Exploring Use of Internet-Delivered Cognitive Behaviour Therapy (ICBT) by Diverse Ethnocultural People of Saskatchewan

Depression Clinical Trial

Official title:

Pathways and Barriers to Access and Utilization of Internet-Delivered Cognitive Behaviour Therapy (ICBT) by Diverse Ethnocultural People of Saskatchewan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05523492
• Other study ID #: 2019-197b
• Status: Completed
• Phase: N/A
• Start date: June 14, 2022
• Est. completion date: February 20, 2023

Study information

• Verified date: May 2023
• Source: University of Regina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In an attempt to increase timely and accessible psychological treatment for depression and anxiety, Internet-delivered Cognitive Behaviour Therapy (ICBT) has emerged. In ICBT, patients review treatment materials online and complete relevant exercises to learn cognitive behavioural strategies. They also commonly access brief therapist support through weekly emails or phone calls. Data analysis of ICBT offered via the Online Therapy Unit in Saskatchewan has found lower participation in ICBT among individuals from diverse (non-white/ Caucasian) ethnocultural backgrounds. Furthermore, feedback from participants has identified opportunities to improve ICBT by: 1) simplifying language to improve clarity; 2) adding audiovisual content to aid with learning ICBT strategies; and 3) adding in diverse examples/stories to show applicability of ICBT to individuals with diverse backgrounds. The purpose of this study is to evaluate an ICBT program that has been improved in this way, called the Culturally Enhanced Wellbeing Course. Specifically, the observational pilot study with 30 clients from diverse ethnocultural backgrounds aims to examine improvements in depression and anxiety from pre to post treatment as well as patient experiences with the Culturally Enhanced Wellbeing Course.

Description:

In the last 10 years, the Online Therapy Unit has successfully provided ICBT to more than 10000 people experiencing mental health problems and there has been a growing demand and utilization of ICBT in Saskatchewan. However, a recent analysis of service utilization trends over six years shows that there has been a consistently low (11%) participation from the people of diverse (non-white/ Caucasian) ethnocultural groups in the ICBT program, called the Wellbeing Course. Furthermore, the number of ICBT lessons completed by the participants of diverse ethnocultural backgrounds was significantly lower compared to white/Caucasian participants. Review of feedback from participants from diverse ethnocultural backgrounds indicated a need to simplify the language of the course, and diversify the narratives in the stories which accompany the lessons to illustrate how the exercises can be used and how past participants have found the course. Participants also suggested the addition of audiovisual elements in conjunction with text throughout the lessons to improve understanding of materials. In this study, we will aim to evaluate the Culturally Enhanced Wellbeing Course among 30 treatment-seeking adults in Saskatchewan from diverse cultural backgrounds. The Culturally Enhanced Wellbeing Course will be evaluated through pre-post-treatment assessments using self-report questionnaires and individual semi-structured telephone interviews conducted toward the end of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: February 20, 2023
• Est. primary completion date: February 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• 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
• Self-identifying as having a diverse ethnocultural background

Exclusion Criteria:

• Have a severe unmanaged 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
• Depression

Intervention

Behavioral:
• Internet-delivered Cognitive Behavioural Therapy
All clients will receive the Culturally Enhanced Wellbeing Course. The Course was originally developed at Macquarie University in Australia and was then culturally enhanced by the Online Therapy Unit in Saskatchewan Canada. The course is a trans-diagnostic Internet-delivered cognitive behaviour therapy intervention targeting symptoms of depression and anxiety. 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 order over 8 weeks. Therapists will spend ~15 mins. per week/per client offering support via emails and or phone calls.

Locations

Country	Name	City	State
Canada	Department of Psychology	Regina	Saskatchewan

Sponsors (2)

Lead Sponsor	Collaborator
University of Regina	Saskatchewan Health Research Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Health Questionnaire 9-item (PHQ-9)	Tracking the 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 1-8, and 20 week from enrollment
Primary	Generalized Anxiety Disorder 7-item (GAD-7)	Tracking the 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 1-8 and 20 week from enrollment
Primary	ICBT Experience Interview Guide	This measure includes 12 items to gain feedback on participant experience of Wellbeing Course.	Week 6
Primary	Mid-point Additional Resource Satisfaction Questionnaire	Gathering feedback on the Additional Resources up to this time point. This measure includes 3 questions, one in which is open-ended.	Week 4 from enrollment
Primary	Post-treatment Additional Resource Satisfaction Questionnaire	Gathering feedback on the Additional Resources up to this time point. This measure includes 3 questions, one in which is open-ended.	Week 8 from enrollment
Primary	Mid-point Patient Story Satisfaction Questionnaire	Gathering feedback on the patient stories up to this time point. This measure includes 4 questions to quantify quality of participant Stories.	Week 4 from enrollment
Primary	Post-treatment Patient Story Satisfaction Questionnaire	Gathering feedback on the patient stories up to this time point. This measure includes 4 questions to quantify quality of participant Stories.	Week 8 from enrollment
Secondary	Adjustment Disorder New Model 8 (ADNM)	Measure includes 8 questions to determine severity of impact of a specific event. High scores indicate a greater degree of Adjustment Disorder	Baseline (Screening) week 8 and week 20 from enrollment
Secondary	Treatment Satisfaction	Measure includes 17 questions assessing satisfaction with various aspects of ICBT and also negative effects of treatment. Items are not summed but are examined individually.	Week 8 from enrollment