Therapist-Guided Internet-Delivered CBT for Chronic Conditions: Predictors of Change
1 other identifier
interventional
260
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2025
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 8, 2025
CompletedFirst Submitted
Initial submission to the registry
November 14, 2025
CompletedFirst Posted
Study publicly available on registry
November 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
December 2, 2025
November 1, 2025
12 months
November 14, 2025
November 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Depression
Patient Health Questionnaire-9 (PHQ-9). Tracking the change in depression symptoms. 9 items are measured on a 4-point Likert scale ranging from 0-3. Scores are summed with total scores ranging from 0 to 27. Higher scores are associated with higher depression severity.
Baseline (Screening), weeks 1-8, and 20 from enrollment
Anxiety
Generalized Anxiety Disorder-7 (GAD-7). Tracking the change in anxiety symptoms. 7 items are measured on a 4-point Likert scale ranging from 0-3. Scores are summed into a total score ranging from 0 to 21, with higher scores indicating more severe self-reported levels of anxiety.
Baseline (Screening), weeks 1-8 and 20 from enrollment
Secondary Outcomes (3)
Average Pain Severity
Baseline (Screening), week 8 and week 20 from enrollment
Functional Impairment
Baseline (Screening), weeks 4, 8, and 20 from enrollment
Treatment Satisfaction
Week 8
Other Outcomes (6)
Treatment Credibility/Expectancy
Baseline (Screening) and week 4
Engagement Metrics
Weeks 2 to 8
Working Alliance
Week 4
- +3 more other outcomes
Study Arms (1)
Chronic Health Conditions Course_Therapist Guided ICBT
EXPERIMENTALAll 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Reginalead
- Macquarie University, Australiacollaborator
- Government of Saskatchewan, Ministry of Healthcollaborator
Study Sites (2)
Online Therapy Unit, University of Regina
Regina, Saskatchewan, S4S 0A2, Canada
Online Therapy Unit
Regina, Saskatchewan, S4S 0A2, Canada
Related Publications (3)
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.
PMID: 33567994BACKGROUNDDear 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.
PMID: 35367986BACKGROUNDMehta 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.
PMID: 35921055BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heather Hadjistavropoulos, PhD
University of Regina
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2025
First Posted
November 18, 2025
Study Start
October 8, 2025
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
December 2, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share