About The Study

The goal of this study is to see if a computer-based treatment program can improve sleep and cognitive (mental) function in people living with HIV (PLHIV) who are experiencing insomnia (difficulty sleeping). This study is expected to produce important data that could lead to effective treatments and strategies for improving sleep and brain function in PLHIV that are experiencing cognitive decline. Results from this study could also lead to a larger-scale trial.

About The Disease

Sleep problems, such as insomnia, are more frequent and severe in PLHIV compared to the general population. These sleep difficulties can make thinking and concentrating more difficult and impact responses and adherence to treatment. Digital cognitive behavioral therapy for insomnia (dCBT-I) is a computer-based treatment program that teaches strategies to improve sleep. This program has been shown to improve sleep and daytime function (concentration, productivity) in people with insomnia. Even though studies have shown that amount and quality of sleep are very important for the well-being of those living with HIV, very few studies have looked at sleep treatment programs for this population.

CBT-I is a program aimed at helping people change the behaviours that cause or worsen insomnia. It includes a range of techniques that deal with behavioural, mental, and educational aspects of the problem. It has been shown to be an effective treatment for people dealing from insomnia, but it has proven difficult to use with all patients because of the required amount of time spent with therapists. Web-based (digital) CBT-I has been developed to overcome this barrier and make it more convenient to access.

Study Approach

This insomnia-intervention sub-study will include 60 participants who have already agreed to participate in the Brain Health Now study and are eligible to participate.

If assigned to the ‘immediate start’ group, participants will begin the online program right away. If assigned to the delayed start group, participants will be provided with a link to high quality information about sleep hygiene. About 3 months later, these participants will be provided with the online program. All participants will have the same access to the online program over the course of the study. The computer-based dCBT-I will involve a total of 6 sessions lasting less than half an hour, which can be completed over 6-12 weeks. Information regarding sleep quality will be recorded throughout the study and cognitive ability will be measured before and following the dCBT-I program.

If you would like more information on this clinical study, please contact Dr. Lesley Fellows (Lesley.fellows@mcgill.ca) at (514) 398-8481 or Dr. Marie-Josée Brouillette at (514) 843-2090.

Eligibility Requirements

Required

  • Evidence of insomnia disorder
  • 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.
  • Able to speak English

Not Allowed

  • 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

Additional Information

If you would like more information on this clinical study, please contact Dr. Lesley Fellows (Lesley.fellows@mcgill.ca) at (514) 398-8481 or Dr. Marie-Josée Brouillette at (514) 843-2090.

Principal Investigators

Here’s who is leading this study.

Can’t find what you’re looking for? Email ctninfo@ctnplus.ca.

Participating Sites

Here’s where this study is being conducted.

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