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

NCT ID: NCT06446089

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-12-31

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.

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.

Conditions

Perinatal Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

THP: cognitive behavior therapy and behavioral activation

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Shahirose Sadrudin Premji

Professor and Sally Smith Chair in Nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shahirose Premji, PhD, NP

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

Queen's University

Kingston, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Shahirose Premji, PhD, NP

Role: CONTACT

shahirose.premji@queensu.ca

613-533-6000 ext. 79885

Facility Contacts

Shahirose S Premji, NP, PhD

Role: primary

shahirose.premji@queensu.ca

1-613-533-6000 ext. 79885

Other Identifiers

FRN 154988

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

6041350

Identifier Type: -

Identifier Source: org_study_id