An interventional study of Transdiagnostic Internet-delivered Cognitive Behaviour Therapy and Brief Internet-Delivered Cognitive Behaviour Therapy for Insomnia in Insomnia, Anxiety and Depression, sponsored by University of Regina. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-22.
Sponsored by University of Regina · Not applicable, Interventional, and Treatment
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.
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This study's enrollment of 217 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
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Exclusion Criteria:
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.
Behavioral: Transdiagnostic Internet-delivered Cognitive Behaviour Therapy
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.
Behavioral: Transdiagnostic Internet-delivered Cognitive Behaviour Therapy · Behavioral: Brief Internet-Delivered Cognitive Behaviour Therapy for Insomnia
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).
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.
Insomnia Severity Index (ISI)
Change in insomnia symptoms from pre-treatment (Week 1) to post-treatment (8 weeks) and from pre-treatment to follow-up (20 weeks). The ISI is a brief measure of insomnia comprised of 7 questions that ask about difficulties falling asleep, staying asleep, and waking too early, which respondents answer on a scale from 0 (None) to 4 (Very Severe), producing a score between 0 and 28.
Time frame: Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up)
Patient Health Questionnaire 9-item (PHQ-9)
Change in depression symptoms from pre-treatment (Week 1) to post-treatment (8 weeks) and from pre-treatment to follow-up (20 weeks). The PHQ-9 is a 9-item self-report measure of symptoms of depression that produces a total depression severity score ranging from 0-27.
Time frame: Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up)
Generalized Anxiety Disorder (GAD-7)
Change in anxiety symptom from pre-treatment (Week 1) to post-treatment (8 weeks) and from pre-treatment to follow-up (20 weeks). The GAD-7 is a 7-item self-report measure of symptoms of anxiety that produces a total anxiety severity score ranging from 0-21.
Time frame: Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up)
Panic Disorder Severity Scale (PDSS)
Change in symptoms of panic. The PDSS is a 7-item measure of common symptoms of panic disorder. Respondents answer each item on a 0-4 scale, producing a total score between 0 and 28.
Time frame: Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up)
Social Interaction Anxiety Scale and Social Phobia Scale - Short Form (SIAS-6/SPS-6)
Change in symptoms of social anxiety. The SIAS-6/SPS-6 includes 12 items related to common symptoms of social anxiety that are summed to create a total score.
Time frame: Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up)
Treatment Satisfaction
A treatment satisfaction questionnaire that includes questions about the patient's opinion of the program and the working alliance they developed with their therapist. Patients will also be asked whether they would recommend the treatment to others. Patients will then complete the Working Alliance Inventory-Short a 12-item measure of the therapeutic alliance.
Time frame: Week 8 (post-treatment)
Lesson Completion
The program website will record when patients access each lesson, providing a way to calculate the proportion of patients who complete each lesson and treatment overall.
Time frame: Ongoing throughout treatment (Weeks 1-8)
Plan to share: Yes — Other researchers may ask to review IPD from this trial following completion of data collection. For the purposes of meta-analyses or other legitimate uses, IPD will be provided after being fully de-identified.
Supporting information: Study protocol, Icf, Csr
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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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