Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy

University of Regina

Status: Completed

Conditions: Insomnia; Depression; Anxiety

Treatments: Behavioral: Brief Internet-Delivered Cognitive Behaviour Therapy for Insomnia; Behavioral: Transdiagnostic Internet-delivered Cognitive Behaviour Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04512768

2019-204

Details and patient eligibility

About

Transdiagnostic Internet-delivered Cognitive Behaviour Therapy (ICBT) is an efficacious treatment option for anxiety and depression; however, not all patients benefit equally and some leave treatment before program completion. Comorbid symptoms of insomnia are extremely common among individuals seeking ICBT, yet sleep problems are rarely a primary focus of treatment in transdiagnostic ICBT despite insomnia being a known risk factor for anxiety and depression. This trial is designed to test whether an ICBT program for anxiety and depression can be improved by providing therapy for insomnia alongside the standard transdiagnostic program. For this randomized controlled trial, patients will be randomly assigned to receive either the standard ICBT program for anxiety and depression, which includes only brief supplementary information about sleep (n = 68), or a modified version that includes a lesson specifically on sleep (n = 132). The sleep lesson will introduce patients to two key behavioural strategies: sleep restriction and stimulus control, which previous research has demonstrated are effective at reducing insomnia. Patients will monitor their sleep throughout treatment and will complete measures of insomnia, anxiety and depression before treatment, at the end of the 8-week program, and 3 months after program conclusion to allow for a comparison of patient outcomes and completion rates between conditions. The acceptability of the new intervention will also be assessed by asking participants to provide feedback on the new materials and to complete measures of treatment satisfaction and working alliance.

Enrollment: 217 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants must reside in Saskatchewan
• Participants must have access to a computer and feel comfortable using the internet
• Participants must be willing to provide a medical contact (e.g., family doctor) in case of medical emergency
• Participants must endorse some symptoms of anxiety or depression
• Participants must also endorse significant symptoms of insomnia (Insomnia Severity Index score of 10 or above)

Exclusion criteria

• High risk of suicide
• Unmanaged severe psychiatric illness (e.g., psychosis, mania)
• Severe alcohol or addictions problems that require referral
• High probability that another sleep disorder for which sleep restriction may be contraindicated is present (e.g., restless leg syndrome, sleep apnea, or sleep problems that are exclusively related to shift work)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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217 participants in 2 patient groups

Standard ICBT

Active Comparator group

Description:

Participants in the Standard ICBT condition will receive an 8-week transdiagnostic course for anxiety and depression called The Wellbeing Course, originally developed by Macquarie University, Australia.

Treatment:

Behavioral: Transdiagnostic Internet-delivered Cognitive Behaviour Therapy

Sleep-Enhanced ICBT

Experimental group

Description:

Participants in the Sleep-Enhanced ICBT condition will receive an 8-week transdiagnostic course for anxiety and depression called The Wellbeing Course, originally developed by Macquarie University, Australia. In addition, participants in the Sleep-Enhanced ICBT condition will also receive a newly developed lesson designed to target insomnia.

Treatment:

Behavioral: Transdiagnostic Internet-delivered Cognitive Behaviour Therapy

Behavioral: Brief Internet-Delivered Cognitive Behaviour Therapy for Insomnia