Post Partum DepressionNCT03837392
Efficacy of Brief Acceptance and Commitment Therapy (ACT) for Perinatal Anxiety
A study testing Baseline Assessment (18-26 weeks pregnant), Online Intervention and Phone Coaching Interventions and Follow Up Assessments: 34-36 weeks pregnant and 4-week postpartum in people with Post Partum Depression and Perinatal Depression, run by University of Iowa at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Post Partum Depression, Perinatal Depression, Post Partum Anxiety
- What is being tested?
- Baseline Assessment (18-26 weeks pregnant), Online Intervention and Phone Coaching Interventions and Follow Up Assessments: 34-36 weeks pregnant and 4-week postpartum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study Examining the Efficacy of Brief Acceptance and Commitment Therapy (ACT) for Perinatal Anxiety
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.
Read the 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.
- Being tested
- 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
- Keywords
- Pregnancy, Mental Health
- Medical subject headings
- Depression, Postpartum, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Online Intervention and Phone Coaching InterventionsBehavioural
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.
Follow Up Assessments: 34-36 weeks pregnant and 4-week postpartumDiagnostic 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.
Follow Up Assessments: 8 weeks postpartumDiagnostic test
The follow-up assessment at 8-weeks postpartum will be completed via phone.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Past 1 month
Secondary outcomes (2)
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).
Measured: up to 12 month
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.
Measured: up to 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start1 Jun 2020
- Primary completion31 Jan 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Partum DepressionStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Thomas, University of Iowa
- Investigators
- Emily B K Thomas, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837392
- Sponsor's protocol ID
- 202002658
- Status last verified
- Jul 2023
- First submitted
- 8 Feb 2019
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Examining the Efficacy of Brief Acceptance and Commitment Therapy (ACT) for Perinatal Anxiety
- ClinicalTrials.gov ID
- NCT03837392
- Acronym / sponsor ID
- 202002658
- Keywords
- Pregnancy, Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 12 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acceptance and Commitment Therapy | Experimental | 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 postpartumAcceptance 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 | Active comparator | 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 postpartumControl 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Acceptance and Commitment Therapy, Supportive Psychoeducation |
| Online Intervention and Phone Coaching InterventionsACT 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. | Behavioural | Acceptance and Commitment Therapy, Supportive Psychoeducation |
| Follow Up Assessments: 34-36 weeks pregnant and 4-week postpartumThe 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. | Diagnostic test | Acceptance and Commitment Therapy, Supportive Psychoeducation |
| Follow Up Assessments: 8 weeks postpartumThe follow-up assessment at 8-weeks postpartum will be completed via phone. | Diagnostic test | Acceptance and Commitment Therapy, Supportive Psychoeducation |
Primary outcome
Change in Inventory of Mood and Anxiety Symptoms (IMAS-R) scores from Baseline
Time frame: Past 1 month
The IMAS-R provides continuous and diagnostic scores on mood, anxiety, and distress symptoms.
2 secondary outcomes
Change in Five Facet Mindfulness Questionnaire
Time frame: up to 12 month
Change in Acceptance and Action Questionnaire (AAQ-2) from Baseline
Time frame: up to 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily B K Thomas, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline Assessment (18-26 weeks pregnant), Online Intervention and Phone Coaching Interventions and Follow Up Assessments: 34-36 weeks pregnant and 4-week postpartum in people with Post Partum Depression and Perinatal Depression, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Inventory of Mood and Anxiety Symptoms (IMAS-R) scores from Baseline (time frame: Past 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.