NCT04512768

Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy

Treating Comorbid Insomnia in Patients Receiving Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy for Anxiety and Depression: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 217 (actual)
• Sponsor: University of Regina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Insomnia
• Anxiety
• Depression

Interventions

Type	Name	Description
BEHAVIORAL	Transdiagnostic Internet-delivered Cognitive Behaviour Therapy	All participants receive an 8-week transdiagnostic course for anxiety and depression called The Wellbeing Course, originally developed by Macquarie University, Australia. The course is comprised of 5 lessons, beginning with psychoeducation and an introduction to the cognitive behavioural model, and then introducing key skills for managing anxiety and depression, including thought challenging, de-arousal strategies, graded exposure, behavioural activation, and relapse prevention. The course also includes supplementary resources that briefly provide information on related common concerns, such as managing worry, communication, assertiveness, problem solving, and a brief resource on sleep that provides limited psychoeducation and sleep hygiene information. Participants receive weekly brief therapist support via secure message or telephone from qualified counselors (social workers, psychologists).
BEHAVIORAL	Brief Internet-Delivered Cognitive Behaviour Therapy for Insomnia	A new sleep lesson will replace the existing resource, developed using a patient-oriented process, that provides information and skills to aid with insomnia. The sleep lesson includes psychoeducation on the nature of sleep problems and factors that affect sleep, such as circadian rhythm. Two key behavioural strategies are introduced: sleep restriction, which requires the patient to avoid napping and sleep on a strict schedule for several weeks until they begin to feel naturally sleepy at night; and stimulus control, which asks the participant to only spend time in bed when prepared to sleep and avoid other activities (e.g., work, TV) in bed. Patients will record how much they sleep each night and provide ratings of sleep quality and fatigue each week. Therapists will support patients in adjusting their sleep schedule. Patients are encouraged to apply skills they learn during the Wellbeing Course to sleep problems, for example, by applying thought challenging to beliefs about sleep.

Timeline

• Start date: 2020-09-09
• Primary completion: 2021-04-30
• Completion: 2021-04-30
• First posted: 2020-08-14
• Last updated: 2022-09-22

Locations

1 site across 1 country: Canada