ACT for High-risk Pregnancy

Not Applicable

Completed

• Conditions: Acceptance and Commitment Therapy
• Interventions: Other: Acceptance and Commitment Therapy

• Registration Number: NCT04193514
• Lead Sponsor: Southern Methodist University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-15
• Study First Submitted: 2019-12-06
• Study First Submitted QC: 2019-12-06
• Study First Posted: 2019-12-10
• Status Verified: 2022-02
• Primary Completion: 2022-02-01
• Last Update Submitted: 2022-02-01
• Study Completion: 2022-02-02
• Last Update Posted: 2022-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acceptance and Commitment Therapy	Acceptance and Commitment Therapy	-

Primary Outcome Measures

Name	Time	Method
Positive and Negative Affect Schedule (PANAS)	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 Outcome Measures

Name	Time	Method
Depression Anxiety Stress Scale (DASS-21)	1 week	The DASS-21 is a 21-item self-report measure consisting of three subscales (depression, anxiety and stress). Answers range from 0 (did not apply to me at all) to 3 (applied to me very much).
Edinburgh Postnatal Depression Scale (EPDS)	1 week	The EPDS is a 10-item self-report measure of maternal depression. Scores range from 0 to 3, with a maximum score of 30.

Trial Locations

Locations (1)

Southern Methodist University; 🇺🇸 Dallas, Texas, United States