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

The Feasibility of a Culturally Tailored Mobile App-based Thinking Healthy Program for Mental Health Support of East Asian Pregnant Immigrants in Canada

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.

Study Overview

• Status: Recruiting
• Conditions: Perinatal Depression
• Intervention / Treatment: Behavioral: THP: cognitive behavior therapy and behavioral activation

Detailed Description

Common mental health conditions during pregnancy include depression and anxiety. Having an immigrant status and belonging to an ethnic minority group is linked to an increased likelihood of perinatal mental health problems. The lack of culturally tailored and innovative intervention is a predominant factor affecting mental health outcomes for immigrant women. Psychological and psychosocial interventions have been reported to significantly improve non-migrant women's mental health. The Thinking Healthy Program (THP), a low-intensity, low-cost, psychosocial intervention ("talking therapies") based on cognitive behavioural therapy, is comprised of 12, 1-hour sessions with content organized in modules (e.g., preparing for the baby, baby's arrival) that have associated activities (e.g., mood chart). In China, the THP has been culturally and linguistically adapted using rigorous processes and delivered to support women in the management of perinatal depression. To improve access and ensure a more impactful outcome to the culturally adapted THP, a mobile App was created in China with a brief Chinese version of the culturally adapted THP.

The primary objective of this study is to (1) assess the feasibility (acceptability and usability) of the linguistically and culturally adapted THP delivered through a mobile App to Chinese immigrant pregnant women residing in Canada; and (2) examine the process of recruitment, retention, and adherence to intervention to inform a future trial. The secondary objective is to produce preliminary evidence on the effectiveness of the brief Chinese version of THP on immigrant women's mental well-being, specifically depression.

A sequential explanatory mixed-method feasibility study involving a pre-post design in which a single group will be assembled and assessed quantitatively at baseline, 3-4 weeks after initiation of brief Chinese version of the THP intervention and again at 6-8 weeks following the birth of their baby. A subset of participants that have engaged with the intervention (n=up to 15) will be invited to individual semi-structured telephone interview to share their experience with the intervention.

A convenience sample of 50 participants will be recruited for the intervention, with a subset of 15 participants to be individually interviewed via the telephone.

Participants will be recruited through social media (WeChat and Xiaohongshu), research team members' University mailing list, dissemination to professional colleagues (e.g., Obstetrics and Gynecologists), and collaboration with social and health-based organizations that serve the East Asian community in Canada.

At baseline, the sociodemographic characteristics, immigrant characteristics, health/obstetric history, and history of psychological well-being will be assessed. Potential covariates that will be assessed once include acculturation (baseline; Vancouver Index of Acculturation) and preterm birth (at 6 to 8 weeks postpartum) while all others including pregnancy-related anxiety (Pregnancy-Related Anxiety Scale), depression severity (Patient Health Questionnaire-9), somatic symptoms (Patient Health Questionnaire-15), psychological stress (Perceived Stress Scale-10), resilience (Connor-Davidson Resilience Scale-10), social support (Multidimensional Scale of Perceived Social Support), mother-infant relationship (prenatal section of the Pre- and Postnatal Bonding Scale), and patient activation (Behavioural Activation for Depression Scale) will be assessed at baseline and follow-up (3-4 weeks after initiation of intervention and/or 6 to 8 weeks post-partum), using the scales and instruments listed above.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shahirose Premji, PhD, NP; Phone Number: 79885 613-533-6000; Email: shahirose.premji@queensu.ca

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 3N6
      • Recruiting
      • Queen's University
      • Contact: Shahirose S Premji, NP, PhD; Phone Number: 79885 1-613-533-6000; Email: shahirose.premji@queensu.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Women currently being treated for mental conditions, including depression

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Adapted THP group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of app-based THP	Edinburgh Postnatal depression scale (EPDS; 10 items). Assess change of mean scores from baseline to treatment completion (at 3-4 weeks), and 6-8 weeks after the birth of the baby, adjusting for significant predictors (e.g. social support, mother-infant bonding).	Baseline, 3-4 weeks after initiation of intervention, and 6-8 weeks post-partum

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preterm birth	Pregnancy/Delivery/Puerperium Outcome questions (5 items)	6-8 weeks post-partum
Acculturation	Vancouver Index of Acculturation (18 items)	Baseline
Pregnancy-related anxiety	Pregnancy-Related Anxiety Scale (10 items)	Baseline, & 3-4 weeks after initiation of intervention
Somatic symptoms	PHQ-15 (14 items)	Baseline, 3-4 weeks after initiation of intervention, and 6-8 weeks post-partum
Psychological stress	Perceived Stress Scale (10 items)	Baseline, 3-4 weeks after initiation of intervention, and 6-8 weeks post-partum
Resilience	Connor-Davidson Resilience Scale (10 items)	Baseline, 3-4 weeks after initiation of intervention, and 6-8 weeks post-partum
Social support	Multidimensional Scale of Perceived Social Support (12 items)	Baseline, 3-4 weeks after initiation of intervention, and 6-8 weeks post-partum
Mother-infant relationship	Pre- and Postnatal Bonding Scale (5 items)	Baseline, 3-4 weeks after initiation of intervention, and 6-8 weeks post-partum
Patient activation	PREMIUM Abbreviated activation scale (5 items)	Baseline & 3-4 weeks after initiation of intervention
Depression severity	Patient Health Questionnaire-9 (PHQ-9)	Baseline, 3-4 weeks after initiation of intervention, and 6-8 weeks post-partum

Collaborators and Investigators

• Sponsor: Queen's University
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Shahirose Premji, PhD, NP, Queen's University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: May 23, 2024
• First Submitted That Met QC Criteria: May 31, 2024
• First Posted (Actual): June 6, 2024

Study Record Updates

• Last Update Posted (Actual): July 28, 2025
• Last Update Submitted That Met QC Criteria: July 23, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: immigrant women; East-Asian immigrants
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 6041350; FRN 154988 (Other Grant/Funding Number: Canadian Institutes of Health Research)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No