- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03837392
Efficacy of Brief Acceptance and Commitment Therapy (ACT) for Perinatal Anxiety
A Pilot Study Examining the Efficacy of Brief Acceptance and Commitment Therapy (ACT) for Perinatal Anxiety
Study Overview
Status
Detailed Description
The study's major theme is "to examine the efficacy of a brief Acceptance and Commitment Therapy (ACT) intervention in treating perinatal anxiety symptoms, as compared to a supportive control condition."
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult women (ages 18-45) who are between 18-26 weeks pregnant
- Fluency in English
- Ability to give informed consent and comply with study procedures (including phone and internet access)
- Elevated GAD-7 score (10+)
- Women must be receiving prenatal care
- Singleton pregnancy
Exclusion Criteria:
- Prisoners
- Inability to give informed consent and comply with study procedures
- Past/current mania, past/current psychoses (assessed with Psychosis Screening Questionnaire)
- No therapy appointments in last 60 days (not currently in psychotherapy).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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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.
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.
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.
The follow-up assessment at 8-weeks postpartum will be completed via phone.
|
Active Comparator: 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.
|
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.
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.
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.
The follow-up assessment at 8-weeks postpartum will be completed via phone.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Inventory of Mood and Anxiety Symptoms (IMAS-R) scores from Baseline
Time Frame: Past 1 month
|
The IMAS-R provides continuous and diagnostic scores on mood, anxiety, and distress symptoms.
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Past 1 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Five Facet Mindfulness Questionnaire
Time Frame: up to 12 month
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This assessment is a 39-item measure where the scale is from 1 (never or rarely true) to 5 (very often or always true).
FFMQ measures five facets of mindfulness with respect to one's own experience: observing (8 items), describing (8 items), acting with (8 items), non-judging (8 items), and non-reacting (7 items).
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up to 12 month
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Change in Acceptance and Action Questionnaire (AAQ-2) from Baseline
Time Frame: up to 12 month
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AAQ-2 will be used to measure psychological inflexibility, avoidance behavior, and maladaptive coping.
This is a 7 item measure with a scale of 1 (never true) to 7 (always true).
Lower scores indicate lesser experiential avoidance.
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up to 12 month
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences in Infant Birth Outcomes
Time Frame: After delivery
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Infant birth outcomes will be obtained from medical records
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After delivery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Emily B K Thomas, PhD, University of Iowa
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202002658
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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