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Completed

NCT Number: NCT03304392

Therapist-guided Internet-delivered Cognitive Behavioural Therapy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Online Therapy Unit, University of Regina

Regina, Saskatchewan, S4S 0A2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in depression

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

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

  2. Change in anxiety

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

    Measured by Generalize Anxiety Disorder - 7 Item (GAD7)

Secondary outcomes

  1. Change in psychological distress

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

    Measured by Kessler 10-Item Scale

  2. Change in disability

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

    Measure by Sheehan Disability Scale-3 Item

  3. Change in panic symptoms

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

    Measured by Panic Disorder Severity Scale-Self Report

  4. Change in social anxiety symptoms

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

    Measured by Social Interaction Anxiety Scale

  5. Change in social phobia symptoms

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

    Measured by Social Phobia Scale-Short form

  6. Change in post-traumatic symptoms

    Time frame: 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

    Measured by PTSD Checklist 5

  7. Change in quality of life symptoms

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

    Measured by EQ-5D-5L

  8. Change in treatment costs

    Time frame: Part 1 and 2: baseline, 3 months, 6 months, and 1 year follow up; Part 3: baseline and 1 year follow up

    Measured by Treatment Inventory of Costs in Psychiatric Patients (TIC-P) Adapted for Canada

  9. Therapeutic alliance

    Time frame: 8 weeks

    Measured by Working Alliance Inventory-Short Form

  10. Treatment credibility

    Time frame: baseline and 8 weeks

    Measured by Credibility Questionnaire

  11. Treatment satisfaction

    Time frame: 8 weeks

    Measured by Internet-CBT Treatment Satisfaction Measure

  12. Engagement

    Time frame: 8 weeks

    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

Sponsors and collaborators

Lead sponsor

University of Regina

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 9, 2017
Registry last updated
Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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