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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Regina

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

260 Participants
are divided into 1 treatment group
Group A: Chronic Health Conditions Course_Therapist Guided ICBTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (Screening), weeks 1-8, and 20 from enrollment
2

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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

1

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.

Time frame
Baseline (Screening) and week 4
2

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.

Time frame
Weeks 2 to 8
3

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.

Time frame
Week 4
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.

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Regina

Lead sponsor

Macquarie University, Australia

Collaborator

Government of Saskatchewan, Ministry of Health

Collaborator