The Effectiveness of a Relaxation Technique on the Quality of Life and Symptoms in People Living With HIV

Quality of life of people living with HIV is strongly affected by the presence of one or more symptoms, such as sleep problems, fatigue, muscle pain, anxiety and depressive symptoms. Autogenic training has shown positive effects on these symptoms in different populations, but there is very little evidence on the effects of this relaxation technique in people living with HIV.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Other: autogenic training

Detailed Description

The aim of this project is to evaluate the effectiveness of a relaxation technique, autogenic training, on the quality of life and the physical and psychological symptoms in people living with HIV.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2W1T8
      • CHUM
    • Montréal, Quebec, Canada, H4A3J1
      • CUSM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Being older than 18 ;
• have a diagnosis of HIV;
• present at least one of the following symptoms during the preceding two weeks: sleep problems, fatigue, pain, anxiety or symptoms of depression;
• understand and speak French and;
• be able to follow the instructions to learn the relaxation technique.

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: autogenic training; Autogenic training	Other: autogenic training; autogenic training
EXPERIMENTAL: wait list; usual care for 6 months Autogenic training after 6 months	Other: autogenic training; autogenic training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Reported Outcomes Quality of Life-human immunodeficiency virus (PROQOL-HIV)	The PROQOL-HIV questionnaire is composed of 43 Likert-type items (5-point scale ranging from 0=never to 4=always), including 39 items targeting 8 domains of HRQL and general health: physical health and symptoms (9 items), treatment impact (10 items), emotional distress (4 items), health concerns (4 items), body change (4 items), intimate relationships (3 items), social relationships (2 items), and stigma (2 items). Four extra items dealing with religious beliefs, finance, having children, and satisfaction with care are not part of the scoring scheme, but are used to gather additional information from the respondent. Responses to items will be totaled for each dimension and standardized on a scale from 0 to 100 points, in which higher values indicate a better health state.	3 and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburgh Sleep Quality Index (PSQI)	Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality and quantity. The19-item self-report questionnaire yields 7 component scores: subjective sleep quality, sleep latency, duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction each weighted equally on a 0-3 scale. The seven component scores are then summed to yield a global PSQI score, which has a range of 0-21; higher scores indicate worse sleep quality.	3 and 6 months
Fatigue Severity Scale (FSS)	Fatigue severity scale (FSS) is a 9-items instrument with seven items related to fatigue interference, one item related to the experience of fatigue itself and one item about what causes fatigue. Each item is scored on a 7-point Likert scale ranging from 1 (''strongly disagree'') to 7 (''strongly agree''). The mean score of the 9 items is used to estimate fatigue severity.	3 and 6 months
Brief Pain Inventory	Brief Pain Inventory (BPI) is a two-factor instrument that measures pain severity and pain interference. The pain severity factor has four items, all rated on a 0 ''No pain'' to 10 ''Pain as bad as you can imagine'' Likert scale. The pain interference factor has seven items, all rated on a 0 ''Does not interfere'' to 10 ''Interferes completely'' Likert scale. Arithmetic mean of the four severity items can be used as measures of pain severity; the arithmetic mean of the seven interference items can be used as a measure of pain interference	3 and 6 months
State -Trait Anxiety Inventory (STAI)	State-Trait Anxiety Inventory (STAI) is a 40-items instrument that measures state anxiety and trait anxiety. Each type of anxiety has its own scale of 20 different questions that are scored on a 4-point Likert scale ranging from 1 "Almost never" to 4 "Almost always". Scores range from 20 to 80, with higher scores correlating with greater anxiety.	3 and 6 months
PHQ-9	Patient Health Questionnaire (PHQ-9) is a 9-item instrument that measure depressive symptoms severity. PhQ-9 score ranges from 0 to 27, because each of the 9 items can be scores from 0 "not at all" to 3 "nearly every day". Higher scores indicate higher severity.	3 and 6 months

Collaborators and Investigators

• Sponsor: Université de Montréal
• Collaborators: Fonds de la Recherche en Santé du Québec
• Investigators: Principal Investigator: Pilar Ramirez-Garcia, PhD, Université de Montréal

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2015
• Primary Completion (ACTUAL): June 1, 2018
• Study Completion (ACTUAL): December 1, 2018

Study Registration Dates

• First Submitted: April 18, 2019
• First Submitted That Met QC Criteria: April 22, 2019
• First Posted (ACTUAL): April 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 11, 2019
• Last Update Submitted That Met QC Criteria: September 9, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: pain; fatigue; quality of life; depression; anxiety; relaxation; symptoms; sleep problems
• Other Study ID Numbers: 2016-5940:PRG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No