Brief Acceptance-based Therapy for Pregnant Women With High-risk Pregnancy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Positive and Negative Affect Schedule (PANAS)
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Acceptance and Commitment Therapy
Intervention: Acceptance and Commitment Therapy (Other)
Treatment as Usual
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)
Investigators
Heather McClary
Director of Research Compliance
Southern Methodist University