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NCT Number: NCT07233980

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

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.

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Key information

Conditions

Chronic Physical Health Conditions Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Online Therapy Unit, Regina, Saskatchewan, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet-delivered CBT - Chronic Conditions Course (CCC)

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.

Primary outcomes

  1. Depression

    Time frame: Baseline (Screening), weeks 1-8, and 20 from enrollment

    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.

  2. Anxiety

    Time frame: Baseline (Screening), weeks 1-8 and 20 from enrollment

    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.

Secondary outcomes

  1. Average Pain Severity

    Time frame: Baseline (Screening), week 8 and week 20 from enrollment

    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.

  2. Functional Impairment

    Time frame: Baseline (Screening), weeks 4, 8, and 20 from enrollment

    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.

  3. Treatment Satisfaction

    Time frame: Week 8

    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.

Other outcomes

  1. Treatment Credibility/Expectancy

    Time frame: Baseline (Screening) and week 4

    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.

  2. Engagement Metrics

    Time frame: Weeks 2 to 8

    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.

  3. Working Alliance

    Time frame: Week 4

    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.

  4. Adaptive Actions

    Time frame: Baseline (Screening), weeks 4, 8, and 20 post enrollment

    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.

  5. Therapeutic Realization

    Time frame: Baseline(Screening), weeks 4, 8, and 20 from enrollment

    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.

  6. Treatment Adherence

    Time frame: Calculated at Week 8

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Heather Hadjistavropoulos, PhD

CONTACT

[email protected]

306-585-5133

Marcie Nugent, MSW

CONTACT

[email protected]

306-337-3331

Sponsors and collaborators

Lead sponsor

University of Regina

Other

Collaborators

  • Government of Saskatchewan, Ministry of Health
  • Macquarie University, Australia

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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