N/A
N=161
Connecting Women to Care: Home-based Psychotherapy for Women With MST Living in Rural Areas
PTSD
Bottom Line
View on ClinicalTrials.gov: NCT03429166 ↗Enrolled (actual)
161
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Clinician Assessed Severity of PTSD — 41.74; 43.06; 27.78; 34.00 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Skills Training in Affective and Interpersonal Regulation (Behavioral); Present Centered Therapy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- VA Office of Research and Development
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinician Assessed Severity of PTSD |
41.74; 43.06; 27.78; 34.00; 28.88; 34.05 | — |
| SECONDARY PTSD Symptom Severity (Self-Report) |
47.52; 49.12; 38.17; 41.88; 28.82; 34.64 | — |
| SECONDARY Social Support |
68.16; 65.49; 72.30; 66.92; 76.44; 68.34 | — |
| SECONDARY Emotion Regulation Difficulties |
107.31; 109.51; 96.79; 103.48; 86.26; 97.45 | — |
| SECONDARY Depression |
35.50; 36.13; 29.27; 32.10; 23.04; 28.06 | — |
| SECONDARY Posttraumatic Maladaptive Beliefs |
46.73; 48.44; 41.79; 45.99; 36.74; 43.01 | — |
| SECONDARY Psychosocial Functioning |
14.88; 15.10; 13.07; 13.47; 11.26; 11.84 | — |
Summary
Military sexual trauma (MST) is a common duty-related stressor which occurs among one in four female Veterans and is associated with substantial concerns about social isolation and high rates of PTSD. Women with MST also experience numerous person-level barriers to care including the desire to avoid male-dominated VA clinics, transportation difficulties and childcare responsibilities. Treatment programs that address the social and mental health needs of this population and acknowledge barriers to care that disproportionately affect women are lacking. The proposed study will use a hybrid effectiveness-implementation design to evaluate the in-home delivery of a gender-sensitive, evidence-based coping skills program to improve social and role functioning as well as reduce PTSD and will prioritize enrolling rural women in a representative manner. If the program is found to be successful at improving social functioning and PTSD, and in reducing barriers to care, it will provide a tremendous benefit to women Veterans with MST, particularly those in rural areas.
Eligibility Criteria
Inclusion Criteria
- Veteran
- A positive screen for MST
- A positive PTSD screen defined as PC-PTSD cut-off of > 3
Exclusion Criteria
- Substance abuse not in remission for at least 3 months
- Current psychotic symptoms
- unmedicated mania or bipolar disorder
- prominent current suicidal or homicidal ideation
- Cognitive impairment indicated by chart diagnoses or observable cognitive difficulties
- Current involvement in a violent relationship defined as more than casual contact
- e.g., dating or living with an abusive partner
Data sourced from ClinicalTrials.gov (NCT03429166). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.