NCT04512768

Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy

Completed NA Last updated 22 September 2022

What this trial tests

NA trial testing Transdiagnostic Internet-delivered Cognitive Behaviour Therapy in Insomnia in 217 participants. Completed in 30 April 2021.

Timeline

9 September 2020

Primary endpoint
30 April 2021

30 April 2021

Quick facts

Lead sponsor	University of Regina
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	217
Start date	9 September 2020
Primary completion	30 April 2021
Estimated completion	30 April 2021
Sites	1 location across Canada

Drugs / interventions tested

• Transdiagnostic Internet-delivered Cognitive Behaviour Therapy
• Brief Internet-Delivered Cognitive Behaviour Therapy for Insomnia

Conditions studied

• Insomnia — all drugs for Insomnia →
• Anxiety — all drugs for Anxiety →
• Depression — all drugs for Depression →

Sponsor

University of Regina

Who can join

18 and older, any sex, with Insomnia or Anxiety. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Treating comorbid insomnia in patients enrolled in therapist-assisted transdiagnostic internet-delivered cognitive behaviour therapy for anxiety and depression: A randomized controlled trial.
   Edmonds M, Peynenburg V, Kaldo V, Jernelöv S, et al · · 2024 · cited 3× · PMID 38425505 · DOI 10.1016/j.invent.2024.100729