search
Back to results

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

Primary Purpose

Post Partum Depression, Perinatal Depression, Post Partum Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Baseline Assessment (18-26 weeks pregnant)
Online Intervention and Phone Coaching Interventions
Follow Up Assessments: 34-36 weeks pregnant and 4-week postpartum
Follow Up Assessments: 8 weeks postpartum
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Post Partum Depression focused on measuring Pregnancy, Mental Health

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • University of Iowa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Acceptance and Commitment Therapy

Supportive Psychoeducation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.

Full Information

First Posted
February 8, 2019
Last Updated
July 11, 2023
Sponsor
University of Iowa
search

1. Study Identification

Unique Protocol Identification Number
NCT03837392
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Partum Depression, Perinatal Depression, Post Partum Anxiety, Perinatal Anxiety
Keywords
Pregnancy, Mental Health

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acceptance and Commitment Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Supportive Psychoeducation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Baseline Assessment (18-26 weeks pregnant)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Online Intervention and Phone Coaching Interventions
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Follow Up Assessments: 34-36 weeks pregnant and 4-week postpartum
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Follow Up Assessments: 8 weeks postpartum
Intervention Description
The follow-up assessment at 8-weeks postpartum will be completed via phone.
Primary Outcome Measure Information:
Title
Change in Inventory of Mood and Anxiety Symptoms (IMAS-R) scores from Baseline
Description
The IMAS-R provides continuous and diagnostic scores on mood, anxiety, and distress symptoms.
Time Frame
Past 1 month
Secondary Outcome Measure Information:
Title
Change in Five Facet Mindfulness Questionnaire
Description
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).
Time Frame
up to 12 month
Title
Change in Acceptance and Action Questionnaire (AAQ-2) from Baseline
Description
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.
Time Frame
up to 12 month
Other Pre-specified Outcome Measures:
Title
Differences in Infant Birth Outcomes
Description
Infant birth outcomes will be obtained from medical records
Time Frame
After delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily B K Thomas, PhD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs