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

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ClinicalTrials.gov Identifier: NCT01901796
Recruitment Status : Recruiting
First Posted : July 17, 2013
Last Update Posted : October 26, 2016
Sponsor:
Collaborators:
Norlien Foundation
Women and Children's Health Research Institute, Canada
Information provided by (Responsible Party):
Dawn Kingston, University of Calgary

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.

Condition or disease Intervention/treatment Phase
Anxiety Depression Behavioral: Cognitive Behavioral Therapy Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Integrated Maternal Psychosocial Assessment to Care Trial (IMPACT): Intervening Early to Improve Maternal and Family Well-being.
Study Start Date : January 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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



Primary Outcome Measures :
  1. The primary outcome of this study is the feasibility/acceptability of integrated psychosocial care and its components. [ Time Frame: 6 weeks post randomization ]
    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


Secondary Outcome Measures :
  1. Maternal depression, anxiety, stress [ Time Frame: on recruitment, 6 weeks post randomization and 3 months postpartum ]
    Depression, Anxiety, and Stress Scale (DASS-21) Self-reported by mother on emailed questionnaire

  2. Maternal coping [ Time Frame: on recruitment, 6 weeks post-randomization and 3 months postpartum ]
    The Brief Cope Self-reported by mother on emailed questionnaire

  3. Relationship Adjustment [ Time Frame: on recruitment, 6 weeks post-randomization and 3 months postpartum ]
    Scale: Dyadic Adjustment Scale, DAS-7 Self-reported by mother on emailed questionnaire

  4. Parenting Stress [ Time Frame: 3 months postpartum ]
    Parenting Stress Scale Self-reported by mother

  5. Parenting competence [ Time Frame: 3 months postpartum ]
    Parenting Sense of Competence Scale Self-reported by mother on emailed questionnaire

  6. Maternal-infant attachment [ Time Frame: 3 months postpartum ]
    Maternal Attachment Inventory (MAI) Self-reported by mother on emailed questionnaire

  7. Trait anxiety [ Time Frame: on recruitment, 6 weeks postrandomization, 3 months postpartum ]
    State Trait Anxiety Inventory (STAI) Self-reported by mother on emailed questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01901796


Contacts
Contact: Dawn A Kingston, Ph.D 4032202634 dawn.kingston@ucalgary.ca
Contact: Dawn B Kingston, M.A. 4032202634 marie.lanesmith@ucalgary.ca

Locations
Canada, Alberta
Westview Health Centre Recruiting
Stony Plain, Alberta, Canada, T7Z 2M7
Contact: Suzanne Squires, MD, CCFP    780-968-3600    suzsquires@me.com   
Contact: Melanie Currie, MD, CCFP    780-968-3600    mcurriemd@gmail.com   
Principal Investigator: Dawn A Kingston, Ph.D         
Sponsors and Collaborators
University of Calgary
Norlien Foundation
Women and Children's Health Research Institute, Canada
Investigators
Principal Investigator: Dawn A Kingston, Ph.D University of Calgary

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dawn Kingston, Associate Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT01901796     History of Changes
Other Study ID Numbers: 00036912
First Posted: July 17, 2013    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016

Keywords provided by Dawn Kingston, University of Calgary:
Anxiety
Depression
CBT

Additional relevant MeSH terms:
Depression
Behavioral Symptoms