A Sleep Program to Improve Sleep Quality in People With HIV

NCT02571595 | Terminated

• 2 other identifiers: 14-368-BMBCTN S 290
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Sleep problems, such as insomnia, are more frequent and intense in individuals living with HIV. These sleep difficulties can increase the difficulties in thinking and concentrating. Digital cognitive behavioral therapy for insomnia (dCBT-I) is a computer-based treatment intervention that provides strategies to improve sleep. This intervention has been shown to improve sleep and daytime function (concentration, productivity) in people with insomnia. However, the effects of this intervention in people living with HIV are unknown.

Conditions

HIV - Human Immunodeficiency Virus; Insomnia Disorder

Keywords

HIV - Human Immunodeficiency Virus; digital cognitive behavioural therapy for insomnia (dCBT-I); insomnia; cognitive Impairment; concentration; productivity

Outcome Measures

Primary Outcomes (1)

• Ratio of total sleep time over time in bed

  Obtained from the online self-reported sleep diaries aggregated over 7 days, completed at study entry and again at 12 weeks

  12 weeks

Secondary Outcomes (5)

• Insomnia Severity as assessed by the Insomnia Severity Index

  12 weeks

• Cognitive performance as assessed by the Brief Cognitive Ability Measure (B-CAM)

  9 months

• Anxiety and Depression symptoms as assessed by the Hospital Anxiety Depression Scale

  9 months

• Quality of life as assessed by the WHO-QOL-HIV

  9 months

• Quality of life as assessed by the EQ-5D

  9 months

Study Arms (2)

Immediate dCBT-I group

EXPERIMENTAL

Digital cognitive behavioural therapy for insomnia (dCBT-I) is a 6 session training program (spanning 6 to 12 weeks) designed to improve sleep. Participants in the immediate dCBT-I group will receive the Sleepio intervention shortly after enrollment.

Behavioral: Digital cognitive behavioural therapy for insomnia (dCBT-I)

Waitlist control group

EXPERIMENTAL

Participants in the waitlist control group will receive sleep hygiene recommendations from validated online resources for HIV patients (http://www.catie.ca/en/positiveside/winter-2013/sleep-tight) around the time of enrollment. They will start the digital cognitive behavioural therapy for insomnia (dCBT-I) intervention 12-14 weeks after the initial enrollment.

Behavioral: Digital cognitive behavioural therapy for insomnia (dCBT-I)

Interventions

Digital cognitive behavioural therapy for insomnia (dCBT-I) BEHAVIORAL

dCBT-I is a computer-based treatment intervention that provides strategies to improve sleep and daytime function (concentration, productivity) in individuals with insomnia

Also known as: Sleepio

Immediate dCBT-I group; Waitlist control group

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Evidence of insomnia disorder (Sleep Condition Indicator \[SCI\] ≤ 16)
• Able to have convenient weekly access to the Internet
• Stable medical condition
• Have been on a stable HAART regimen for \> 6 months
• Have not had a change in medications that could potentially interfere with sleep or cognition in the past 4 months.

You may not qualify if:

• Berlin questionnaire score indicating high risk of obstructive sleep apnea
• Known history of sleep disorders (e.g., narcolepsy, hypersomnia, restless legs syndrome, REM-sleep behavior disorder) which currently require or previously required treatment
• Ongoing involvement in night shift work
• Not able to complete the 12 weeks of the sleep intervention due to a scheduling conflict

Sponsors & Collaborators

• McGill University: lead
• Sleepio: collaborator

Study Sites (1)

Montreal Neurological Institute and Hospital (McGill University)

Montreal, Quebec, H3A 2B4, Canada

Location

Related Publications (25)

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  PMID: 26762403 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Sleep Initiation and Maintenance Disorders; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Study Officials

• Lesley K Fellows, MD, DPhil

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurologist

Study Record Dates

• First Submitted: August 25, 2015
• First Posted: October 8, 2015
• Study Start: May 1, 2015
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: August 12, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)