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

Primary Purpose

Anxiety, Depression, Chronic Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Team-Guided ICBT
Self-Guided ICBT
Sponsored by
University of Regina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring anxiety, depression, internet-delivered cognitive behaviour therapy, randomized controlled trial, patient-centered, knowledge implementation, mental health system, therapist-assistance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Online Therapy Unit, University of Regina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Team-Guided ICBT

Self-Guided ICBT

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Change in depression
Measured by Patient Health Questionnaire - 9 Item (PHQ-9)
Change in anxiety
Measured by Generalize Anxiety Disorder - 7 Item (GAD7)

Secondary Outcome Measures

Change in psychological distress
Measured by Kessler 10-Item Scale
Change in disability
Measured by World Health Organization Disability Assessment Schedule - 12 Item
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
Change in pain
Measured by Brief Pain Inventory-Short Form
Change in fatigue
Measured by Fatigue Symptom Inventory
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
Change in self-efficacy
Measured by Self-Efficacy for Managing Chronic Disease 6-item Scale
Change in treatment costs
Measured by Treatment Inventory of Costs in Psychiatric Patients (TIC-P) Adapted for Canada
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.
Treatment satisfaction
Measured by Internet-CBT Treatment Satisfaction Measure

Full Information

First Posted
April 9, 2018
Last Updated
December 15, 2021
Sponsor
University of Regina
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1. Study Identification

Unique Protocol Identification Number
NCT03500237
Brief Title
Internet-delivered Cognitive Behaviour Therapy for Chronic Conditions: Comparing Low Intensity Delivery Models
Official Title
Effectiveness of Internet-delivered Cognitive Behaviour Therapy for Chronic Conditions: Comparing Low Intensity Delivery Models
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
April 16, 2018 (Actual)
Primary Completion Date
August 24, 2021 (Actual)
Study Completion Date
August 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Regina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression, Chronic Disease
Keywords
anxiety, depression, internet-delivered cognitive behaviour therapy, randomized controlled trial, patient-centered, knowledge implementation, mental health system, therapist-assistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
188 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Team-Guided ICBT
Arm Type
Experimental
Arm Description
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.
Arm Title
Self-Guided ICBT
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Team-Guided ICBT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Self-Guided ICBT
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in depression
Description
Measured by Patient Health Questionnaire - 9 Item (PHQ-9)
Time Frame
baseline, 8 weeks, 3 months
Title
Change in anxiety
Description
Measured by Generalize Anxiety Disorder - 7 Item (GAD7)
Time Frame
baseline, 8 weeks, 3 months
Secondary Outcome Measure Information:
Title
Change in psychological distress
Description
Measured by Kessler 10-Item Scale
Time Frame
baseline, 8 weeks, 3 months
Title
Change in disability
Description
Measured by World Health Organization Disability Assessment Schedule - 12 Item
Time Frame
baseline, 8 weeks, 3 months
Title
Change in quality of life symptoms
Description
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
Time Frame
baseline, 8 weeks, 3 months
Title
Change in pain
Description
Measured by Brief Pain Inventory-Short Form
Time Frame
baseline, 8 weeks, 3 months
Title
Change in fatigue
Description
Measured by Fatigue Symptom Inventory
Time Frame
baseline, 8 weeks, 3 months
Title
Change in life satisfaction
Description
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
Time Frame
baseline, 8 weeks, 3 months
Title
Change in self-efficacy
Description
Measured by Self-Efficacy for Managing Chronic Disease 6-item Scale
Time Frame
baseline, 8 weeks, 3 months
Title
Change in treatment costs
Description
Measured by Treatment Inventory of Costs in Psychiatric Patients (TIC-P) Adapted for Canada
Time Frame
baseline, 3 months
Title
Treatment credibility
Description
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.
Time Frame
baseline
Title
Treatment satisfaction
Description
Measured by Internet-CBT Treatment Satisfaction Measure
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Hadjistavropoulos, PhD
Organizational Affiliation
University of Regina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Online Therapy Unit, University of Regina
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4S 0A2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35921055
Citation
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.
Results Reference
derived

Learn more about this trial

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

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