Biopsychosocial Effect of Service Dog Training on Post-traumatic Stress (PTS) and Post Concussive Symptoms

NCT03907254 | Completed

• 1 other identifier: WRNMMC-2018-0159
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Posttraumatic Stress Disorder; Traumatic Brain Injury

Outcome Measures

Primary Outcomes (11)

• Change in symptom severity using the Post-traumatic Stress Checklist (PCL-5)

  A 20-item self-report measure that assesses changes in symptom severity of PTSD to include, monitoring symptom change during/after treatment, screening individuals for PTSD, and making a provisional PTSD diagnosis. This instrument will be used for inclusion criteria for the study as well as to assess change during the course of the study.

  The PCL-5 will be collected at screening as part of the inclusion criteria, and subsequently once a week until the end of the 10-week study period, as well as at the 3-month follow-up visit.

• Change in symptom severity using the Generalized Anxiety Disorder-7 (GAD-7)

  A 7-item self-report measure that assesses an individual's level of anxiety from 0 (least severe) to 21 (most severe). The measure has excellent internal consistency (Cronbach alpha = 0.92) and test-retest reliability (intraclass correlation = 0.83). GAD-7 takes less than 5 minutes to complete.

  The GAD-7 will be collected once a week from start of study until the end of the 10-week study period, as well as at the 3-month follow-up visit.

• Change in symptom severity using the Patient Health Questionnaire (PHQ-9)

  A 9-item measure of depression from 0 (least severe) to 27 (most severe). The measure has excellent internal reliability (Cronbach's alpha = 0.89), and discriminant validity was supported by ROC analyses that indicated area under the curve for the PHQ-9 in diagnosing depression was 0.095.

  The PHQ-9 will be collected once a week from start of study until the end of the 10-week study period, as well as at the 3-month follow-up visit.

• Change in symptom severity using the Connor-Davidson Resilience Scale (CD-RISC)

  A 25-item self-report measure to help quantify resilience and, as a clinical measure, to assess treatment response on a scale from 0 (least resilient) to 100 (most resilient). The measure has high internal consistency (Cronbach's alpha = 0.89) and test-retest reliability (intra-class correlation = 0.87).

  The CD-RISC will be completed at the 4-week, 7-week, 10-week, and 3-month follow-up visits.

• Change in symptom severity using the Defense and Veterans Pain Rating Scale (DVPRS)

  A visual pain scale to assess individual's pain intensity on a scale of 0-10 (10 being most severe pain), with an additional 4 questions to assess pain's interference with the participant's activity, sleep, mood, and stress.

  The DVPRS will be completed at the 4-week, 7-week, 10-week, and 3-month follow-up visits, as well as after each participant training session (twice a week).

• Change in symptom severity using the Perceived Stress Scale (PSS)

  A 10-item measure that assesses an individual's appraisal of their life stressors from 0 (least perceived stress) to 40 (most perceived stress). The PSS demonstrates good reliability (0.84 to 0.86) and face validity, and it is predictive of biological indicators of stress in humans with correlation coefficients ranging from 0.52 to 0.76 for symptomalogical measures.

  The PSS will be completed at the 4-week, 7-week, 10-week, and 3-month follow-up visits.

• Change in symptom severity using the Pittsburgh Sleep Quality Index (PSQI)

  A 19-item self-report measure (with 5 additional questions rated by the bedpartner or roommate) evaluating sleep quality and disturbances with lower scores indicating better sleep. The PSQI demonstrates high internal reliability (Cronbach's alpha = 0.83) and test-retest reliability (r = 0.68 to 0.79).

  The PSQI will be completed at the 4-week, 7-week, 10-week, and 3-month follow-up visits.

• Change in symptom severity using the CDC's Health-related Quality of Life Instrument (HRQOL-14)

  A 14-item self-report measure that assesses quality of life based on "healthy days" measures and symptoms and activity limitations.

  The HRQOL-14 will be completed at the 4-week, 7-week, 10-week, and 3-month follow-up visits.

• Changes in cortisol

  Blood collection not exceeding 40 mL per time point.

  Blood will be collected at baseline (Week 0-1), Week 3, Week 6, and at the 3 month follow-up visit.

• Changes in cytokines

  Blood collection not exceeding 40 mL per time point. Cytokines strongly associated with PTSD and depression include pro-inflammatory factors IFNG, IL-12, IL-6, and TNF alpha. Cytokines will be measured by multiplex or single immunoassays.

  Blood will be collected at baseline (Week 0-1), Week 3, Week 6, and at the 3 month follow-up visit.

• Gene expression

  Blood collection not exceeding 40 mL. DNA genomic variants will be measured by whole genome sequencing.

  Blood will be collected at baseline for full genome sequencing.

Secondary Outcomes (14)

• Changes in scores on Service Dog Training Program (SDTP) Trainer Evaluation Form

  The SDTP Trainer Evaluation Form will be completed by the professional dog trainer after each training session, which occurs twice a week from Week 4 through Week 10.

• Lexington Attachment to Pets Scale (LAPS)

  The LAPS will be collected at Week 4.

• Life Events Checklist for DSM-5 (LEC-5)

  The LEC-5 will be collected at Weeks 4 and 10.

• Medical Outcome Study - Social Support Survey (MOS-SSS)

  The MOS-SSS will be collected at Week 4 and the 3-month follow-up visit.

• Neurobehavioral Symptom Inventory (NSI)

  The NSI will be collected weekly from start of session through the 10-week training period, and again at the 3-month follow-up visit.

Study Arms (1)

National Capital Region (NCR)

EXPERIMENTAL

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).

Other: Service Dog Training Program

Interventions

Service Dog Training Program OTHER

Participants will spend one hour, two times a week working with professional service dog trainers in order to shape the dog's behavior for it's future role as a service dog for service members with mobility impairments.

National Capital Region (NCR)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be 18-65 years old at time of consent.
• Participants must be DEERS eligible men or women from active duty, reserve, National Guard components, retirees, dependents and other Secretarial Designees.
• Participants must have a diagnosis of one of the following:
• PTSD or PTS symptoms (participants must score greater than or equal to 30 on the PCL-5 at screening)
• Anxiety Disorder NOS, Unspecified Trauma Related Disorder, Unspecified Anxiety Disorder, or Adjustment Disorder with evidence of the Service Member experiencing one or more traumatic event (meeting Criterion A of PTSD in DSM 5), and evidence of intrusion symptoms, avoidance symptoms, negative changes in cognitions and mood, and alterations in arousal and reactivity related to the traumatic event or events (Criteria B, C, D, and E of PTSD in DSM 5) persisting beyond 30 days (Criterion F of PTSD in DSM 5)
• Participant may be of any race, ethnicity, or gender.
• Participants with a history of clinician diagnosed TBI are eligible to participate, given the considerable overlap between PTS symptomatology and post-concussive symptoms postacutely.
• Participant must be able to speak and read English, and be able to consent.

You may not qualify if:

• Participants must not be younger than 18 years old or other than 65 years old at the time of consent.
• Participant must not show current suicidal/homicidal plans (if the participant expresses current suicidal/homicidal plans, clearance from the participant's current behavioral health team can be provided).
• Participant must not exhibit violent or psychotic behavior.
• Participant must not currently or in the past month have been in an inpatient psychiatric health treatment program.
• Participant must not currently have an active substance abuse disorder or been in a substance abuse program in the past month.
• Participant must not have problems that limit cognitive competency to understand study procedures, including the ability to provide informed consent (e.g., severe TBI). Participant must not be unwilling to answer the study questionnaires.
• Participant must not be afraid of or allergic to dogs.
• Participant cannot be enrolled or participating in any other interventional study for PTS or PTSD treatment.
• Participants cannot currently or in the past six months have participated in clinical service dog training. Clinical service dog training is defined as a type of animal assisted therapy where patients train service dogs as part of a complementary treatment intervention aimed at reducing symptoms associated with physical and psychological injuries. Individuals who have completed a group or individual session in the past six months that only provided an informational overview of the service dog training program will be eligible for this study.

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• Walter Reed National Military Medical Center: collaborator
• Uniformed Services University of the Health Sciences: collaborator

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Paul Pasquina, MD

  Walter Reed National Military Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Up to 156 participants will be recruited in the National Capital Region (NCR) for a ten-week longitudinal pre-post study, in which each participant will serve as their own control. Additionally, up to 104 participants will be recruited for a three-week longitudinal parallel-randomized study through the National Intrepid Center of Excellence (NICoE) four-week Intensive Outpatient Program (IOP). A three-month post-intervention follow-up will be conducted for both designs (optional for IOP participants).

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: April 8, 2019
• Study Start: March 5, 2019
• Primary Completion: October 7, 2022
• Study Completion: October 7, 2022
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)