HIV InfectionsPhase 3NCT00529971
A Randomized Controlled Trial of a Mindfulness-Based Stress Reduction Intervention for Men Living With HIV
A Phase 3 study testing MBSR group in people with HIV Infections, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- HIV Infections
- What is being tested?
- MBSR group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2003to Dec 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male
- Living with HIV
- 18-70 years of age
- Fluent in English
- Lives within one hour of the hospital
Who cannot join
- Severe depression
- Current suicide ideation
- Substance abuse
- Impaired cognitive function
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- MBSR group, Control
- 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
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBSR groupBehavioural
8-week MBSR group, 3 hours per week plus one all day retreat
ControlOther
Treatment as usual, which could include medications or psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants in the first arm participate in an 8-week MBSR group Receives: Behavioral: MBSR group |
| 2 | Active comparator | Participants assigned to the control arm do not receive the MBSR program but may or may not be receiving current psychotherapy or counselling Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects in the MBSR group will have greater improvement in measures of psychosocial functioning (i.e. anxiety, depression, HIV-related distress, affectivity) at 8 weeks and 6-months post-intervention
Measured: 8 weeks and 6 months after start of intervention
Subjects in the MBSR group will demonstrate significantly greater improvement on measures of worry and rumination at 8 weeks and 6-months post-intervention
Measured: 8 weeks and 6 months after start of intervention
MBSR will result in greater improvement in pain compared to the control arm
Measured: 8 weeks and 6 months after start of intervention
Secondary outcomes (1)
Reductions in anxiety and depression during MBSR will be moderated by reductions in worry and ruminations, respectively
Measured: 8 weeks and 6 months after start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2007 (estimated)
- Study startDec 2003
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital, Canadian Foundation for AIDS Research (CANFAR)
- Investigators
- Bill Gayner, M.S.W., Principal investigator, MOUNT SINAI HOSPITALMary Jane Esplen, Ph.D., Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00529971
- Sponsor's protocol ID
- 015005
- Status last verified
- Sep 2007
- First submitted
- 11 Sep 2007
- Last updated
- 3 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Mindfulness-Based Stress Reduction Intervention for Men Living With HIV
- ClinicalTrials.gov ID
- NCT00529971
- Acronym / sponsor ID
- 015005
- Conditions
- HIV Infections
- Keywords
- Mindfulness, HIV, Male, Living with HIV, 18-70 years of age, live within one hour of hospital, fluent in English, Complementary Therapies
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Collaborators
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital, Canadian Foundation for AIDS Research (CANFAR)
- Study start
- Dec 2003
- Study completion
- Dec 2006 (actual)
- First posted
- 14 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: MBSR groupParticipants in the first arm participate in an 8-week MBSR group |
| 2 | Active comparator | Other: ControlParticipants assigned to the control arm do not receive the MBSR program but may or may not be receiving current psychotherapy or counselling |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male
- Living with HIV
- 18-70 years of age
- Fluent in English
- Lives within one hour of the hospital
Key exclusion criteria (4 listed)
- Severe depression
- Current suicide ideation
- Substance abuse
- Impaired cognitive function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBSR group8-week MBSR group, 3 hours per week plus one all day retreat | Behavioural | 1 |
| ControlTreatment as usual, which could include medications or psychotherapy | Other | 2 |
Primary outcome
Subjects in the MBSR group will have greater improvement in measures of psychosocial functioning (i.e. anxiety, depression, HIV-related distress, affectivity) at 8 weeks and 6-months post-intervention
Time frame: 8 weeks and 6 months after start of intervention
Subjects in the MBSR group will demonstrate significantly greater improvement on measures of worry and rumination at 8 weeks and 6-months post-intervention
Time frame: 8 weeks and 6 months after start of intervention
MBSR will result in greater improvement in pain compared to the control arm
Time frame: 8 weeks and 6 months after start of intervention
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bill Gayner, M.S.W. principal investigator
MOUNT SINAI HOSPITAL
Mary Jane Esplen, Ph.D. principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MBSR group in people with HIV Infections, run by Mount Sinai Hospital, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjects in the MBSR group will have greater improvement in measures of psychosocial functioning (i.e. anxiety, depression, HIV-related distress, affectivity) at 8 weeks and 6-months post-intervention (time frame: 8 weeks and 6 months after start of intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2007.