Relaxation, Depressive Symptoms, Quality of Life in People Living With HIV: a Pilot Study

May 4, 2021 updated by: Pilar Ramirez-Garcia, RN, PhD, Université de Montréal

Relaxation, Depressive Symptoms, Quality of Life, Immunological and Virological Status o in People Living With HIV: a Pilot Study

Progressive muscle relaxation (PMR) and autogenic training (AT) are effective relaxation techniques to reduce depressive symptoms. However, no studies on their effectiveness have been conducted among people living with HIV and depressive symptoms. The primary aim of this pilot study was to assess the feasibility and acceptability of PMR and AT interventions among people living with HIV who have depressive symptoms. A secondary aim was to assess the potential effectiveness of these interventions on depressive symptoms and quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study was a three-arm pilot randomized control trial with mixed methods. Participants were randomized to PMR, AT, or control group (CG), with four assessments (baseline, one-, three-, and six-month). The PMR and AT interventions consisted of six one-hour sessions of individual training over 12 weeks and home practice. Recruitment, attrition, and completion rates were calculated. Depressive symptoms and quality of life were assessed at all times. Participants' perceptions of the interventions were collected in semi-structured interviews.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H2X 0A9
        • Research center CHUM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18 years
  • HIV diagnosis of at least two years
  • Depressive symptoms between 5 and 14 in the PHQ-9 scale
  • Untreated with antidepressants or psychotherapy
  • Able to speak and understand French

Exclusion Criteria:

  • Started antiretroviral treatment within the last 6 months
  • Start or already receiving Interferon

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Jacobson progressive muscular relaxation
Behavioral: Jacobson progressive muscular relaxation
PMR involves learning to identify the tension in specific muscle groups by tightening and relaxing each muscle group. It includes three different exercises: 1) contraction-relaxation of 12 large muscle groups in the arms, legs, and trunk; 2) identification and relaxation of tensions without the need for movement or contractions; and 3) contraction-relaxation of 12 small muscle groups in the neck, eyes, and mouth
Experimental: Schultz's autogenic training
Behavioral: Schultz's autogenic training
AT is a relaxation technique that is based on body attitude, reduction of exterior stimulation, inner concentration, and mental repetition of verbal formulas [28]. These formulas are organized into six exercises: 1) heaviness; 2) warmth; 3) calm and regular heart function; 4) self-regulation of respiration; 5) warmth in the upper abdominal area; and 6) agreeable cooling of the forehead.
No Intervention: control
The CG continued to receive their standard care. After data collection at the six-month follow-up, the CG participants were invited to attend one of two relaxation interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in depressive symptoms measured with Personal Health Questionnaire (PHQ-9) assessed at 3 months
Time Frame: baseline and 3 months
Depressive symptoms at 3 months will be measured with Personal Health Questionnaire (PHQ-9)
baseline and 3 months
Change from baseline in depressive symptoms measured with Personal Health Questionnaire (PHQ-9) assessed at 6 months
Time Frame: baseline and 6 months
Depressive symptoms at 6 months will be measured with Personal Health Questionnaire (PHQ-9)
baseline and 6 months
Change from baseline in depressive symptoms measured with Personal Health Questionnaire (PHQ-9)assessed at 1 month
Time Frame: baseline and 1 month
Depressive symptoms at 1 month will be measured with Personal Health Questionnaire (PHQ-9)
baseline and 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in quality of life measured with (MOS-HIV) Medical Outcome Study-HIV assessed at 6 months
Time Frame: baseline and 6 months
Quality of life at 6 months will be measured with MOS-HIV) Medical Outcome Study-HIV
baseline and 6 months
Change from baseline in quality of life measured with MOS-HIV) Medical Outcome Study-HIV assessed at 3 months
Time Frame: baseline and 3 months
Quality of life at 3 months will be measured with MOS-HIV) Medical Outcome Study-HIV
baseline and 3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in viral load assessed at 6 months
Time Frame: baseline and 6 months
Change from baseline in viral load assessed at 6 months
baseline and 6 months
Change from baseline in CD4+ T cells count at 6 months
Time Frame: baseline and 6 months
Change from baseline in CD4+ T cells count at 6 months
baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Montréal

Collaborators

Laval University
RRISIQ

Investigators

  • Principal Investigator: Pilar Ramirez Garcia, PhD, Université de Montréal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2013

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

July 10, 2013

First Submitted That Met QC Criteria

July 16, 2013

First Posted (Estimate)

July 17, 2013

Study Record Updates

Last Update Posted (Actual)

May 6, 2021

Last Update Submitted That Met QC Criteria

May 4, 2021

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RELHIV-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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