NCT01901016|Completed
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Sponsor study identifier
interventional
42
1 country
1
Study Start
June 2013
Actual (reported)Primary Completion
September 2015
Actual (reported)Study Completion
December 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2013
Actual (reported)July 10, 2013
Actual (reported)July 17, 2013
Actual (reported)September 2015
Actual (reported)December 2015
Actual (reported)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
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
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
Jacobson progressive muscular relaxation
Schultz's autogenic training
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.
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
Research center CHUM
Montreal, Quebec, H2X 0A9, Canada
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.
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.
Pilar Ramirez Garcia, PhD
Université de Montréal
42 participants (actual enrollment reported by the registry).
First Submitted
July 10, 2013
First Posted
July 17, 2013
Study Start
June 2013
Actual (reported)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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
September 2015
Actual (reported)Study Completion
December 2015
Actual (reported)Last Updated
May 6, 2021
Record last verified: 2018-05
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Source: ClinicalTrials.gov.
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