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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
260
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.
Online Therapy Unit, University of Regina
Regina, Saskatchewan, Canada
NOT_YET_RECRUITINGOnline Therapy Unit
Regina, Saskatchewan, Canada
RECRUITINGDepression
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.
Time frame: 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.
Time frame: Baseline (Screening), weeks 1-8 and 20 from enrollment
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.
Time frame: 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.
Time frame: 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.
Time frame: Week 8
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