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ACT for High-risk Pregnancy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04193514
Enrollment
60
Registered
2019-12-10
Start date
2019-11-15
Completion date
2022-02-02
Last updated
2022-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acceptance and Commitment Therapy

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.

Interventions

OTHERAcceptance 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.

Sponsors

Southern Methodist University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Positive and Negative Affect Schedule (PANAS)1 weekThe 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

MeasureTime frameDescription
Depression Anxiety Stress Scale (DASS-21)1 weekThe 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).
Edinburgh Postnatal Depression Scale (EPDS)1 weekThe EPDS is a 10-item self-report measure of maternal depression. Scores range from 0 to 3, with a maximum score of 30.

Other

MeasureTime frameDescription
Acceptance and Action Questionnaire (AAQ-II)1 weekThe 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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026