ACT for High-risk Pregnancy

NCT ID: NCT04193514

Last Updated: 2022-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-15
• Study Completion Date: 2022-02-02

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acceptance and Commitment Therapy

Group Type: EXPERIMENTAL

Acceptance and Commitment Therapy

Intervention Type: 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.

Treatment as Usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Southern Methodist University

OTHER

Sponsor Role: lead

Responsible Party

Heather McClary

Director of Research Compliance

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Southern Methodist University

Dallas, Texas, United States

Countries

United States

Other Identifiers

H19-102-TUNN

Identifier Type: -

Identifier Source: org_study_id