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

NCT03429166 | Completed Results

• 1 other identifier: IIR 16-070
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 2

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.

Conditions

PTSD

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 16, 24 and 32 weeks

Secondary Outcomes (6)

• PTSD Symptom Severity (Self-Report)

  Baseline, 8, 16, 24 and 32 weeks

• Social Support

  Baseline, 8, 16, 24 and 32 weeks

• Emotion Regulation Difficulties

  Baseline, 8, 16, 24 and 32 weeks

• Depression

  Baseline, 8, 16, 24 and 32 weeks

• Posttraumatic Maladaptive Beliefs

  Baseline, 8, 16, 24 and 32 weeks

Study Arms (2)

STAIR stands for Skills Training in Affective and Interpersonal Regulation

EXPERIMENTAL

STAIR stands for Skills Training in Affective and Interpersonal Regulation a non-trauma-focused treatment

Behavioral: Skills Training in Affective and Interpersonal Regulation

Present Centered Therapy

ACTIVE COMPARATOR

PCT , a non-trauma-focused treatment

Behavioral: Present Centered Therapy

Interventions

Skills Training in Affective and Interpersonal Regulation BEHAVIORAL

A non-trauma-focused treatment

Also known as: STAIR

STAIR stands for Skills Training in Affective and Interpersonal Regulation

Present Centered Therapy BEHAVIORAL

A non-trauma-focused treatment

Present Centered Therapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veteran
• A positive screen for MST
• A positive PTSD screen defined as PC-PTSD cut-off of \> 3

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• San Diego Veterans Healthcare System: collaborator

Study Sites (2)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

Location

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

Location

Related Publications (15)

• Weiss BJ, Azevedo K, Webb K, Gimeno J, Cloitre M. Telemental Health Delivery of Skills Training in Affective and Interpersonal Regulation (STAIR) for Rural Women Veterans Who Have Experienced Military Sexual Trauma. J Trauma Stress. 2018 Aug;31(4):620-625. doi: 10.1002/jts.22305. Epub 2018 Aug 2.

  PMID: 30070399 RESULT

• Jackson C, Weiss BJ, Cloitre M. STAIR Group Treatment for Veterans with PTSD: Efficacy and Impact of Gender on Outcome. Mil Med. 2019 Jan 1;184(1-2):e143-e147. doi: 10.1093/milmed/usy164.

  PMID: 30007286 RESULT

• Cloitre M, Khan C, Mackintosh MA, Garvert DW, Henn-Haase CM, Falvey EC, Saito J. Emotion regulation mediates the relationship between ACES and physical and mental health. Psychol Trauma. 2019 Jan;11(1):82-89. doi: 10.1037/tra0000374. Epub 2018 May 10.

  PMID: 29745688 RESULT

• Ben-Ezra M, Karatzias T, Hyland P, Brewin CR, Cloitre M, Bisson JI, Roberts NP, Lueger-Schuster B, Shevlin M. Posttraumatic stress disorder (PTSD) and complex PTSD (CPTSD) as per ICD-11 proposals: A population study in Israel. Depress Anxiety. 2018 Mar;35(3):264-274. doi: 10.1002/da.22723. Epub 2018 Feb 16.

  PMID: 29451956 RESULT

• Schnyder U, Schafer I, Aakvaag HF, Ajdukovic D, Bakker A, Bisson JI, Brewer D, Cloitre M, Dyb GA, Frewen P, Lanza J, Le Brocque R, Lueger-Schuster B, Mwiti GK, Oe M, Rosner R, Schellong J, Shigemura J, Wu K, Olff M. The global collaboration on traumatic stress. Eur J Psychotraumatol. 2017 Nov 30;8(sup7):1403257. doi: 10.1080/20008198.2017.1403257. eCollection 2017.

  PMID: 29435201 RESULT

• Cloitre M, Garvert DW, Weiss BJ. Depression as a moderator of STAIR Narrative Therapy for women with post-traumatic stress disorder related to childhood abuse. Eur J Psychotraumatol. 2017 Oct 10;8(1):1377028. doi: 10.1080/20008198.2017.1377028. eCollection 2017.

  PMID: 29038682 RESULT

• Hyland P, Shevlin M, Cloitre M, Karatzias T, Vallieres F, McGinty G, Fox R, Power JM. Quality not quantity: loneliness subtypes, psychological trauma, and mental health in the US adult population. Soc Psychiatry Psychiatr Epidemiol. 2019 Sep;54(9):1089-1099. doi: 10.1007/s00127-018-1597-8. Epub 2018 Oct 6.

  PMID: 30293176 RESULT

• Karatzias T, Hyland P, Bradley A, Fyvie C, Logan K, Easton P, Thomas J, Philips S, Bisson JI, Roberts NP, Cloitre M, Shevlin M. Is Self-Compassion a Worthwhile Therapeutic Target for ICD-11 Complex PTSD (CPTSD)? Behav Cogn Psychother. 2019 May;47(3):257-269. doi: 10.1017/S1352465818000577. Epub 2018 Oct 2.

  PMID: 30277191 RESULT

• Kazlauskas E, Gegieckaite G, Hyland P, Zelviene P, Cloitre M. The structure of ICD-11 PTSD and complex PTSD in Lithuanian mental health services. Eur J Psychotraumatol. 2018 Jan 11;9(1):1414559. doi: 10.1080/20008198.2017.1414559.

  PMID: 33680347 RESULT

• Olff M, Amstadter A, Armour C, Birkeland MS, Bui E, Cloitre M, Ehlers A, Ford JD, Greene T, Hansen M, Lanius R, Roberts N, Rosner R, Thoresen S. A decennial review of psychotraumatology: what did we learn and where are we going? Eur J Psychotraumatol. 2019 Nov 20;10(1):1672948. doi: 10.1080/20008198.2019.1672948. eCollection 2019.

  PMID: 31897268 RESULT

• Coventry PA, Meader N, Melton H, Temple M, Dale H, Wright K, Cloitre M, Karatzias T, Bisson J, Roberts NP, Brown JVE, Barbui C, Churchill R, Lovell K, McMillan D, Gilbody S. Psychological and pharmacological interventions for posttraumatic stress disorder and comorbid mental health problems following complex traumatic events: Systematic review and component network meta-analysis. PLoS Med. 2020 Aug 19;17(8):e1003262. doi: 10.1371/journal.pmed.1003262. eCollection 2020 Aug.

  PMID: 32813696 RESULT

• Ho GWK, Karatzias T, Vallieres F, Bondjers K, Shevlin M, Cloitre M, Ben-Ezra M, Bisson JI, Roberts NP, Astill Wright L, Hyland P. Complex PTSD symptoms mediate the association between childhood trauma and physical health problems. J Psychosom Res. 2021 Mar;142:110358. doi: 10.1016/j.jpsychores.2021.110358. Epub 2021 Jan 12.

  PMID: 33508705 RESULT

• McGinty G, Fox R, Ben-Ezra M, Cloitre M, Karatzias T, Shevlin M, Hyland P. Sex and age differences in ICD-11 PTSD and complex PTSD: An analysis of four general population samples. Eur Psychiatry. 2021 Oct 4;64(1):e66. doi: 10.1192/j.eurpsy.2021.2239.

  PMID: 34602122 RESULT

• Rashkovsky K, Morabito DM, Chargin B, Chang CJ, Morland LA, Cloitre M. Treatment outcomes of sexual minority women (SMW) veterans with military sexual trauma (MST). Psychol Trauma. 2025 Dec 18:10.1037/tra0002077. doi: 10.1037/tra0002077. Online ahead of print.

  PMID: 41411035 DERIVED

• O'Doherty L, Whelan M, Carter GJ, Brown K, Tarzia L, Hegarty K, Feder G, Brown SJ. Psychosocial interventions for survivors of rape and sexual assault experienced during adulthood. Cochrane Database Syst Rev. 2023 Oct 5;10(10):CD013456. doi: 10.1002/14651858.CD013456.pub2.

  PMID: 37795783 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Amanda Borsky, PhD
• Organization: VA HSR&D

amanda.borsky@va.gov

2024435739

Study Officials

• Marylene Cloitre, PhD

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 12, 2018
• Study Start: September 3, 2018
• Primary Completion: May 31, 2022
• Study Completion: December 30, 2022
• Last Updated: April 25, 2025
• Results First Posted: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)