NCT00529971

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at below P25 for phase_3 hiv-infections

Timeline
Completed

Started Dec 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2007

Completed
Last Updated

October 3, 2007

Status Verified

September 1, 2007

First QC Date

September 11, 2007

Last Update Submit

October 2, 2007

Conditions

HIV Infections

Keywords

MindfulnessHIVMaleLiving with HIV18-70 years of agelive within one hour of hospitalfluent in EnglishComplementary TherapiesHIV Therapeutic Vaccine

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    8 weeks and 6 months after start of intervention

  • MBSR will result in greater improvement in pain compared to the control arm

    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

    8 weeks and 6 months after start of intervention

Study Arms (2)

1

EXPERIMENTAL

Participants in the first arm participate in an 8-week MBSR group

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

Other: Control

Interventions

MBSR groupBEHAVIORAL

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

1
ControlOTHER

Treatment as usual, which could include medications or psychotherapy

2

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male
  • Living with HIV
  • years of age
  • Fluent in English
  • Lives within one hour of the hospital

You may not qualify if:

  • Severe depression
  • Current suicide ideation
  • Substance abuse
  • Impaired cognitive function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Bill Gayner, M.S.W.

    MOUNT SINAI HOSPITAL

    PRINCIPAL INVESTIGATOR

  • Mary Jane Esplen, Ph.D.

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2007

First Posted

September 14, 2007

Study Start

December 1, 2003

Study Completion

December 1, 2006

Last Updated

October 3, 2007

Record last verified: 2007-09

Locations

CA(1)