Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy

NCT04512768 | Completed

• 1 other identifier: 2019-204
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Internet-delivered Cognitive Behaviour Therapy; Insomnia; Depression; Anxiety; Transdiagnostic

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (4)

• Panic Disorder Severity Scale (PDSS)

  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)

  Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up)

• Treatment Satisfaction

  Week 8 (post-treatment)

• Lesson Completion

  Ongoing throughout treatment (Weeks 1-8)

Study Arms (2)

Standard ICBT

ACTIVE COMPARATOR

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

Sleep-Enhanced ICBT

EXPERIMENTAL

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

Interventions

Transdiagnostic Internet-delivered Cognitive Behaviour Therapy BEHAVIORAL

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).

Sleep-Enhanced ICBT; Standard ICBT

Brief Internet-Delivered Cognitive Behaviour Therapy for Insomnia BEHAVIORAL

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.

Sleep-Enhanced ICBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Regina: lead
• Saskatchewan Centre for Patient-Oriented Research: collaborator

Study Sites (1)

Online Therapy Unit, University of Regina

Regina, Saskatchewan, S4S 0A2, Canada

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Michael Edmonds, MA

  University of Regina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 14, 2020
• Study Start: September 9, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data will be available for a period beginning 6 months after the conclusion of the trial until 5 years have elapsed.
• Access Criteria: Data will be provided to researchers who provide a methodologically sound proposal and present a request for data that is within our operational capacity to provide. Additionally, researchers must provide information about how they will use and store the data, as well as sign an agreement related to the use of the data.

Locations

CA (1)