Posttraumatic Stress Symptom
Conditions
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.
Interventions
OTHERSurvivor Mom Companion
Weekly intervention sessions will follow the survivor Moms' Companion manualized modules. One module each week. The module centers on reinforcement of information introduced in each previous module, then emotional support, and referrals to additional services or specialists as needed. Participants in each session will practice applying knowledge and skills using the module's vignettes. Process guides prompt inquiry about in vivo management of post-traumatic stress disorder reactions and emotional and interpersonal responses to events since the last session. Each module may require 45 minutes of self-study before each session and 45 minutes of in-session time spent with the interventionist.
Sponsors
State University of New York at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dissociative Subtype of Post Traumatic Stress Scale | This will be administered prior to the intervention as part of the starting assessment and repeated after the intervention to assess any changes. | Scale to assess dissociative symptoms. Each item on the measure is rated on a 5-point scale (0=Not at all; 1=Once or twice; 2=Almost every day; 3=About once a day, and 4=More than once a day). The total score can range from 0 to 32, with higher scores indicating greater severity of dissociative experiences. |
| Childhood Trauma Questionnaire | This will be administered prior to the intervention as part of the starting assessment. | For eligibility screening we will use the 5 sentinel items from the Childhood Trauma Questionnaire. The higher the score is, the greater the severity of abuse for that scale. There are four categories of severity for each trauma type: None (minimal); Low (to Moderate); Moderate (to Severe); and Severe (to Extreme). |
| Primary Care Post Traumatic Stress Disorder Screen for Diagnostic and Statistical Manual of Mental Disorders-5 | This will be administered at the prior to the intervention as part of the starting assessment. | The Primary Care post-traumatic stress Screen for Diagnostic and Statistical Manual of Mental Disorders is a 5-item screen designed to identify individuals with probable post-traumatic stress disorder. Primary Care Post Traumatic Stress Disorder considered positive if the respondent answers yes to any 3 items in the questions listed in the scale. |
| Adverse Childhood Experiences Questionnaire | This will be administered prior to the intervention as part of the starting assessment. | Scale to assess the presence of childhood trauma. If the Adverse childhood experience score is 1-3 without Adverse Childhood Experience, the responder is at intermediate risk for toxic stress. If the Adverse childhood experience score is 1-3 and there is the likelihood of at least one Adverse childhood experience-associated condition, or if the Adverse childhood experiences score is 4 or higher, the responder is at high risk for toxic stress. |
| Post Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders | This will be administered prior to the intervention as part of the starting assessment and repeated after the intervention to assess any changes. | Scale to assess presence of post-traumatic stress symptoms. Severity can be determined adding scores of each item together to determine a total score. A total score of 33 or higher may indicate severe post-traumatic stress disorder. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| State Trait Anger Expression Inventory | This will be administered prior to the intervention as part of the starting assessment and repeated after the intervention to assess any changes. | A psychometric assessment that measures the experience and control of anger. scores are classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80). A higher score signifies higher anxiety. |
| Symptoms Checklist-90 Revised/Interpersonal Sensitivity Subscale | This will be administered prior to the intervention as part of the starting assessment and repeated after the intervention to assess any changes. | Instrument help evaluate a broad range of psychological problem symptoms. Using a five-point scale ranging from not at all to extremely, each item assesses the severity of distress the respondent experienced in the last 7 days. Each item is graded from 1 to 5 according to the severity (none, mild, moderate, severe and extreme). The scores of the items were regarded as extreme when the total is between 30-36. |
| Difficulties in Emotion Regulation Scale Short Form | This will be administered prior to the intervention as part of the starting assessment and repeated after the intervention to assess any changes. | Covers four dimensions of emotional regulation; awareness and understanding of emotions, acceptance of emotions and the ability to engage in goal-directed behavior. All subscales are scored so that higher values reflect greater difficulty with emotion regulation. |
| Patient Health Questionnaire-9 | This will be administered prior to the intervention as part of the starting assessment and repeated after the intervention to assess any changes. | A multipurpose instrument for screening and measuring severity of depression. In the scale 1-4 = minimal depression, 5-9 = mild depression, 10-14 = moderate depression, 15-19 = moderately severe depression and 20-27= severe depression. Thus, the higher the total score the higher the perceived level of depression. |
Countries
United States
Outcome results
None listed