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Clinical Trials/NCT03837392
NCT03837392
Completed
Not Applicable

A Pilot Study Examining the Efficacy of Brief Acceptance and Commitment Therapy (ACT) for Perinatal Anxiety

University of Iowa1 site in 1 country30 target enrollmentJune 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post Partum Depression
Sponsor
University of Iowa
Enrollment
30
Locations
1
Primary Endpoint
Change in Inventory of Mood and Anxiety Symptoms (IMAS-R) scores from Baseline
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This protocol will test the hypothesis that Acceptance and Commitment Therapy (ACT) is effective in reducing anxiety and depressive symptoms during the perinatal and postpartum periods. Participants should expect their participation in the study to last 9-12 months.

Detailed Description

The study's major theme is "to examine the efficacy of a brief Acceptance and Commitment Therapy (ACT) intervention in treating perinatal anxiety symptoms, as compared to a supportive control condition." The perinatal and postpartum periods are known to be a vulnerable time for the development of mental health symptomatology, with approximately 7% of women developing postpartum depression in the first three months following childbirth. One known predictor of postpartum depression is perinatal anxiety and distress. The impact of postpartum depression extends beyond the mother, whose distress and daily functioning are affected, with adverse effects on infant development and care. The need for interventions and preventive interventions has been widely indicated for over two decades. This protocol will describe two conditions, the effects of which will be contrasted to determine the efficacy of ACT in treating anxiety and depressive symptoms among perinatal women. The ACT condition will be compared to a supportive psychoeducation intervention. The effects of the intervention will be determined in terms of self-report measures (anxiety and depressive symptoms, flexibility, mindfulness, social satisfaction) and diagnostic interviews (depression, anxiety). The impact of trauma history and psychodiagnostic history will be examined as moderating factors and/or covariates in the examination of the intervention's efficacy. This protocol will test the hypothesis that ACT is effective in reducing anxiety and depressive symptoms during the perinatal and postpartum periods. Second, the investigators will examine the intergenerational impact of the intervention on the offspring via offspring birth outcomes, as reported in the electronic medical record. Finally, the investigators will explore mediators and moderators of the treatment outcomes. This work will advance the understanding of the impact of brief interventions on perinatal well-being and improve the ability to disseminate empirically supported interventions for pregnant mothers.

Registry
clinicaltrials.gov
Start Date
June 1, 2020
End Date
June 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Emily Thomas

Clinical Assistant Professor

University of Iowa

Eligibility Criteria

Inclusion Criteria

  • Adult women (ages 18-45) who are between 18-26 weeks pregnant
  • Fluency in English
  • Ability to give informed consent and comply with study procedures (including phone and internet access)
  • Elevated GAD-7 score (10+)
  • Women must be receiving prenatal care
  • Singleton pregnancy

Exclusion Criteria

  • Inability to give informed consent and comply with study procedures
  • Past/current mania, past/current psychoses (assessed with Psychosis Screening Questionnaire)
  • No therapy appointments in last 60 days (not currently in psychotherapy).

Outcomes

Primary Outcomes

Change in Inventory of Mood and Anxiety Symptoms (IMAS-R) scores from Baseline

Time Frame: Past 1 month

The IMAS-R provides continuous and diagnostic scores on mood, anxiety, and distress symptoms.

Secondary Outcomes

  • Change in Acceptance and Action Questionnaire (AAQ-2) from Baseline(up to 12 month)
  • Change in Five Facet Mindfulness Questionnaire(up to 12 month)

Study Sites (1)

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