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

NCT03837392 | Completed

• 1 other identifier: 202002658
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Partum Depression; Perinatal Depression; Post Partum Anxiety; Perinatal Anxiety

Keywords

Pregnancy; Mental Health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Five Facet Mindfulness Questionnaire

  up to 12 month

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

  up to 12 month

Other Outcomes (1)

• Differences in Infant Birth Outcomes

  After delivery

Study Arms (2)

Acceptance and Commitment Therapy

EXPERIMENTAL

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.

Diagnostic Test: Baseline Assessment (18-26 weeks pregnant); Behavioral: Online Intervention and Phone Coaching Interventions; Diagnostic Test: Follow Up Assessments: 34-36 weeks pregnant and 4-week postpartum; Diagnostic Test: Follow Up Assessments: 8 weeks postpartum

Supportive Psychoeducation

ACTIVE COMPARATOR

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.

Diagnostic Test: Baseline Assessment (18-26 weeks pregnant); Behavioral: Online Intervention and Phone Coaching Interventions; Diagnostic Test: Follow Up Assessments: 34-36 weeks pregnant and 4-week postpartum; Diagnostic Test: Follow Up Assessments: 8 weeks postpartum

Interventions

Baseline Assessment (18-26 weeks pregnant) DIAGNOSTIC_TEST

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.

Acceptance and Commitment Therapy; Supportive Psychoeducation

Online Intervention and Phone Coaching Interventions BEHAVIORAL

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.

Acceptance and Commitment Therapy; Supportive Psychoeducation

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

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.

Acceptance and Commitment Therapy; Supportive Psychoeducation

Follow Up Assessments: 8 weeks postpartum DIAGNOSTIC_TEST

The follow-up assessment at 8-weeks postpartum will be completed via phone.

Acceptance and Commitment Therapy; Supportive Psychoeducation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Depression, Postpartum; Psychological Well-Being

Interventions

Gravidity; Postpartum Period

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Pregnancy; Reproduction; Reproductive History; Epidemiologic Factors; Public Health; Environment and Public Health

Study Officials

• Emily B K Thomas, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: February 12, 2019
• Study Start: June 1, 2020
• Primary Completion: January 31, 2023
• Study Completion: June 30, 2023
• Last Updated: July 12, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)