Clinical trial NCT06446089: A Chinese Version of the Thinking Health Program for East Asian Pregnant Immigrant People in Canada
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perinatal Depression
Keywords: immigrant women
East-Asian immigrants
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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
* 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

Primary outcomes:
measure: Score on the System Usability Scale (SUS) 10 points
timeFrame: At 3-4 weeks
measure: Acceptability of app-based THP
timeFrame: At 3-4 weeks
measure: Recruitment to study
timeFrame: During recruitment to study, expected 4 months
measure: Retention in study
timeFrame: Through study completion, an average of 12 months.
measure: Adherence to intervention
timeFrame: Through intervention duration, an average of 3-4 weeks.
Secondary outcomes:
measure: Effectiveness of app-based THP
timeFrame: Baseline, at 3-4 weeks, and 6-8 weeks post-partum
Other outcomes:
measure: Pregnancy-related anxiety
timeFrame: Baseline, at 3-4 weeks
measure: Somatic symptoms
timeFrame: Baseline, at 3-4 weeks, and 6-8 weeks post-partum
measure: Psychological stress
timeFrame: Baseline, at 3-4 weeks, and 6-8 weeks post-partum
measure: Resilience
timeFrame: Baseline, at 3-4 weeks, and 6-8 weeks post-partum
measure: Social support
timeFrame: Baseline, at 3-4 weeks, and 6-8 weeks post-partum
measure: Mother-infant relationship
timeFrame: Baseline, at 3-4 weeks, and 6-8 weeks post-partum
measure: Patient activation
timeFrame: Baseline, at 3-4 weeks
measure: Preterm birth
timeFrame: 6-8 weeks post-partum
measure: Acculturation
timeFrame: Baseline
Locations:
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
Study officials:
affiliation: Queen's University
name: Shahirose Premji, PhD, NP
role: PRINCIPAL_INVESTIGATOR
References: