A Randomized Controlled Trial of a Mindfulness-Based Stress Reduction Intervention for Men Living With HIV
|First Submitted Date ICMJE||September 11, 2007|
|First Posted Date ICMJE||September 14, 2007|
|Last Update Posted Date||October 3, 2007|
|Start Date ICMJE||December 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00529971 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Reductions in anxiety and depression during MBSR will be moderated by reductions in worry and ruminations, respectively [ Time Frame: 8 weeks and 6 months after start of intervention ]|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||A Randomized Controlled Trial of a Mindfulness-Based Stress Reduction Intervention for Men Living With HIV|
|Official Title ICMJE||A Randomized Controlled Trial of a Mindfulness-Based Stress Reduction Intervention for Men Living With HIV|
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.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Condition ICMJE||HIV Infections|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||December 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 70 Years (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Canada|
|Removed Location Countries|
|NCT Number ICMJE||NCT00529971|
|Other Study ID Numbers ICMJE||015005|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Mount Sinai Hospital, Canada|
|PRS Account||Mount Sinai Hospital, Canada|
|Verification Date||September 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP