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

NCT ID: NCT01901016

Last Updated: 2021-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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HIV Depressive Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Jacobson progressive muscular relaxation

Jacobson progressive muscular relaxation

Group Type EXPERIMENTAL

Jacobson progressive muscular relaxation

Intervention Type 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

Schultz's autogenic training

Schultz's autogenic training

Group Type EXPERIMENTAL

Schultz's autogenic training

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RRISIQ

UNKNOWN

Sponsor Role collaborator

Laval University

OTHER

Sponsor Role collaborator

Université de Montréal

OTHER

Sponsor Role lead

Responsible Party

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Pilar Ramirez-Garcia, RN, PhD

Assistant Professor, Faculty of nursing & Researcher at CHUM research centre

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pilar Ramirez Garcia, PhD

Role: PRINCIPAL_INVESTIGATOR

Université de Montréal

Locations

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Research center CHUM

Montreal, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 36528982 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32621729 (View on PubMed)

Other Identifiers

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RELHIV-13

Identifier Type: -

Identifier Source: org_study_id

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