NCT03957330

Therapeutic Moderators of Therapist-assisted Internet-delivered Cognitive Behavior Therapy

Completed NA Last updated 18 November 2021

What this trial tests

NA trial testing Internet-delivered cognitive behaviour therapy in Anxiety in 631 participants. Completed in 20 May 2021.

Timeline

20 May 2019

Primary endpoint
20 May 2021

20 May 2021

Quick facts

Lead sponsor	University of Regina
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	treatment
Enrollment	631
Start date	20 May 2019
Primary completion	20 May 2021
Estimated completion	20 May 2021
Sites	1 location across Canada

Drugs / interventions tested

• Internet-delivered cognitive behaviour therapy

Conditions studied

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

Sponsor

University of Regina

Who can join

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

Sponsor's own description

Depression and anxiety are common and prevalent conditions that often go untreated. In an attempt to increase timely and accessible psychological treatment, Internet-delivered cognitive behavioural therapy (ICBT) has emerged. ICBT involves delivering therapeutic content via structured online lessons. This is often combined with therapist guidance, such as once per week contact via secure messaging or phone calls over several months. Over the past several years, the investigators have been studying the efficacy of ICBT for symptoms of depression and anxiety and found \~70% of patient's fully complete treatment and demonstrate large improvement in symptoms. Although outcomes of ICBT are very impressive, there is some room for improvement in terms of completion rates and outcomes.

In this three-factorial randomized controlled trial, the investigators aim to contribute to the literature by examining whether the efficacy of ICBT in routine practice is moderated by amount of contact (once versus twice a week), inclusion of homework reflection questionnaire (yes vs no) and location of therapist (specialized unit vs community mental health clinic). Follow-up measures will be carried out at 3, 6 and 12 months after randomization. Primary outcomes are reduced anxiety and depression. Secondary outcomes include psychological distress, panic, social anxiety, trauma, health anxiety, quality of life, disability, intervention usage (e.g., completion rates, log-ins, emails sent), satisfaction, therapeutic alliance, and costs (e.g., health care utilization).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Utilization, Patient Characteristics, and Longitudinal Improvements among Patients from a Provincially Funded Transdiagnostic Internet-delivered Cognitive Behavioural Therapy Program: Observational Study of Trends over 6 Years.
   Hadjistavropoulos HD, Peynenburg V, Thiessen DL, Nugent M, et al · · 2022 · cited 36× · PMID 33840264 · DOI 10.1177/07067437211006873
2. A pragmatic factorial randomized controlled trial of transdiagnostic internet-delivered cognitive behavioural therapy: Exploring benefits of homework reflection questionnaires and twice-weekly therapist support.
   Hadjistavropoulos HD, Peynenburg V, Thiessen DL, Nugent M, et al · · 2020 · cited 19× · PMID 33335846 · DOI 10.1016/j.invent.2020.100357
3. Understanding Client Difficulties in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy: A Qualitative Analysis of Homework Reflections.
   Peynenburg V, Wilhelms A, Sapkota R, Nugent M, et al · · 2022 · cited 2× · PMID 35887989 · DOI 10.3390/jcm11144226
4. Prediction of treatment outcome in patients receiving internet-delivered cognitive behavioural therapy for depressive and anxiety symptoms: a machine learning analysis of data from a healthcare-embedded longitudinal study.
   Roemmel N, Bahmane S, Hadjistavropoulos HD, Nugent M, et al · · 2025 · PMID 40903086 · DOI 10.1136/bmjopen-2024-097651