Integrated Maternal Psychosocial Assessment to Care Trial (IMPACT) Full Trial

Depression Clinical Trial

Official title:

Integrated Maternal Psychosocial Assessment to Care Trial (IMPACT): Intervening Early to Improve Maternal and Family Well-being.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01901796
• Other study ID #: 00036912
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2014
• Est. completion date: December 2020

Study information

• Verified date: November 2019
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5000
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression

Intervention

Behavioral:
• Cognitive Behavioral Therapy
Cognitive Behavioral Therapy- an effective, non-pharmacological treatment for depression and anxiety.

Locations

Country	Name	City	State
Canada	Westview Health Centre	Stony Plain	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
University of Calgary	Norlien Foundation, Women and Children's Health Research Institute, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Maternal coping	The Brief Cope Self-reported by mother on emailed questionnaire	on recruitment, 6 weeks post-randomization and 3 months postpartum
Secondary	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
Secondary	Parenting Stress	Parenting Stress Scale Self-reported by mother	3 months postpartum
Secondary	Parenting competence	Parenting Sense of Competence Scale Self-reported by mother on emailed questionnaire	3 months postpartum
Secondary	Maternal-infant attachment	Maternal Attachment Inventory (MAI) Self-reported by mother on emailed questionnaire	3 months postpartum
Secondary	Trait anxiety	State Trait Anxiety Inventory (STAI) Self-reported by mother on emailed questionnaire	on recruitment, 6 weeks postrandomization, 3 months postpartum