Therapeutic Moderators of Therapist-assisted Internet-delivered Cognitive Behavior Therapy

Depression Clinical Trial

Official title:

Therapeutics Moderators of Therapist-assisted Internet-delivered Cognitive Behavior Therapy for Depression and Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03957330
• Other study ID #: 2019-038
• Status: Completed
• Phase: N/A
• Start date: May 20, 2019
• Est. completion date: May 20, 2021

Study information

• Verified date: November 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 often go untreated. In an attempt to increase timely and accessible psychological treatment, Internet-delivered cognitive behavioural therapy (ICBT) has emerged. ICBT involves delivering therapeutic content via structured online lessons. This is often combined with therapist guidance, such as once per week contact via secure messaging or phone calls over several months. Over the past several years, the investigators have been studying the efficacy of ICBT for symptoms of depression and anxiety and found ~70% of patient's fully complete treatment and demonstrate large improvement in symptoms. Although outcomes of ICBT are very impressive, there is some room for improvement in terms of completion rates and outcomes.

In this three-factorial randomized controlled trial, the investigators aim to contribute to the literature by examining whether the efficacy of ICBT in routine practice is moderated by amount of contact (once versus twice a week), inclusion of homework reflection questionnaire (yes vs no) and location of therapist (specialized unit vs community mental health clinic). Follow-up measures will be carried out at 3, 6 and 12 months after randomization. Primary outcomes are reduced anxiety and depression. Secondary outcomes include psychological distress, panic, social anxiety, trauma, health anxiety, quality of life, disability, intervention usage (e.g., completion rates, log-ins, emails sent), satisfaction, therapeutic alliance, and costs (e.g., health care utilization).

Description:

Based on past research of ICBT in routine care, patients and therapists have expressed an interest in "personalizing" the delivery of ICBT, for example, by increasing the amount of therapist support available (from once a week to twice a week) to reflect the unique needs and preferences of the patients. Patients also express an interest in personalizing "therapy messages". One current barrier to offering more personalized messages, however, is that patients do not consistently provide information on their use of new treatment strategies, as well as strengths and challenges of using strategies. As a result, therapists find it difficult to personalize their messages. One method of overcoming this difficulty is to systematically ask patients to reflect on their use of treatment strategies (e.g., monitoring thoughts, challenging thoughts, controlled breathing, pleasant activities, and exposure) through questionnaires rather than relying on patients to provide this information in emails. Another factor that could moderate ICBT efficacy is therapist location. Some therapists who provide ICBT work in a specialized unit where there is primary focus on ICBT and daily attention to following ICBT guidelines. Other therapists deliver ICBT from community mental health clinics where the primary focus of the setting is on face-to-face care and there is lower familiarity with ICBT. It is possible that ICBT may be more effectively delivered in a setting where the primary focus is on ICBT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 631
• Est. completion date: May 20, 2021
• Est. primary completion date: May 20, 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, weeks 2, 4, 5, 7, 8 and 3-, 6-, and 12-month follow-up
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, weeks 2, 4, 5, 7, 8, and 3-, 6-, and 12-month follow-up
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.	Time Frame: Baseline, week 8, and 3-, 6-, and 12-month follow-up
Secondary	Social Interaction Anxiety Scale (6 items) and 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 48, with higher scores representing more severe self-reported symptoms of social anxiety	Time Frame: Baseline, Week 8, 3-, 6-, and 12-month follow-up
Secondary	PTSD Check List 5	Change in post-traumatic symptoms. The measure consists of 20 questions rated 0 to 4; higher scores indicate more trauma symptoms The first section assesses for exposure to a traumatic event using a checklist question. If the client endorses exposure to a traumatic event, they are provided the second section, which assesses severity of trauma symptoms. Items are summed into a total score, which can range between 0 and 80. Higher scores represent more severe self-reported symptoms of trauma.	Baseline, week 8 and 3-, 6-, and 12-month follow-up
Secondary	Short Health Anxiety Inventory-14	Change in health anxiety. 14 items with higher scores indicating higher levels of self-reported health anxiety.	Baseline, week 8 and 3-, 6-, and 12-month follow-up
Secondary	Kessler Psychological Distress	Change in psychological distress. Measured by 10-item scale rated 0 to 4; total score is created by summing items; higher scores signify greater psychological distress	Baseline, week 8, and 3-, 6-, and 12-month follow-up
Secondary	Quality of life questionnaire (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, week 8, and 3-, 6-, and 12-month follow-up
Secondary	Sheehan Disability Scale 3-item	Change in disability. Measure consists of 3 items rated 0 to 10 and summed to create total score, with higher scores indicating greater disability	Baseline, week 8, and 3-, 6-, and 12-month follow-up
Secondary	Treatment Inventory of Costs in Psychiatric Patients (TIC-P) Adapted for Canada	Change in treatment costs. A series of yes and no, rating, and frequency questions that are designed to ascertain the volume of medical consumption and productivity losses associated with mental health problems. Questions are independently analyzed and, therefore, the TIP-C does not include a total score.	Baseline and 3-, 6-, and 12-month follow-up
Secondary	Treatment Credibility Questionnaire	Change in treatment credibility. 4 items are summed into a total score. Higher scores representing greater perceptions of ICBT credibility.	Baseline, week 8, and 3-month follow-up
Secondary	Working Alliance Inventory Short-Form	Measures therapeutic alliance. Scores are summed into three sub-total scores, which respectively assess various domains of the therapeutic relationship (i.e., goal, task, and bond). Sub-total scores each range between 5 and 20, with higher scores representing better therapeutic relationship in each of the three domains assessed.	Baseline, week 8, and 3-, 6-, and 12-month follow-up
Secondary	Treatment 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	Week 8
Secondary	Treatment Satisfaction and Negative Effects Questionnaires	Measure includes 19 questions assessing satisfaction with various aspects of Internet-CBT and also negative effects of treatment	Week 8