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

Not Applicable

Completed

• Conditions: Post Partum Depression; Perinatal Anxiety; Post Partum Anxiety; Perinatal Depression
• Interventions: Diagnostic Test: Baseline Assessment (18-26 weeks pregnant); Behavioral: Online Intervention and Phone Coaching Interventions

• Registration Number: NCT03837392
• Lead Sponsor: University of Iowa

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.

Study Timeline

• Study First Submitted: 2019-02-08
• Study First Submitted QC: 2019-02-08
• Study First Posted: 2019-02-12
• Study Start: 2020-06-01
• Primary Completion: 2023-01-31
• Study Completion: 2023-06-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-11
• Last Update Posted: 2023-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acceptance and Commitment Therapy	Baseline Assessment (18-26 weeks pregnant)	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.
Acceptance and Commitment Therapy	Online Intervention and Phone Coaching 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.
Supportive Psychoeducation	Baseline Assessment (18-26 weeks pregnant)	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.
Supportive Psychoeducation	Online Intervention and Phone Coaching 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.

Primary Outcome Measures

Name	Time	Method
Change in Inventory of Mood and Anxiety Symptoms (IMAS-R) scores from Baseline	Past 1 month	The IMAS-R provides continuous and diagnostic scores on mood, anxiety, and distress symptoms.

Secondary Outcome Measures

Name	Time	Method
Change in Acceptance and Action Questionnaire (AAQ-2) from Baseline	up to 12 month	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.
Change in Five Facet Mindfulness Questionnaire	up to 12 month	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).

Trial Locations

Locations (1)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States