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Clinical Trials/NCT04193514
NCT04193514
Completed
N/A

Brief Acceptance-based Therapy for Pregnant Women With High-risk Pregnancy

Southern Methodist University1 site in 1 country60 target enrollmentNovember 15, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Acceptance and Commitment Therapy
Sponsor
Southern Methodist University
Enrollment
60
Locations
1
Primary Endpoint
Positive and Negative Affect Schedule (PANAS)
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

This study is designed to reduce the psychological distress of women with high-risk pregnancy. Women who express interest and are eligible will have the opportunity to participate in a 7-day acceptance therapy. This therapy is based on the theory that attempts to control internal states, thoughts and feelings can contribute to symptoms of depression, anxiety and/or stress. This study aims to educate women about how the willingness to experience uncomfortable pregnancy-related sensations and thoughts, rather than fighting them, can provide relief. The therapy is completed virtually, with the first therapy session done over video call with the therapist. Following, participants complete the remaining six days of therapy on their own using a work book. All women participating in the study will be asked to complete a series of self-report questionnaires before, during, and immediately following treatment, as well as twice postpartum. Participants will receive up to $60 and a work book for participation.

Registry
clinicaltrials.gov
Start Date
November 15, 2019
End Date
February 2, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Heather McClary

Director of Research Compliance

Southern Methodist University

Eligibility Criteria

Inclusion Criteria

  • Pregnant women with a current high-risk pregnancy.
  • Patients must be willing to engage in brief Acceptance-Commitment Therapy
  • Patients must be English-speaking.
  • Ages 18 years or older.

Exclusion Criteria

  • Active suicidal ideation or self-harm in the past year; any previous history of suicide attempts.
  • History of bipolar disorder, psychosis, mental retardation or organic brain damage.
  • Currently using substances (alcohol, nicotine, marijuana, etc.)
  • Actively participating in psychotherapy for emotional or psychological problems from another provider

Outcomes

Primary Outcomes

Positive and Negative Affect Schedule (PANAS)

Time Frame: 1 week

The PANAS is a 20-item self-report measure for positive and negative affect. Answers range from 1 (very slightly/not al all) to 5 (extremely).

Secondary Outcomes

  • Depression Anxiety Stress Scale (DASS-21)(1 week)
  • Edinburgh Postnatal Depression Scale (EPDS)(1 week)

Study Sites (1)

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