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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01901016
Enrollment
42
Registered
2013-07-17
Start date
2013-06-30
Completion date
2015-12-31
Last updated
2021-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Symptoms, HIV

Keywords

HIV, depressive symptoms, quality of life, relaxation, viral load, CD4+ T cell count

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.

Interventions

BEHAVIORALJacobson progressive muscular relaxation

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

BEHAVIORALSchultz's autogenic training

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.

Sponsors

RRISIQ
CollaboratorUNKNOWN
Laval University
CollaboratorOTHER
Université de Montréal
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in depressive symptoms measured with Personal Health Questionnaire (PHQ-9) assessed at 6 monthsbaseline and 6 monthsDepressive 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 monthsbaseline and 3 monthsDepressive 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 monthbaseline and 1 monthDepressive symptoms at 1 month will be measured with Personal Health Questionnaire (PHQ-9)

Secondary

MeasureTime frameDescription
Change from baseline in quality of life measured with MOS-HIV) Medical Outcome Study-HIV assessed at 3 monthsbaseline and 3 monthsQuality 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 monthsbaseline and 6 monthsQuality of life at 6 months will be measured with MOS-HIV) Medical Outcome Study-HIV

Other

MeasureTime frameDescription
Change from baseline in viral load assessed at 6 monthsbaseline and 6 monthsChange from baseline in viral load assessed at 6 months
Change from baseline in CD4+ T cells count at 6 monthsbaseline and 6 monthsChange from baseline in CD4+ T cells count at 6 months

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026