Acceptance and Commitment Therapy Clinical Trial
Official title:
Brief Acceptance-based Therapy for Pregnant Women With High-risk Pregnancy
Verified date | February 2022 |
Source | Southern Methodist University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Southern Methodist University | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
Southern Methodist University |
United States,
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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