Clinical trial NCT06318663: Survivor Mom Companion Comparison Study
Official title: Survivor Moms' Companion: A Perinatal PTSD Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Symptom
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Childhood Trauma Questionnaire
timeFrame: This will be administered prior to the intervention as part of the starting assessment.
measure: Primary Care Post Traumatic Stress Disorder Screen for Diagnostic and Statistical Manual of Mental Disorders-5
timeFrame: This will be administered at the prior to the intervention as part of the starting assessment.
measure: Adverse Childhood Experiences Questionnaire
timeFrame: This will be administered prior to the intervention as part of the starting assessment.
measure: Post Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders
timeFrame: This will be administered prior to the intervention as part of the starting assessment and repeated after the intervention to assess any changes.
measure: Dissociative Subtype of Post Traumatic Stress Scale
timeFrame: This will be administered prior to the intervention as part of the starting assessment and repeated after the intervention to assess any changes.
Secondary outcomes:
measure: Patient Health Questionnaire-9
timeFrame: This will be administered prior to the intervention as part of the starting assessment and repeated after the intervention to assess any changes.
measure: State Trait Anger Expression Inventory
timeFrame: This will be administered prior to the intervention as part of the starting assessment and repeated after the intervention to assess any changes.
measure: Symptoms Checklist-90 Revised/Interpersonal Sensitivity Subscale
timeFrame: This will be administered prior to the intervention as part of the starting assessment and repeated after the intervention to assess any changes.
measure: Difficulties in Emotion Regulation Scale Short Form
timeFrame: This will be administered prior to the intervention as part of the starting assessment and repeated after the intervention to assess any changes.
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Buffalo Prenatal-Perinatal Network
state: New York
Study officials:
affiliation: State University of New York at Buffalo
name: Mickey Sperlich, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bernstein DP, Stein JA, Newcomb MD, Walker E, Pogge D, Ahluvalia T, Stokes J, Handelsman L, Medrano M, Desmond D, Zule W. Development and validation of a brief screening version of the Childhood Trauma Questionnaire. Child Abuse Negl. 2003 Feb;27(2):169-90. doi: 10.1016/s0145-2134(02)00541-0.
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citation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
citation: Spielberger CD. Professional manual for the State-Trait Anger Expression Inventory-2 (STAXI-2). Odessa,FL: Psychological Assessment Resources; 1999.
citation: Derogatis LR, Lipman RS, Covi L. SCL-90. Administration, scoring and procedures manual-I for the R (revised) version and other instruments of the Psychopathology Rating Scales Series. Chicago: Johns Hopkins University School of Medicine; 1977.
citation: Kaufman EA, Xia M, Fosco G, Yaptangco M, Skidmore CR, Crowell SE. The Difficulties in Emotion Regulation Scale Short Form (DERS-SF): Validation and replication in adolescent and adult samples. Journal of Psychopathology and Behavioral Assessment. 2016 Sep;38(3):443-55. doi: 10.1007/s10862-015-9529-3
citation: Kelly PJ, Kyngdon F, Ingram I, Deane FP, Baker AL, Osborne BA. The Client Satisfaction Questionnaire-8: Psychometric properties in a cross-sectional survey of people attending residential substance abuse treatment. Drug Alcohol Rev. 2018 Jan;37(1):79-86. doi: 10.1111/dar.12522. Epub 2017 May 7.