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Behavioral Intervention

Follow Up Assessments: 34-36 weeks pregnant and 4-week postpartum for Perinatal Anxiety

N/A

Waitlist Available

Led By Emily B Kroska, PhD

Research Sponsored by University of Iowa

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 month

Awards & highlights

Study Summary

This trial will test whether a psychological intervention called Acceptance and Commitment Therapy (ACT) is effective in reducing anxiety and depressive symptoms during pregnancy and after childbirth. The study will last 9-12 months.

Eligible Conditions

Perinatal Anxiety
Postpartum Anxiety
Postpartum Depression

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Inventory of Mood and Anxiety Symptoms (IMAS-R) scores from Baseline

Secondary outcome measures

Change in Acceptance and Action Questionnaire (AAQ-2) from Baseline

Change in Five Facet Mindfulness Questionnaire

Other outcome measures

Differences in Infant Birth Outcomes

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Acceptance and Commitment TherapyExperimental Treatment4 Interventions

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.

Group II: Supportive PsychoeducationActive Control4 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Follow Up Assessments: 8 weeks postpartum

2020

N/A

~30

Baseline Assessment (18-26 weeks pregnant)

2020

N/A

~30

Online Intervention and Phone Coaching Interventions

2020

N/A

~30

Follow Up Assessments: 34-36 weeks pregnant and 4-week postpartum

2020

N/A

~30

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of IowaLead Sponsor

446 Previous Clinical Trials

879,472 Total Patients Enrolled

Emily B Kroska, PhDPrincipal InvestigatorUniversity of Iowa

Emily B K Thomas, PhDPrincipal InvestigatorUniversity of Iowa

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I qualify to partake in this experiment?

"This clinical trial needs 80 participants who experience anxiety and are between 18-45 years of age. The study is specifically targeting adult female patients (18-45) that have been pregnant for no more than 26 weeks, have a GAD-7 score of 10 or higher, and are receiving prenatal care."

Answered by AI

Is recruitment for this experiment open at the moment?

"This trial, as reported on clinicaltrials.gov, is actively seeking patients for participation. It was initially posted in June of 2020 and amended lastly on May 16th 2022."

Answered by AI

How many individuals are being administered this treatment protocol?

"Affirmative. Clinicaltrials.gov reveals that recruitment for this medical trial, which was originally published on June 1st 2020, is ongoing. Around 80 participants from a single site are needed to fill the clinical study's quota."

Answered by AI

Does the upper age limit for this trial exclude individuals below 55?

"This trial may only be joined by individuals in the 18-45 age bracket. Conversely, there are 274 and 1161 studies that have a lower or higher threshold for eligibility respectively."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy of Brief Acceptance and Commitment Therapy (ACT) for Perinatal Anxiety

Emily Thomas 2020. "Efficacy of Brief Acceptance and Commitment Therapy (ACT) for Perinatal Anxiety". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03837392.