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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorQueen's University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • THP: cognitive behavior therapy and behavioral activation

    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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Adapted THP groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Score on the System Usability Scale (SUS) 10 points

Objective measurement of usability of internet-based cognitive behavioural therapy

Time frame
3-4 weeks after initiation of intervention
2

Acceptability of app-based THP

Structured questions based on seven domains of Sekhon's Theoretical Framework of Acceptability

Time frame
3-4 weeks after initiation of intervention
3

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.

Time frame
During recruitment to study, expected 4 months
4

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.

Time frame
Through study completion, an average of 12 months.

Secondary outcomes

1

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).

Time frame
Baseline, 3-4 weeks after initiation of intervention, and 6-8 weeks post-partum

Other outcomes

1

Pregnancy-related anxiety

Pregnancy-Related Anxiety Scale (10 items)

Time frame
Baseline, & 3-4 weeks after initiation of intervention
2

Somatic symptoms

PHQ-15 (14 items)

Time frame
Baseline, 3-4 weeks after initiation of intervention, and 6-8 weeks post-partum
3

Psychological stress

Perceived Stress Scale (10 items)

Time frame
Baseline, 3-4 weeks after initiation of intervention, and 6-8 weeks post-partum
4

Resilience

Connor-Davidson Resilience Scale (10 items)

Time frame
Baseline, 3-4 weeks after initiation of intervention, and 6-8 weeks post-partum

Sponsors and contacts

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