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

Therapist-Guided Internet-Delivered Cognitive Behaviour Therapy (CBT) for Chronic Conditions (Chronic Conditions Course; CCC): Single-Group Predictors of Change in Routine Care

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Physical Health Conditions
• Intervention / Treatment: Behavioral: Internet-delivered CBT - Chronic Conditions Course (CCC)

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.

• Study Type: Interventional
• Enrollment (Estimated): 260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marcie Nugent, MSW; Phone Number: 306-337-3331; Email: marcie.nugent@uregina.ca
• Study Contact Backup: Name: Heather Hadjistavropoulos, PhD; Phone Number: 306-585-5133; Email: heather.hadjistavropoulos@uregina.ca

Study Locations

• Canada
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4S 0A2
      • Recruiting
      • Online Therapy Unit
      • Contact: Marcie Nugent, MSW; Phone Number: 306-337-3331; Email: marcie.nugent@uregina.ca
      • Contact: Heather Hadjistavropoulos, PhD; Phone Number: 306-585-5133; Email: heather.hadjistavropoulos@uregina.ca
    • Regina, Saskatchewan, Canada, S4S 0A2
      • Not yet recruiting
      • Online Therapy Unit, University of Regina
      • Principal Investigator: Heather Hadjistavropoulos, PhD
      • Contact: Marcie Nugent, MSW; Phone Number: 306-337-3331; Email: marcie.nugent@uregina.ca
      • Contact: Heather Hadjistavropoulos, PhD; Phone Number: 306-585-5133; Email: heather.hadjistavropoulos@uregina.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Pain Severity	Visual Analogue Scale-Pain (VAS-Pain). The VAS-pain is a 3-item scale assessing pain experienced in the past 7-days. Items are rated on a line scale ranging from 0-10, and scores are summed into a total score ranging from 0-30. Higher scores indicate greater pain severity.	Baseline (Screening), week 8 and week 20 from enrollment
Functional Impairment	Work and Social Adjustment Scale (WSAS). The WSAS is a measure of functional impairment experienced in different interpersonal and intrapersonal domains due to mental and physical health challenges. It includes 5 items rated on a 9-point Likert scale ranging from 0-8. Scores are summed to produce a total score between 0-40. Higher scores indicate greater impairment in functioning.	Baseline (Screening), weeks 4, 8, and 20 from enrollment
Treatment Satisfaction	Treatment Satisfaction Questionnaire (TSQ). A 13-item questionnaire used to assess satisfaction with treatment and negative effects experienced by clients during treatment. The questionnaire uses a combination of Likert scale [5-point (0-4) and 6-point (0-5)], open-ended, and dichotomous yes/no response options to gauge participants' perceptions of the course. The questionnaire was developed by Macquarie University, and has been adapted for use by the OTU. A total score is not produced for this measure.	Week 8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Credibility/Expectancy	Credibility and Expectancy Questionnaire (CEQ). Measures treatment credibility and expectancy using 6 items, with two subscales. First three items correspond to the credibility subscale and the following three items correspond to the expectancy subscale. Items are measured on 9-point Likert scale ranging from 1-9. Subscale scores range from 3 to 27. Higher scores in each subscale indicate greater treatment credibility or treatment expectancy respectively.	Baseline (Screening) and week 4
Engagement Metrics	Homework Reflection Questionnaire. A 5-item questionnaire assessing week-to-week experience in the course, with items inquiring about the lesson participants worked on; effort exerted towards skills; helpfulness of lessons; and client successes, challenges and experiences over the previous week. A combination of checklist, Likert scale [7-point (1-7)], and open-ended response options are used to gauge participants' participation. The questionnaire is used by clinicians to monitor treatment. No overall score is produced.	Weeks 2 to 8
Working Alliance	Working Alliance Inventory for Guided Internet Interventions (WAI-I). The WAI-I is a 12-item measure assessing therapist-client alliance and client-program alliance. Items are measured on a 5-point Likert scale ranging from 1-5, and scores are summed to produce a total score ranging from 12 to 60. Higher scores on this scale indicate higher levels of client-program alliance and therapist-client alliance.	Week 4
Adaptive Actions	Things You Do Questionnaire-15 (TYDQ-15). A measure of behaviors associated with mental health. 15 items are measured on a 5-point Likert scale ranging from 0-4. Subscales include Healthy Routine, Healthy Thinking, Social Connection, Meaningful Activities, and Goals and Plans. Scores are summed into subscale scores ranging from 0 to 12, and a total score ranging from 0 to 60, with higher scores indicating increased engagement in behaviours associated with mental health.	Baseline (Screening), weeks 4, 8, and 20 post enrollment
Therapeutic Realization	Demoralization and Insight Scale (DIS). The DIS is a 9-item revised version of the Therapeutic Realization Scale-revised, used to assess the extent to which clients feels less demoralized and gain insight during treatment. Items on this scale are measured on a 4-point Likert scale ranging from 0-3, and scores are summed to produce a total score ranging from 0-27. Higher scores indicate higher therapeutic realization.	Baseline(Screening), weeks 4, 8, and 20 from enrollment
Treatment Adherence	The Online Therapy Unit system collects information on the number of lessons completed, and number of emails client exchange with their therapist. Clients' adherence to treatment is calculated by averaging the sum of all lessons completed, all emails sent and all emails received from therapists.	Calculated at Week 8

Collaborators and Investigators

• Sponsor: University of Regina
• Collaborators: Macquarie University, Australia; Government of Saskatchewan, Ministry of Health
• Investigators: Principal Investigator: Heather Hadjistavropoulos, PhD, University of Regina

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• Trial registration of the second large pragmatic RCT

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Estimated): November 18, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Predictors; Internet-delivered cognitive behavior therapy; Therapist assistance; Chronic physical health conditions
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Behavior; Anxiety Disorders; Depression
• Other Study ID Numbers: 2018-045b

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No