Peer Mentorship: An Intervention To Promote Effective Pain Self-Management In Adolescents
Condition: Irritable Bowel Syndrome (IBS); Functional Abdominal Pain; Fibromyalgia; Complex Regional Pain Syndrome (CRPS); Myofacial Pain; Chronic Daily Headaches; Migraine Headaches; Chronic Pain
MeSH terms: Fibromyalgia; Irritable Bowel Syndrome; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Migraine Disorders; Headache Disorders; Syndrome; Chronic Pain; Headache; Abdominal Pain; Facial Pain
Study type: Interventional

Summary: 
      This protocol matches child subjects with peer mentors of similar age who have learned to
      function successfully with a chronic pain disorder. The trained mentors will present
      information to the subjects in a supervised and monitored interaction via telephone and
      computer for 2 months and encourage participation in skill-building programs. Children will
      be tested for improvement in pain and functioning at 2 months and again at 4 months to see if
      improvements persist. The investigators hypothesize that children who received peer mentor
      support will show more improvement in pain and functioning at 2 and 4 months into treatment
      than those in a control group who do not receive mentor support.
    

Detailed description: 
      Background:

      Chronic intractable non-malignant pain, including such functional disorders as irritable
      bowel syndrome is now recognized as a significant problem in children and adolescents, with
      potential long-term impact on the child's physical, social, and academic functioning, as well
      as on the family as a whole. A recent study of more than 5000 Dutch school children under 18
      found that more than 25% reported suffering recurrent or continuous pain for more than 3
      months, with the prevalence increasing with age; and a survey of 735 German children aged
      10-18 using a modified version of the same instrument found the same for 45.5%. The most
      common types of pain in these two studies were headache, abdominal pain, limb pain, and back
      pain. This data would appear to confirm earlier estimates that recurrent headache, including
      migraine, occurs in 11% to 26% of children ages 7-15; recurrent abdominal pain in 10-15% and
      recurrent limb pain in 4-18% in children ages 7-15. Many such children apparently continue to
      function effectively, attending school and continuing normal activities, with medical
      intervention only for acute episodes. A smaller, but significant, number, however, find
      themselves unable to self-manage their pain. They become patients with chronic pain and
      disability, falling into a cyclical pattern of pain, impaired functioning in physical,
      school, social, and even family and self-care domains, "doctor-seeking" and over-utilization
      of medications, and psychosocial distress, including anxiety and depression.

      Functional impairment, particularly in academic work and social participation, is likely to
      have long-term effects on the individual's quality of life, even aside from the possibility
      that pain and physical limitations may persist into adulthood. Several well-designed studies
      using quantitative measures have provided evidence that impaired functioning in children with
      chronic pain is strongly associated with psychosocial distress and with lower quality of
      life. In particular, children with unexplained chronic pain, pain not associated with an
      organic diagnosis, often report significant dysfunctions in normal activities, such as
      schoolwork, sleep, family activities, and athletic activities. But, although impaired
      functioning is a major factor in lower quality of life for children with chronic pain, we
      still know relatively little about the prevalence and severity of functional impairment, why
      some children experience more limitations than others, and which treatment interventions are
      the most effective in improving function.

      The available evidence also indicates that children show different levels of adjustment to
      chronic pain over time. Chronic idiopathic musculoskeletal pain has been shown to persist in
      59% of cases for as long as nine years; in this study, the authors found the children to have
      pain and disability levels comparable to children with juvenile chronic arthritis, but lower
      levels of psychosocial functioning. Hunfeld, Perquin, and colleagues in Rotterdam have traced
      the persistence of chronic benign pain in 30-45% of cases for up to two years and three
      years, with no increase in intensity or frequency. In the latter study, open-ended interviews
      elicited information about functioning and coping skills, and identified continuing problems
      with physical activity, mental concentration, social interaction, and psychological stress
      (becoming "moody"), particularly when the pain was severe. The researchers found, however,
      that several children had developed their own strategies to maximize functionality despite
      the continuing pain: "…pain had become part of the daily lives of several adolescents, who
      structured their activities and sleeping hours to prevent aggravation of pain". A recent
      cluster analysis of 117 children with chronic pain divided them into three groups on the
      basis of a set of psychosocial and behavioral measures: those who were highly distressed and
      disabled; those who showed low levels of distress and disability; and those who showed only
      moderate levels of distress and disability, but whose family environment scored low on
      cohesion.

      Although several factors may account for children's differential ability to function and to
      adjust to persistent chronic pain, the child's sense of self-competence has been identified
      as a key variable in recent literature. Claar and colleagues, for example, found that in
      adolescents and young adults with irritable bowel syndrome, the relationship between pain and
      functional disability was moderated by the individual's sense of academic, social, and
      athletic competence. The concept of self-competence (a general sense of mastery) overlaps
      with that of self-efficacy (a task-specific sense of mastery), developed by Albert Bandura in
      the late 1970s and early 1980s 18. The concept of self-efficacy suggests an explanation for
      the relationship between coping skills, perceived ability to cope, and reduction in physical
      and psychological disability. Bandura argued that a sense of self-efficacy enables the
      individual to persist even with a task of great difficulty until it is mastered, to reject
      negative thoughts and to "bring cognitive or cerebral productions into being" that will
      assist in achieving the goal.

      To summarize briefly, impaired functioning in all domains is a major and potentially a
      long-term problem for children with recurrent or chronic pain and their families, which are a
      significant segment of the American population. Children show significant variations in their
      ability to cope with pain and continue to function, and some children learn better
      functioning over time. The child's own sense of self-competence, or task-specific
      self-efficacy, is one important factor which may reinforce or moderate the child's
      functioning. Functional disability is clearly associated with psychosocial distress. But
      these factors are also mutually reinforcing; while children with more psychosocial distress
      may have more problems functioning with pain, certainly children who experience pain and
      attendant functional problems are likely to react with anxiety and/or depression.

      Current Therapeutic Interventions: When chronic pain can not be fully alleviated, the optimal
      goal is for the patient to learn effective ways to continue functioning and to self-manage
      pain; several therapeutic programs have been developed, based on theories of health behavior
      change, to assist the patient in this process. The earliest of these, the operant learning
      model developed by Wilbert Fordyce and colleagues in the late 1970s, demonstrated that
      individuals could be induced to alter their behavior - specifically, to engage in active
      exercise and limit dependence on medication - in response to social and other forms of
      positive reinforcement. Fordyce's program proved helpful to many patients, but was criticized
      for its determinist emphasis on observable behavior and disregard of the fact that patients
      are "active information processors", and that their behavior is not merely a response to
      learned cues but shaped by cognitive processes, such as expectations of increasing pain or
      anxieties about physiological harm.

      The revised therapeutic programs that developed in response to these criticisms drew on
      overlapping models linking health beliefs to health behavior and to self-efficacy as
      described by Bandura. These new models rely on an expectancy-value theory of behavior; that
      behavioral change is not a simple learned response to reinforcement, but that learning is
      influenced by the individual's cognitive belief (expectancy) that s/he will be able to change
      functioning with positive consequences (self-efficacy) and by his/her expectations (values)
      of the potential benefits of and barriers to behavioral change. Thus the new therapeutic
      programs, the most well-known and widely practiced of which is cognitive-behavioral therapy
      (CBT), seek to mediate behavioral change through cognitive relearning. The cognitive
      behavioral therapist uses a number of methods -- including education about pain, verbal
      reinforcement for positive cognitions and actions, biofeedback, group therapy allowing
      patients to observe and learn from each other, and teaching of cognitive tools to repress
      negative thoughts -- to help the patient develop positive expectations of behavior change,
      minimize negative expectations, and internalize the conviction of his/her own ability to
      overcome barriers and effectively self-manage pain In effect, the patient becomes the agent
      of change.

      CBT has been shown to be effective in controlled trials of treatment pain in cancer patients;
      of chronic low-back pain; of osteoarthritic knee pain; of sickle cell disease; of pediatric
      migraine; and of recurrent abdominal pain in children. CBT with family involvement has been
      found to be an effective intervention for adolescents with chronic pain and chronic fatigue
      31-33. Flor, Fydrich, and Turk's 1992 analysis of 65 studies of multidisciplinary treatments
      for chronic low back pain in adults, covering a number of variants of cognitive, behavioral,
      and coping skills training packages, noted that many of the studies were "marginal" in
      quality, but nevertheless demonstrated that these methods were superior to no treatment and
      to single-modality treatment -- medical or physical therapy -- in decreasing pain and
      impairment, improving mood, promoting return to work, and decreasing health services
      utilization. "Even at follow up, patients...are functioning better than 75%" of control
      groups; the findings of efficacy are "quite impressive". A recent systematic review of
      behavioral treatment for low back pain again found only six studies "of high quality". The
      authors nevertheless thought the evidence strong that behavioral therapy had at least "a
      moderate positive effect" on pain intensity and "small positive effects" on functional
      status; but they noted that "it is still unknown what type of patients benefit most" from
      behavioral therapies.

      A well-designed intervention, it appears, is not enough: not all patients will benefit from
      CBT. As Dennis Turk, the leading exponent of CBT, has stated, patient motivation is at least
      one of the critical factors in successful outcomes of this therapeutic model. Jensen and
      colleagues have recently proposed a cogent general model that integrates the varied
      theoretical approaches to describe a dynamic process that pivots on this concept of
      motivation, or readiness to change. An individual's readiness to change, they argue, is
      essential to his/her ability to learn successful pain self-management through new behaviors;
      and readiness is a dynamic function of 1) his/her perceived importance of the change (beliefs
      of the costs and benefits of change, past experience with change (learning history), and
      current contingencies (availability of social and material support) and 2) his/her
      self-efficacy beliefs (personal experience, modeling provided by others, verbal persuasion,
      and perceived barriers). They suggest some clinical approaches for enhancing readiness and
      promoting change, including encouragement to practice self-management; allowing the patient
      to observe other pain patients practice self-management; support of positive beliefs and
      non-judgmental non-support of negative beliefs; and development of a plan to address real or
      perceived barriers; and they call for research into interventions along these lines to
      enhance motivation.

      Another formulation recently proposed by Sharp stresses the patient's cognitive activity in
      appraising and evaluating his or her pain, and its ongoing and interactive effects on mood,
      behavior, and somatic focus. The patient's initial response to the pain is a function of
      cultural beliefs, learning history, and current contingencies, he argues, but then is
      continually reinterpreted with ongoing events. In particular, anxiety about recurrent pain
      and avoidance of activity that might cause pain will help to perpetuate the patient's
      hypervigilance for signs of recurring pain (as described by Eccleston and Crombez) and
      his/her perceived inability to manage the pain. Moreover, Sharp contends that this attitude
      of "learned helplessness" may be perpetuated by physicians who have failed to offer helpful
      treatment or even to confirm the physical reality of the patient's suffering. "That is,
      patients could start to believe that 'nothing has worked so far so why would any future
      treatment help?" A patient who has reached this point is likely to have a negative assessment
      both of the benefits of pain self-management and of his/her own ability or self-efficacy to
      learn these skills, and will therefore show a lack of readiness to change.

      In this study, we will consider adolescent pain patients and whether a new type of innovation
      can promote their readiness to change and to learn pain self-management skills, that will
      promote positive outcomes in pain reduction and improved functioning.

      Findings from our Current Research: Our interdisciplinary group, comprised of researchers
      from anthropology, history, pediatrics, psychology, and sociology, has collected quantitative
      and interview data on 74 adolescent children presenting between 2003 and 2006 to the
      Pediatric Pain, Pediatric Gastroenterology, and Pediatric Neurology Clinics with recurrent or
      persistent pain. We have completed preliminary analysis of the qualitative data for a subset
      of 37 (28 girls and 9 boys, average age 13.97) for whom intake and six-month follow-up data
      was obtained. These children reported suffering pain for periods ranging from one month to
      "all my life": the average computed duration was 53.6 months, or about 4.5 years. All of them
      had seen at least one physician prior to referral to UCLA and the majority had seen three or
      more.

      The children's levels of functioning varied considerably on the quantitative measures, but
      the evidence from the long, semi-structured interviews (conducted prior to the first Clinic
      appointment and at 6 months) shows that virtually all were distressed by some level of
      impairment. Those who had had pain for several years reported that pain had become part of
      daily life and that they adjusted their lives around it: Many of the children also stated
      that their unexplained chronic pain, which a series of doctors had not been able to diagnose,
      had given them a sense of isolation and difference from others, and a sense of powerlessness,
      that contributed to their distress:

      Those children seen in the Pediatric Pain Clinic (28, or 76% of the 37) were given
      recommendations to choose one or more of a list of complementary and alternative medicine
      (CAM) providers who work with the clinic; these include several who teach pain
      self-management skills, including a physical therapist, yoga therapist, biofeedback trainer,
      and guided imagery/hypnotherapist. These recommendations were made in addition to those for
      tests, changes in medication or other therapies. Children seen in the GI or Neuro Clinic
      might be given a recommendation for PT or another CAM treatment, but it was not a
      standardized part of the treatment plan. At the follow-up interview, the children were asked
      whether their pain and functioning had improved, and also to talk about their participation
      in any of the CAM therapies:

      Better, pain improved or resolved by medication change - 8; 22%

      Better, participation in active CAM had helped - 8; 22%

      Better, medication change and participation in an active CAM therapy - 4; 11%

      Same, meds had not helped, no interest in CAM - 6; 16%

      Same, meds had not helped, CAM not tried because not recommended or because of reimbursement
      issues - 5; 13%

      Same, meds had not helped, child tried CAM but did not persist - 2; 6%

      Worse, meds had not helped, no interest in CAM - 1; 3%

      Worse, meds had not helped, CAM too expensive - 1; 3%

      Worse, meds had not helped, child tried CAM but did not persist - 1; 3%

      Worse for other reasons (intervening surgery had increased pain) - 1; 3%

      These findings are not presented as supportive evidence of the benefits of CAM therapy.
      Rather, they indicate, that, in this group of children, aside from a small group helped by a
      medication change and one outlier case, those who were self-motivated to participate in a
      therapy that taught them active self-management consistently reported better outcomes than
      those who were not self-motivated or who were unable to do so.

      Why did 16 of the children choose not to participate or persist in participating in
      recommended CAM therapy? One possible explanation is that they lacked confidence that a new
      therapy will work when many others have failed to work and believed that their pain was a
      different and intractable problem that doctors did not know how to treat and that they could
      not manage themselves. Another is that they were not given the opportunity to observe others;
      were not given sufficient reinforcement from family or other significant contacts for
      participation; and were not helped to overcome any perceived barriers to access.

      On the basis of this preliminary data, considered in the light of current theoretical models,
      we propose the following hypotheses:

        -  Adolescents who participate actively in learning a pain-management skill will show more
           improvement in pain and functioning at 2 and 4 months than those who do not.

        -  Adolescents who lack peer support for learning a pain management skill will not follow
           through with learning such a skill without further reinforcement, even if recommended as
           part of a treatment plan.

        -  Adolescents may be helped to adhere to treatments that involve learning a pain
           management skill which will improve their pain and functioning by talking to others who
           have learned such a skill; by receiving ongoing positive reinforcement; and by being
           helped to overcome perceived barriers.

      We propose to test our hypotheses through a trial of a peer mentorship intervention, using
      trained adolescents who have successfully learned pain management skills as mentors. The
      mentor will help to relieve the child's sense of isolation and difference by relating their
      similar experiences, provide models of successful skill learning and reinforce the mentored
      subject's participation in skill learning activities.
    

Intervention name(s): Mentorship
Intervention type(s): Behavioral
Intervention description(s): Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties.
Other intervention name(s): support; education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peer Support; Social Support; Chronic Pain; Behavioral Interventions for Pain; Adolescents; Children; Pediatric; Mentorship; Complementary and Alternative Medicine; CAM; Pain; Pain Management; Behavioral