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

NCT03924921 | Completed

• 1 other identifier: 2016-5940:PRG
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

HIV

Keywords

relaxation; quality of life; symptoms; pain; depression; anxiety; sleep problems; fatigue

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Pittsburgh Sleep Quality Index (PSQI)

  3 and 6 months

• Fatigue Severity Scale (FSS)

  3 and 6 months

• Brief Pain Inventory

  3 and 6 months

• State -Trait Anxiety Inventory (STAI)

  3 and 6 months

• PHQ-9

  3 and 6 months

Study Arms (2)

autogenic training

EXPERIMENTAL

Autogenic training

Other: autogenic training

wait list

EXPERIMENTAL

usual care for 6 months Autogenic training after 6 months

Other: autogenic training

Interventions

autogenic training OTHER

autogenic training

autogenic training; wait list

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Université de Montréal: lead
• Fonds de la Recherche en Santé du Québec: collaborator

Study Sites (2)

CHUM

Montreal, Quebec, H2W1T8, Canada

Location

CUSM

Montreal, Quebec, H4A3J1, Canada

Location

MeSH Terms

Conditions

Pain; Depression; Anxiety Disorders; Parasomnias; Fatigue

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Pilar Ramirez-Garcia, PhD

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: April 23, 2019
• Study Start: April 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 11, 2019

Record last verified: 2019-04

Locations

CA (2)