About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Women currently being treated for mental conditions, including depression
Trial design
Single group
Treatments tested in this trial
THP: cognitive behavior therapy and behavioral activation
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Score on the System Usability Scale (SUS) 10 points
Objective measurement of usability of internet-based cognitive behavioural therapy
Acceptability of app-based THP
Structured questions based on seven domains of Sekhon's Theoretical Framework of Acceptability
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.
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.
Secondary outcomes
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).
Other outcomes
Pregnancy-related anxiety
Pregnancy-Related Anxiety Scale (10 items)
Somatic symptoms
PHQ-15 (14 items)
Psychological stress
Perceived Stress Scale (10 items)
Resilience
Connor-Davidson Resilience Scale (10 items)
Sponsors and contacts
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