Efficacy of Brief Acceptance and Commitment Therapy (ACT) for Perinatal Anxiety
NCT ID: NCT03837392
Last Updated: 2023-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
30 participants
INTERVENTIONAL
2020-06-01
2023-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Brief Internet-Based Acceptance and Commitment Therapy Intervention for Parents in the Postpartum
NCT05173285
Behavioral Activation for Perinatal Depression
NCT01401231
Exploring the Effectiveness of a Brief CBT Intervention for Anxious Pregnant Women
NCT03103217
Group Cognitive Behavioural Therapy (CBT) for Perinatal Anxiety
NCT04581681
Effects of Interpersonal Psychotherapy on Depression During and After Pregnancy
NCT00380419
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The perinatal and postpartum periods are known to be a vulnerable time for the development of mental health symptomatology, with approximately 7% of women developing postpartum depression in the first three months following childbirth. One known predictor of postpartum depression is perinatal anxiety and distress. The impact of postpartum depression extends beyond the mother, whose distress and daily functioning are affected, with adverse effects on infant development and care. The need for interventions and preventive interventions has been widely indicated for over two decades.
This protocol will describe two conditions, the effects of which will be contrasted to determine the efficacy of ACT in treating anxiety and depressive symptoms among perinatal women. The ACT condition will be compared to a supportive psychoeducation intervention. The effects of the intervention will be determined in terms of self-report measures (anxiety and depressive symptoms, flexibility, mindfulness, social satisfaction) and diagnostic interviews (depression, anxiety). The impact of trauma history and psychodiagnostic history will be examined as moderating factors and/or covariates in the examination of the intervention's efficacy.
This protocol will test the hypothesis that ACT is effective in reducing anxiety and depressive symptoms during the perinatal and postpartum periods. Second, the investigators will examine the intergenerational impact of the intervention on the offspring via offspring birth outcomes, as reported in the electronic medical record. Finally, the investigators will explore mediators and moderators of the treatment outcomes. This work will advance the understanding of the impact of brief interventions on perinatal well-being and improve the ability to disseminate empirically supported interventions for pregnant mothers.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Acceptance and Commitment Therapy
Acceptance and Commitment Therapy (ACT) - participants in this arm will take part in an online ACT + psychoeducation intervention. The intervention will provide psychoeducation surrounding perinatal anxiety and depression as well as on engaging social support and coping strategies. The ACT portion of the intervention will focus on developing psychological flexibility, which is defined as behaviorally pursuing one's values even in the presence of barriers (e.g., thoughts, emotions). Following the online intervention, the participants will be contacted for two phone coaching calls -- each lasting about 30-45 minutes.
Baseline Assessment (18-26 weeks pregnant)
At baseline, participants will complete several interviews and questionnaires online and via phone to determine psychological history, current functioning, history of trauma, coping styles, and demographic variables.
Online Intervention and Phone Coaching Interventions
ACT is a cognitive-behavioral therapy that seeks to promote psychological flexibility. The active comparator is the Supportive Control. Two phone coaching sessions will occur 2- and 4-weeks post-intervention in both conditions.
Follow Up Assessments: 34-36 weeks pregnant and 4-week postpartum
The follow-up assessments at 34-36 weeks pregnancy and 4-weeks postpartum will be completed via REDCap, an online secure survey platform in order to reduce participant burden.
Follow Up Assessments: 8 weeks postpartum
The follow-up assessment at 8-weeks postpartum will be completed via phone.
Supportive Psychoeducation
Control group - participants in this arm will take part in an online psychoeducation and support intervention. This intervention will focus on psychoeducation surrounding perinatal anxiety and depression, as well as on engaging social support and coping strategies. Following the online intervention, the participants will be contacted for two phone coaching calls -- each lasting about 30-45 minutes.
Baseline Assessment (18-26 weeks pregnant)
At baseline, participants will complete several interviews and questionnaires online and via phone to determine psychological history, current functioning, history of trauma, coping styles, and demographic variables.
Online Intervention and Phone Coaching Interventions
ACT is a cognitive-behavioral therapy that seeks to promote psychological flexibility. The active comparator is the Supportive Control. Two phone coaching sessions will occur 2- and 4-weeks post-intervention in both conditions.
Follow Up Assessments: 34-36 weeks pregnant and 4-week postpartum
The follow-up assessments at 34-36 weeks pregnancy and 4-weeks postpartum will be completed via REDCap, an online secure survey platform in order to reduce participant burden.
Follow Up Assessments: 8 weeks postpartum
The follow-up assessment at 8-weeks postpartum will be completed via phone.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Baseline Assessment (18-26 weeks pregnant)
At baseline, participants will complete several interviews and questionnaires online and via phone to determine psychological history, current functioning, history of trauma, coping styles, and demographic variables.
Online Intervention and Phone Coaching Interventions
ACT is a cognitive-behavioral therapy that seeks to promote psychological flexibility. The active comparator is the Supportive Control. Two phone coaching sessions will occur 2- and 4-weeks post-intervention in both conditions.
Follow Up Assessments: 34-36 weeks pregnant and 4-week postpartum
The follow-up assessments at 34-36 weeks pregnancy and 4-weeks postpartum will be completed via REDCap, an online secure survey platform in order to reduce participant burden.
Follow Up Assessments: 8 weeks postpartum
The follow-up assessment at 8-weeks postpartum will be completed via phone.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Fluency in English
3. Ability to give informed consent and comply with study procedures (including phone and internet access)
4. Elevated GAD-7 score (10+)
5. Women must be receiving prenatal care
6. Singleton pregnancy
Exclusion Criteria
2. Inability to give informed consent and comply with study procedures
3. Past/current mania, past/current psychoses (assessed with Psychosis Screening Questionnaire)
4. No therapy appointments in last 60 days (not currently in psychotherapy).
18 Years
45 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Iowa
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Emily Thomas
Clinical Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Emily B K Thomas, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Iowa
Iowa City, Iowa, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
202002658
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.