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

Perinatal Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06446089
• Other study ID #: 6041350
• Secondary ID: FRN 154988
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Queen's University
• Contact: Shahirose Premji, PhD, NP
• Phone: 613-533-6000
• Email: shahirose.premji[@]queensu.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 post completion 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), 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 (after intervention and/or 6 to 8 weeks postpartum), using the scales and instruments listed above.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

• who screen positive for depression with Patient Health Questionnaire-9 (PHQ-9) score > 5; AND

• understand both spoken and written Mandarin language; AND

• have access to internet and a smartphone with android operating system; 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

Related Conditions & MeSH terms

• Depression
• Perinatal Depression

Intervention

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.

Locations

Country	Name	City	State
Canada	Queen's University	Kingston	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Shahirose Sadrudin Premji	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pregnancy-related anxiety	Pregnancy-Related Anxiety Scale (10 items)	Baseline, at 3-4 weeks
Other	Somatic symptoms	PHQ-15 (14 items)	Baseline, at 3-4 weeks, and 6-8 weeks post-partum
Other	Psychological stress	Perceived Stress Scale (10 items)	Baseline, at 3-4 weeks, and 6-8 weeks post-partum
Other	Resilience	Connor-Davidson Resilience Scale (10 items)	Baseline, at 3-4 weeks, and 6-8 weeks post-partum
Other	Social support	Multidimensional Scale of Perceived Social Support (12 items)	Baseline, at 3-4 weeks, and 6-8 weeks post-partum
Other	Mother-infant relationship	Pre- and Postnatal Bonding Scale (5 items)	Baseline, at 3-4 weeks, and 6-8 weeks post-partum
Other	Patient activation	PREMIUM Abbreviated activation scale (5 items)	Baseline, at 3-4 weeks
Other	Preterm birth	Pregnancy/Delivery/Puerperium Outcome questions (5 items)	6-8 weeks post-partum
Other	Acculturation	Vancouver Index of Acculturation (18 items)	Baseline
Primary	Score on the System Usability Scale (SUS) 10 points	Objective measurement of usability of internet-based cognitive behavioural therapy	At 3-4 weeks
Primary	Acceptability of app-based THP	Structured questions based on seven domains of Sekhon's Theoretical Framework of Acceptability	At 3-4 weeks
Primary	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
Primary	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.
Primary	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	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, at 3-4 weeks, and 6-8 weeks post-partum