Integrated Maternal Psychosocial Assessment to Care Trial (IMPACT) Full Trial
Integrated Maternal Psychosocial Assessment to Care Trial (IMPACT): Intervening Early to Improve Maternal and Family Well-being.
연구 개요
상세 설명
One of the main reasons that women do not receive treatment is that their mood and anxiety problems are not detected. Despite recommendations and high rates of acceptance by providers and women, only a minority of providers conduct psychosocial assessments as part of routine prenatal care. Computer-based 'screening' is an acceptable and feasible approach to assessment of sensitive issues including prenatal and postnatal intimate partner violence, mental health problems, and postpartum depression by patients and providers. It is well-suited for busy clinical settings and is advantageous in that it offers a consistent approach to assessment, is resource-sparing, can be tailored to meet the specific needs of patients, can be used with audio/video for low literacy, provides a real-time summary for patients/providers,achieves similar or higher rates of disclosure of violence and mental health problems, and is preferred by patients because they perceive it as more anonymous compared to interviews or questionnaires.
However, psychosocial assessment on its own is ineffective in preventing or treating mood disorders and unethical in the absence of treatment options. As such, many providers do not assess pregnant women for mood disorders because non-pharmacological treatments are frequently unavailable and pregnant women prefer them. Cognitive behavioural therapy (CBT) is a highly effective, non-pharmacological treatment for depression and anxiety and is recommended by perinatal national Australian guidelines as a potentially effective EARLY intervention for reducing the risk of maternal-child outcomes.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Alberta
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Stony Plain, Alberta, 캐나다, T7Z 2M7
- Westview Health Centre
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion criteria:
Pregnant women will be eligible for Phase 2 if they are:
- < 28 weeks gestation (to provide the opportunity to complete 6 modules and follow-up questionnaires prior to delivery)
- able to speak/read English; and (3) willing to complete email questionnaires
Exclusion Criteria:
- >28 weeks gestation
- unable to speak/read English
- unable to complete email questionnaires
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Screening and CBT
Screening and Cognitive Behavioral Therapy.
The intervention group will be screened and if they need criteria they will complete the 6, 30-minute online, interactive CBT modules over 6 weeks.
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Cognitive Behavioral Therapy- an effective, non-pharmacological treatment for depression and anxiety.
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간섭 없음: Usual care
Usual prenatal care
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The primary outcome of this study is the feasibility/acceptability of integrated psychosocial care and its components.
기간: 6 weeks post randomization
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Feasibility/acceptability of the intervention will be assessed through individual face-to-face or telephone-based semi-structured qualitative interviews of both clinic staff and women in the intervention group.
The field does not allow for all questions to be provided.
Sample question for clinic staff is 'What aspects made it easy/challenging to use the tablet for prenatal assessment as part of routine prenatal care?' Sample questions for intervention group participants: 1)How did you feel about answering these kinds of questions on a tablet?; 2)Please describe any concerns you had about answering these questions on a tablet; 3)How would you prefer the results to be shared with you
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6 weeks post randomization
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Maternal depression, anxiety, stress
기간: on recruitment, 6 weeks post randomization and 3 months postpartum
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Depression, Anxiety, and Stress Scale (DASS-21) Self-reported by mother on emailed questionnaire
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on recruitment, 6 weeks post randomization and 3 months postpartum
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Maternal coping
기간: on recruitment, 6 weeks post-randomization and 3 months postpartum
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The Brief Cope Self-reported by mother on emailed questionnaire
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on recruitment, 6 weeks post-randomization and 3 months postpartum
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Relationship Adjustment
기간: on recruitment, 6 weeks post-randomization and 3 months postpartum
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Scale: Dyadic Adjustment Scale, DAS-7 Self-reported by mother on emailed questionnaire
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on recruitment, 6 weeks post-randomization and 3 months postpartum
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Parenting Stress
기간: 3 months postpartum
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Parenting Stress Scale Self-reported by mother
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3 months postpartum
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Parenting competence
기간: 3 months postpartum
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Parenting Sense of Competence Scale Self-reported by mother on emailed questionnaire
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3 months postpartum
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Maternal-infant attachment
기간: 3 months postpartum
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Maternal Attachment Inventory (MAI) Self-reported by mother on emailed questionnaire
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3 months postpartum
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Trait anxiety
기간: on recruitment, 6 weeks postrandomization, 3 months postpartum
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State Trait Anxiety Inventory (STAI) Self-reported by mother on emailed questionnaire
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on recruitment, 6 weeks postrandomization, 3 months postpartum
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공동 작업자 및 조사자
수사관
- 수석 연구원: Dawn A Kingston, Ph.D, University of Calgary
간행물 및 유용한 링크
일반 간행물
- Bright KS, Stuart S, Mcneil DA, Murray L, Kingston DE. Feasibility and Acceptability of Internet-Based Interpersonal Psychotherapy for Stress, Anxiety, and Depression in Prenatal Women: Thematic Analysis. JMIR Form Res. 2022 Jun 10;6(6):e23879. doi: 10.2196/23879.
- Bright KS, Mughal MK, Wajid A, Lane-Smith M, Murray L, Roy N, Van Zanten SV, Mcneil DA, Stuart S, Kingston D. Internet-based interpersonal psychotherapy for stress, anxiety, and depression in prenatal women: study protocol for a pilot randomized controlled trial. Trials. 2019 Dec 30;20(1):814. doi: 10.1186/s13063-019-3897-z.
- Kingston D, Austin MP, Hegadoren K, McDonald S, Lasiuk G, McDonald S, Heaman M, Biringer A, Sword W, Giallo R, Patel T, Lane-Smith M, van Zanten SV. Study protocol for a randomized, controlled, superiority trial comparing the clinical and cost- effectiveness of integrated online mental health assessment-referral-care in pregnancy to usual prenatal care on prenatal and postnatal mental health and infant health and development: the Integrated Maternal Psychosocial Assessment to Care Trial (IMPACT). Trials. 2014 Mar 6;15:72. doi: 10.1186/1745-6215-15-72.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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