Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04512768
• Other study ID #: 2019-204
• Status: Completed
• Phase: N/A
• Start date: September 9, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: September 2022
• Source: University of Regina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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).
• 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.

Locations

Country	Name	City	State
Canada	Online Therapy Unit, University of Regina	Regina	Saskatchewan

Sponsors (2)

Lead Sponsor	Collaborator
University of Regina	Saskatchewan Centre for Patient-Oriented Research

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up)
Primary	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.	Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up)
Primary	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.	Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up)
Secondary	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.	Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up)
Secondary	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.	Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up)
Secondary	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.	Week 8 (post-treatment)
Secondary	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.	Ongoing throughout treatment (Weeks 1-8)