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

July 10, 2013
July 16, 2013
June 2013
September 2014   (final data collection date for 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 ] [ 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)
Same as current
Complete list of historical versions of study NCT01901016 on ClinicalTrials.gov Archive Site
  • 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
Same as current
  • 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 ]
Same as current
 
Relaxation, Depressive Symptoms, Quality of Life, Immunological and Virological Status in People Living With HIV: a Pilot Study
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • HIV
  • Depressive Symptoms
  • Behavioral: Jacobson progressive muscular relaxation
    Jacobson progressive muscular relaxation
  • Behavioral: Schultz's autogenic training
    Schultz's autogenic training
  • Experimental: Jacobson progressive muscular relaxation
    Jacobson progressive muscular relaxation
    Intervention: Behavioral: Jacobson progressive muscular relaxation
  • Experimental: Schultz's autogenic training
    Schultz's autogenic training
    Intervention: Behavioral: Schultz's autogenic training
  • No Intervention: control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
December 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Pilar Ramirez-Garcia, Ph.D 514-343-7295 pilar.ramirez.garcia@umontreal.ca
Canada
 
NCT01901016
RELHIV-13
No
Pilar Ramirez-Garcia, Université de Montréal
Université de Montréal
  • RRISIQ
  • Laval University
Not Provided
Université de Montréal
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP