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Completed

NCT Number: NCT04193514

ACT for 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.

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Key information

Conditions

Acceptance and Commitment Therapy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Southern Methodist University

Dallas, Texas, 75205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Positive and Negative Affect Schedule (PANAS)

    Time frame: 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 outcomes

  1. Depression Anxiety Stress Scale (DASS-21)

    Time frame: 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).

  2. Edinburgh Postnatal Depression Scale (EPDS)

    Time frame: 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.

Other outcomes

  1. Acceptance and Action Questionnaire (AAQ-II)

    Time frame: 1 week

    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).

Sponsors and collaborators

Lead sponsor

Southern Methodist University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Dec 10, 2019
Registry last updated
Feb 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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