ACT for High-risk Pregnancy

NCT04193514 | Completed

• 1 other identifier: H19-102-TUNN
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acceptance and Commitment Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Depression Anxiety Stress Scale (DASS-21)

  1 week

• Edinburgh Postnatal Depression Scale (EPDS)

  1 week

Other Outcomes (1)

• Acceptance and Action Questionnaire (AAQ-II)

  1 week

Study Arms (2)

Acceptance and Commitment Therapy

EXPERIMENTAL

Other: Acceptance and Commitment Therapy

Treatment as Usual

NO INTERVENTION

Interventions

Acceptance and Commitment Therapy OTHER

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.

Acceptance and Commitment Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Southern Methodist University: lead

Study Sites (1)

Southern Methodist University

Dallas, Texas, 75205, United States

Location

MeSH Terms

Interventions

Acceptance and Commitment Therapy

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research Compliance

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: December 10, 2019
• Study Start: November 15, 2019
• Primary Completion: February 1, 2022
• Study Completion: February 2, 2022
• Last Updated: February 17, 2022

Record last verified: 2022-02

Locations

US (1)