Recruiting

ICBT

Sponsor:

University of Regina

Code:

NCT07233980

Conditions

Chronic Physical Health Conditions

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Internet-delivered CBT - Chronic Conditions Course (CCC)

Study Details

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.

Conditions

Chronic Physical Health Conditions

Study ID

NCT07233980

Start date

Oct 8, 2025

Status verified date

Nov, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

260 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Primary outcome measure

  • Depression [ Time Frame: Baseline (Screening), weeks 1-8, and 20 from enrollment ]
  • Anxiety [ Time Frame: Baseline (Screening), weeks 1-8 and 20 from enrollment ]

Central Contacts and Locations

Central contacts

Locations

Online Therapy Unit

Recruiting

Regina, Saskatchewan, Canada, S4S 0A2

Contacts

More Information

Sponsor

University of Regina

Last update posted

Dec 2, 2025

Last verified

Nov, 2025

Keywords

  • Internet-delivered cognitive behavior therapy
  • Anxiety
  • Depression
  • Chronic physical health conditions
  • Therapist assistance
  • Predictors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Regina on 2025-12-02.