44 Psychosomatics 44:1, January-February 2003

Randomized Trial of Cognitive Behavior Therapy Versus

Supportive Psychotherapy for HIV-Related Peripheral
Neuropathic Pain
SUSAN EVANS, PH.D., BARUCH FISHMAN, PH.D.
LISA SPIELMAN, PH.D., ANABEL HALEY, M.A.
The feasibility and acceptability of cognitive behavior therapy for HIV-related peripheral neuro-
pathic pain was examined and the potential efcacy of the intervention was compared with that
of supportive psychotherapy in reducing pain, pain-related interference with functioning, and dis-
tress. Sixty-one patients were randomly assigned to receive six weekly sessions of cognitive be-
havior therapy or supportive psychotherapy. Thirty-three subjects completed the protocol. Both
groups showed signicant reductions in pain. The cognitive behavior group improved in most do-
mains of pain-related functional interference and distress; the supportive psychotherapy group
showed fewer gains. The high dropout rate suggests that psychotherapeutic treatments for HIV-
related pain may have limited feasibility and acceptability. (Psychosomatics 2003; 44:4450)
Received Feb. 15, 2002; revision received May 7, 2002; accepted May
22, 2002. From the Department of Psychiatry, Weill Medical College of
Cornell University, New York. Address reprint requests to Dr. Evans, 425
E. 61st St., Suite 1350, New York, NY 10021; sue2002@med.cornell.edu
(e-mail).
Copyright 2003 The Academy of Psychosomatic Medicine.
P
ain is one of the most prevalent symptoms in ambu-
latory AIDS patients
1
and is often associated with sig-
nicant psychological distress. Breitbart et al.
2
found that
more than 60% of ambulatory patients with AIDS-related
pain reported functional impairment and interference with
mood and enjoyment of life.
HIV-related peripheral neuropathy is one of the more
common and painful conditions directly related to HIV in-
fection, affecting as many as 30% of people with AIDS.
36
Distal sensory polyneuropathy characterized by paresthe-
sias, numbness, and burning sensations in the feet, usually
in a symmetrical pattern, is the most common form of neu-
ropathy in patients with AIDS.
7
Although the prevalence
of many AIDS-related conditions may be decreasing sec-
ondary to the development of new antiretroviral therapies,
peripheral neuropathy continues to be a signicant problem
and may, in fact, be on the rise because many nucleoside
antiretrovirals may cause or exacerbate neuropathy.
The standard approach to pain management in HIV/
AIDS centers on analgesic medications with or without
adjuvant antidepressant pharmacotherapy. Recent reports
have suggested the potential efcacy of anticonvulsant
medication in decreasing HIV neuropathic pain.
8
Despite
the availability of effective medications to treat pain, some
patients may refuse to consider pharmacologic treatment
for their pain. Barriers to analgesic use reported by AIDS
patients include fear of addiction and tolerance, side ef-
fects, disease progression, and fear of injections.
2
Lack of
knowledge and access may also prevent some patients from
receiving treatment.
9
Nonpharmacological approaches
such as cognitive behavior therapy may provide HIV/AIDS
patients with alternative or adjuvant treatments for pain.
Cognitive behavior strategies can effectively alleviate
pain-related suffering in patients with advanced diseases.
10
The cognitive behavior approach to pain management is
based on a theoretical understanding of the relationship
between symptoms (e.g., pain) and suffering. According to
this understanding, symptoms and suffering are not syn-
Evans et al.
Psychosomatics 44:1, January-February 2003 45
onymous, and the presence of pain does not necessarily
produce suffering.
11
Because suffering results from per-
ceptions and interpretations that produce a sense of per-
sonal disintegration, modication of these mental pro-
cesses can reduce suffering.
Although considerable research has demonstrated the
efcacy of this modality in alleviating pain in several medi-
cal conditions,
1215
to our knowledge, no randomized trials
specically testing a cognitive behavior intervention for
HIV-related pain have been reported. In a small pilot study,
the authors found that a cognitive behavior approach may
be helpful in patients suffering from HIV-related pain.
16
The purpose of this study was twofold: 1) to test the
feasibility and acceptability of a manualized cognitive be-
havior treatment in comparison with standard supportive
psychotherapy for HIV-positive patients suffering frompe-
ripheral neuropathic pain and 2) to make a preliminary ex-
amination of the potential efcacy of the cognitive behav-
ior intervention compared with supportive psychotherapy
in reducing levels of pain, pain-related interference with
functioning, and distress.
METHOD
Subjects
Subjects were seropositive men and women with HIV-
related peripheral neuropathy recruited by means of notices
posted in newspapers and at hospitals, community-based
AIDS organizations, and clinics. Subjects who reported
pain intensity and functional interference that at its worst
was at least in the moderate range were included in the
study. The diagnosis of peripheral neuropathy was con-
rmed by consulting the subjects medical doctor.
Procedure
All interviewers were doctoral students in clinical and
health psychology programs who underwent extensive re-
liability training with a consulting psychiatrist. Interrater
agreement among assessors demonstrated a high level of
reliability (intraclass correlation coefcient0.86). The
interviewers were blind to the treatment assignment of the
subjects. The therapists were graduate psychology students
who participated in a training programand attended weekly
supervision meetings to protect against drift in techniques
and to ensure treatment precision. An expert clinical psy-
chologist monitored and rated the videotaped sessions for
adherence to the study protocol.
Each participant was seen for an initial baseline visit
during which self-rating measures and clinician-adminis-
tered interviews were completed. Eligible subjects main-
tained a pain diary for 1 week, after which they returned
for a second set of baseline measures and were randomly
assigned to receive the cognitive behavior intervention or
supportive psychotherapy. Patients returned weekly for 1-
hour therapy sessions over the next 6 weeks and repeated
the baseline measures at the end of treatment.
Measures
The Brief Pain Inventory
17
consists of a series of ques-
tions regarding pain, its quality, and its interference in func-
tioning. This measure uses numerical rating scales (ranging
from 0 to 10) to rate current pain and pain over the last
week at its worst, least, and average level. Pain-related in-
terference with functioning is measured in seven domains:
general activity, mood, walking, normal work, relations
with others, sleep, and enjoyment of life. The sum of the
scores for these items provides an index of overall pain-
related interference. The Brief Pain Inventory has demon-
strated both reliability and validity across cultures and lan-
guages and has been adopted widely for use in studies of
the effectiveness of pain treatment.
18
Subjects maintained an analgesic medication diary and
recorded the total number of milligrams of analgesic in-
gested per day to provide a daily analgesic consumption
score. Changes in analgesics (to more or less potent anal-
gesics) were noted, and appropriate equivalent doses were
applied.
The Brief Symptom Inventory, a 53-item version of
the SCL-90, provides subscale scores for self-ratings in
nine symptom areas and focuses on experience with symp-
toms in the past week.
19
The subscales include ratings of
depression, generalized anxiety, phobic anxiety, somatiza-
tion, hostility, and interpersonal sensitivity. The instrument
also includes a global severity index reecting overall dis-
tress; higher scores indicate more severe symptoms. The
Brief Symptom Inventory is a reliable and valid measure
of psychiatric symptoms that has been used extensively in
assessing medically ill patients, including HIV-infected in-
dividuals.
20
The self-report Beck Depression Inventory
21
measures
various symptoms, affects, and thoughts characteristic of
depression. It yields a score corresponding to the patients
severity of depression at the time of assessment. Interrater
reliability coefcients ranged from 0.81 to 0.86. Concur-
rent validity has been demonstrated by signicant corre-
A Randomized Psychotherapy Trial for HIV-Related Pain
46 Psychosomatics 44:1, January-February 2003
lations between psychiatric ratings of depression and Beck
Depression Inventory scores (r0.600.74).
The 17-item clinician-rated Hamilton Depression Rat-
ing Scale
22
measures cognitive, affective, and somatic char-
acteristics of depression. Interrater reliability coefcients
have ranged from 0.84 to 0.90. The Hamilton depression
scale is the most commonly used depression measure in
clinical trials involving HIV-positive and non-HIV-positive
patients.
The physical symptoms of HIV illness were analyzed
by using a medical symptom checklist designed for this
study. The checklist items were based on the signs and
symptoms that best differentiated HIV-positive and HIV-
negative subjects in earlier longitudinal studies conducted
by Perry et al.
23
The Karnofsky Performance Scale
24
is a clinician-
rated scale concentrating on patients physical and motor
functions. It was designed primarily for use with patients
suffering from terminal illness, particularly cancer. How-
ever, it has been used successfully with patients with AIDS.
Ratings range in deciles from 100% to 0%.
The Coping Strategies Questionnaire
25
is a self-report
questionnaire that measures the frequency of use of six
cognitive strategies for coping with pain (diverting atten-
tion, coping self-statements, praying and hoping, reinter-
pretation of pain sensations, catastrophizing, ignoring pain)
and one behavioral strategy (increased behavioral activi-
ties). Patients rate how often they use each strategy on a
7-point scale (none to always).
The Inventory of Negative Thoughts in Response to
Pain
26
is composed of negative self-statements drawn from
clinical interviews with pain patients. Respondents use a
5-point Likert-like rating scale to indicate how often they
have had each negative thought during a are-up of pain.
RESULTS
Subject Characteristics at Baseline
Thirteen seropositive women and 48 seropositive men
were randomly assigned to study groups. Four women and
24 men were assigned to the cognitive behavior interven-
tion group, and nine women and 24 men were assigned to
the supportive psychotherapy group. Table 1 reports the
subjects demographic and medical characteristics at base-
line. Forty-six percent of the subjects met the Centers for
Disease Control and Prevention criteria for an AIDS-
dening condition, and the majority were receiving highly
active antiretroviral therapy and some form of pain medi-
cation. Almost half of the subjects reported none to mini-
mal relief of their pain. The mean Brief Pain Inventory
rating of the average level of pain intensity was 5.7
TABLE 1. Demographic and Medical Characteristics at Baseline of Subjects in a Study of Cognitive Behavior and Supportive
Psychotherapeutic Interventions for HIV-Related Peripheral Neuropathic Pain (N61)
Characteristic Mean SD N %
Age (years) 46.5 7.9
Education
Less than high school 26 43
Completed high school or equivalent 10 16
Some college or more 25 41
Nonwhite 39 64
Receiving disability 46 75
Method of contracting HIV
Sex with other men 30 49
Intravenous drug use 11 18
Heterosexual contact 13 21
Transfusion 1 2
Combination of factors/unknown 7 11
CD4 count (cells/mm
3
) 338 291
Viral load (HIV RNA copies/ml) 175,694 502,565
Number of HIV symptoms 5.2 2.4
Receiving highly active retroviral therapy 40 66
Receiving pain medication 43 70
Nonopioid 12 20
Weak opioid 3 5
Narcotic opioid 7 11
Anticonvulsant 13 21
Tricyclic antidepressant 8 13
Reported none to minimal relief of pain 25 41
Evans et al.
Psychosomatics 44:1, January-February 2003 47
(SD2.1, range010), and mean ratings of current pain
and pain at its least were 5.2 (SD2.3, range010) and
3.8 (SD2.4, range010), respectively. The mean rating
of the intensity of pain at its worst was 7.4 (SD1.9,
range210). Sixty-nine percent of the subjects reported
their worst pain to be in the severe range. The mean overall
score for pain-related functional interference was 39.4
(SD15.5, actual range465, possible range070).
The average ratings for pain-related interference in each of
the seven functional domains were 5.7 (SD2.6) for gen-
eral activity, 5.7 (SD2.6) for mood, 6.1 (SD2.8) for
walking, 5.8 (SD3.4) for normal work, 4.5 (SD2.9)
for relations with others, 5.5 (SD2.8) for sleep, and 6.0
(SD2.6) for enjoyment of life (possible range010 for
all seven items). Overall, these scores indicate that the
mean ratings of pain intensity and pain-related interference
with functioning were in the moderate range, except for
the rating of pain at its least, which was in the mild range,
and pain at its worst, which was in the severe range.
The mean Beck Depression Inventory score was 13.1
(SD7.0, range130) and mean Hamilton depression
scale score was 9.7 (SD4.5, range021), indicating
mild to moderate depressive symptoms. Measures of physi-
cal functioning with the Karnofsky Performance Scale in-
dicated that only 5% of the group required considerable as-
sistance in carrying out activities of daily living and that the
majority were able to care for themselves despite some lim-
itations.
Correlates of Pain
Pain intensity and pain-related interference with func-
tioning at baseline were not signicantly associated with
measures of physical health, including the most recent CD4
count, viral load, and medical symptom ratings. As shown
in Table 2, ratings of pain intensity and the index of overall
pain-related interference with functioning were signi-
cantly correlated with depressive symptoms as measured
by the Beck Depression Inventory, anxiety and somatiza-
tion as measured by the Brief Symptom Inventory, and
overall distress as measured by the global severity index
of the Brief Symptom Inventory. Pain and interference with
functioning were also signicantly correlated with negative
thinking as measured by the Inventory of Negative
Thoughts in Response to Pain and with catastrophizing as
measured by the Coping Strategies Questionnaire.
Attrition
Twenty-eight participants dropped out before week six
of the 6-week treatment. More participants dropped out of
the cognitive behavior intervention (N16) than dropped
out of supportive psychotherapy (N12). Sixty-four per-
cent of the dropouts (N18) attended only one session.
The 28 dropouts did not differ from completers on any
demographic or medical characteristics. As for psycholog-
ical status, the dropouts had signicantly higher scores than
the completers on the Hamilton depression scale (t2.09,
df59, p0.05) and higher scores on the Brief Symptom
Inventory obsessive-compulsive subscale (t2.16, df
55, p0.05). It is interesting to note that the use of coping
self-statements was a signicant predictor of remaining in
the study (t2.7, df53, p0.01), suggesting that the
completers utilized certain cognitive strategies (e.g., I tell
myself to be brave and carry on despite the pain).
Treatment Outcomes
Thirty-three subjects completed the six-session pro-
tocol (21 subjects in the supportive psychotherapy group
TABLE 2. Correlation Between Baseline Measures of Pain and Distress in Subjects With HIV-Related Peripheral Neuropathic Pain
(N61)
Correlation
Brief Symptom Inventory
Pain Measure
Beck
Depression
Inventory
Global
Severity
Index Anxiety Somatization Depression
Inventory of
Negative Thoughts
in Response
to Pain
Coping Strategies
Questionnaire,
Frequency
of Catastrophizing
Intensity 0.42** 0.33* 0.41** 0.35** n.s. 0.32* 0.49***
Interference with functioning 0.48*** 0.44** 0.44** 0.42** 0.29* 0.59*** 0.61***
*p0.05.
**p0.01.
***p0.001.
A Randomized Psychotherapy Trial for HIV-Related Pain
48 Psychosomatics 44:1, January-February 2003
TABLE 3. Pre- and Posttreatment Scores on Measures of Pain and Distress in Subjects With HIV-Related Peripheral Neuropathic Pain
Who Received Six Weekly Sessions of a Cognitive Behavior or Supportive Psychotherapeutic Intervention
Subjects Who Received Cognitive
Behavior Intervention (N12)
Subjects Who Received Supportive
Psychotherapy (N21)
Pretreatment Posttreatment Pretreatment Posttreatment
Measure Mean SD Mean SD Mean SD Mean SD
Pain
Intensity
Worst pain 7.4 2.1 4.8 2.7 7.1 2.1 5.8
a
2.4
Least pain 3.6 2.2 2.1
a
2.3 4.1 2.2 3.1
a
1.9
Average level of pain 6.0 2.2 3.4
a
2.5 5.7 1.8 3.2
b
2.4
Current pain 5.0 1.9 2.4
a
2.5 5.3 2.3 3.2
b
2.4
Interference with functioning
General activity 6.1 2.6 2.8
a
2.7 6.0 2.6 3.9 2.6
Mood 5.3 1.9 3.0
a
2.3 5.8 2.9 4.4 2.8
Walking 6.8 2.6 3.6
a
3.2 6.8 2.5 5.8 3.0
Normal work 6.1 3.0 2.8
a
2.8 6.2 2.8 4.9
a
2.8
Relations with others 5.0 2.9 2.9 2.7 4.9 3.0 3.8 3.4
Sleep 5.0 2.7 2.1
b
2.4 5.6 2.9 4.0
a
3.1
Enjoyment of life 6.0 1.8 2.7
b
2.2 6.1 2.6 4.6
a
3.7
Distress
Beck Depression Inventory score 13.4 7.3 7.8
b
5.9 11.8 5.9 10.6 8.1
Hamilton Depression Rating Scale score 8.1 2.9 6.4 5.2 9.0 4.6 10.6 5.2
Affective symptoms 3.6 2.7 2.2
b
2.6 3.1 2.3 3.7 2.5
Vegetative symptoms 3.8 1.2 5.4 3.1 3.5 3.3 6.0 3.1
Brief Symptom Inventory subscale score
Depression 0.87 0.82 0.50 0.88 0.79 0.87 0.74 0.81
Anxiety 0.62 0.44 0.18
a
0.23 0.60 0.57 0.63 0.76
Psychosis 0.55 0.45 0.45 0.60 0.29 0.74 0.45 0.55
Somatization 1.1 0.48 0.64
a
0.37 1.1 0.68 1.0 0.69
Hostility 0.53 0.39 0.50
b
0.57 0.13 0.2.0 0.52 0.75
Phobic anxiety 0.38 0.27 0.11
a
0.29 0.48 0.54 0.57 0.79
Obsessive-compulsive 1.2 0.64 0.78
a
0.57 0.93 0.68 1.0 0.90
Paranoid ideation 0.61 0.46 0.31 0.59 0.47 0.52 0.59 0.80
Global severity index 0.76 0.35 0.41
a
0.37 0.70 0.52 0.72 0.67
Karnofsky Performance Scale score 77.3 10.5 80.4 9.6 77.1 4.9 78.3 5.1
a
Signicant within-group difference between pre- and posttreatment measures (p0.05, Wilcoxon matched-pairs signed-ranks test).
b
Signicant within-group difference between pre- and posttreatment measures (p0.01, Wilcoxon matched-pairs signed-ranks test).
and 12 subjects in the cognitive behavior intervention
group). Comparison of the baseline characteristics of the
study completers in each group showed no signicant dif-
ferences on measure of pain intensity, pain-related inter-
ference with functioning, and distress. Table 3 summarizes
the two groups pre- and posttreatment scores on measures
of pain intensity, interference, and distress. Both the cog-
nitive behavior intervention group and the supportive psy-
chotherapy group showed signicant reductions in mea-
sures of pain intensity. As for pain-related interference with
functioning, the cognitive behavior intervention group
showed signicant reductions in interference for most do-
mains, including general activity, mood, walking, normal
work, sleep, and enjoyment of life. The supportive psy-
chotherapy group also demonstrated reductions in interfer-
ence in normal work, sleep, and enjoyment of life. The
cognitive behavior intervention group showed signicant
reductions on most measures of distress, including the
Beck Depression Inventory, the affective symptoms sub-
scale of the Hamilton depression scale, several subscales
of the Brief Symptom Inventory, and the global severity
index of the Brief Symptom Inventory. The supportive psy-
chotherapy group did not exhibit signicant reductions on
any of the distress measures, including the Beck Depres-
sion Inventory, the Hamilton depression scale, the Brief
Symptom Inventory, and the global severity index of the
Brief Symptom Inventory. Neither group showed a reduc-
tion on the Karnofsky Performance Scale.
Table 4 shows the mean change scores (pre- to post-
treatment) for the cognitive behavior intervention and sup-
Evans et al.
Psychosomatics 44:1, January-February 2003 49
TABLE 4. Change in Pre- to Posttreatment Scores on Measures of Pain and Distress in Subjects With HIV-Related Peripheral
Neuropathic Pain Who Received 6 Weekly Sessions of a Cognitive Behavior or Supportive Psychotherapeutic Intervention
Change in Pre- to Posttreatment Score
Subjects who Received
Cognitive Behavior
Intervention (N12)
Subjects who Received
Supportive Psychotherapy
(N21)
Measure Mean SD Mean SD
Pain
Intensity
Worst pain 2.5 4.0 1.3 2.3
Least pain 1.4 2.2 1.1 2.1
Average level of pain 2.6 3.2 1.3 2.1
Current pain 2.4 2.7 2.2 2.6
Interference with functioning 18.2 17.0 10.3 14.4
Distress
Hamilton Depression Rating Scale score
a
1.7 4.6 1.4 5.7
Beck Depression Inventory
a
4.8 5.4 1.2 6.9
Brief Symptom Inventory global severity index
a
0.32 0.38 0.02 0.44
Karnofsky Performance Scale score 3.1 8.7 1.2 6.5
a
Signicant difference between groups (p0.05, Mann-Whitney test).
portive psychotherapy groups. Although means and stan-
dard deviations are reported, Mann-Whitney Uvalues were
calculated on ranked scores because of the small size of
the study groups. The cognitive behavior intervention
group demonstrated greater reductions in pain intensity and
pain-related interference with functioning than the suppor-
tive psychotherapy group, but these differences were not
statistically signicant. On measures of distress, the cog-
nitive behavior intervention group showed a signicantly
greater reduction in depressive symptoms as measured by
the Hamilton depression scale (Mann Whitney U61,
p0.02), compared with the supportive psychotherapy
group, and a signicantly greater reduction in level of dis-
tress as measured by the global severity index of the Brief
Symptom Inventory (Mann-Whitney U56.5, p0.03).
No signicant difference between groups was found for the
Karnofsky Performance Scale score. No signicant change
in analgesic use was noted in either group.
DISCUSSION
This group of ambulatory HIV/AIDS patients with periph-
eral neuropathy as their primary pain complaint experi-
enced on average a moderate intensity of pain, a moderate
level of pain-related interference with functioning, and dis-
tress in the mild to moderate range. Subjects worst pain
was in the range of severe intensity and was largely unre-
lieved by medication or other treatments. These ndings
extend previous documentation of the undertreatment of
pain in AIDS patients, which has been found to be wide-
spread.
27
Pain intensity and pain-related interference with
functioning were not signicantly associated with indicators
of disease such as CD4 count, viral load, and the presence
of physical symptoms. Pain intensity and pain-related inter-
ference with functioning were signicantly correlated with
some measures of anxiety, depression, and dysfunctional
cognitive patterns (i.e., negative thinking, catastrophizing).
The signicant dropout rate in this study suggests that
the acceptability and feasibility of psychotherapeutic treat-
ments for pain in HIV-positive patients are limited. Al-
though the aims and procedures of the study were carefully
reviewed with subjects before their participation, anecdotal
reports from subjects who dropped out of the study sug-
gested that they were looking for medical management of
their pain and did not see the relevance of talking ther-
apy. Also, subjects in the cognitive behavior intervention
group may have perceived certain aspects of the treatment
(e.g., homework) as burdensome rather than therapeutic.
For treatment completers, these preliminary results
suggest that psychotherapy interventions, particularly a
coping skills training program (e.g., cognitive behavior in-
tervention), may be helpful in reducing the intensity of
pain, as well as the interference with functioning and the
distress associated with pain. It is interesting to note that
the subjects who remained in treatment were found at base-
line to be more likely to use a cognitive strategy that in-
A Randomized Psychotherapy Trial for HIV-Related Pain
50 Psychosomatics 44:1, January-February 2003
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volved coping self-statements, such as I tell myself to be
brave and carry on despite the pain. This nding suggests
a certain goodness of t between a cognitive coping style
and the perception of potential benets from a psycho-
therapeutic approach to pain management.
Conclusions
The results of this study provide preliminary data sup-
porting a cognitive behavior intervention as a vehicle for
reducing pain and suffering is some patients with HIVneu-
ropathic pain. Limitations of this study include the signi-
cant rate of attrition after random assignment to treatment
groups, thereby leading to a potential selection bias. This
limitation may restrict the generalizability of this treatment
approach to the AIDS population. Further research is
needed to determine whether cognitive behavior therapy is
an efcacious treatment for HIV-related peripheral neuro-
pathic pain.
The authors thank Judith Rabkin, Ph.D., Marcus
Boon, Ph.D., Dean Haglin, and the study participants for
their contributions. This study was supported by NIMH
grant MH-58558-02 to Dr. Evans.