Relaxation, Depressive Symptoms, Quality of Life, Immunological and Virological Status o in People Living With HIV: a Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Université de Montréal
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Change from baseline in depressive symptoms measured with Personal Health Questionnaire (PHQ-9) assessed at 6 months
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Jacobson progressive muscular relaxation
Jacobson progressive muscular relaxation
Intervention: Jacobson progressive muscular relaxation (Behavioral)
Schultz's autogenic training
Schultz's autogenic training
Intervention: Schultz's autogenic training (Behavioral)
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.
Outcomes
Primary Outcomes
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)
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)
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
- Change from baseline in quality of life measured with MOS-HIV) Medical Outcome Study-HIV assessed at 3 months(baseline and 3 months)
- Change from baseline in quality of life measured with (MOS-HIV) Medical Outcome Study-HIV assessed at 6 months(baseline and 6 months)
Investigators
Pilar Ramirez-Garcia, RN, PhD
Assistant Professor, Faculty of nursing & Researcher at CHUM research centre
Université de Montréal