Survivor Mom Companion Comparison Study (SMC)

University at Buffalo (UB)

Status: Completed

Conditions: Posttraumatic Stress Symptom

Treatments: Other: Survivor Mom Companion

Study type: Interventional

Funder types: Other

Identifiers

NCT06318663

STUDY00007685

Details and patient eligibility

About

The overall goal of the SMC is to help reduce posttraumatic stress symptomology for pregnant persons with a history of trauma.

Full description

The study is a pilot randomized waitlist-controlled trial that examines the preliminary efficacy of the SMC for reducing PTSD symptomology as compared to a waitlist control group. Also, it aims to assess the feasibility and acceptability of the SMC. It examines how changes in the theorized mechanisms (emotion regulation, interpersonal sensitivity) mediate the relationship between the intervention and PTSD symptomology.

Enrollment: 39 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• English- or Spanish-speaking
• Currently pregnant or in the postpartum period
• Age 18 and older
• A history of trauma and PTSD
• Able to comprehend the study protocol and consent form and provide verbal consent and
• able to commit to a minimum of 4 weekly intervention sessions.

Exclusion criteria

• Non-English or non-Spanish-speaking,
• less than 18 years of age,
• those with psychotic conditions or developmental disabilities requiring guardianship,
• those with high-risk pregnancies necessitating extended bedrest or inpatient care, and
• those unable to commit to completing the intervention sessions.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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39 participants in 2 patient groups, including a placebo group

Survivor Mom Companion Program

Active Comparator group

Description:

Participants in the Survivor Moms' Companion intervention will complete a minimum of 4 Survivor Moms' Companion psychoeducational modules with weekly tutor support and will then complete an ending assessment. Sessions with tutors are conducted over the phone or in person at the Buffalo Prenatal and Perinatal Network and last for 45 minutes.

Treatment:

Other: Survivor Mom Companion

Waitlist Control

Placebo Comparator group

Description:

Participants in the waitlist control group will complete the baseline assessment over the phone, wait six weeks, and then complete the ending assessment. Those on the waitlist will then be offered the Survivor Moms' Companion intervention. Sessions with tutors are conducted over the phone or in person at the Buffalo Prenatal and Perinatal Network and last for 45 minutes.

Treatment:

Other: Survivor Mom Companion