Therapist-guided Internet-delivered Cognitive Behavioural Therapy

NCT ID: NCT03304392

Last Updated: 2020-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 449 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-11
• Study Completion Date: 2019-10-15

Brief Summary

Depression and anxiety are prevalent and disabling conditions that often go untreated. Internet-delivered Cognitive Behaviour Therapy (ICBT) is a relatively new approach to treatment that is a convenient way for patients to access care. ICBT is typically highly standardized and involves patients reviewing weekly lessons over the Internet. Patients also receive brief weekly support from a therapist via secure emails or phone calls. Past research shows that ~75% of patients complete ICBT and report large symptom improvements. Although these results are very promising, research also suggests that ICBT could potentially be improved by being more personalized in terms of amount of therapist contact, especially for clients with more severe symptoms. The current trial will involve therapists who work in a clinic that specializes in ICBT. Over one year, 440 patients with depression and/or anxiety will be randomized to either receive standardized (5 lessons completed in 8 weeks; once week therapist contact) or personalized ICBT (5 lessons completed in 8 weeks; personalized therapist contact depending on needs of patient). Psychosocial outcomes of patients in the two treatment arms will be compared post-treatment and at 3-month, 6-month, and 1-year follow-up from enrollment. Data on intervention usage, satisfaction measures, and costs will also be assessed.

Conditions

Anxiety; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Personalized ICBT

An 8-week transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants. All clients will receive support from registered social workers, psychologists or supervised graduate students, with experience delivering ICBT, with contact depending upon group allocation. In addition to the online program, therapists, registered social workers, psychologists or supervised graduate students, with experience delivering ICBT will provide support within one business day of client emails. Amount of contact will be personalized to patients' needs.

Group Type: EXPERIMENTAL

Personalized ICBT

Intervention Type: BEHAVIORAL

An 8-week transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants. All clients will receive support from registered social workers, psychologists or supervised graduate students, with experience delivering ICBT, with contact depending upon group allocation. In addition to the online program, therapists, registered social workers, psychologists or supervised graduate students, with experience delivering ICBT will provide support within one business day of client emails. Amount of contact will be personalized to patients' needs.

Standard ICBT

An 8-week transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants. All clients will receive support from registered social workers, psychologists or supervised graduate students, with experience delivering ICBT, with contact depending upon group allocation. In addition to the online program, therapists, registered social workers, psychologists or supervised graduate students, with experience delivering ICBT will provide support by email only once a week. Therapist will spend approximately 15 minutes per week/per client.

Group Type: ACTIVE_COMPARATOR

Standard ICBT

Intervention Type: BEHAVIORAL

An 8-week transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants. All clients will receive support from registered social workers, psychologists or supervised graduate students, with experience delivering ICBT, with contact depending upon group allocation. In addition to the online program, therapists, registered social workers, psychologists or supervised graduate students, with experience delivering ICBT will provide support by email only once a week. Therapist will spend approximately 15 minutes per week/per client.

Interventions

Personalized ICBT

An 8-week transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants. All clients will receive support from registered social workers, psychologists or supervised graduate students, with experience delivering ICBT, with contact depending upon group allocation. In addition to the online program, therapists, registered social workers, psychologists or supervised graduate students, with experience delivering ICBT will provide support within one business day of client emails. Amount of contact will be personalized to patients' needs.

Intervention Type: BEHAVIORAL

Standard ICBT

An 8-week transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants. All clients will receive support from registered social workers, psychologists or supervised graduate students, with experience delivering ICBT, with contact depending upon group allocation. In addition to the online program, therapists, registered social workers, psychologists or supervised graduate students, with experience delivering ICBT will provide support by email only once a week. Therapist will spend approximately 15 minutes per week/per client.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 18 years of age or older
• residing in Saskatchewan, Canada
• endorsing symptoms of anxiety or depression
• 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 province during treatment; concerns about online therapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

University of Regina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heather D Hadjistavropoulos, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Regina

Locations

Online Therapy Unit, University of Regina

Regina, Saskatchewan, Canada

Countries

Canada

Other Identifiers

375860

Identifier Type: -

Identifier Source: org_study_id