Therapist-guided Internet-delivered Cognitive Behavioural Therapy

Depression Clinical Trial

Official title:

Advancing Mental Health Care by Improving the Delivery of Therapist-guided, Internet-delivered Cognitive Behavioural Therapy in Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03304392
• Other study ID #: 375860
• Status: Completed
• Phase: N/A
• Start date: October 11, 2017
• Est. completion date: October 15, 2019

Study information

• Verified date: November 2019
• Source: University of Regina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 449
• Est. completion date: October 15, 2019
• Est. primary completion date: October 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Canada	Online Therapy Unit, University of Regina	Regina	Saskatchewan

Sponsors (2)

Lead Sponsor	Collaborator
University of Regina	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in psychological distress	Measured by Kessler 10-Item Scale	baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
Secondary	Change in disability	Measure by Sheehan Disability Scale-3 Item	baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
Secondary	Change in panic symptoms	Measured by Panic Disorder Severity Scale-Self Report	baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
Secondary	Change in social anxiety symptoms	Measured by Social Interaction Anxiety Scale	baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
Secondary	Change in social phobia symptoms	Measured by Social Phobia Scale-Short form	baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
Secondary	Change in post-traumatic symptoms	Measured by PTSD Checklist 5	Administered to only those participants meeting criteria for post-traumatic stress based on the modified brief Life Events Checklist for DSM 5 (LEC-5) at each time point: baseline, 3 months, 6 months, and 1 year follow up
Secondary	Change in quality of life symptoms	Measured by EQ-5D-5L	baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
Secondary	Change in treatment costs	Measured by Treatment Inventory of Costs in Psychiatric Patients (TIC-P) Adapted for Canada	Part 1 and 2: baseline, 3 months, 6 months, and 1 year follow up; Part 3: baseline and 1 year follow up
Secondary	Therapeutic alliance	Measured by Working Alliance Inventory-Short Form	8 weeks
Secondary	Treatment credibility	Measured by Credibility Questionnaire	baseline and 8 weeks
Secondary	Treatment satisfaction	Measured by Internet-CBT Treatment Satisfaction Measure	8 weeks
Secondary	Engagement	Measured by: number of lessons completed, number of days of access, number of emails sent to therapist, number of phone calls with therapist, number of emails from therapist to client, total words emailed to therapist, total words emailed from therapist to patient	8 weeks