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.

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.

Study Overview

• Status: Unknown
• Conditions: Depression; Anxiety
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 5000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Stony Plain, Alberta, Canada, T7Z 2M7
      • Westview Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion criteria:

Pregnant women will be eligible for Phase 2 if they are:

1. < 28 weeks gestation (to provide the opportunity to complete 6 modules and follow-up questionnaires prior to delivery)
2. able to speak/read English; and (3) willing to complete email questionnaires

Exclusion Criteria:

1. >28 weeks gestation
2. unable to speak/read English
3. unable to complete email questionnaires

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Cognitive Behavioral Therapy; Cognitive Behavioral Therapy- an effective, non-pharmacological treatment for depression and anxiety.
No Intervention: Usual care; Usual prenatal care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal depression, anxiety, stress	Depression, Anxiety, and Stress Scale (DASS-21) Self-reported by mother on emailed questionnaire	on recruitment, 6 weeks post randomization and 3 months postpartum
Maternal coping	The Brief Cope Self-reported by mother on emailed questionnaire	on recruitment, 6 weeks post-randomization and 3 months postpartum
Relationship Adjustment	Scale: Dyadic Adjustment Scale, DAS-7 Self-reported by mother on emailed questionnaire	on recruitment, 6 weeks post-randomization and 3 months postpartum
Parenting Stress	Parenting Stress Scale Self-reported by mother	3 months postpartum
Parenting competence	Parenting Sense of Competence Scale Self-reported by mother on emailed questionnaire	3 months postpartum
Maternal-infant attachment	Maternal Attachment Inventory (MAI) Self-reported by mother on emailed questionnaire	3 months postpartum
Trait anxiety	State Trait Anxiety Inventory (STAI) Self-reported by mother on emailed questionnaire	on recruitment, 6 weeks postrandomization, 3 months postpartum

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Women and Children's Health Research Institute, Canada; Norlien Foundation
• Investigators: Principal Investigator: Dawn A Kingston, Ph.D, University of Calgary

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: July 10, 2013
• First Submitted That Met QC Criteria: July 16, 2013
• First Posted (Estimate): July 17, 2013

Study Record Updates

• Last Update Posted (Actual): November 13, 2019
• Last Update Submitted That Met QC Criteria: November 11, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Depression; Anxiety; CBT
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 00036912