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A Randomized Controlled Trial of a Mindfulness-Based Stress Reduction Intervention for Men Living With HIV

NCT00529971 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2007-10-03

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

BEHAVIORAL

MBSR group

8-week MBSR group, 3 hours per week plus one all day retreat

OTHER

Control

Treatment as usual, which could include medications or psychotherapy

Sponsors & Collaborators

  • Samuel Lunenfeld Research Institute, Mount Sinai Hospital

    collaborator OTHER

  • Canadian Foundation for AIDS Research (CANFAR)

    collaborator OTHER

  • Mount Sinai Hospital, Canada

    lead OTHER

Principal Investigators

  • Bill Gayner, M.S.W. · MOUNT SINAI HOSPITAL

  • Mary Jane Esplen, Ph.D. · University Health Network, Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-31
Completion
2006-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00529971 on ClinicalTrials.gov