Skip to main content
OpenTrials
Completed

NCT Number: NCT01901016

Relaxation, Depressive Symptoms, Quality of Life 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Behavior Behavioral Symptoms Depression Depressive Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research center CHUM

Montreal, Quebec, H2X 0A9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Jacobson progressive muscular relaxation

Behavioral

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

Schultz's autogenic training

Behavioral

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.

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

Secondary outcomes

  1. 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

  2. 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

Other outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Université de Montréal

Other

Collaborators

  • Laval University
  • RRISIQ

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 17, 2013
Registry last updated
May 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.