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Completed

NCT Number: NCT05523492

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

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.

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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

Department of Psychology

Regina, Saskatchewan, S4S 0A2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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
  • 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

Treatment and study plan

Internet-delivered cognitive behavioural therapy

Behavioral

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.

Primary outcomes

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

    Time frame: Baseline (Screening), weeks 1-8, and 20 week from enrollment

    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.

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

    Time frame: Baseline (Screening), weeks 1-8 and 20 week from enrollment

    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.

  3. ICBT Experience Interview Guide

    Time frame: Week 6

    This measure includes 12 items to gain feedback on participant experience of Wellbeing Course.

  4. Mid-point Additional Resource Satisfaction Questionnaire

    Time frame: Week 4 from enrollment

    Gathering feedback on the Additional Resources up to this time point. This measure includes 3 questions, one in which is open-ended.

  5. Post-treatment Additional Resource Satisfaction Questionnaire

    Time frame: Week 8 from enrollment

    Gathering feedback on the Additional Resources up to this time point. This measure includes 3 questions, one in which is open-ended.

  6. Mid-point Patient Story Satisfaction Questionnaire

    Time frame: Week 4 from enrollment

    Gathering feedback on the patient stories up to this time point. This measure includes 4 questions to quantify quality of participant Stories.

  7. Post-treatment Patient Story Satisfaction Questionnaire

    Time frame: Week 8 from enrollment

    Gathering feedback on the patient stories up to this time point. This measure includes 4 questions to quantify quality of participant Stories.

Secondary outcomes

  1. Adjustment Disorder New Model 8 (ADNM)

    Time frame: Baseline (Screening) week 8 and week 20 from enrollment

    Measure includes 8 questions to determine severity of impact of a specific event. High scores indicate a greater degree of Adjustment Disorder

  2. Treatment Satisfaction

    Time frame: Week 8 from enrollment

    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.

Sponsors and collaborators

Lead sponsor

University of Regina

Other

Collaborators

  • Saskatchewan Health Research Foundation

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 31, 2022
Registry last updated
May 10, 2023

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.

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