A Chinese Version of the Thinking Health Program for East Asian Pregnant Immigrant People in Canada

NCT06446089 | Recruiting

• 2 other identifiers: 6041350FRN 154988
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to determine the feasibility of using a psychosocial intervention culturally adapted in China to support perinatal mental well-being of Chinese immigrant pregnant women in Canada. The intervention is adapted from the Thinking Healthy Program (THP), available through a mobile application, and will be offered to Chinese immigrant pregnant women (22 weeks' gestation or greater) residing in Canada, who are over the age of 18, and speak Mandarin. The main questions this study aims to answer are:

• Will the Chinese version of the THP be acceptable to Chinese immigrant pregnant women residing in Canada and will they use the program which is delivered through a mobile App?
• How well does the process of recruiting, keeping participants in the study and helping them complete the activities work, so it can be used for a future larger study? Women interested in the study and who meet the study criteria will complete a questionnaire at the start of the study, then use the THP for three weeks, complete questionnaires 3-4 weeks after completing the intervention and 6-8 weeks after having their baby(ies). Some may be asked to participate in an individual interview.

Conditions

Perinatal Depression

Keywords

immigrant women; East-Asian immigrants

Outcome Measures

Primary Outcomes (5)

• Score on the System Usability Scale (SUS) 10 points

  Objective measurement of usability of internet-based cognitive behavioural therapy

  3-4 weeks after initiation of intervention

• Acceptability of app-based THP

  Structured questions based on seven domains of Sekhon's Theoretical Framework of Acceptability

  3-4 weeks after initiation of intervention

• Recruitment to study

  Through RedCap-captured data and study intervention App-derived user data. Number of participants approached and recruited to the study will be tracked, and reported in a participant flow diagram.

  During recruitment to study, expected 4 months

• Retention in study

  Number of participants lost to follow-up (i.e., these may include dropouts who use the brief Chinese version of the THP mobile App but fail to complete the follow-up assessments), as well as number of participants with partial or complete data for analysis will be tracked.

  Through study completion, an average of 12 months.

• Adherence to intervention

  Defined as the extent to which individuals experience the content of the brief Chinese version of the THP mobile App (i.e., average amount of time participants spend on the modules, average amount of time participants use of the health assistants and tools within the app). Measured through App-derived user data.

  Through intervention duration, an average of 3-4 weeks.

Secondary Outcomes (1)

• Effectiveness of app-based THP

  Baseline, 3-4 weeks after initiation of intervention, and 6-8 weeks post-partum

Other Outcomes (10)

• Pregnancy-related anxiety

  Baseline, & 3-4 weeks after initiation of intervention

• Somatic symptoms

  Baseline, 3-4 weeks after initiation of intervention, and 6-8 weeks post-partum

• Psychological stress

  Baseline, 3-4 weeks after initiation of intervention, and 6-8 weeks post-partum

Study Arms (1)

Adapted THP group

EXPERIMENTAL

Participants will be invited to complete three modules relevant to the health and well-being of mothers and fetus/infants during the perinatal period, through an Android based app on their mobile device. In addition, each section incorporates the three healthy thinking steps to help the mother negotiate each of the three areas. After the introductory session, each session involves four tasks that mothers are required to complete. The tasks include 1) a review of the key message from the previous section, 2) a review of the mood chart, 3) engaging in the three steps to thinking healthy on the designated area for the section, and 4) practicing suggested activities between sessions.

Behavioral: THP: cognitive behavior therapy and behavioral activation

Interventions

THP: cognitive behavior therapy and behavioral activation BEHAVIORAL

The adapted THP takes into account cultural and linguistic characteristics of the participants. Participants will be invited to complete three modules on an Android based app on their mobile, populated with information and activities from the adapted THP.

Adapted THP group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pregnant women at ≥ 22 weeks of gestation; AND
• ≥ 18 years old; AND
• are first or second-generation Chinese immigrants residing in Canada (who identify as someone with East Asian cultural and ethnic background born outside of Canada or have at least one parent born outside of Canada); AND
• understand both spoken and written Mandarin language; AND
• have access to internet and a smartphone with Android operating system or willing to download an Android emulator to operate the App; AND
• are willing to download and use the study mobile App with brief Chinese version of THP for "talking therapy" with accompanying activities.

You may not qualify if:

• Women currently being treated for mental conditions, including depression

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Queen's University

Kingston, Ontario, K7L 3N6, Canada

RECRUITING

Study Officials

• Shahirose Premji, PhD, NP

  Queen's University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shahirose Premji, PhD, NP

CONTACT

613-533-6000; shahirose.premji@queensu.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Sally Smith Chair in Nursing

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 6, 2024
• Study Start: October 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)