NCT03837392

Efficacy of Brief Acceptance and Commitment Therapy (ACT) for Perinatal Anxiety

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Iowa · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post Partum Depression
• Perinatal Depression
• Post Partum Anxiety
• Perinatal Anxiety

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Baseline Assessment (18-26 weeks pregnant)	At baseline, participants will complete several interviews and questionnaires online and via phone to determine psychological history, current functioning, history of trauma, coping styles, and demographic variables.
BEHAVIORAL	Online Intervention and Phone Coaching Interventions	ACT is a cognitive-behavioral therapy that seeks to promote psychological flexibility. The active comparator is the Supportive Control. Two phone coaching sessions will occur 2- and 4-weeks post-intervention in both conditions.
DIAGNOSTIC_TEST	Follow Up Assessments: 34-36 weeks pregnant and 4-week postpartum	The follow-up assessments at 34-36 weeks pregnancy and 4-weeks postpartum will be completed via REDCap, an online secure survey platform in order to reduce participant burden.
DIAGNOSTIC_TEST	Follow Up Assessments: 8 weeks postpartum	The follow-up assessment at 8-weeks postpartum will be completed via phone.

Timeline

• Start date: 2020-06-01
• Primary completion: 2023-01-31
• Completion: 2023-06-30
• First posted: 2019-02-12
• Last updated: 2023-07-12

Locations

1 site across 1 country: United States