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

NCT01901016 | Completed

• 1 other identifier: RELHIV-13
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Depressive Symptoms

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Change from baseline in quality of life measured with (MOS-HIV) Medical Outcome Study-HIV assessed at 6 months

  baseline and 6 months

• Change from baseline in quality of life measured with MOS-HIV) Medical Outcome Study-HIV assessed at 3 months

  baseline and 3 months

Other Outcomes (2)

• Change from baseline in viral load assessed at 6 months

  baseline and 6 months

• Change from baseline in CD4+ T cells count at 6 months

  baseline and 6 months

Study Arms (3)

Jacobson progressive muscular relaxation

EXPERIMENTAL

Jacobson progressive muscular relaxation

Behavioral: Jacobson progressive muscular relaxation

Schultz's autogenic training

EXPERIMENTAL

Schultz's autogenic training

Behavioral: Schultz's autogenic training

control

NO INTERVENTION

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.

Interventions

Jacobson progressive muscular relaxation BEHAVIORAL

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

Jacobson progressive muscular relaxation

Schultz's autogenic training BEHAVIORAL

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.

Schultz's autogenic training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Started antiretroviral treatment within the last 6 months
• Start or already receiving Interferon

Sponsors & Collaborators

• Université de Montréal: lead
• RRISIQ: collaborator
• Laval University: collaborator

Study Sites (1)

Research center CHUM

Montreal, Quebec, H2X 0A9, Canada

Location

Related Publications (2)

• Ramirez Garcia MP, Leclerc-Loiselle J, Cote J, Brouillette MJ, Thomas R. Effect of autogenic training on quality of life and symptoms in people living with HIV: A mixed method randomized controlled trial. Complement Ther Clin Pract. 2023 Feb;50:101716. doi: 10.1016/j.ctcp.2022.101716. Epub 2022 Dec 13.

  PMID: 36528982 DERIVED

• 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.

  PMID: 32621729 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Pilar Ramirez Garcia, PhD

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Faculty of nursing & Researcher at CHUM research centre

Study Record Dates

• First Submitted: July 10, 2013
• First Posted: July 17, 2013
• Study Start: June 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 6, 2021

Record last verified: 2018-05

Locations

CA (1)