ACT for High-risk Pregnancy

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

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 Overview

• Status: Completed
• Conditions: Acceptance and Commitment Therapy
• Intervention / Treatment: Other: Acceptance and Commitment Therapy

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75205
      • Southern Methodist University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Treatment as Usual
Experimental: Acceptance and Commitment Therapy	Other: Acceptance and Commitment Therapy; The intervention is a 7-day self-guided acceptance-based intervention using a published Acceptance and Commitment Therapy self-help work book. This therapy is based on the theory that rigid attempts to control internal states, thoughts and feelings, and other forms of experiential avoidance contribute to symptom development and maintenance of depression, anxiety and/or stress. The therapy includes two components: (a) educating patients about the exacerbation of stress and negative affect through rigid attempts at experiential avoidance, and (b) introducing acceptance and the willingness to experience pregnancy-related sensations and cognitions as an alternative to experiential control, through the practice of intentional and non-judgmental paying attention to one's thoughts, feelings, images and bodily sensations (including aversive symptoms) and learning to see thoughts as an ongoing process distinct from self rather than merely an event with literal meaning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive and Negative Affect Schedule (PANAS)	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).	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression Anxiety Stress Scale (DASS-21)	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).	1 week
Edinburgh Postnatal Depression Scale (EPDS)	The EPDS is a 10-item self-report measure of maternal depression. Scores range from 0 to 3, with a maximum score of 30.	1 week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptance and Action Questionnaire (AAQ-II)	The AAQ-II is a 7-item self-report questionnaire designed to measure psychological flexibility. Scores on this measure range from 1 (never true) to 7 (always true).	1 week

Collaborators and Investigators

• Sponsor: Southern Methodist University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2019
• Primary Completion (Actual): February 1, 2022
• Study Completion (Actual): February 2, 2022

Study Registration Dates

• First Submitted: December 6, 2019
• First Submitted That Met QC Criteria: December 6, 2019
• First Posted (Actual): December 10, 2019

Study Record Updates

• Last Update Posted (Actual): February 17, 2022
• Last Update Submitted That Met QC Criteria: February 1, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: H19-102-TUNN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No