Integrated Maternal Psychosocial Assessment to Care Trial (IMPACT) Full Trial
1 other identifier
interventional
5,000
1 country
1
Brief Summary
We hypothesize that the intervention will: (1) offer a feasible approach for providing mental healthcare to pregnant women and have a high level of acceptability by pregnant women and healthcare providers; (2) reduce symptoms of depression, stress, anxiety, and parenting stress; improve parenting competence, coping, and relationship adjustment compared to usual care; and (3) reduce the risk of poor maternal-infant attachment. As such, this early intervention holds promise for reducing maternal mental health morbidity and its negative influences on infants, children, and families.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable anxiety
Started Jan 2014
Longer than P75 for not_applicable anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2013
CompletedFirst Posted
Study publicly available on registry
July 17, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedNovember 13, 2019
November 1, 2019
6.9 years
July 10, 2013
November 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome of this study is the feasibility/acceptability of integrated psychosocial care and its components.
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
6 weeks post randomization
Secondary Outcomes (7)
Maternal depression, anxiety, stress
on recruitment, 6 weeks post randomization and 3 months postpartum
Maternal coping
on recruitment, 6 weeks post-randomization and 3 months postpartum
Relationship Adjustment
on recruitment, 6 weeks post-randomization and 3 months postpartum
Parenting Stress
3 months postpartum
Parenting competence
3 months postpartum
- +2 more secondary outcomes
Study Arms (2)
Screening and CBT
EXPERIMENTALScreening 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.
Usual care
NO INTERVENTIONUsual prenatal care
Interventions
Cognitive Behavioral Therapy- an effective, non-pharmacological treatment for depression and anxiety.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \>28 weeks gestation
- unable to speak/read English
- unable to complete email questionnaires
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Calgarylead
- Norlien Foundationcollaborator
- Women and Children's Health Research Institute, Canadacollaborator
Study Sites (1)
Westview Health Centre
Stony Plain, Alberta, T7Z 2M7, Canada
Related Publications (3)
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.
PMID: 35687403DERIVEDBright 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.
PMID: 31888712DERIVEDKingston 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.
PMID: 24597683DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dawn A Kingston, Ph.D
University of Calgary
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 10, 2013
First Posted
July 17, 2013
Study Start
January 1, 2014
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
November 13, 2019
Record last verified: 2019-11