HIVNCT01901016
Relaxation, Depressive Symptoms, Quality of Life in People Living With HIV: a Pilot Study
A study testing Jacobson progressive muscular relaxation and Schultz's autogenic training in people with HIV and Depressive Symptoms, run by Université de Montréal at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Depressive Symptoms
- What is being tested?
- Jacobson progressive muscular relaxation and Schultz's autogenic training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Started antiretroviral treatment within the last 6 months
- Start or already receiving Interferon
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relaxation, Depressive Symptoms, Quality of Life, Immunological and Virological Status o in People Living With HIV: a Pilot Study
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.
Read the 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.
- Conditions
- HIV, Depressive Symptoms
- Being tested
- Jacobson progressive muscular relaxation, Schultz's autogenic training
- Keywords
- HIV, depressive symptoms, quality of life, relaxation, viral load, CD4+ T cell count
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jacobson progressive muscular relaxationBehavioural
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 trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Jacobson progressive muscular relaxation | Experimental | Jacobson progressive muscular relaxation Receives: Behavioral: Jacobson progressive muscular relaxation |
| Schultz's autogenic training | Experimental | Schultz's autogenic training Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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
Quality of life at 6 months will be measured with MOS-HIV) Medical Outcome Study-HIV
Measured: baseline and 6 months
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
Measured: baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- RRISIQ, Laval University
- Responsible party
- Principal investigator, Pilar Ramirez-Garcia, RN, PhD, Université de Montréal
- Investigators
- Pilar Ramirez Garcia, PhD, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01901016
- Sponsor's protocol ID
- RELHIV-13
- Status last verified
- May 2018
- First submitted
- 10 Jul 2013
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36528982Ramirez-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.
PubMed 32621729
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relaxation, Depressive Symptoms, Quality of Life, Immunological and Virological Status o in People Living With HIV: a Pilot Study
- ClinicalTrials.gov ID
- NCT01901016
- Acronym / sponsor ID
- RELHIV-13
- Conditions
- HIV, Depressive Symptoms
- Keywords
- HIV, depressive symptoms, quality of life, relaxation, viral load, CD4+ T cell count
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Collaborators
- RRISIQ, Laval University
- Study start
- Jun 2013 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Jacobson progressive muscular relaxation | Experimental | Behavioral: Jacobson progressive muscular relaxationJacobson progressive muscular relaxation |
| Schultz's autogenic training | Experimental | Behavioral: Schultz's autogenic trainingSchultz'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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Started antiretroviral treatment within the last 6 months
- Start or already receiving Interferon
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jacobson progressive muscular relaxationPMR 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 | Behavioural | Jacobson progressive muscular relaxation |
| Schultz's autogenic trainingAT 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. | Behavioural | Schultz's autogenic training |
Primary outcome
Change from baseline in depressive symptoms measured with Personal Health Questionnaire (PHQ-9) assessed at 3 months
Time frame: baseline and 3 months
Depressive 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 6 months
Time frame: baseline and 6 months
Depressive 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 1 month
Time frame: baseline and 1 month
Depressive symptoms at 1 month will be measured with Personal Health Questionnaire (PHQ-9)
2 secondary outcomes
Change from baseline in quality of life measured with (MOS-HIV) Medical Outcome Study-HIV assessed at 6 months
Time frame: baseline and 6 months
Change from baseline in quality of life measured with MOS-HIV) Medical Outcome Study-HIV assessed at 3 months
Time frame: baseline and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Derived from this study: PubMed 36528982Ramirez 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.
- Derived from this study: PubMed 32621729Ramirez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pilar Ramirez Garcia, PhD principal investigator
Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jacobson progressive muscular relaxation and Schultz's autogenic training in people with HIV and Depressive Symptoms, run by Université de Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in depressive symptoms measured with Personal Health Questionnaire (PHQ-9) assessed at 3 months (time frame: baseline and 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01901016, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.