NCT05523492

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 14, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2023

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

8 months

First QC Date

August 29, 2022

Last Update Submit

May 8, 2023

Conditions

Keywords

anxietydepressiontherapist-assistanceinternet-delivered cognitive behaviour therapypatient-centred therapyknowledge implementationmental health system

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • ICBT Experience Interview Guide

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

    Week 6

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Adjustment Disorder New Model 8 (ADNM)

    Baseline (Screening) week 8 and week 20 from enrollment

  • Treatment Satisfaction

    Week 8 from enrollment

Study Arms (1)

Culturally Enhanced Wellbeing Course

EXPERIMENTAL

For this study, the ICBT program, called the Wellbeing Course was culturally enhanced by simplifying language for individuals with limited command of English, acknowledging cultural differences and increase representation in imagery. Audiovisual components were included to provide a brief summary of each lesson. Furthermore, additional client stories were added to the intervention to diversify narratives and be more representative of the clients seeking this intervention.

Behavioral: Internet-delivered Cognitive Behavioural Therapy

Interventions

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.

Culturally Enhanced Wellbeing Course

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology

Regina, Saskatchewan, S4S 0A2, Canada

Location

Related Publications (1)

  • Sapkota RP, Valli E, Dear BF, Titov N, Hadjistavropoulos HD. Satisfaction, engagement, and outcomes in internet-delivered cognitive behaviour therapy adapted for people of diverse ethnocultural groups: an observational trial with benchmarking. Front Psychiatry. 2024 Mar 4;15:1270543. doi: 10.3389/fpsyt.2024.1270543. eCollection 2024.

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Heather Hadjistavropoulos, PhD

    University of Regina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2022

First Posted

August 31, 2022

Study Start

June 14, 2022

Primary Completion

February 20, 2023

Study Completion

February 20, 2023

Last Updated

May 10, 2023

Record last verified: 2023-05

Locations