Follow Up Assessments: 34-36 weeks pregnant and 4-week postpartum for Anxiety Disorders

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Iowa, Iowa City, IA
Anxiety Disorders+7 More
Follow Up Assessments: 34-36 weeks pregnant and 4-week postpartum - DiagnosticTest
Eligibility
18 - 65
Female
Eligible conditions
Anxiety Disorders

Study Summary

This study is evaluating whether a form of therapy may help reduce anxiety and depressive symptoms during the perinatal and postpartum periods.

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Eligible Conditions

  • Anxiety Disorders
  • Depression, Postpartum
  • Melancholia
  • Depression
  • Postpartum Anxiety
  • Perinatal Anxiety
  • Postpartum Depression
  • Perinatal Depression
  • Depressive Disorder

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Follow Up Assessments: 34-36 weeks pregnant and 4-week postpartum will improve 1 primary outcome, 2 secondary outcomes, and 1 other outcome in patients with Anxiety Disorders. Measurement will happen over the course of After delivery.

After delivery
Differences in Infant Birth Outcomes
Past 1 month
Change in Inventory of Mood and Anxiety Symptoms (IMAS-R) scores from Baseline
up to 12 month
Change in Acceptance and Action Questionnaire (AAQ-2) from Baseline
Change in Five Facet Mindfulness Questionnaire

Trial Safety

Trial Design

2 Treatment Groups

Supportive Psychoeducation
Acceptance and Commitment Therapy

This trial requires 80 total participants across 2 different treatment groups

This trial involves 2 different treatments. Follow Up Assessments: 34-36 Weeks Pregnant And 4-week Postpartum is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Acceptance and Commitment TherapyAcceptance 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 PsychoeducationControl 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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 month
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 12 month for reporting.

Who is running the study

Principal Investigator
E. T.
Prof. Emily Thomas, Clinical Assistant Professor
University of Iowa

Closest Location

University of Iowa - Iowa City, IA

Eligibility Criteria

This trial is for female patients between 18 and 65 years old. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for anxiety disorders?

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Almost all known psychological treatments may be used to treat anxiety disorders: psychodynamic-based therapy, cognitive behavioral therapy, relaxation therapy, and relaxation techniques, but psychodynamic-based therapies and cognitive behavioral therapy-based relaxation therapies can be particularly useful in treating specific anxiety disorders. In addition, hypnosis, guided imagery therapy, and biofeedback have been shown to reduce the duration and severity of panic attacks. The use of medication to treat panic disorder is less conclusive, and medication only appears to be effective in certain situations.

Unverified Answer

How many people get anxiety disorders a year in the United States?

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Between 9% and 29% of adults have at least one anxiety disorder and between 0.4% and 4.4% meet criteria for the specific phobias. Anxiety disorders are highly prevalent in this population, especially among female adolescents and adults. Clinicians should be aware of these numbers, as there is substantial unmet need for efficacious interventions in women and children with anxiety disorders and specific phobias.

Unverified Answer

What causes anxiety disorders?

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These data suggest that there is an increased risk of anxiety disorders before a child is born, and children with a family history of anxiety disorders report increased stressors, anxiety, and depressive symptoms before their birth.

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What are the signs of anxiety disorders?

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Anxiety symptoms include insomnia, stress, concentration problems, and headaches. Other symptoms such as fear of going outside, difficulty attending, and panic attack may occur. It is important to note that anxiety can be a symptom and cause of depression. Anxiety is an essential contributor to mood disorders with both conditions occurring commonly in the same environments. Anxiety symptoms and disorders could worsen social and vocational abilities. The treatment for an anxiety disorder is different from treatment of a depression. Patients with anxiety disorders may benefit from psychotherapy which includes cognitive behavioral therapy. Anxiety symptoms and disorders could be treated using medications that decrease the symptoms while also improving the outlook.\n\nDementia is the deterioration of memory, thinking, and behavior that occurs.

Unverified Answer

What is anxiety disorders?

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Anxiety disorders are the most common mental disorders affecting one out of ten adults in an Australian adult population. The prevalence of panic disorder and generalized anxiety disorder is higher than that of other specific anxiety disorders. Women have more than twice as many anxiety disorders as men.

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Can anxiety disorders be cured?

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Data from a recent study imply that anxiety disorders do not heal themselves. Nevertheless, studies that are based on the self as a subject source of data may produce false results and therefore it is advisable to study anxiety disorders using the observer as a subjects source of information.

Unverified Answer

How does follow up assessments: 34-36 weeks pregnant and 4-week postpartum work?

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Follow up care is not standardized in the maternity care setting. For most mothers in Ontario who receive the standard postpartum follow up care, the 4-week postpartum care did not cover all postpartum concerns; this has implications to the success of this follow up care, and the impact it has on the mothers' satisfaction with the care they receive.

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Have there been any new discoveries for treating anxiety disorders?

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There is a need for new anxiety treatments since most drugs of known effectiveness are already being widely used. In addition, more research should be done to find new ways of treating anxiety disorders with fewer side effects.

Unverified Answer

Does follow up assessments: 34-36 weeks pregnant and 4-week postpartum improve quality of life for those with anxiety disorders?

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The follow up assessments did not improve QOL of pregnant women with anxiety disorders. Results from a recent paper of this study highlight the need for a randomized trial with at least six months postpartum.

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Is follow up assessments: 34-36 weeks pregnant and 4-week postpartum safe for people?

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Findings from a recent study shows that the provision of post-partum follow up telephone conversations, where all results are discussed with and received by respondents, is safe for patients with chronic disease, and increases adherence to follow up.

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Has follow up assessments: 34-36 weeks pregnant and 4-week postpartum proven to be more effective than a placebo?

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Pregnant women treated with citalopram or paroxetine and their immediate postpartum periods had decreased rates of anxiety, symptoms, and number of episodes. This was shown to be even more important for women who had a high baseline rate of PTSD. Follow up analyses were also performed and the researchers were able to examine the efficacy in those who were not treatment-naive at the beginning of the study. The participants had a greater average decrease in symptoms (except for nightmares) than treatment-naive participants. An analysis of qualitative data confirmed that both citalopram and paroxetine were effective treatments in alleviating symptoms to a statistically significant level.

Unverified Answer

What is follow up assessments: 34-36 weeks pregnant and 4-week postpartum?

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Many of the maternal questions on the HADS do not have an obvious response for either the positive or negative response for anxiety or depression. The questionnaire should not be used during the postpartum follow-up. The questionnaire should only be used 4 to 8 weeks after the birth. The information obtained is helpful in informing the woman, as well as her healthcare team of her psychiatric symptoms. Her postnatal depression and anxiety should be assessed to help manage and prevent this mental wellbeing complication of pregnancy, after which care is needed.

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