Pre-treatment ATQ .17* .35***
Pre-treatment DAS .23**
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Table 4
Multivariate prediction equations for post-treatment GI symptom improvement indices

Predictors Standardized beta coefcients Sig. R R2 DR2 Sig. DR2

Discomfort Index
Baseline DSI impact/event ratio
.257 .003 .304 .092
Pre-tx. total # of current Axis I disorders
.176 .042 .348 .121 .029 .042
Bowel regularity Index
Pre-Tx. SF-36 physical functioning .214 .012 .214 .046

Table 5
Multivariate prediction equation for post-treatment IBS specic quality of life

Predictors Standardized beta coefcients Sig. R R2 DR2 Sig. DR2

Pre-treatment BDI .084 .280 .356 .127

Baseline pain and tenderness (GI Diary) .044 .580 .468 .219 .092 o.001
Baseline diarrhea (GI Diary) .198 .006 .513 .263 .044 .007
Race (1 caucasian, 0 minority)
.172 .013 .546 .298 .035 .013
Baseline DSI impact/event ratio .070 .344 .578 .334 .036 .010
Pre-treatment state anxiety .188 .013 .598 .358 .024 .033
SF-36 social function
.110 .250 .633 .401 .043 .003
Pre-treatment IBS-QOL .329 o.001 .678 .460 .059 o.001

Note: BDIBeck Depression Inventory, DSIDaily Stress Inventory.

Depression Inventory score, baseline DSI Impact to Event ratio, and pre-treatment SF-36 Social
Functioning score.

Improvement in psychological distress

In Table 6 is the nal multivariate prediction equation for post-treatment GSI score. Similar to
the analyses on IBS-QOL, we conducted this analysis in our hierarchical stepwise fashion. On the
rst conceptual step were the demographics, baseline GI symptoms, QOL measures, and other
psychological tests. The second conceptual step contained the pre-treatment scores on our four
measures of psychological distress, the STAI, BDI and PSWQ. The last conceptual step was the
pre-treatment score on the GSI. The nal equation contained eight predictors and accounted for
47.2% of variance in post-treatment GSI scores and was highly signicant (F[8,123] 13.76,
po:001).
When we repeated these analyses as a purely stepwise multiple regression, the nal equation
contained only four variables and accounted for 46.1% of variance. Pre-treatment GSI, pre-
treatment trait anxiety and pre-treatment BDI were the three common predictors. As with
predicting post-treatment IBS-QOL, for the prediction of post-treatment GSI score, variables
from a variety of domains enter the nal equation: pre-treatment score on the Automatic
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Table 6
Multivariate prediction equation for post-treatment global severity index

Predictors Standardized beta coefcients Sig. R R2 DR2 Sig. DR2

Pre-treatment SF-36 mental health .115 .192 .364 .133

Baseline DSIaverage no. events .118 .112 .457 .209 .076 .001
Pre-treatment ATQ .039 .623 .510 .260 .052 .003
Baseline constipation .146 .031 .535 .286 .025 .036
Pre-treatment presence of past axis I disorder
(1 present, 0 absent) .086 .224 .556 .309 .024 .040
Pre-treatment trait anxiety .257 .014 .642 .413 .103 o.001
Pre-treatment BDI .209 .019 .664 .441 .028 .014
Pre-treatment GSI .276 .008 687 .472 .031 .008

Note: ATQAutomatic Thoughts Questionnaire, DSIDaily Stress Inventory, BDIBeck Depression Inventory,
GSIGlobal Severity Index (of BSI).

Table 7
Multivariate prediction equations for 3-month follow-up GI symptom improvement indices

Predictors Standardized beta coefcients SIG. R R2 DR2 Sig. DR2

Discomfort index
Pre-tx. hassles frequency
.198 .021 .220 .048
Pre-tx. DAS
.186 .031 .283 .080 .032 .043
Baseline bloating (GI Diary) .220 .012 .332 .110 .031 .044
Baseline DSI impact/event ratio
.201 .022 .385 .148 .038 .022
Bowel regularity index
GAD (1 present, 0 absent) .177 .022 .183 .034
Pre-tx. SF-36 physical functioning .142 .065 .232 .054 .020 .050

Note: DASDysfunctional Attitude Scale, DSIDaily Stress Inventory, GADGeneralized Anxiety Disorder.

Thoughts Questionnaire (ATQ), presence of any past Axis I psychiatric disorder, baseline
constipation score, baseline DSI score for number of events, pre-treatment trait anxiety, pre-
treatment BDI and pre-treatment GSI score.

Prediction of 3-month follow-up status

GI symptom changes
We followed the same procedures in deriving multivariate prediction equations for the results at
a 3-month follow-up point. In Table 7 are the two equations for predicting changes in GI
symptoms as measured by the daily GI symptom diary.
For the Pain/Discomfort Index, pre-treatment Hassles Scale frequency, pre-treatment
Dysfunctional Attitude Scale score, baseline DSI impact to event ratio and level of bloating as
measured by the pre-treatment GI diary combine to account for almost 15% of the variance in
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Discomfort Index at the 3-month follow-up point. Only the DSI I/E ratio entered the end of
treatment prediction equation for Discomfort Index.
For the Bowel Regularity Index, we could account for only 5.4% of the variance with two
variables: whether the patient had met criteria for GAD at pre-treatment and the pre-treatment
score on the SF-36 Physical Functioning subscale. The latter variable had predicted post-
treatment Bowel Regularity Index.

IBS quality of life

As with the post-treatment results, we do noticeably better predict the subjective measures such
as scores on the IBS specic QOL scale. Table 8 presents the summary of the hierarchical stepwise
approach to developing a prediction scheme for this variable.
Six variables combine to account for 37% of the variance in the 3-month IBS-QOL scale score.
Five of the six entered the prediction of post-treatment IBS-QOL scores. Added to pre-treatment
BDI score, baseline diarrhea score, race, SF-36 Social functioning and pre-treatment IBS QOL
scores, were pre-treatment DSI frequency score rather than the DSI I/E ratio. The overall
prediction regression is highly signicant (F[6,118] 11.69, po:001).

Overall psychological distress (GSI)

Finally, in Table 9 is the prediction equation for the 3-month follow-up global measure of
psychological distress, the Global Severity Index of the BSI. With seven variables we can predict
50% of the variance in a regression equation that is highly signicant (F[7,117] 16.73, po:001).
The majority of the variables had entered the post-treatment equation signicantly (pre-treatment
GSI [entered on last step], pre-treatment trait anxiety, baseline DSI frequency score and pre-
treatment SF-36 Mental Health score. The new predictors were level of education, a cognitive
variable the pre-treatment score on the Dysfunctional Attitudes Scale (instead of pre-treatment
ATQ score that entered at post-treatment), and pre-treatment state anxiety scale scores. When
variables are allowed to enter the equation freely but in a stepwise fashion, we account for 48.5%
of variance with four variables.

Table 8
Multivariate prediction equation for 3-month follow-up IBS specic quality of life

Predictors Standardized beta coefcients Sig. R R2 DR2 Sig. DR2

Pre-treatment BDI .235 .005 .407 .166

Baseline diarrhea (GI Diary) .200 .008 .485 .235 .070 .001
Race (1 caucasian, 0 minority)
.130 .084 .516 .267 .031 .025
Baseline DSI frequency .092 .236 .539 .291 .024 .044
SF-36 Social function
.100 .302 .577 .333 .042 .007
Pre-treatment IBS-QOL .263 .007 .611 .373 .040 .007

Note: BDIBeck Depression Inventory, DSIDaily Stress Inventory.

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Table 9
Multivariate prediction equation for 3-month follow-up global severity index

Predictors Standardized beta coefcients Sig. R R2 DR2 Sig. DR2

SF-36 mental health score
.053 .539 .455 .207

Baseline DSI, frequency .195 .007 .545 .297 .090 o.001
Education (Years)
.155 .023 .569 .324 .027 .030
Pre-treatment DAS .057 .438 .596 .356 .032 .016
Pre-treatment trait anxiety .191 .073 .667 .444 .089 o.001
Pre-treatment state anxiety .133 .132 .683 .467 .022 .029
Pre-treatment GSI .283 .006 .707 .500 .034 .006

Note: DSIDaily Stress Inventory, DASDysfunctional Attitude Scale, GSIGlobal Severity Index.

Discussion

Our nding of signicant predictors for change in both psychosocial outcomes and GI
symptoms stands in contrast to most of the other recent large scale RCTs, which for the most part
have only reported signicant predictions with subjective measures of QOL (Creed et al., 2003;
Drossman et al., 2003) or patient satisfaction with treatment (Drossman et al., 2003). One
exception to this was Gonsalkorale et al. (2002), who did nd signicant predictors for GI
symptom relief in their effectiveness trial of hypnotherapy.
With that said, our most striking nding was that we were able to obtain signicant
multivariate prediction for all four outcome measures: both indices of GI symptom change and
subjective results with QOL and overall psychological state. Another striking aspect of our results
is how much stronger, in terms of variance accounted for, the prediction equations are for the two
subjective measures, IBS specic QOL and overall level of psychological distress, than the
equations are for our two indices of change in GI symptoms. In predicting change in GI
symptoms, we are able to account for 415% of variance with only one to four predictors.
Although the nal multivariate regression equations are highly signicant (typically po.001), the
amount of variance accounted for is 310 times less than one nds for the subjective measures.
Our ndings for the improvement in GI symptoms replicate some earlier research ndings.
Thus, we currently nd more Axis I psychiatric disorders are signicantly associated with less
improvement in the Discomfort Index (abdominal pain, tenderness and bloating). This replicates
our (Blanchard et al., 1992a, b, Study 2) earlier nding from a CBT trial but is contrary to the
ndings of Galovski and Blanchard (1998) with hypnotherapy. Whorwell et al. (1987) and Harvey
et al. (1989), both using hypnotherapy, also found poorer response with more psychopathology.
A contrary result emerged in the 3-month follow-up prediction for which the presence of GAD
signicantly predicted more reduction in the Bowel Regularity Index (but not the Discomfort
Index). This nding agrees with Guthrie et al.s (1991) results with psychodynamic psychotherapy
that the presence of anxiety and depression are associated with better outcome. About half of the
previous studies (see Table 1) have suggested that psychopathology inhibits outcome, at least
immediately post-treatment, although we did nd some inconsistency with respect to this at
3-month follow-up. The extent to which psychopathology inuences outcome remains to be seen.
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Our ndings of signicant prediction of GI symptom reduction by measures of QOL have no

counterparts in earlier research. The predictive value of baseline DSI values and Hassles Scale
frequency (for 3-month Discomfort Index) may be similar to Guthrie et al.s (1991) nding that
pre-treatment stressful-event-related-abdominal-pain predicted better response to psychodynamic
psychotherapy.
Our last consistency with the previous literature is our nding that age was a signicant
(negative) univariate predictor of end of treatment Bowel Regularity Index. In other words, the
older the patient, the less improvement. Whorwell et al. (1987) made a similar observation that
older patients responded less well to hypnotherapy.
When we turn to the two subjective measures of change, prediction, as we noted earlier,
improves to where we can account for 3750% of the variance. Creed et al. (2003) had similar
levels of prediction of the change in SF-36 Physical component, a measure of quality of life. The
predictors, however, are noticeably different. For example, variables related to early, or later,
sexual abuse are not predictors of QOL or Psychological Distress for us, whereas they were for
both Creed et al. (2003) and Drossman et al. (2003). Work status is a signicant predictor of QOL
for Creed et al. (2003) for both psychotherapy and drug treatment. We did nd degree of
interference in family or social life was related signicantly to end of treatment QOL, but it did
not enter either of the multivariate QOL prediction equations.
Drossman et al. (2003) found signicant relations between depression (as measured by the BDI)
and response to their CBT treatment (less depressed respond more favorably on global rating of
well being). Similarly, we found pre-treatment BDI score entered the prediction equations for
QOL at both end of treatment and 3-month follow-up such that higher pre-treatment BDI scores
were associated with poorer outcome on the IBS specic QOL measure, again suggesting that the
presence of psychopathology can interfere with outcome in some patients.
The variables that load signicantly for predicting end of treatment (or 3-month follow-up)
QOL or global level of psychological distress defy easy characterization. There are demographic
variables (race, education level), illness severity levels (baseline pain and tenderness, baseline
constipation, etc.), psychiatric status variables (presence of current Axis I mood disorder, presence
of GAD, history of past Axis I disorder), current psychological status variables (pre-treatment
BDI, trait anxiety, state anxiety), cognitive variables (Dysfunctional Attitude Scale scores), and
QOL variables. This situation seems appropriate since we are dealing with a complex
biopsychosocial illness being treated by a complex therapy (cognitive therapy).

Limitations

There are, of course, limitations to this research. First is that the sample was overwhelmingly
Caucasian. This limits the generalizability of the ndings, especially since race did emerge as a
multivariate predictor. Second, one could always wish for a larger sample so that the initial
prediction equations could be derived on one large subsample and cross-validated on a second
large subsample. Unfortunately this was not possible.
The nal limitation is the modest level of prediction found for the improvement in GI
symptoms. Although they are signicant, they are not impressive. It seems that other variables,
beyond the very wide net we cast, must be responsible for change in the actual GI symptoms of
IBS when it is treated with cognitive therapy. Despite these limitations, we are pleased to be able
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E.B. Blanchard et al. / Behaviour Research and Therapy 44 (2006) 317337 335

to identify signicant predictors of treatment response as they pertain to both the physical
symptom domain, and subjective well-being domain.

Acknowledgments

This research was supported by a grant from NIH, DK-54211. We would like to acknowledge
the assistance of Annette Payne, Eric Kuhn, Mark Sykes, Dianna Rowell, Janine Walsh, Tara
Galovski, and Elizabeth Mundy in Albany, and Rebecca Firth, Ann Marie Carosella and
Leonard Katz in Buffalo for their roles in this research.

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