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

• ClinicalTrials.gov Identifier: NCT03500237
• Recruitment Status: Completed
• First Posted: April 18, 2018
• Last Update Posted: December 16, 2021
• Sponsor: University of Regina
• Information provided by (Responsible Party): University of Regina

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Anxiety; Depression; Chronic Disease	Behavioral: Team-Guided ICBT; Behavioral: Self-Guided ICBT	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 188 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effectiveness of Internet-delivered Cognitive Behaviour Therapy for Chronic Conditions: Comparing Low Intensity Delivery Models
• Actual Study Start Date: April 16, 2018
• Actual Primary Completion Date: August 24, 2021
• Actual Study Completion Date: August 24, 2021

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures :

1. Change in depression [ Time Frame: baseline, 8 weeks, 3 months ]
   Measured by Patient Health Questionnaire - 9 Item (PHQ-9)
2. Change in anxiety [ Time Frame: baseline, 8 weeks, 3 months ]
   Measured by Generalize Anxiety Disorder - 7 Item (GAD7)

Secondary Outcome Measures :

1. Change in psychological distress [ Time Frame: baseline, 8 weeks, 3 months ]
   Measured by Kessler 10-Item Scale
2. Change in disability [ Time Frame: baseline, 8 weeks, 3 months ]
   Measured by World Health Organization Disability Assessment Schedule - 12 Item
3. Change in quality of life symptoms [ Time Frame: baseline, 8 weeks, 3 months ]
   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
4. Change in pain [ Time Frame: baseline, 8 weeks, 3 months ]
   Measured by Brief Pain Inventory-Short Form
5. Change in fatigue [ Time Frame: baseline, 8 weeks, 3 months ]
   Measured by Fatigue Symptom Inventory
6. Change in life satisfaction [ Time Frame: baseline, 8 weeks, 3 months ]
   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
7. Change in self-efficacy [ Time Frame: baseline, 8 weeks, 3 months ]
   Measured by Self-Efficacy for Managing Chronic Disease 6-item Scale
8. Change in treatment costs [ Time Frame: baseline, 3 months ]
   Measured by Treatment Inventory of Costs in Psychiatric Patients (TIC-P) Adapted for Canada
9. Treatment credibility [ Time Frame: baseline ]
   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.
10. Treatment satisfaction [ Time Frame: 8 weeks ]
    Measured by Internet-CBT Treatment Satisfaction Measure

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Canada, Saskatchewan

Online Therapy Unit, University of Regina

Regina, Saskatchewan, Canada, S4S 0A2

Sponsors and Collaborators

University of Regina

Investigators

• Principal Investigator: Heather Hadjistavropoulos, PhD; University of Regina

More Information

• Responsible Party: University of Regina
• ClinicalTrials.gov Identifier: NCT03500237
• Other Study ID Numbers: 2018-045
• First Posted: April 18, 2018
• Last Update Posted: December 16, 2021
• Last Verified: December 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Regina:

anxiety; depression; internet-delivered cognitive behaviour therapy; randomized controlled trial; patient-centered; knowledge implementation; mental health system; therapist-assistance

Additional relevant MeSH terms:

Chronic Disease; Depression; Behavioral Symptoms; Disease Attributes; Pathologic Processes