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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV, Depressive Symptoms

Intervention / Treatment
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* Behavioral: Jacobson progressive muscular relaxation
* Behavioral: Schultz's autogenic training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jacobson progressive muscular relaxation<br>Jacobson progressive muscular relaxation | Behavioral: Jacobson progressive muscular relaxation<br>* 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<br>|
| Experimental: Schultz's autogenic training<br>Schultz's autogenic training | Behavioral: Schultz's autogenic training<br>* 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.<br>|
| No Intervention: control<br>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?
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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 | 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 | 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 | 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 | 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 | Quality of life at 3 months will be measured with MOS-HIV) Medical Outcome Study-HIV | baseline and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, depressive symptoms, quality of life, relaxation, viral load, CD4+ T cell count