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

NCT ID: NCT03500237

Last Updated: 2021-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-16

Study Completion Date

2021-08-24

Brief Summary

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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.

Detailed Description

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Conditions

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Anxiety Depression Chronic Disease

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Team-Guided ICBT

Intervention Type BEHAVIORAL

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.

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).

Group Type ACTIVE_COMPARATOR

Self-Guided ICBT

Intervention Type BEHAVIORAL

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).

Interventions

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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.

Intervention Type 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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Regina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heather Hadjistavropoulos, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Regina

Locations

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Online Therapy Unit, University of Regina

Regina, Saskatchewan, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 35921055 (View on PubMed)

Other Identifiers

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2018-045

Identifier Type: -

Identifier Source: org_study_id