Trial Radar AI | ||
|---|---|---|
De klinische studie NCT06746740 voor Seksueel geweld is recruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
Eén studie komt overeen met de filtercriteria
Kaartweergave
Developing and Testing a Trauma-Informed Exercise Intervention for Women Veterans With Histories of Sexual Violence
Informatie over klinische studies is voornamelijk in het Engels beschikbaar. Trial Radar AI kan echter helpen! Klik op 'Leg studie uit' om de informatie over de studie te bekijken en te bespreken in de taal van uw keuze.
De klinische studie NCT06746740 is een interventioneel studie bij Seksueel geweld met de status recruterend. Het doel is om 40 deelnemers te includeren vanaf 1 oktober 2025. De studie wordt geleid door VA Office of Research and Development en de voltooiing is gepland op 31 maart 2030. Laatste update op ClinicalTrials.gov: 23 oktober 2025.
Beknopte samenvatting
Exposure to sexual violence disproportionally impacts women Veterans and can have profound negative impacts on daily functioning. Current treatments for sexual violence focus on psychiatric symptoms and ignore frequently co-occurring physical and psychosocial concerns. Exercise can improve trauma-related physical, mental, and psychosocial health conditions and may help women who have experienced sexual violence. Yet, women Veterans experience many barriers to participating in exercise and prefer interventions that are tailored to their preferences. This proposal will develop and test an exercise intervention tailored specifically to women Veterans who have experienced sexual violence. Treatment development will be informed by women Veterans with histories of sexual violence and their providers. Feasibility and acceptability will be tested, and outcomes will be explored to inform future research. This intervention is urgently needed to address gaps in integrative care and persistent trauma-related health concerns among women Veterans with histories of sexual violence.
Uitgebreide beschrijving
Women Veterans (WVs) disproportionately experience sexual violence (SV) throughout their lifetime. These experiences of SV are often repeated, resulting in a lifelong pattern of SV victimization which can have profound negative impacts on physical, mental, and psychosocial functioning and quality of life. Current VHA policies highlight the need for integrative interventions which effectively address the diverse negative health sequelae associated with lifetime SV. Yet, there is currently a gap in treatment offerings that address broad psychiatric, physical, and psychosocial health impacts of SV. Exercise has been shown to improve trauma-related mental health conditions among survivors of SV and improve trauma-related multimorbidity among Veterans with a PTSD diagnosis. Yet, many barriers exist to exercise among WVs which contribute to low exercise engagement from this group. This Career Development Award (CDA-2) thus aims to develop and test a trauma-informed telehealth exercise intervention tailored for WVs with histories of SV. Treatment development will be guided by 1) previous interventions completed among Veterans with PTSD, 2) documented preferences among women with histories of SV, and 3) trauma-informed approaches and integration of stakeholder feedback. During phase one of this project, the investigators will conduct pre-implementation stakeholder interviews with WVs with histories of SV and related healthcare providers to provide guidance on the structure and content of the proposed intervention. This information will be used to create the program manual for the proposed intervention. During phase two of this project, WVs aged 21-65 with lifetime history of SV will be recruited to participate in an open trial consisting of a 12-week, online physical activity program including aerobic and strength training. Qualitative data will be collected in parallel with quantitative outcomes to assesses the primary feasibility and acceptability outcomes. Exploratory outcomes will include functional status. Candidate outcomes to be assessed include physical, mental, and psychosocial health outcomes. This pilot trail will extend the understanding for trauma-informed exercise approaches for WVs with histories of SV and of the feasibility, acceptability, and potential benefits of exercise for this group. Results will be used to develop a fully powered randomized controlled trial for WVs with histories of SV.
Officiële titel
Developing and Testing a Trauma-Informed Exercise Intervention for Women Veterans With Histories of Sexual Violence
Aandoeningen
Seksueel geweldAndere studie-ID's
- D5308-W
- is 1IK2RX005308-01A1 (Ander subsidie-/financieringsnummer) (VA Rehabilitation Research and Development)
NCT-ID
Startdatum (Werkelijk)
2025-10-01
Laatste update geplaatst
2025-10-23
Verwachte einddatum
2030-03-31
Inschrijving (Geschat)
40
Studietype
Interventioneel
FASE
N.v.t.
Status
Recruterend
Trefwoorden
women Veterans
sexual violence
exercise
transdiagnostic
sexual violence
exercise
transdiagnostic
Primaire doel
Behandeling
Toewijzing
N.v.t.
Interventiemodel
Enkele groep
Blindering
Geen (Open-label)
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelExercise Exercise intervention | Oefening Adapted with input from phase 1 |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Feasibility - recruitment interest | ratio interested of those approached for the workshop | through study completion, an average of one year |
feasibility, enrollment rate | Ratio enrolled (consented) of those approached | through study completion, an average of one year |
feasibility qualitative via Narrative Evaluation of Intervention Interview | Identification of challenges and facilitators during the recruitment process as assessed by study staff as well as feedback from focus group participants generated using the Narrative Evaluation of Intervention Interview (NEII). This is an interview composed of 16 open ended questions that allows participants to evaluate the process and outcomes of the intervention. Reviewers will generate a list of themes based on the responses to this interview. | Through study completion, an average of 3 months. |
acceptability - Veteran adherence | Attendance rate for the 12-week intervention | Through study completion, an average of one year. |
Acceptability- Quantitative satisfaction via Client satisfaction questionnaire Change | Client satisfaction questionnaire (CSQ-8), total scores range from 8 to 32 with higher scores indicating higher satisfaction. | assessed at BL, 12 weeks, 24 week follow up |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Functional Status - The World Health Organization Disability Assessment Schedule 2.0 (WHODAS-2) | The World Health Organization Disability Assessment Schedule 2.0 (WHODAS-2) is a 36-item self-report tool that assesses functioning in the past 30 days among six specific domains (i.e., cognition, physical mobility, self-care, social, domestic/occupational, and participation in society) and provides an overall disability score. Higher scores indicate greater disability | baseline, post-intervention (12 weeks), follow up (24 weeks) |
Physical Function - arm curls | number of curls in 30 seconds | baseline, post-intervention (12 weeks), follow up (24 weeks) |
Physical Activity Level - Godin Leisure-Time Exercise Questionnaire (GLTEQ) | The Godin Leisure-Time Exercise Questionnaire (GLTEQ) is a validated brief inventory assessing activity domains and aerobic activity in a typical week. Duration in minutes of exercise multiplied by number of times per week, in the past 7 days. Total minutes per week calculated; mean reported. | baseline, post-intervention (12 weeks), follow up (24 weeks) |
PTSD - PTSD Checklist-5 (PCL-5) for DSM-V | The PTSD Checklist-5 (PCL-5) for DSM-V is a 20-item self-report measure that assesses the extent to which an individual is bothered by each PTSD symptom during the past month using a 5-point Likert-type scale. Higher scores indicating more severe symptoms | baseline, post-intervention (12 weeks), follow up (24 weeks) |
Anxiety - Depression Anxiety and Stress Scale (DASS 21) | Depression Anxiety and Stress Scale (DASS 21) provides scores for depression, anxiety, and stress subscales, with higher scores indicating worse outcomes. Each item is scored on a 4-point scale (0 = Did not apply to me at all, to 3 = Applied to me very much or most of the time) | baseline, post-intervention (12 weeks), follow up (24 weeks) |
Depression - Patient Health Questionnaire (PHQ-9) | Will be assessed with the 9-item Patient Health Questionnaire. The total score can range from 0 to 27. Higher scores indicate greater severity of depression. | baseline, post-intervention (12 weeks), follow up (24 weeks) |
Psychosocial function- The Brief Inventory of Psychosocial Functioning (IPF-Brief) | Participants rank each of the 7 statements based on their overall experience over the past month on a scale from 0 (not at all) to 6 (very much). 7 is marked if the statement is not applicable. Higher scores indicate more impaired psychosocial functioning. | baseline, post-intervention (12 weeks), follow up (24 weeks) |
Pain - Short-Form McGill Pain Questionnaire | Short-Form McGill Pain Questionnaire is an 22-item measure assess pain quality/intensity. Total score ranges from 0-45. Higher scores indicate more severe pain. | baseline, post-intervention (12 weeks), follow up (24 weeks) |
Fatigue - Multidimensional Fatigue Inventory (MFI) | is a 20-item instrument that measures dimensions of fatigue. scores range from 20 to 100 with higher scores indicating greater fatigue | baseline, post-intervention (12 weeks), follow up (24 weeks) |
Health Status - 12-Item Short Form Health Survey (SF-12) | The 12-Item Short Form Health Survey (SF-12) will be used to assess overall health. Score ranging from 0 to 100. A higher score indicating a better quality of life. | baseline, post-intervention (12 weeks), follow up (24 weeks) |
Quality of Life - The Quality of Life Scale (QOLS) | Participants answer each question on a 7 point scale. It is scored by adding up the score on each item to get a minimum potential score of 16 and a maximum total score of 112. Higher scores indicate a higher quality of life. | baseline, post-intervention (12 weeks), follow up (24 weeks) |
Exercise Motivation - Behavioral Regulation in Exercise Questionnaire (BREQ-3) | Behavioral Regulation in Exercise Questionnaire (BREQ-3) uses 23 items to measure exercise motivation types, Using a 5 point Likert scale, the maximum score is 5 which indicates a high level of that particular sub-scale of motivation, e.g. intrinsic motivation or amotivation. | baseline, post-intervention (12 weeks), follow up (24 weeks) |
Physical function - chair stands | number of chair stands in 30 seconds | baseline, post-intervention (12 weeks), follow up (24 weeks) |
physical function - balance | time balancing on one foot | baseline, post-intervention (12 weeks), follow up (24 weeks) |
physical function - 2 minute step test | number of knee raised in 2 minutes | baseline, post-intervention (12 weeks), follow up (24 weeks) |
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
21 Years
Geslachten die in aanmerking komen voor de studie
Vrouw
Accepteert gezonde vrijwilligers
Ja
- Veteran self-identifies as woman
- has a history of sexual violence at any point in their lifetime
- between the ages of 21 an 65
- currently does not meet physical activity level guidelines
- reports some functional difficulties that indicate some interference in daily life
- safe and private location to engage in the virtual exercise program
does not identify a safe and private location for exercise participation
severe drug or alcohol use disorder within the past year
clinically significant:
- neurological disorder
- systemic illness affecting central nervous system function
- history of seizure disorder in the past 5 years
- uncontrolled diabetes
- end stage liver disease or currently receiving dialysis
- physical disabilities precluding use of exercise equipment
- significant cognitive impairment
- active signs and symptoms of CVD
- metabolic
- renal disease
- if taking antidepressants must have stable regimen
- if in psychotherapy maintain therapy throughout trial
VA Office of Research and DevelopmentCentraal Contactpersoon
Contact: Michelle M Pebole, PhD MA, (857) 364-4989, [email protected]
1 Studielocaties in 1 landen
Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA, Boston, Massachusetts, 02130-4817, United States
Michelle M Pebole, PhD MA, Contact, 857-364-4989, [email protected]
Michelle M Pebole, PhD MA, Hoofdonderzoeker
Recruterend