Psychosomatics 44:44-50, February 2003
© 2003 The Academy of Psychosomatic Medicine
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., and
Anabel Haley, M.A.
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{at}med.cornell.edu (e-mail).
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ABSTRACT
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The feasibility and acceptability of cognitive behavior therapy for HIV-related peripheral neuropathic pain was examined and the potential efficacy of the intervention was compared with that of supportive psychotherapy in reducing pain, pain-related interference with functioning, and distress. Sixty-one patients were randomly assigned to receive six weekly sessions of cognitive behavior therapy or supportive psychotherapy. Thirty-three subjects completed the protocol. Both groups showed significant reductions in pain. The cognitive behavior group improved in most domains 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.
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INTRODUCTION
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Pain is one of the most prevalent symptoms in ambulatory AIDS patients1 and is often associated with significant 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 infection, affecting as many as 30% of people with AIDS.3–6 Distal sensory polyneuropathy characterized by paresthesias, numbness, and burning sensations in the feet, usually in a symmetrical pattern, is the most common form of neuropathy in patients with AIDS.7 Although the prevalence of many AIDS-related conditions may be decreasing secondary to the development of new antiretroviral therapies, peripheral neuropathy continues to be a significant 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 efficacy 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 effects, 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 synonymous, and the presence of pain does not necessarily produce suffering.11 Because suffering results from perceptions and interpretations that produce a sense of personal disintegration, modification of these mental processes can reduce suffering.
Although considerable research has demonstrated the efficacy of this modality in alleviating pain in several medical conditions,12–15 to our knowledge, no randomized trials specifically 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 behavior treatment in comparison with standard supportive psychotherapy for HIV-positive patients suffering from peripheral neuropathic pain and 2) to make a preliminary examination of the potential efficacy of the cognitive behavior intervention compared with supportive psychotherapy in reducing levels of pain, pain-related interference with functioning, and distress.
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METHOD
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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 confirmed by consulting the subject's medical doctor.
Procedure
All interviewers were doctoral students in clinical and health psychology programs who underwent extensive reliability training with a consulting psychiatrist. Interrater agreement among assessors demonstrated a high level of reliability (intraclass correlation coefficient=0.86). The interviewers were blind to the treatment assignment of the subjects. The therapists were graduate psychology students who participated in a training program and attended weekly supervision meetings to protect against drift in techniques and to ensure treatment precision. An expert clinical psychologist 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-administered interviews were completed. Eligible subjects maintained 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 Inventory17 consists of a series of questions regarding pain, its quality, and its interference in functioning. 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 interference 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 demonstrated both reliability and validity across cultures and languages 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 ingested per day to provide a daily analgesic consumption score. Changes in analgesics (to more or less potent analgesics) 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 symptoms in the past week.19 The subscales include ratings of depression, generalized anxiety, phobic anxiety, somatization, hostility, and interpersonal sensitivity. The instrument also includes a global severity index reflecting overall distress; 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 individuals.20
The self-report Beck Depression Inventory21 measures various symptoms, affects, and thoughts characteristic of depression. It yields a score corresponding to the patient's severity of depression at the time of assessment. Interrater reliability coefficients ranged from 0.81 to 0.86. Concurrent validity has been demonstrated by significant correlations between psychiatric ratings of depression and Beck Depression Inventory scores (r=0.60–0.74).
The 17-item clinician-rated Hamilton Depression Rating Scale22 measures cognitive, affective, and somatic characteristics of depression. Interrater reliability coefficients 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 Scale24 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. However, it has been used successfully with patients with AIDS. Ratings range in deciles from 100% to 0%.
The Coping Strategies Questionnaire25 is a self-report questionnaire that measures the frequency of use of six cognitive strategies for coping with pain (diverting attention, coping self-statements, praying and hoping, reinterpretation of pain sensations, catastrophizing, ignoring pain) and one behavioral strategy (increased behavioral activities). 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 flare-up of pain.
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RESULTS
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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 intervention group, and nine women and 24 men were assigned to the supportive psychotherapy group. Table 1 reports the subjects' demographic and medical characteristics at baseline. Forty-six percent of the subjects met the Centers for Disease Control and Prevention criteria for an AIDS-defining condition, and the majority were receiving highly active antiretroviral therapy and some form of pain medication. Almost half of the subjects reported none to minimal relief of their pain. The mean Brief Pain Inventory rating of the average level of pain intensity was 5.7 (SD=2.1, range=0–10), and mean ratings of current pain and pain at its least were 5.2 (SD=2.3, range=0–10) and 3.8 (SD=2.4, range=0–10), respectively. The mean rating of the intensity of pain at its worst was 7.4 (SD=1.9, range=2–10). 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 (SD=15.5, actual range=4–65, possible range=0–70). The average ratings for pain-related interference in each of the seven functional domains were 5.7 (SD=2.6) for general activity, 5.7 (SD=2.6) for mood, 6.1 (SD=2.8) for walking, 5.8 (SD=3.4) for normal work, 4.5 (SD=2.9) for relations with others, 5.5 (SD=2.8) for sleep, and 6.0 (SD=2.6) for enjoyment of life (possible range=0–10 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.
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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 (N=61)
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The mean Beck Depression Inventory score was 13.1 (SD=7.0, range=1–30) and mean Hamilton depression scale score was 9.7 (SD=4.5, range=0–21), indicating mild to moderate depressive symptoms. Measures of physical functioning with the Karnofsky Performance Scale indicated that only 5% of the group required considerable assistance in carrying out activities of daily living and that the majority were able to care for themselves despite some limitations.
Correlates of Pain
Pain intensity and pain-related interference with functioning at baseline were not significantly 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 significantly correlated with depressive symptoms as measured by the Beck Depression Inventory, anxiety and somatization 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 significantly 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.
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TABLE 2. Correlation Between Baseline Measures of Pain and Distress in Subjects With HIV-Related Peripheral Neuropathic Pain (N=61)
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Attrition
Twenty-eight participants dropped out before week six of the 6-week treatment. More participants dropped out of the cognitive behavior intervention (N=16) than dropped out of supportive psychotherapy (N=12). Sixty-four percent of the dropouts (N=18) attended only one session. The 28 dropouts did not differ from completers on any demographic or medical characteristics. As for psychological status, the dropouts had significantly higher scores than the completers on the Hamilton depression scale (t=–2.09, df=59, p<0.05) and higher scores on the Brief Symptom Inventory obsessive-compulsive subscale (t=–2.16, df=55, p<0.05). It is interesting to note that the use of coping self-statements was a significant predictor of remaining in the study (t=–2.7, df=53, p<0.01), 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 protocol (21 subjects in the supportive psychotherapy group and 12 subjects in the cognitive behavior intervention group). Comparison of the baseline characteristics of the study completers in each group showed no significant differences on measure of pain intensity, pain-related interference with functioning, and distress. Table 3 summarizes the two groups' pre- and posttreatment scores on measures of pain intensity, interference, and distress. Both the cognitive behavior intervention group and the supportive psychotherapy group showed significant reductions in measures of pain intensity. As for pain-related interference with functioning, the cognitive behavior intervention group showed significant reductions in interference for most domains, including general activity, mood, walking, normal work, sleep, and enjoyment of life. The supportive psychotherapy group also demonstrated reductions in interference in normal work, sleep, and enjoyment of life. The cognitive behavior intervention group showed significant reductions on most measures of distress, including the Beck Depression Inventory, the affective symptoms subscale of the Hamilton depression scale, several subscales of the Brief Symptom Inventory, and the global severity index of the Brief Symptom Inventory. The supportive psychotherapy group did not exhibit significant reductions on any of the distress measures, including the Beck Depression Inventory, the Hamilton depression scale, the Brief Symptom Inventory, and the global severity index of the Brief Symptom Inventory. Neither group showed a reduction on the Karnofsky Performance Scale.
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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
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Table 4 shows the mean change scores (pre- to posttreatment) for the cognitive behavior intervention and supportive psychotherapy groups. Although means and standard deviations are reported, Mann-Whitney U values 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 supportive psychotherapy group, but these differences were not statistically significant. On measures of distress, the cognitive behavior intervention group showed a significantly greater reduction in depressive symptoms as measured by the Hamilton depression scale (Mann Whitney U=61, p<0.02), compared with the supportive psychotherapy group, and a significantly greater reduction in level of distress as measured by the global severity index of the Brief Symptom Inventory (Mann-Whitney U=56.5, p<0.03). No significant difference between groups was found for the Karnofsky Performance Scale score. No significant change in analgesic use was noted in either group.
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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
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DISCUSSION
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This group of ambulatory HIV/AIDS patients with peripheral neuropathy as their primary pain complaint experienced on average a moderate intensity of pain, a moderate level of pain-related interference with functioning, and distress in the mild to moderate range. Subjects' worst pain was in the range of severe intensity and was largely unrelieved by medication or other treatments. These findings extend previous documentation of the undertreatment of pain in AIDS patients, which has been found to be widespread.27 Pain intensity and pain-related interference with functioning were not significantly associated with indicators of disease such as CD4 count, viral load, and the presence of physical symptoms. Pain intensity and pain-related interference with functioning were significantly correlated with some measures of anxiety, depression, and dysfunctional cognitive patterns (i.e., negative thinking, catastrophizing).
The significant dropout rate in this study suggests that the acceptability and feasibility of psychotherapeutic treatments for pain in HIV-positive patients are limited. Although 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 suggested that they were looking for medical management of their pain and did not see the relevance of "talking" therapy. 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 intervention), 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 baseline to be more likely to use a cognitive strategy that involved coping self-statements, such as "I tell myself to be brave and carry on despite the pain." This finding suggests a certain "goodness of fit" between a cognitive coping style and the perception of potential benefits from a psychotherapeutic approach to pain management.
Conclusions
The results of this study provide preliminary data supporting a cognitive behavior intervention as a vehicle for reducing pain and suffering is some patients with HIV neuropathic pain. Limitations of this study include the significant 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 efficacious treatment for HIV-related peripheral neuropathic pain.
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ACKNOWLEDGMENTS
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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.
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ABSTRACT
INTRODUCTION
