Clinical trial NCT01901796: Integrated Maternal Psychosocial Assessment to Care Trial (IMPACT) Full Trial
Official title: Integrated Maternal Psychosocial Assessment to Care Trial (IMPACT): Intervening Early to Improve Maternal and Family Well-being.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Depression
Keywords: Anxiety
Depression
CBT
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Norlien Foundation
name: Women and Children's Health Research Institute, Canada
First posted: 2013-07-17
Enrollment: 5000
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The primary outcome of this study is the feasibility/acceptability of integrated psychosocial care and its components.
timeFrame: 6 weeks post randomization
Secondary outcomes:
measure: Maternal depression, anxiety, stress
timeFrame: on recruitment, 6 weeks post randomization and 3 months postpartum
measure: Maternal coping
timeFrame: on recruitment, 6 weeks post-randomization and 3 months postpartum
measure: Relationship Adjustment
timeFrame: on recruitment, 6 weeks post-randomization and 3 months postpartum
measure: Parenting Stress
timeFrame: 3 months postpartum
measure: Parenting competence
timeFrame: 3 months postpartum
measure: Maternal-infant attachment
timeFrame: 3 months postpartum
measure: Trait anxiety
timeFrame: on recruitment, 6 weeks postrandomization, 3 months postpartum
Other outcomes:
Locations:
city: Stony Plain
country: Canada
facility: Westview Health Centre
state: Alberta
Study officials:
affiliation: University of Calgary
name: Dawn A Kingston, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.