Anxiety, Depression
Conditions
Keywords
anxiety, depression, internet-delivered cognitive behaviour therapy, randomized controlled trial, patient-centred, personalized therapy, knowledge implementation, mental health system, therapist-assistance, booster session, factorial design
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
Canadian Institutes of Health Research (CIHR)
University of Regina
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire 9-item (PHQ-9) | 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. |
| Generalized Anxiety Disorder 7-item (GAD-7) | 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
| Measure | Time frame | Description |
|---|---|---|
| Social Phobia Scale-Short form (6 items) | 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 |
| Quality of Life (EQ-ED-5L) | 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. |
| Mental Health Service Use, Medication, and Employment | 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. |
| Treatment Satisfaction | 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 |
| Panic Disorder Severity Scale Self-report | 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. |
| Sheehan Disability Scale (SDS) | 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. |
| Life Events Checklist for DSM-5 (LEC-5) | 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. |
| PTSD Checklist for DSM-5 (PCL-5) | 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. |
| Insomnia Severity Index (ISI) | Baseline | Measure includes 7 questions rated on a 0-4 point scale with higher scores indicative of higher levels of insomnia. |
| Social Interaction Anxiety Scale (6 items) | 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 |
Countries
Canada
Outcome results
None listed