Skip to main content
OpenTrials
Completed

NCT Number: NCT04228575

Optimizing Duration of Therapist-guided Internet-delivered Cognitive Behaviour Therapy

Depression and anxiety are common and prevalent conditions that are frequently under treated. In an attempt to increase timely and accessible psychological treatment, Internet-delivered Cognitive Behaviour Therapy (ICBT) has emerged. ICBT involves delivering therapeutic content to manage depression and or anxiety via structured online lessons. This is often combined with brief therapist guidance, for example once per week for 8 weeks via secure messaging or phone calls. Although outcomes of ICBT are very impressive, there is room for improvement in terms of completion rates and outcomes. Feedback from patients suggest that some patients would prefer longer term support or follow-up care.

In this two-factorial randomized controlled trial, the investigators aim to contribute to the literature by examining whether the efficacy of ICBT is improved by offering an extended period of support to clients (from 8 weeks to 12 weeks) and being offered a booster session at 16 weeks after treatment enrollment (yes vs no). Follow-up assessments will be conducted at 8, 16 and 26 weeks after treatment enrollment. Primary outcomes are reduced anxiety and depression. Secondary outcomes include reduced panic, social anxiety, trauma, quality of life, disability, work productivity, and healthcare use.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

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

About this study

Past research of ICBT offered in routine care has found that patients and therapists often recommend "personalizing" the delivery of ICBT, for example, by increasing the length of time therapist support is available or offering booster sessions after treatment has ended. To date, in terms of ICBT, there has been limited research on the impact of extending support after treatment materials have been delivered or offering a booster session.

In this trial, the investigators will examine if the efficacy of ICBT is improved by offering an extended period of support to clients (from 8 weeks to 12 weeks) or by being offered a booster session at 16 weeks after treatment enrollment (yes vs no). Follow-up assessments will be conducted at 8, 16 and 26 weeks after treatment enrollment. Primary outcomes are reduced anxiety and depression. Secondary outcomes include reduced panic, social anxiety, trauma, quality of life, disability, work productivity, and healthcare use. The impact of these factors on intervention usage (e.g., completion rates, log-ins, emails sent) and treatment satisfaction will also be examined.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years or older
  • Endorse symptoms of anxiety or depression
  • Resident of Saskatchewan
  • Access to a computer and the Internet

Exclusion criteria

  • Have a severe psychiatric illness (e.g. psychosis)
  • Assessed as being at high risk of suicide
  • Report severe problems with alcohol or drugs
  • Report severe cognitive impairment

Treatment and study plan

Internet-delivered cognitive behaviour therapy

Behavioral

All clients will receive the Wellbeing Course developed at Macquarie University, Australia. The Wellbeing Course is a transdiagnostic Internet-delivered cognitive behaviour intervention targeting symptoms of depressive and anxiety disorders. It comprises 5 online lessons targeting: 1) symptom identification and the cognitive behavioural model; 2) thought monitoring and challenging; 3) de-arousal strategies and pleasant activity scheduling; 4) graduated exposure; and 5) relapse prevention. Materials are presented in a didactic (i.e., text-based with visual images) and case-enhanced learning format (i.e., educational stories demonstrate the application of skills) and include homework activities. Lessons are released gradually in a standardized order over 8 weeks. Phone calls will only be made if there is a significant clinical issue requiring therapist attention that cannot be addressed over email (e.g., sudden increase in symptoms). Therapists will spend ~15 mins. per week/per client.

Primary outcomes

  1. Patient Health Questionnaire 9-item (PHQ-9)

    Time frame: Baseline (Screening), weeks 1-12, 16 and 26 week from enrollment

    Change in depression symptoms. 9 items are summed into a total score, with scores ranging from 0 to 27. Higher scores are associated with higher depression severity.

  2. Generalized Anxiety Disorder 7-item (GAD-7)

    Time frame: Baseline (Screening), weeks 1-12 and 16 and 26 week from enrollment

    Change in anxiety symptoms. 7 items are summed into a total score ranging from 0 to 21, with higher scores indicating more severe self-reported levels of anxiety.

Secondary outcomes

  1. Panic Disorder Severity Scale Self-report

    Time frame: Baseline (Screening), week 8, 16 and 26 week from enrollment

    Change in panic symptoms. Items are summed into a total score. Total scores range between 0 and 28, with higher scores representing more severe self-reported symptoms of panic.

  2. Social Interaction Anxiety Scale (6 items)

    Time frame: Baseline (Screening), week 8, 16 and 26 week from enrollment

    Change in social anxiety symptoms. Items from the two measures are summed into a total score. Total scores range between 0 and 24, with higher scores representing more severe self-reported symptoms of social phobia

  3. Social Phobia Scale-Short form (6 items)

    Time frame: Baseline (Screening), week 8, 16 and 26 week from enrollment

    Change in social anxiety symptoms. Items from the two measures are summed into a total score. Total scores range between 0 and 24, with higher scores representing more severe self-reported symptoms of social phobia

  4. Quality of Life (EQ-ED-5L)

    Time frame: Baseline (Screening), week 8, 16 and 26 week from enrollment

    Change in quality of life. Items are summed into six sub-total scores. The first five sub-total scores respectively assess various domains of quality of life (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression).

    Each of the five sub-total scores range between 1 and 5, with higher scores representing greater self-reported severity and impairment in these various domains. The last sub-total score provides an overall index of health and can range between 0 and 100, with higher scores representing better self-reported health.

  5. Mental Health Service Use, Medication, and Employment

    Time frame: Baseline (Screening) and Week 26 week from enrollment

    This measure is 19 items and measures direct and indirect cost of mental health symptoms. Frequency of visits to health specialists (e.g., family doctor, walk-in clinic, psychiatrist, psychologist, social worker, nurse/community nurse/psychiatric nurse) or use of health services (e.g. psychiatric day-patient/part-time treatment, alcohol or drug treatment program, self-help group, ambulance/paramedics, crisis service, hospital admission) in the previous 3 months for mental health reasons are collected. Medication use/changes in previous 3 months for mental health concerns. Questions about occupation, hours in contract, and time off work in previous 3 months for mental health concerns.

  6. Treatment Satisfaction

    Time frame: Week 8, 16 and 26 week from enrollment

    Measure includes 19 questions assessing satisfaction with various aspects of Internet-CBT and also negative effects of treatment

  7. Insomnia Severity Index (ISI)

    Time frame: Baseline

    Measure includes 7 questions rated on a 0-4 point scale with higher scores indicative of higher levels of insomnia.

  8. Sheehan Disability Scale (SDS)

    Time frame: Baseline (Screening), week 8, 16 and 26 week from enrollment

    Higher total scores indicate a greater degree of impairment. Total scores range from 0 to 30. Scores in each of 3 specific life domains range from 0 to 10.

  9. Life Events Checklist for DSM-5 (LEC-5)

    Time frame: Baseline (Screening)

    Life Events Checklist for DSM-5 (LEC-5). A checklist of common traumatic events used to establish the nature of the traumatic events a respondent has experienced. This questionnaire is not intended to be scored but is used for descriptive purposes.

  10. PTSD Checklist for DSM-5 (PCL-5)

    Time frame: Baseline (Screening), week 8, 16 and 26 week from enrollment

    Higher total scores indicate greater severity of posttraumatic stress. Scores range from 0 to 80.

Sponsors and collaborators

Lead sponsor

University of Regina

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Optimizing Duration of Therapist-guided Internet-delivered Cognitive Behaviour Therapy for Anxiety and Depression

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 14, 2020
Registry last updated
Dec 16, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.