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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01901016
• Other study ID #: RELHIV-13
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: December 2015

Study information

• Verified date: May 2018
• Source: Université de Montréal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms
• HIV

Intervention

Behavioral:
• Jacobson 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
• Schultz'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.

Locations

Country	Name	City	State
Canada	Research center CHUM	Montréal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Université de Montréal	Laval University, RRISIQ

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in viral load assessed at 6 months	Change from baseline in viral load assessed at 6 months	baseline and 6 months
Other	Change from baseline in CD4+ T cells count at 6 months	Change from baseline in CD4+ T cells count at 6 months	baseline and 6 months
Primary	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
Primary	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
Primary	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	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
Secondary	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