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

Not Applicable

Completed

• Conditions: HIV; Depressive Symptoms
• Interventions: Behavioral: Jacobson progressive muscular relaxation; Behavioral: Schultz's autogenic training

• Registration Number: NCT01901016
• Lead Sponsor: Université de Montréal

Brief Summary

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.

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 Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-07-10
• Study First Submitted QC: 2013-07-16
• Study First Posted: 2013-07-17
• Primary Completion: 2015-09
• Study Completion: 2015-12
• Status Verified: 2018-05
• Last Update Submitted: 2021-05-04
• Last Update Posted: 2021-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Jacobson progressive muscular relaxation	Jacobson progressive muscular relaxation	Jacobson progressive muscular relaxation
Schultz's autogenic training	Schultz's autogenic training	Schultz's autogenic training

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Research center CHUM; 🇨🇦 Montréal, Quebec, Canada