ACT for High-risk Pregnancy

Acceptance and Commitment Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04193514
• Other study ID #: H19-102-TUNN
• Status: Completed
• Phase: N/A
• Start date: November 15, 2019
• Est. completion date: February 2, 2022

Study information

• Verified date: February 2022
• Source: Southern Methodist University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acceptance and Commitment Therapy

Intervention

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.

Locations

Country	Name	City	State
United States	Southern Methodist University	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Southern Methodist University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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