NCT00312936

Brief Summary

We are exploring the effect that an 8 week stress reduction program based in mindfulness practices will have on the experience of medication side effects reported by HIV-infected men and women taking antiretroviral therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P75+ for phase_1 hiv-infections

Timeline
Completed

Started Jul 2006

Typical duration for phase_1 hiv-infections

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

May 16, 2016

Status Verified

May 1, 2016

Enrollment Period

2.3 years

First QC Date

April 7, 2006

Last Update Submit

May 12, 2016

Conditions

HIV Infections

Keywords

Medication adherenceMedication complianceQuality of LifeStress reductionmindfulness based stress reductionHIV/AIDStreatment experienced

Outcome Measures

Primary Outcomes (1)

  • Patient reported number and severity of ART side effects

    6 months

Secondary Outcomes (2)

  • Health related quality of life

    6 months

  • ART adherence

    6 months

Study Arms (2)

Wait List

NO INTERVENTION

MBSR

EXPERIMENTAL

8 week mindfulness based stress reduction

Behavioral: Mindfulness-based Stress Reduction (MBSR)

Interventions

Mindfulness-based Stress Reduction (MBSR)BEHAVIORAL

8 week program

MBSR

Eligibility Criteria

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

You may qualify if:

  • HIV+ serostatus, evidenced by letter from provider, or official HIV test results.
  • Currently (prior 30 days) on an acknowledged ART regimen.
  • Reporting a level of side effect-related bother for the previous 30 days at or above eight (corresponding to the 40th% in another sample) on the side effect and symptom distress scale used in other studies.1, 89
  • Ability to provide informed consent to be a research participant.
  • English speaking.

You may not qualify if:

  • Current enrollment in a behavioral coping or HIV adherence intervention research study or MBSR program. A list of such studies/programs is kept and updated throughout the study.
  • Severe cognitive impairment as assessed by trained interviewer and confirmed by PI;
  • Active psychosis as assessed by trained interviewer and confirmed by PI;
  • Indication of active substance abuse that would interfere with capacity to participate in MBSR.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94105, United States

Location

Related Links

MeSH Terms

Conditions

HIV InfectionsMedication AdherenceAcquired Immunodeficiency Syndrome

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorSlow Virus Diseases

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Mallory O Johnson, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2006

First Posted

April 11, 2006

Study Start

July 1, 2006

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

May 16, 2016

Record last verified: 2016-05

Locations

US(1)