Preventing Maternal Mood, Anxiety, and Trauma Symptoms After Cesarean Delivery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorUniversity of Colorado, Denver

About this trial

Perinatal mental health disorders are the most prevalent perinatal comorbidity and are associated with the primary cause of maternal mortality in the United States (US) - suicide. Diagnosis of a high-risk pregnancy and cesarean delivery (CD) are both associated with increased risk for perinatal mood, anxiety, and trauma symptoms (PMATS). There is a deficit in resources and access to mental health treatment for pregnant patients, with some treatments being cost-prohibitive and requiring multiple sessions. Additionally, current approaches to addressing PMATS are reactive rather than preventive. There is evidence in the non-obstetric population that single-session cognitive behavioral therapy interventions targeting anxiety sensitivity (fear of fear) can prevent the development of anxiety and trauma symptoms when individuals are exposed to trauma. The investigators developed a low-cost, 1-hour, single-session prevention intervention that included psychoeducation about anxiety sensitivity, coupled with a brief exposure to the operating room environment and CD procedures. To revise the implementation plan and intervention (CARE: Communication, Agency, Readiness, Empowerment for cesarean delivery \[CD\]) for use in large L\&D units with a broader population of patients, a fully powered multisite randomized control trial (RCT) is needed. Before initiating such a trial, work needs to be done to modify the intervention and implementation through a process of iterative refinement to enhance the acceptability, appropriateness, and feasibility of implementation in L\&D units across the country, as well as its efficacy at engaging with the target mechanism (anxiety sensitivity). Using a logic model to guide the iterative refinement process through fast feedback loops and an atmosphere of co-creation, study investigators will gather critical input from stakeholders (individuals with lived experiences, community partners, front-line clinicians, and hospital staff) via 12 workgroups, 12 user-testing design sessions, and repeated engagement with a steering council. Following this refinement process, a treatment development pilot RCT at a large L\&D unit will assess the efficacy of CARE for CD by probing engagement with the target mechanism, as well as assess the feasibility of implementation. Finally, the updated logic model and pilot trial results will inform the development of a protocol for a multisite RCT through engagement with expert consultants in a community engagement studio and further feedback from the steering council.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pregnant Patients at 22-37 weeks gestation

Single or multiple gestation

Nulliparous or multiparous (with prior vaginal or cesarean delivery)

Antepartum admission for at least 3 days

Disqualifiers

Lack of capacity to consent

Medical factors prohibiting participation in the intervention as determined by the inpatient obstetric medical team.

Anticipated cesarean within 7 days of enrollment

Trial design

Design model

Parallel

Treatments tested in this trial

  • BE-OR: Brief Intervention to the Operating Room

    Behavioral

    See intervention group section for details

  • Interaction: Facetime with Clinical Provider

    Other intervention

    See Interaction group section for details

Treatment groups

80 Participants
are divided into 3 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: Interaction ControlExperimental treatment 1 intervention
Group C: Care as UsualNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Anxiety-sensitivity Index 3

18-item scale that yields a primary outcome score and subscale scores. Higher scores indicate higher anxiety sensitivity. Minimum score 0. Maximum score 72.

Time frame
Baseline
2

Anxiety-sensitivity Index 3

18-item scale that yields a primary outcome score and subscale scores. Higher scores indicate higher anxiety sensitivity. Minimum score 0. Maximum score 72.

Time frame
Approximately 3 days (range=1-5) after intervention (CARE and interaction control conditions) or approximately 5 days (range = 3-7) after enrollment (care as usual condition)

Secondary outcomes

1

Adverse Childhood Experience Questionnaire

10-question scale regarding adverse social experiences in childhood. Higher score reflects higher adverse experiences. Minimum score 0. Maximum score 10.

Time frame
Baseline
2

Wijma Delivery Expectancy/Experience Questionnaire

33-item measure of fear of childbirth expectancy. Higher scores are related to higher fear regarding childbirth. Higher scores indicate more fear. Minimum score 0. Maximum score 165.

Time frame
Baseline
3

State-Trait Anxiety Inventory

20-item scale to assess state anxiety symptom intensity. Higher scores indicate more intense anxiety symptoms. Minimum score 20. Maximum score 80.

Time frame
Baseline
4

Columbia Suicide Severity Rating Scale

6-item scale to assess presence of suicidal ideation, plan and intent. Answers are yes or no. With any yes answer indicating some form of suicidality.

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator