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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Canada1 site
  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5

Other trials in Canada

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 groups in NCT00529971
Study groupRoleWhat they receive
1ExperimentalParticipants in the first arm participate in an 8-week MBSR group
Receives: Behavioral: MBSR group
2Active comparatorParticipants 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.

  1. 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

  2. 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

  3. 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)
  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.

  1. First posted14 Sep 2007 (estimated)
  2. Study startDec 2003
  3. Study completionDec 2006

Resources

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)
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

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.

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Clinical Trial NCT00529971 | AzTrials