Clinical trial NCT03837392: Efficacy of Brief Acceptance and Commitment Therapy (ACT) for Perinatal Anxiety
Official title: A Pilot Study Examining the Efficacy of Brief Acceptance and Commitment Therapy (ACT) for Perinatal Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Partum Depression
Perinatal Depression
Post Partum Anxiety
Perinatal Anxiety
Keywords: Pregnancy
Mental Health
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2019-02-12
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This protocol will test the hypothesis that Acceptance and Commitment Therapy (ACT) is effective in reducing anxiety and depressive symptoms during the perinatal and postpartum periods. Participants should expect their participation in the study to last 9-12 months.

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.

Eligibility criteria: Inclusion Criteria:

1. Adult women (ages 18-45) who are between 18-26 weeks pregnant
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:

1. Prisoners
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).

Primary outcomes:
measure: Change in Inventory of Mood and Anxiety Symptoms (IMAS-R) scores from Baseline
timeFrame: Past 1 month
Secondary outcomes:
measure: Change in Five Facet Mindfulness Questionnaire
timeFrame: up to 12 month
measure: Change in Acceptance and Action Questionnaire (AAQ-2) from Baseline
timeFrame: up to 12 month
Other outcomes:
measure: Differences in Infant Birth Outcomes
timeFrame: After delivery
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Emily B K Thomas, PhD
role: PRINCIPAL_INVESTIGATOR
References: