Therapist-Guided Internet-Delivered CBT for Chronic Conditions: Predictors of Change

NCT ID: NCT07233980

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-08
• Study Completion Date: 2026-12-31

Brief Summary

Chronic health conditions are common, disabling, and often co-occur with depression and anxiety. Internet-delivered cognitive behaviour therapy (ICBT) reduces barriers to treatment and has been adapted for chronic conditions. A transdiagnostic approach is promising because it is both effective and convenient in that clients with diverse conditions receive the same program. Both therapist-guided and self-guided formats have been found effective; however, in routine care therapist support is most common to ensure that clients have support to personalize care.

This study evaluates the therapist-guided Chronic Conditions Course (CCC) and examines predictors of change. Past research shows that the most robust predictors of ICBT outcomes are baseline severity, adherence, credibility, and working alliance. However, few studies of ICBT for chronic conditions have examined predictors together. Moreover, the researchers are aware of no studies that have examined these core predictors in routine delivery of ICBT for those with chronic health conditions alongside other predictors-such as changes in thoughts and adaptive actions. A limitation of past work is that predictor analyses were typically secondary to trials designed for other purposes. This study directly addresses that gap by prospectively modeling predictors of change in routine care.

Detailed Description

The CCC is well supported by prior research. Dear and colleagues have completed several large trials validating the effectiveness of the CCC in addressing chronic health conditions. In the first large Randomized Controlled Trial (RCT; N=676), the researchers compared adults with diverse chronic conditions (e.g., multiple sclerosis, arthritis, epilepsy, diabetes, lupus, kidney disease, endometriosis, chronic pain, Parkinson's disease, chronic fatigue syndrome, COPD) when randomly assigned to the course compared to treatment as usual (Dear et al., 2022). Results showed significant improvements in depression, anxiety and disability versus treatment-as-usual, maintained at 12 months post-treatment. Effects were comparable to face-to-face care, requiring only ~10-20% of clinician time per patient. In a second large pragmatic RCT (N=850), with 24-month follow-up, preliminary results suggest clinically significant reductions in depression/anxiety, and improvements in disability and quality of life are maintained over time.

In Saskatchewan, the CCC is now offered as routine care (no cost) via the Online Therapy Unit (OTU). An RCT (N=178) by the team comparing therapist-guided (offered by a team of registered therapists based on scheduling) versus self-directed CCC found similar satisfaction, completion, and outcomes across formats. Most recently in a subsequent routine care sample (N=121) clients were found to make significant improvement in adaptive actions during treatment, but the study did not allow for comparison of the role or adaptive behaviours in predicting outcomes relative to other variables. The current study is a single-arm interventional trial designed to investigate predictors of outcome (primary outcomes are depression and anxiety). Variables of interest include baseline symptom severity, adherence, credibility, working alliance, adaptive actions, and therapeutic realizations controlling for demographic variables.

Conditions

Chronic Physical Health Conditions

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chronic Health Conditions Course_Therapist Guided ICBT

All clients eligible for ICBT who report having a chronic health condition will receive the Wellbeing for Chronic Health Conditions Course. The course consists of 5 ICBT lessons released gradually over 8 weeks. Clients will also receive weekly support via secure messaging from a trained therapist for the duration of the course.

Group Type: EXPERIMENTAL

Internet-delivered CBT - Chronic Conditions Course (CCC)

Intervention Type: BEHAVIORAL

The Wellbeing Course for Chronic Health Conditions is a transdiagnostic, internet-delivered cognitive behavioral intervention developed at Macquarie University. It is designed to help people living with chronic health conditions develop skills and strategies to maintain quality of life and emotional wellbeing. The course comprises 5 core online lessons released gradually over 8 weeks, targeting symptom identification, challenging unhelpful thoughts, pleasant activity scheduling, activity pacing and graded exposure, and relapse prevention. Each lesson is accompanied by downloadable exercise worksheets, case stories, and additional resources addressing challenges that clients may face alongside their chronic health conditions, such as assertive communication. Lesson materials are presented in a didactic, text-based format with visual supports. Therapists spend approximately 15 minutes each week responding to clients' messages and providing support.

Interventions

Internet-delivered CBT - Chronic Conditions Course (CCC)

The Wellbeing Course for Chronic Health Conditions is a transdiagnostic, internet-delivered cognitive behavioral intervention developed at Macquarie University. It is designed to help people living with chronic health conditions develop skills and strategies to maintain quality of life and emotional wellbeing. The course comprises 5 core online lessons released gradually over 8 weeks, targeting symptom identification, challenging unhelpful thoughts, pleasant activity scheduling, activity pacing and graded exposure, and relapse prevention. Each lesson is accompanied by downloadable exercise worksheets, case stories, and additional resources addressing challenges that clients may face alongside their chronic health conditions, such as assertive communication. Lesson materials are presented in a didactic, text-based format with visual supports. Therapists spend approximately 15 minutes each week responding to clients' messages and providing support.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Saskatchewan resident (as funding is provided by Saskatchewan government);
• Aged 18 years or older;
• self-reported diagnosed with chronic physical health condition affecting mental health;
• Access to a computer and the Internet;
• Consent to treatment/research

Exclusion Criteria

• Current severe psychiatric or medical condition that requires immediate treatment and or would interfere with participation (e.g. current mania or psychosis, actively suicidal or unable to keep themselves safe, medical condition requiring immediate surgery or other invasive treatment, cognitive difficulties);
• Taking part in another treatment in our clinic;
• Living outside of Saskatchewan

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Macquarie University, Australia

OTHER

Sponsor Role: collaborator

Government of Saskatchewan, Ministry of Health

UNKNOWN

Sponsor Role: collaborator

University of Regina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heather Hadjistavropoulos, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Regina

Locations

Online Therapy Unit, University of Regina

Regina, Saskatchewan, Canada

Site Status: NOT_YET_RECRUITING

Online Therapy Unit

Regina, Saskatchewan, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Marcie Nugent, MSW

Role: CONTACT

marcie.nugent@uregina.ca

306-337-3331

Heather Hadjistavropoulos, PhD

Role: CONTACT

heather.hadjistavropoulos@uregina.ca

306-585-5133

Facility Contacts

Marcie Nugent, MSW

Role: primary

marcie.nugent@uregina.ca

306-337-3331

Heather Hadjistavropoulos, PhD

Role: backup

heather.hadjistavropoulos@uregina.ca

306-585-5133

Marcie Nugent, MSW

Role: primary

marcie.nugent@uregina.ca

306-337-3331

Heather Hadjistavropoulos, PhD

Role: backup

heather.hadjistavropoulos@uregina.ca

306-585-5133

References

Zalaznik D, Strauss AY, Halaj A, Barzilay S, Fradkin I, Katz BA, Ganor T, Ebert DD, Andersson G, Huppert JD. Patient alliance with the program predicts treatment outcomes whereas alliance with the therapist predicts adherence in internet-based therapy for panic disorder. Psychother Res. 2021 Nov;31(8):1022-1035. doi: 10.1080/10503307.2021.1882712. Epub 2021 Feb 10.

Reference Type: BACKGROUND

PMID: 33567994 (View on PubMed)

Dear BF, Scott AJ, Fogliati R, Gandy M, Karin E, Dudeney J, Nielssen O, McDonald S, Heriseanu AI, Bisby MA, Sharpe L, Jones MP, Ali S, Titov N. The Chronic Conditions Course: A Randomised Controlled Trial of an Internet-Delivered Transdiagnostic Psychological Intervention for People with Chronic Health Conditions. Psychother Psychosom. 2022;91(4):265-276. doi: 10.1159/000522530. Epub 2022 Apr 1.

Reference Type: BACKGROUND

PMID: 35367986 (View on PubMed)

Mehta SH, Nugent M, Peynenburg V, Thiessen D, La Posta G, Titov N, Dear BF, Hadjistavropoulos HD. Internet-delivered cognitive behaviour therapy for chronic health conditions: self-guided versus team-guided. J Behav Med. 2022 Oct;45(5):674-689. doi: 10.1007/s10865-022-00346-x. Epub 2022 Aug 3.

Reference Type: BACKGROUND

PMID: 35921055 (View on PubMed)

Related Links

https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12620000969965

Trial registration of the second large pragmatic RCT

Other Identifiers

2018-045b

Identifier Type: -

Identifier Source: org_study_id