PTSDCWCNCT03429166
Connecting Women to Care: Home-based Psychotherapy for Women With MST Living in Rural Areas
A study testing Skills Training in Affective and Interpersonal Regulation and Present Centered Therapy in people with PTSD, run by VA Office of Research and Development at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- PTSD
- What is being tested?
- Skills Training in Affective and Interpersonal Regulation and Present Centered Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Sep 2018to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran
- A positive screen for MST
- A positive PTSD screen defined as PC-PTSD cut-off of > 3
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161
About this study
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.
Read the 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.
- Conditions
- PTSD
- Being tested
- Skills Training in Affective and Interpersonal Regulation, Present Centered Therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skills Training in Affective and Interpersonal RegulationBehavioural
Also called STAIR
A non-trauma-focused treatment
Present Centered TherapyBehavioural
A non-trauma-focused treatment
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Skills Training in Affective and Interpersonal Regulation |
| Present Centered Therapy | Active comparator | PCT , a non-trauma-focused treatment Receives: Behavioral: Present Centered Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 16, 24 and 32 weeks
Secondary outcomes (6)
PTSD Symptom Severity (Self-Report)
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.
Measured: Baseline, 8, 16, 24 and 32 weeks
Social Support
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.
Measured: Baseline, 8, 16, 24 and 32 weeks
Emotion Regulation Difficulties
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.
Measured: Baseline, 8, 16, 24 and 32 weeks
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.
Measured: Baseline, 8, 16, 24 and 32 weeks
Posttraumatic Maladaptive Beliefs
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.
Measured: Baseline, 8, 16, 24 and 32 weeks
Psychosocial Functioning
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.
Measured: Baseline, 8, 16, 24 and 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start3 Sep 2018
- Primary completion31 May 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- San Diego Veterans Healthcare System
- Responsible party
- Sponsor
- Investigators
- Marylene Cloitre, PhD, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429166
- Sponsor's protocol ID
- IIR 16-070
- Acronym
- CWC
- Status last verified
- Apr 2025
- First submitted
- 5 Feb 2018
- Last updated
- 25 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30070399Jackson 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.
PubMed 30007286Cloitre 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.
PubMed 29745688Ben-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.
PubMed 29451956Schnyder 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.
PubMed 29435201Cloitre 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.
PubMed 29038682Hyland 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.
PubMed 30293176Karatzias 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.
PubMed 30277191Kazlauskas 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.
PubMed 33680347Olff 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.
PubMed 31897268Coventry 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.
PubMed 32813696Ho 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.
PubMed 33508705McGinty 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.
PubMed 34602122Rashkovsky 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.
PubMed 41411035O'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.
PubMed 37795783
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connecting Women to Care: Home-based Psychotherapy for Women With MST Living in Rural Areas
- ClinicalTrials.gov ID
- NCT03429166
- Acronym / sponsor ID
- CWC / IIR 16-070
- Conditions
- PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- San Diego Veterans Healthcare System
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 12 Feb 2018 (actual)
- Results
- Posted 25 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| STAIR stands for Skills Training in Affective and Interpersonal Regulation | Experimental | Behavioral: Skills Training in Affective and Interpersonal RegulationSTAIR stands for Skills Training in Affective and Interpersonal Regulation a non-trauma-focused treatment |
| Present Centered Therapy | Active comparator | Behavioral: Present Centered TherapyPCT , a non-trauma-focused treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Veteran
- A positive screen for MST
- A positive PTSD screen defined as PC-PTSD cut-off of > 3
Key exclusion criteria (7 listed)
- Substance abuse not in remission for at least 3 months
- Current psychotic symptoms
- Cognitive impairment indicated by chart diagnoses or observable cognitive difficulties
- Current involvement in a violent relationship defined as more than casual contact
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skills Training in Affective and Interpersonal RegulationAlso: STAIRA non-trauma-focused treatment | Behavioural | STAIR stands for Skills Training in Affective and Interpersonal Regulation |
| Present Centered TherapyA non-trauma-focused treatment | Behavioural | Present Centered Therapy |
Primary outcome
Clinician Assessed Severity of PTSD
Time frame: 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.
6 secondary outcomes
PTSD Symptom Severity (Self-Report)
Time frame: Baseline, 8, 16, 24 and 32 weeks
Social Support
Time frame: Baseline, 8, 16, 24 and 32 weeks
Emotion Regulation Difficulties
Time frame: Baseline, 8, 16, 24 and 32 weeks
Depression
Time frame: Baseline, 8, 16, 24 and 32 weeks
Posttraumatic Maladaptive Beliefs
Time frame: Baseline, 8, 16, 24 and 32 weeks
Psychosocial Functioning
Time frame: Baseline, 8, 16, 24 and 32 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30070399Weiss 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.
- Results publication: PubMed 30007286Jackson 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.
- Results publication: PubMed 29745688Cloitre 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.
- Results publication: PubMed 29451956Ben-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.
- Results publication: PubMed 29435201Schnyder 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.
- Results publication: PubMed 29038682Cloitre 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.
- Results publication: PubMed 30293176Hyland 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.
- Results publication: PubMed 30277191Karatzias 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.
- Results publication: PubMed 33680347Kazlauskas 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.
- Results publication: PubMed 31897268Olff 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.
- Results publication: PubMed 32813696Coventry 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.
- Results publication: PubMed 33508705Ho 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.
- Individual participant dataSharing planned: No
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RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marylene Cloitre, PhD principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skills Training in Affective and Interpersonal Regulation and Present Centered Therapy in people with PTSD, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician Assessed Severity of PTSD (time frame: Baseline, 16, 24 and 32 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03429166, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.