A Randomized Controlled Trial of a Mindfulness-Based Stress Reduction Intervention for Men Living With HIV
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will examine the effectiveness of Mindfulness-Based Stress Reduction (MBSR) in
      helping men living with HIV cope with negative emotions and stresses in their life. MBSR is
      an approach to reducing stress for patients with chronic medical conditions. It involves
      systematic training in mindfulness meditation practices to increase quality of life and to
      reduce general stress, anxiety, depression or pain. The effectiveness of MBSR will be
      evaluated by looking at changes in participants' experience of stress, anxiety associated
      with pain management and psychosocial functioning before and after they receive the MBSR
      compared with participants who do not receive the MBSR treatment.

      In order to participate, individuals must be: male, living with HIV, age 18-70 years, live
      within one hour of participating centre, and have a good understanding of the English
      language. Questionnaires will be completed before individuals begin the program, at the end
      of the intensive phase (8 weeks) and at 6 months after the start of the group program. The
      primary program evaluation outcome will be a reduction in stress; secondary evaluation
      outcomes will include the improvements in the physical and emotional experience of pain as
      well as general psychosocial functioning and self-esteem.
    

Detailed description: 
      In most health care settings, psychosocial interventions that target stress and distress
      states that are integrated into routine HIV care will need to serve a large number of
      patients. Due to their time- and cost- efficiency, group approaches are being used
      increasingly in medical settings to address this need. One approach that has been used
      successfully in cancer and other chronic diseases is mindfulness-based stress reduction
      (MBSR), an 8-week manualized treatment program that provides mood management techniques based
      on training in mindfulness, a metacognitive skill. A recent randomized controlled trial in
      cancer demonstrated that this brief intervention significantly reduced anxiety and depression
      symptoms and that these gains were maintained at a six-month follow-up. Similar results have
      been obtained in a heterogeneous sample of medical patients. Although research in this area
      is in its infancy, it does appear that MBSR may be effective in the management of anxiety and
      mood symptoms that are common across various medical conditions and thus may be a good
      treatment option in men living with HIV.

      Preliminary evidence, gathered from a pilot assessment of an MBSR program for HIV positive
      men, demonstrated significant pre- to post-intervention reductions in anxiety and depression,
      as well as overall mood disturbance scores on standardized measures, and thus, MBSR has
      promise in this population. A randomized controlled trial is clearly needed however before
      can be recommended as a psychosocial treatment for men with HIV. It is predicted that MBSR
      will be effective in mitigating anxiety and depressive symptoms, as well as HIV-related
      distress, among HIV patients (Hypothesis #1).

      MBSR appears to be particularly well suited for anxiety- and depression- spectrum symptoms
      because it targets cognitive processes that contribute to and maintains them. Current
      cognitive models emphasize the central role of worry and rumination in the onset and
      maintenance of anxiety and depression, respectively. Worry can perpetuate an upward spiral of
      increased emotional arousal and intrusive thoughts heightening anxiety symptoms. Similarly,
      rumination can escalate a spiraling cycle of dysphoric affect and associated negative
      thinking that can lead eventually to a major depressive episode. (MBSR utilizes training in
      attention regulation that is thought to provide patients with a skill that enables them to
      disengage from patterns of worry and rumination that otherwise would perpetuate negative
      affect. Consistent with this prediction, Dr. Bishop (co-investigator) has found evidence from
      a recently completed pilot study that mindfulness training results in decreased frequency of
      worry and rumination. Although preliminary, MBSR may be associated with decreases in both
      worry and rumination (Hypothesis #2) and that, consistent with current cognitive models,
      decreases in worry and rumination would moderate the reductions in anxiety and depression,
      respectively (Hypothesis #3).

      We are also interested in whether this approach is effective for the management of pain,
      which is prevalent in this population. There is substantial evidence that anxiety, and
      particularly pain-related fear, can heighten the perception of the intensity and
      unpleasantness of pain and that anxiety management can lessen pain. Since we anticipate that
      MBSR will reduce anxiety in this study, we would further expect that it would also reduce the
      subjective experience of pain (Hypothesis #4). There is some evidence from an uncontrolled
      trial suggesting that MBSR may be highly effective for managing chronic pain. If MBSR can be
      used to effectively mitigate pain, then this too would have a recursive effect on mood. Pain
      in medical populations is a significant factor in emotional distress and psychiatric
      morbidity.
    

Intervention name(s): MBSR group; Control
Intervention type(s): Behavioral; Other
Intervention description(s): 8-week MBSR group, 3 hours per week plus one all day retreat; Treatment as usual, which could include medications or psychotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mindfulness; HIV; Male; Living with HIV; 18-70 years of age; live within one hour of hospital; fluent in English; Complementary Therapies; HIV Therapeutic Vaccine