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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04228575
• Other study ID #: 2019-197
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: December 2021
• Source: University of Regina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 410
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder

Intervention

Behavioral:
• Internet-delivered cognitive behaviour therapy
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.

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	Patient Health Questionnaire 9-item (PHQ-9)	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.	Baseline (Screening), weeks 1-12, 16 and 26 week from enrollment
Primary	Generalized Anxiety Disorder 7-item (GAD-7)	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.	Baseline (Screening), weeks 1-12 and 16 and 26 week from enrollment
Secondary	Panic Disorder Severity Scale Self-report	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.	Baseline (Screening), week 8, 16 and 26 week from enrollment
Secondary	Social Interaction Anxiety Scale (6 items)	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	Baseline (Screening), week 8, 16 and 26 week from enrollment
Secondary	Social Phobia Scale-Short form (6 items)	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	Baseline (Screening), week 8, 16 and 26 week from enrollment
Secondary	Quality of Life (EQ-ED-5L)	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.	Baseline (Screening), week 8, 16 and 26 week from enrollment
Secondary	Mental Health Service Use, Medication, and Employment	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.	Baseline (Screening) and Week 26 week from enrollment
Secondary	Treatment Satisfaction	Measure includes 19 questions assessing satisfaction with various aspects of Internet-CBT and also negative effects of treatment	Week 8, 16 and 26 week from enrollment
Secondary	Insomnia Severity Index (ISI)	Measure includes 7 questions rated on a 0-4 point scale with higher scores indicative of higher levels of insomnia.	Baseline
Secondary	Sheehan Disability Scale (SDS)	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.	Baseline (Screening), week 8, 16 and 26 week from enrollment
Secondary	Life Events Checklist for DSM-5 (LEC-5)	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.	Baseline (Screening)
Secondary	PTSD Checklist for DSM-5 (PCL-5)	Higher total scores indicate greater severity of posttraumatic stress. Scores range from 0 to 80.	Baseline (Screening), week 8, 16 and 26 week from enrollment