Ignite Creation Date:
2024-05-05 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00529971
Status:
COMPLETED
Last Update Posted:
2007-10-03
First Post:
2007-09-11
Brief Title:
A Randomized Controlled Trial of a Mindfulness-Based Stress Reduction Intervention for Men Living With HIV
Sponsor:
Mount Sinai Hospital Canada
Organization:
Mount Sinai Hospital Canada
Study Overview
Official Title:
A Randomized Controlled Trial of a Mindfulness-Based Stress Reduction Intervention for Men Living With HIV
Status:
COMPLETED
Status Verified Date:
2007-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None