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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04193514
Other study ID # H19-102-TUNN
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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