Connecting Women to Care: Home-based Psychotherapy for Women With MST Living in Rural Areas

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03429166

Acronym

CWC

Enrollment

204

Registered

2018-02-12

Start date

2018-09-03

Completion date

2022-12-30

Last updated

2025-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PTSD

Brief 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.

Detailed description

Background - Military Sexual Trauma (MST) among women Veterans is a problem of epidemic proportion associated with significant mental health and functional impairment and substantial access to care barriers. Surveillance data indicate that one in four women Veterans reports MST when screened. Compared to women Veterans with other service-related stressors, those experiencing MST have greater mental health problems, are more likely to report difficulty in functioning in social, family and intimate relationships and are more likely to be unemployed and to report difficulties in finding a job. Nevertheless, women with MST engage less frequently in VA health care than other women Veterans. Barriers to care include distance from specialty services, financial difficulties, childcare and family responsibilities, and gender-related discomfort in male-dominated VA facilities. Research over the past decade has identified the problems and concerns of women Veterans with MST but programs addressing their mental health needs and responsive to identified barriers are lacking. The proposed study addresses this gap by evaluating a gender-sensitive, evidence-based skills training program delivered via home-based video technology (HBVT). Specific Aims - The study will conduct a Hybrid Type 1 effectiveness-implementation study to accomplish two aims. The first is to determine the effectiveness of the HBVT-delivered, Skills Training in Affective Regulation (STAIR) relative to a HBVT-delivered nonspecific active comparator, Present Centered Therapy (PCT) among women Veterans with MST. It is hypothesized that STAIR will be superior to PCT in regards to improvement in PTSD symptoms as measured by the Clinician Administered PTSD Scale (CAPS) (primary outcome) as well as in perceived social support and social engagement (secondary outcomes). The second aim is to conduct a multi-stakeholder, mixed method evaluation to inform future potential implementation plans by identify barriers and facilitators of implementing STAIR via HBVT and to contextualize and interpret the quantitative data on treatment processes and clinical effectiveness. Methodology - This is a four-year, two-site Hybrid Type 1 effectiveness-implementation study design. A total of 200 women Veterans with MST and PTSD symptoms with cut-off of 3 or more from the Diagnostic Statistical Manual 5 (DSM-5) PTSD Screen will be enrolled into the study. Participants will be stratified by rurality status in a proportion representative of the national population (34% rural vs. 66% nonrural). Stratification will ensure that resources are dedicated to recruit the identified number of rural women. Within each level of stratification, participants will be randomized into one of two treatments conditions, STAIR or PCT, each of which is comprised of 10 weekly sessions. Assessments will be conducted at five time-points: baseline (week 0), mid-treatment (week 8), immediately posttreatment (week 16), 2-month follow-up (week 24) and 4-month follow-up (week 32). Rurality will be included as a covariate and assessed for variations in aspects such as retention and outcome, which will help inform future implementation plans. Multi-stakeholder mixed-method process evaluation concerning STAIR and the use of in-home delivery of services will include administrator, clinician and patient stakeholders. Expected Results and Anticipated Impacts on Veterans Healthcare - It is expected that the proposed study has the potential to improve the quality of VA healthcare by establishing the effectiveness of a social skills intervention, Skills Training in Affective and Interpersonal Regulation (STAIR) delivered via home-based video technology (HBVT) to women Veterans with MST, particularly those living in rural areas. The treatment simultaneously addresses social concerns and PTSD symptoms, both of which are identified needs of women Veterans who have experienced MST. STAIR has been demonstrated as efficacious in community populations and pilot data with women Veterans with MST indicate similar outcomes regarding improvements in perceived social support, social engagement and PTSD symptoms. The use of HBVT has the potential of increasing access to care to this geographically dispersed and underserved population.

Interventions

BEHAVIORALSkills Training in Affective and Interpersonal Regulation

A non-trauma-focused treatment

BEHAVIORALPresent Centered Therapy

A non-trauma-focused treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Outcomes Assessor)

Intervention model description

The current study proposes a blending of design components of clinical effectiveness and implementation research for the purposes increasing translational gains and providing useful information to inform future implementation that would otherwise not be available or take much longer to obtain. This Hybrid Type 1 design combines a randomized clinical effectiveness trial with a mixed-method, multi-stakeholder process evaluation of the delivery of the intervention.

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Clinician Assessed Severity of PTSD	Baseline, 16, 24 and 32 weeks	Clinician Administered PTSD Scale for the Diagnostic Statistical Manual Fifth Edition (DSM-5) (CAPS-5) Total Severity CAPS-5 is a clinician administered interview which assesses DSM-5 symptom severity and diagnosis. The measure includes 20 items rated on a 5-point Likert scale which ranges from 0 to 80 where higher scores mean worse outcomes.

Secondary

Measure	Time frame	Description
Social Support	Baseline, 8, 16, 24 and 32 weeks	Interpersonal Support Evaluation List -12 (ISEL-12) is a 12 item measure of social support with a Likert scale from 0 to 3. Possible total scores range from 0 to 120 with higher scores indicate greater perceived support.
Emotion Regulation Difficulties	Baseline, 8, 16, 24 and 32 weeks	Difficulties in Emotion Regulation Scale-36 (DERS-36) is a 36 item self-report measure of emotion regulation difficulties that is rated on a scoe of 0 to 5. Possible total scores range from 0 to 180 where higher scores indicate more difficulties.
PTSD Symptom Severity (Self-Report)	Baseline, 8, 16, 24 and 32 weeks	PTSD Checklist for DSM-5 (PCL-5) is a 20 item measure with a Likert scale from 0 to 4. Possible total scores range from 0 to 80, where higher scores indicate more severe symptoms.
Posttraumatic Maladaptive Beliefs	Baseline, 8, 16, 24 and 32 weeks	Posttraumatic Maladaptive Belief Scale (PMBS) is a 15 item self-report measure. Responses are measured on a 7-point scale from 0 to 6. Possible total scores range from 0 to 90 where higher scored indicate strong maladaptive beliefs.
Psychosocial Functioning	Baseline, 8, 16, 24 and 32 weeks	The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Life Activities Subscale is an 8 item measure of how difficult daily life activities are to complete. Responses range from 0 to 4. Possible total scores range from 0 to 32 with higher scores indicating greater difficulties.
Depression	Baseline, 8, 16, 24 and 32 weeks	Beck Depression Inventory-11 (BDI-11) is an 11 item measure. Possible total scores can range from 0 to 63 where higher scores mean more depression.

Countries

United States

Participant flow

Recruitment details

Of 305 candidates who completed screens, 204 completed baseline and 161 met study criteria and were randomized.

Participants by arm

Arm	Count
STAIR Stands for Skills Training in Affective and Interpersonal Regulation STAIR stands for Skills Training in Affective and Interpersonal Regulation a non-trauma-focused treatment Skills Training in Affective and Interpersonal Regulation: A non-trauma-focused treatment	79
Present Centered Therapy Present Centered Therapy (PCT) a non-trauma-focused treatment Present Centered Therapy: A non-trauma-focused treatment	82
Total	161

Baseline characteristics

Characteristic	STAIR Stands for Skills Training in Affective and Interpersonal Regulation	Present Centered Therapy	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	79 Participants	82 Participants	161 Participants
Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity	41.74 units on a scale STANDARD_DEVIATION 11.88	43.06 units on a scale STANDARD_DEVIATION 11.43	42.41 units on a scale STANDARD_DEVIATION 11.7
Race (NIH/OMB) American Indian or Alaska Native	9 Participants	6 Participants	15 Participants
Race (NIH/OMB) Asian	5 Participants	7 Participants	12 Participants
Race (NIH/OMB) Black or African American	17 Participants	17 Participants	34 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants	4 Participants	6 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) White	45 Participants	48 Participants	93 Participants
Region of Enrollment United States	79 Participants	82 Participants	161 Participants
Sex: Female, Male Female	79 Participants	82 Participants	161 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 79	0 / 82
other Total, other adverse events	0 / 79	0 / 82
serious Total, serious adverse events	0 / 79	0 / 82

Outcome results

Primary

Clinician Assessed Severity of PTSD

Clinician Administered PTSD Scale for the Diagnostic Statistical Manual Fifth Edition (DSM-5) (CAPS-5) Total Severity CAPS-5 is a clinician administered interview which assesses DSM-5 symptom severity and diagnosis. The measure includes 20 items rated on a 5-point Likert scale which ranges from 0 to 80 where higher scores mean worse outcomes.

Time frame: Baseline, 16, 24 and 32 weeks

Population: Intent to Treat Analysis is complete for 16 weeks (immediately posttreatment) and 24 weeks (2 month follow-up) and 32 weeks (4 month follow-up)

Arm	Measure	Group	Value (MEAN)	Dispersion
STAIR Stands for Skills Training in Affective and Interpersonal Regulation	Clinician Assessed Severity of PTSD	Baseline (week 0)	41.74 score on a scale	Standard Error 11.88
STAIR Stands for Skills Training in Affective and Interpersonal Regulation	Clinician Assessed Severity of PTSD	Post-treatment (week 16)	27.78 score on a scale	Standard Error 7.69
STAIR Stands for Skills Training in Affective and Interpersonal Regulation	Clinician Assessed Severity of PTSD	2-Month Follow-Up (week 24)	28.88 score on a scale	Standard Error 7.87
STAIR Stands for Skills Training in Affective and Interpersonal Regulation	Clinician Assessed Severity of PTSD	4-Month Follow-Up (week 32)	29.98 score on a scale	Standard Error 7.87
Present Centered Therapy	Clinician Assessed Severity of PTSD	4-Month Follow-Up (week 32)	34.10 score on a scale	Standard Error 7.64
Present Centered Therapy	Clinician Assessed Severity of PTSD	Baseline (week 0)	43.06 score on a scale	Standard Error 11.43
Present Centered Therapy	Clinician Assessed Severity of PTSD	2-Month Follow-Up (week 24)	34.05 score on a scale	Standard Error 7.64
Present Centered Therapy	Clinician Assessed Severity of PTSD	Post-treatment (week 16)	34.00 score on a scale	Standard Error 7.47

Secondary

Depression

Beck Depression Inventory-11 (BDI-11) is an 11 item measure. Possible total scores can range from 0 to 63 where higher scores mean more depression.