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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Université de Montréal
Sponsor:
Collaborators:
RRISIQ
Laval University
Information provided by (Responsible Party):
Pilar Ramirez-Garcia, Université de Montréal
ClinicalTrials.gov Identifier:
NCT01901016
First received: July 10, 2013
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

Prevalence of depression is higher in people living with human immunodeficiency virus (PLHIV) than among seronegative people. Depressive symptoms have been observed in up to 40% of seropositive population. Presence of depressive symptoms has a negative impact on quality of life, optimal compliance of antiretroviral treatment, adoption of safe sexual behaviors, and on immune status and viral load.

Although antidepressants and psychotherapeutic interventions -particularly those with cognitive-behavioral components— have been proven effective in decreasing depressive symptoms in PLHIV, their use is limited among other causes due to misdiagnosis, patient refusal, possible interaction with antiretroviral treatments, or unavailability in the case of psychotherapy. Furthermore, identification and assessment of more accessible interventions that would decrease depressive symptoms and improve quality of life in PLHIV has become a crucial objective in the management of this chronic disease.

A meta-analysis shows that relaxation is an efficient intervention to reduce depressive symptoms in people diagnosed with depression or with high levels of depressive symptoms. According to some authors, relaxation, an easy-to-learn and self-applied intervention, proves to be a simple first line therapy capable of reducing depressive symptoms. However, the amount of relaxation needed to produce an effect on depression was not established in this meta-analysis and there are no results on the effects of relaxation in people whose depressive symptoms were caused by other diseases and only a study which includes PLHIV.

Given the prevalence of depressive symptoms and its consequences on the health of PLHIV and given the effects of relaxation on depressive symptoms, this pilot project aims to evaluate feasibility and acceptability of a relaxation intervention in PLHIV who suffer depressive symptoms, assess the feasibility and acceptability of the research project and assess the preliminary effects of a relaxation intervention.


Condition Intervention
HIV
Depressive Symptoms
Behavioral: Jacobson progressive muscular relaxation
Behavioral: Schultz's autogenic training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study to Determine the Feasibility, Acceptability and Preliminary Effects of Relaxation as a Nursing Intervention for Depressive Symptoms, Quality of Life, Immune Status and Viral Load in People Living With HIV

Resource links provided by NLM:


Further study details as provided by Université de Montréal:

Primary Outcome Measures:
  • Change from baseline in depressive symptoms measured with Personal Health Questionnaire (PHQ-9) assessed at 3 months [ Time Frame: baseline and 3 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Depressive symptoms at 1 month will be measured with Personal Health Questionnaire (PHQ-9)


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Quality of life at 6 months will be measured with MOS-HIV) Medical Outcome Study-HIV

  • 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 ] [ Designated as safety issue: Yes ]
    Quality of life at 3 months will be measured with MOS-HIV) Medical Outcome Study-HIV


Other Outcome Measures:
  • Change from baseline in viral load assessed at 6 months [ Time Frame: baseline and 6 months ] [ Designated as safety issue: Yes ]
  • Change from baseline in CD4+ T cells count at 6 months [ Time Frame: baseline and 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: June 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Jacobson progressive muscular relaxation
Jacobson progressive muscular relaxation
Behavioral: Jacobson progressive muscular relaxation
Jacobson progressive muscular relaxation
Experimental: Schultz's autogenic training
Schultz's autogenic training
Behavioral: Schultz's autogenic training
Schultz's autogenic training
No Intervention: control

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01901016

Contacts
Contact: Pilar Ramirez-Garcia, Ph.D 514-343-7295 pilar.ramirez.garcia@umontreal.ca

Locations
Canada, Quebec
CHUM Recruiting
Montréal, Quebec, Canada, H2W1T8
Contact: Pilar Ramirez-Garcia, Ph.D    514-343-7295    pilar.ramirez.garcia@umontreal.ca   
Principal Investigator: Pilar Ramirez-Garcia, Ph.D         
Sponsors and Collaborators
Université de Montréal
RRISIQ
Laval University
  More Information

No publications provided

Responsible Party: Pilar Ramirez-Garcia, Assistant Professor, Faculty of nursing & Researcher at CHUM research centre, Université de Montréal
ClinicalTrials.gov Identifier: NCT01901016     History of Changes
Other Study ID Numbers: RELHIV-13
Study First Received: July 10, 2013
Last Updated: July 16, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Université de Montréal:
HIV
depressive symptoms
quality of life
relaxation
viral load
CD4+ T cell count

Additional relevant MeSH terms:
Depression
Behavioral Symptoms

ClinicalTrials.gov processed this record on November 20, 2014