Clinical trial NCT04512768: Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
Official title: Treating Comorbid Insomnia in Patients Receiving Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy for Anxiety and Depression: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Anxiety
Depression
Keywords: Internet-delivered Cognitive Behaviour Therapy
Insomnia
Depression
Anxiety
Transdiagnostic
Lead sponsor: University of Regina
Sponsor class: OTHER
Collaborators: name: Saskatchewan Centre for Patient-Oriented Research
First posted: 2020-08-14
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up)
measure: Patient Health Questionnaire 9-item (PHQ-9)
timeFrame: Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up)
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up)
Secondary outcomes:
measure: Panic Disorder Severity Scale (PDSS)
timeFrame: Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up)
measure: Social Interaction Anxiety Scale and Social Phobia Scale - Short Form (SIAS-6/SPS-6)
timeFrame: Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up)
measure: Treatment Satisfaction
timeFrame: Week 8 (post-treatment)
measure: Lesson Completion
timeFrame: Ongoing throughout treatment (Weeks 1-8)
Other outcomes:
Locations:
city: Regina
country: Canada
facility: Online Therapy Unit, University of Regina
state: Saskatchewan
Study officials:
affiliation: University of Regina
name: Michael Edmonds, MA
role: PRINCIPAL_INVESTIGATOR
References: