NCT03711344

Brief Summary

This mixed methods study proposes a culturally adapted cognitive behavioural therapy (CA-CBT) model for a Chinese demographic in Canada. The client population of Chinese youth who have been diagnosed with anxiety and/or depression are the focus of the study. CBT has been proven as a very effective form of therapy, and when adapted can promote positive mental health outcomes for a growing and increasingly vulnerable population. Developing a culturally adapted version of CBT (CA-CBT) for this population adds a practical treatment that improves access to culturally relevant care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Jan 2019

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 18, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

January 4, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

April 28, 2026

Status Verified

January 1, 2019

Enrollment Period

12 months

First QC Date

September 11, 2018

Last Update Submit

April 23, 2026

Conditions

Keywords

Cognitive Behavioral TherapyCultural AdaptationChinese Youth

Outcome Measures

Primary Outcomes (2)

  • Severity levels of depression and anxiety rated by the Hospital Anxiety and Depression Scale (HADS).

    Severity levels of depression and anxiety will be rated pre- and post-intervention by the Hospital Anxiety and Depression Scale (HADS). The scale ranges from 0 to 21 for anxiety and 0 to 21 for depression. A score of 0 to 7 for depression and/or anxiety is considered a normal range. A score of 8 to 10 suggests the potential presence of depression and/or anxiety. A score of 11 or more suggests a likely presence of depression and/or anxiety.

    4 months.

  • Severity levels of depression and anxiety rated by the Bradford Somatic Inventory (BSI).

    Severity levels of depression and anxiety will be rated pre- and post-intervention by the Bradford Somatic Inventory (BSI). The Bradford Somatic Inventory uses "yes" or "no" questions relating to somatic symptoms of anxiety and/or depression. A "yes" response to a question equates to a somatic symptom linked to depression and/or anxiety. The maximum number of "yes" responses is 46 and the minimum is 0. A higher number of "yes" responses suggests a potential increase in the severity of depression and/or anxiety.

    4 months.

Secondary Outcomes (1)

  • Satisfaction of the culturally adapted Cognitive Behavioral Therapy assessed using the Verona Satisfaction Scale.

    4 months.

Study Arms (1)

Culturally adapted Cognitive Behavioral Therapy

EXPERIMENTAL

The experimental group will receive the culturally adapted version of cognitive behavioral therapy.

Behavioral: Cognitive Behavioral Therapy

Interventions

The intervention will be administered by therapists working at community agencies who are experienced at providing Cognitive Behavioral Therapy.

Culturally adapted Cognitive Behavioral Therapy

Eligibility Criteria

Age12 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Self identification as Chinese origin
  • Between the ages of 12 to 21
  • Diagnosed as having depression and/or anxiety

You may not qualify if:

  • Have been affected by psychosis
  • Have been affected by serious addiction
  • Have been affected by cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East Metro Youth Services

Scarborough Village, Ontario, M1H 3C3, Canada

Location

MeSH Terms

Conditions

Anxiety DisordersDepression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Farooq Naeem, M.D.

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR
  • Myra Levy, M.A.

    East Metro Youth Services

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Chinese youth diagnosed with anxiety and/or depression will receive the culturally adapted Cognitive Behavioural Therapy. The severity of the anxiety and/or depression will be evaluated pre- and post-intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2018

First Posted

October 18, 2018

Study Start

January 4, 2019

Primary Completion

December 30, 2019

Study Completion

December 30, 2019

Last Updated

April 28, 2026

Record last verified: 2019-01

Locations