Therapist-guided Internet-delivered Cognitive Behavioural Therapy

NCT03304392 | Completed

• 1 other identifier: 375860
• Study Type: interventional
• Target: 449
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in depression

  Measured by Patient Health Questionnaire - 9 Item (PHQ-9)

  baseline, start of each Lesson 2-5, 8 weeks, 3 months, 6 months, and 1 year follow up

• Change in anxiety

  Measured by Generalize Anxiety Disorder - 7 Item (GAD7)

  baseline, start of each Lesson 2-5, 8 weeks, 3 months, 6 months, and 1 year follow up

Secondary Outcomes (12)

• Change in psychological distress

  baseline, 8 weeks, 3 months, 6 months, and 1 year follow up

• Change in disability

  baseline, 8 weeks, 3 months, 6 months, and 1 year follow up

• Change in panic symptoms

  baseline, 8 weeks, 3 months, 6 months, and 1 year follow up

• Change in social anxiety symptoms

  baseline, 8 weeks, 3 months, 6 months, and 1 year follow up

• Change in social phobia symptoms

  baseline, 8 weeks, 3 months, 6 months, and 1 year follow up

Study Arms (2)

Personalized ICBT

EXPERIMENTAL

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.

Behavioral: Personalized ICBT

Standard ICBT

ACTIVE COMPARATOR

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.

Behavioral: Standard ICBT

Interventions

Personalized ICBT 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.

Personalized ICBT

Standard ICBT 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.

Standard ICBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Regina: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Online Therapy Unit, University of Regina

Regina, Saskatchewan, S4S 0A2, Canada

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Heather D Hadjistavropoulos, PhD

  University of Regina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: October 9, 2017
• Study Start: October 11, 2017
• Primary Completion: October 15, 2019
• Study Completion: October 15, 2019
• Last Updated: February 20, 2020

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)