Clinical trial NCT01901016: Relaxation, Depressive Symptoms, Quality of Life in People Living With HIV: a Pilot Study
Official title: Relaxation, Depressive Symptoms, Quality of Life, Immunological and Virological Status o in People Living With HIV: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Depressive Symptoms
Keywords: HIV
depressive symptoms
quality of life
relaxation
viral load
CD4+ T cell count
Lead sponsor: Université de Montréal
Sponsor class: OTHER
Collaborators: name: RRISIQ
name: Laval University
First posted: 2013-07-17
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in depressive symptoms measured with Personal Health Questionnaire (PHQ-9) assessed at 3 months
timeFrame: baseline and 3 months
measure: Change from baseline in depressive symptoms measured with Personal Health Questionnaire (PHQ-9) assessed at 6 months
timeFrame: baseline and 6 months
measure: Change from baseline in depressive symptoms measured with Personal Health Questionnaire (PHQ-9)assessed at 1 month
timeFrame: baseline and 1 month
Secondary outcomes:
measure: Change from baseline in quality of life measured with (MOS-HIV) Medical Outcome Study-HIV assessed at 6 months
timeFrame: baseline and 6 months
measure: Change from baseline in quality of life measured with MOS-HIV) Medical Outcome Study-HIV assessed at 3 months
timeFrame: baseline and 3 months
Other outcomes:
measure: Change from baseline in viral load assessed at 6 months
timeFrame: baseline and 6 months
measure: Change from baseline in CD4+ T cells count at 6 months
timeFrame: baseline and 6 months
Locations:
city: Montréal
country: Canada
facility: Research center CHUM
state: Quebec
Study officials:
affiliation: Université de Montréal
name: Pilar Ramirez Garcia, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ramirez-Garcia MP, Leclerc-Loiselle J, Gagnon MP, Cote J, Brouillette MJ, Thomas R. A mixed-method randomized feasibility trial evaluating progressive muscle relaxation or autogenic training on depressive symptoms and quality of life in people living with human immunodeficiency virus (HIV) who have depressive symptoms. J Complement Integr Med. 2020 Jul 3;18(1):165-174. doi: 10.1515/jcim-2019-0167.