Internet-delivered Cognitive Behaviour Therapy for Chronic Conditions: Comparing Low Intensity Delivery Models

Effectiveness of Internet-delivered Cognitive Behaviour Therapy for Chronic Conditions: Comparing Low Intensity Delivery Models

Chronic health conditions (e.g., heart disease, cancer, diabetes) represent any physical condition that persist for 3 months or more that requires ongoing management. Chronic health conditions are very common, and increase in prevalence with age. Internet-delivered Cognitive Behaviour Therapy (ICBT) is a promising approach for overcoming these barriers, and improving access to mental health care. In ICBT, clients receive content from traditional face-to-face CBT over the Internet, while receiving support and assistance from a guide through secure e-mail. The Chronic Conditions Course is an 8-week, 5 lesson ICBT program that consists of education and relapse prevention as well as cognitive, behavioural, and physical strategies for managing chronic conditions. This intervention has traditionally been delivered either with no support or with weekly brief (15 minute) individual therapist guidance via email and phone. However, in order to provide a faster response to clients using an on the demand (responding as quickly as possible and for sure within one business day team based approach (e.g., first available therapist responds) may be beneficial.

The proposed trial will examine the Chronic Conditions Course delivered by a team at the Online Therapy Unit based at the University of Regina versus a self-directed program. In the team based approach, participants will be able to contact the Online Therapy Unit if they have any questions regarding the content of the Chronic Conditions Course during the 8 week program. Participants in this group will receive a response from one of the members of the team within one business day. In the self-directed group, clients will receive automatic messages from the Online Therapy Unit that encourage participation during the 8 week program but otherwise will work on the course on their own. All participants will complete questionnaires prior to the start of the program, before each lesson of the program, once they have completed the program, and 3 months after completing the program. The primary outcome measures include anxiety and depression. Secondary outcomes include fatigue, pain, self-efficacy, disability, overall quality of life, and life satisfaction.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety; Chronic Disease
• Intervention / Treatment: Behavioral: Team-Guided ICBT; Behavioral: Self-Guided ICBT

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4S 0A2
      • Online Therapy Unit, University of Regina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years of age or older
• residing in Canada
• endorsing symptoms of anxiety or depression
• diagnosed with a chronic medical health condition
• chronic condition does not impact ability to complete treatment (ex. cognitive impairment)
• able to access a computer and internet service
• willing to provide a physician as emergency contact

Exclusion Criteria:

• high suicide risk
• suicide attempt or hospitalization in the last year
• primary problems with psychosis, alcohol or drug problems, mania
• currently receiving active psychological treatment for anxiety or depression
• not present in country during treatment
• concerns about online therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Team-Guided ICBT; An 8-week transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) for persons with chronic conditions course will be delivered to participants. In addition to the online program, a guide from the Online Therapy Unit team will provide support within one business day of the client's email. The team of guides consist of registered social workers, psychologists or supervised graduate students, with experience delivering ICBT. Amount of contact will be personalized to participants' needs.	Behavioral: Team-Guided ICBT; An 8-week transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) for persons with chronic conditions course will be delivered to participants. In addition to the online program, a guide from the Online Therapy Unit team will respond within one business day of the client's email. The team of guides consist of registered social workers, psychologists or supervised graduate students, with experience delivering ICBT. Amount of contact will be personalized to participants' needs.
Active Comparator: Self-Guided ICBT; An 8-week transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) for persons with chronic conditions course will be delivered to participants. Participants are able to contact the Online Therapy Unit regarding any technical issues with logging onto the site. However, no psychological intervention will be provided. A team member from the Unit will contact the participant only if there is a significant clinical issue requiring attention (e.g., sudden increase in symptoms).	Behavioral: Self-Guided ICBT; An 8-week transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) for persons with chronic conditions course will be delivered to participants. Participants are able to contact the Online Therapy Unit regarding any technical issues with logging onto the site. However, no psychoeducational support will be provided. A team member from the Unit will contact the participant only if there is a significant clinical issue requiring attention (e.g., sudden increase in symptoms).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in depression	Measured by Patient Health Questionnaire - 9 Item (PHQ-9)	baseline, 8 weeks, 3 months
Change in anxiety	Measured by Generalize Anxiety Disorder - 7 Item (GAD7)	baseline, 8 weeks, 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment satisfaction	Measured by Internet-CBT Treatment Satisfaction Measure	8 weeks
Change in psychological distress	Measured by Kessler 10-Item Scale	baseline, 8 weeks, 3 months
Change in disability	Measured by World Health Organization Disability Assessment Schedule - 12 Item	baseline, 8 weeks, 3 months
Change in quality of life symptoms	Measured by 5-level EuroQol-5D version (EQ-5D-5L), items are added for a score ranging from 5-25 with total score indicating: 5-14 Mild problem, 15-24 Moderate, 25 Worst Health State	baseline, 8 weeks, 3 months
Change in pain	Measured by Brief Pain Inventory-Short Form	baseline, 8 weeks, 3 months
Change in fatigue	Measured by Fatigue Symptom Inventory	baseline, 8 weeks, 3 months
Change in life satisfaction	Measured by Satisfaction with Life Scale (SwLS), items are added together to get a score ranging from 5-35; Higher scores are indicative of greater life satisfaction	baseline, 8 weeks, 3 months
Change in self-efficacy	Measured by Self-Efficacy for Managing Chronic Disease 6-item Scale	baseline, 8 weeks, 3 months
Change in treatment costs	Measured by Treatment Inventory of Costs in Psychiatric Patients (TIC-P) Adapted for Canada	baseline, 3 months
Treatment credibility	Measured by Treatment Credibility Questionnaire (TCQ) which contains 4 items. The first three items range from 0-9 with higher scores indicating better outcome, and the fourth item ranges from 0-100%, with higher scores indicating greater improvement in functioning.	baseline

Collaborators and Investigators

• Sponsor: University of Regina

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2018
• Primary Completion (Actual): August 24, 2021
• Study Completion (Actual): August 24, 2021

Study Registration Dates

• First Submitted: April 9, 2018
• First Submitted That Met QC Criteria: April 13, 2018
• First Posted (Actual): April 18, 2018

Study Record Updates

• Last Update Posted (Actual): December 16, 2021
• Last Update Submitted That Met QC Criteria: December 15, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: randomized controlled trial; depression; anxiety; internet-delivered cognitive behaviour therapy; therapist-assistance; knowledge implementation; mental health system; patient-centered
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Disease Attributes; Depression; Chronic Disease
• Other Study ID Numbers: 2018-045

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