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

Perinatal Depression Clinical Trial

Official title:

A Pilot Study Examining the Efficacy of Brief Acceptance and Commitment Therapy (ACT) for Perinatal Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03837392
• Other study ID #: 202002658
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2023
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 30, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depression, Postpartum
• Depressive Disorder
• Perinatal Anxiety
• Perinatal Depression
• Post Partum Anxiety
• Post Partum Depression

Intervention

Diagnostic Test:
• 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.

Behavioral:
• 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.

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Differences in Infant Birth Outcomes	Infant birth outcomes will be obtained from medical records	After delivery
Primary	Change in Inventory of Mood and Anxiety Symptoms (IMAS-R) scores from Baseline	The IMAS-R provides continuous and diagnostic scores on mood, anxiety, and distress symptoms.	Past 1 month
Secondary	Change in Five Facet Mindfulness Questionnaire	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).	up to 12 month
Secondary	Change in Acceptance and Action Questionnaire (AAQ-2) from Baseline	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.	up to 12 month