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Behavioural Intervention

National Capital Region (NCR) for Post-Traumatic Stress Disorder

N/A
Waitlist Available
Led By Paul Pasquina, MD
Research Sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up heart rate will take place at all major study visits (weeks 4, 7, 10, and 3-month follow-up), as well as during each training session twice a week from week 4 through week 10.
Awards & highlights

Study Summary

Preliminary clinical evidence suggests that Service Members with symptoms of post-traumatic stress disorder (PTSD) or Post Traumatic Stress (PTS) who participate in the Service Dog Training Program (SDTP) report improved physical and psychological outcomes, including those with overlapping symptoms associated with traumatic brain injury (TBI) and post-concussion symptoms (PCS). This study intends to examine the psychological, social, and biological effects of learning how to train a future service dog combined with standard of care for individuals with symptoms of Post-Traumatic Stress (PTS), including those with overlapping TBI and persistent Post-Concussive Symptoms (PCS). Biological, social, and behavioral measures will be collected throughout study participation.

Eligible Conditions
  • Post-Traumatic Stress Disorder
  • Traumatic Brain Injury

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~heart rate will take place at all major study visits (weeks 4, 7, 10, and 3-month follow-up), as well as during each training session twice a week from week 4 through week 10.
This trial's timeline: 3 weeks for screening, Varies for treatment, and heart rate will take place at all major study visits (weeks 4, 7, 10, and 3-month follow-up), as well as during each training session twice a week from week 4 through week 10. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in symptom severity using the CDC's Health-related Quality of Life Instrument (HRQOL-14)
Change in symptom severity using the Connor-Davidson Resilience Scale (CD-RISC)
Pain
+8 more
Secondary outcome measures
Assessment of Communication and Interaction Skill (ACIS)
Changes in Anthropometric Data measured in inches
Changes in Blood Pressure
+11 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: National Capital Region (NCR)Experimental Treatment1 Intervention
10-week longitudinal pre-post study, in which each participant will serve as their own control. Each participant will train a service dog using methods that facilitate a relationship between the trainer and dog for the gradual shaping of desired behavior. Self-report measures of behavioral symptoms will be given weekly throughout participation in this study. Biological measures, including blood collection, HR, BP, etc. will be collected at baseline, during the three-week training follow-up, during the six-week training follow-up, and at a three-month post-training follow-up. The researchers will also be collecting self-report assessments from the participant, observational reports from an Occupational Therapist (OT) and electronic health records to track healthcare utilization and social skills (i.e. communication).

Find a Location

Who is running the clinical trial?

Henry M. Jackson Foundation for the Advancement of Military MedicineLead Sponsor
92 Previous Clinical Trials
92,432 Total Patients Enrolled
Walter Reed National Military Medical CenterFED
137 Previous Clinical Trials
34,237 Total Patients Enrolled
Uniformed Services University of the Health SciencesFED
116 Previous Clinical Trials
91,156 Total Patients Enrolled

Frequently Asked Questions

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~43 spots leftby Apr 2025