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| ID | Type | Description | Link |
|---|---|---|---|
| R21HD091896-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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The purpose of this study is to quantify the therapeutic efficacy and role of trained service dogs on socio-emotional functioning among military veterans with posttraumatic stress disorder (PTSD).
The long-term research goal is to evaluate the safety and efficacy of service dogs as a complementary intervention to enhance biopsychosocial functioning in special populations. The objective is to conduct a methodologically rigorous trial to quantify the therapeutic efficacy of service dogs on clinically-important outcomes for veterans with PTSD. Based on preliminary findings and qualitative reports, the central hypothesis is that military veterans with PTSD who are provided service dogs will experience reduced PTSD symptoms related to socio-emotional functioning and arousal modulation. The rationale for this research is that its successful completion will provide an evidence-based demonstration of the efficacy and role of an increasingly used yet poorly tested complementary intervention. The completion of this project is expected to established an initial demonstration of the therapeutic efficacy of service dogs in this population, as well as possible mechanisms of action via specific biological pathways and human-canine interaction profiles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Service Dog | Experimental | Participants in the service dog arm will receive unrestricted, non-study usual care, in addition to a trained service dog. |
|
| Waitlist Control | No Intervention | Participants in the control arm will receive unrestricted, non-study usual care, while on the waitlist for a service dog. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Service Dog | Behavioral | A service dog trained to perform tasks that are specific to PTSD |
|
| Measure | Description | Time Frame |
|---|---|---|
| PTSD Severity and Symptoms Via Self-report | Posttraumatic Stress Disorder Checklist for DSM-V (PCL-5); range 0-80; higher scores indicate worse outcome. | 3 months |
| PTSD Severity and Symptoms Via Clinician Rating | Clinician-Administered PTSD Assessment for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition DSM-V (CAPS-5); range 0-80; higher scores indicate worse outcome. | 3 months |
| Depression | Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Depression 8a; T-score range 38 to 81; 50 indicates the population mean with a standard deviation of 10; minimally important difference greater than or equal to 3 points; higher scores indicate worse outcome. | 3 months |
| Anxiety | Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Anxiety 8a; T-score range 37 to 83; 50 indicates the population mean with a standard deviation of 10; minimally important difference greater than or equal to 3 points; higher scores indicate worse outcome. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Social Isolation | Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Social Isolation 8a; T-score range 33 to 76; 50 indicates the population mean with a standard deviation of 10; higher scores indicate worse outcome. | 3 months |
| Companionship |
| Measure | Description | Time Frame |
|---|---|---|
| Work and Activity Participation | Work Productivity and Activity Impairment Questionnaire (WPAIQ) | 3 months |
| Suicidal Ideation | Columbia Suicide Severity Rating Scale (CSSRS) |
Inclusion criteria for veterans into the study will include:
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| Name | Affiliation | Role |
|---|---|---|
| Marguerite O'Haire, Ph.D. | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85721 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38833250 | Derived | Leighton SC, Rodriguez KE, Jensen CL, MacLean EL, Davis LW, Ashbeck EL, Bedrick EJ, O'Haire ME. Service Dogs for Veterans and Military Members With Posttraumatic Stress Disorder: A Nonrandomized Controlled Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2414686. doi: 10.1001/jamanetworkopen.2024.14686. | |
| 37410417 | Derived | Leighton SC, Rodriguez KE, Zhuang R, Jensen CL, Miller EA, Sabbaghi A, O'Haire ME. Psychiatric service dog placements are associated with better daily psychosocial functioning for military veterans with posttraumatic stress disorder. Psychol Trauma. 2024 Dec;16(Suppl 3):S707-S717. doi: 10.1037/tra0001543. Epub 2023 Jul 6. |
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Of 200 participants recruited and screened, 170 met inclusion criteria and were enrolled and allocated.
Recruitment, eligibility screening, and enrollment occurred between July 2017 and December 2019. Veterans were recruited through the database of an accredited nonprofit service dog organization, K9s For Warriors.
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| ID | Title | Description |
|---|---|---|
| FG000 | Service Dog | Participants in the service dog arm received unrestricted, non-study usual care, in addition to a trained service dog. Service Dog: A service dog trained to perform tasks that are specific to PTSD |
| FG001 | Waitlist Control | Participants in the control arm received unrestricted, non-study usual care, while on the waitlist for a service dog. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Based on a modified Intent-to-Treat analysis, in which participants were excluded if they did not receive the allocated condition.
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| ID | Title | Description |
|---|---|---|
| BG000 | Service Dog | Participants in the service dog arm received unrestricted, non-study usual care, in addition to a trained service dog. Service Dog: A service dog trained to perform tasks that are specific to PTSD |
| BG001 | Waitlist Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | PTSD Severity and Symptoms Via Self-report | Posttraumatic Stress Disorder Checklist for DSM-V (PCL-5); range 0-80; higher scores indicate worse outcome. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
Adverse events were collected through passive surveillance. Participants spontaneously reported adverse events during study assessment periods (equivalent reporting opportunities across both groups) and during a 3-week on-site group class at the service dog organization (intervention group only).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Service Dog | Participants in the service dog arm received unrestricted, non-study usual care, in addition to a trained service dog. Service Dog: A service dog trained to perform tasks that are specific to PTSD |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inpatient hospitalization | Surgical and medical procedures | Non-systematic Assessment | Inpatient hospitalizations not related to the intervention or study (e.g., accidents, pre-existing condition treatment) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dog bite | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Maggie O'Haire | The University of Arizona | 520-621-6767 | maggieohaire@arizona.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2023 | Oct 21, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D000081762 | Human-Animal Interaction |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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Clinician Administered PTSD Scale for DSM-V (CAPS-5) assessments will be completed via telephone by a trained CAPS-5 rater who will be masked to the intervention and treatment arm of each participant.
Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Companionship 6a; T-score range 24 to 64; 50 indicates the population mean with a standard deviation of 10; higher scores indicate better outcome |
| 3 months |
| Ability to Participate in Social Activities | Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Ability to Participate in Social Roles and Activities 8a; T-score range 25 to 65; 50 indicates the population mean with a standard deviation of 10; higher scores indicate better outcome. | 3 months |
| Mental Health Quality of Life | Veterans Rand 12-item Health Survey (VR-12) - Mental Health Component; range 0-100; higher scores indicate better outcome. | 3 months |
| Psychological Well-being | Bradburn Scale of Psychological Wellbeing (BSPW); range -5 to 5; higher scores indicate better outcome. | 3 months |
| Life Satisfaction | Satisfaction with Life Scale (SLS); range 3-35; higher scores indicate better outcome. | 3 months |
| Resilience | Connor-Davidson Resilience Scale (CDRS); range 0-40; higher scores indicate better outcome. | 3 months |
| Anger | Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.1 - Emotional Distress - Anger 5a; T-score range 32-82; 50 indicates the population mean with a standard deviation of 10; higher scores indicate worse outcome. | 3 months |
| Daily Socio-emotional Experiences | Ecological momentary assessment (EMA) Social interaction quality; range 0-6; higher score indicates better outcome. | 3 months |
| 3 months |
| Sleep Quality | Pittsburgh Sleep Quality Assessment (PSQI) | 3 months |
| Sleep Disturbance | Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Sleep Disturbance 8a | 3 months |
| Sleep Actigraphy | Actiwatch 2 (Philips Respironics) | 3 months |
| Salivary Cortisol Awakening Response | Passive drool method (Salimetrics) | 3 months |
| Electrodermal Activity (Skin Conductance) | Embrace wristband (Empatica, Inc.) | 3 months |
Participants in the control arm received unrestricted, non-study usual care, while on the waitlist for a service dog. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| PTSD (PCL-5) | Posttraumatic Stress Disorder Checklist for DSM-V (PCL-5); range 0-80; higher scores indicate worse outcome. | Mean | Standard Deviation | units on a scale |
|
| PTSD (CAPS-5) | Clinician-Administered PTSD Assessment for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition DSM-V (CAPS-5); range 0-80; higher scores indicate worse outcome. | Mean | Standard Deviation | units on a scale |
|
| Depression (PROMIS Depression) | Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Depression 8a; T-score range 38 to 81; 50 indicates the population mean with a standard deviation of 10; minimally important difference greater than or equal to 3 points; higher scores indicate worse outcome. | Mean | Standard Deviation | T-score |
|
| Anxiety (PROMIS Anxiety) | Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Anxiety 8a; T-score range 37 to 83; 50 indicates the population mean with a standard deviation of 10; minimally important difference greater than or equal to 3 points; higher scores indicate worse outcome. | Mean | Standard Deviation | T-score |
|
| PROMIS Social Isolation | Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Social Isolation 8a; T-score range 33 to 76; 50 indicates the population mean with a standard deviation of 10; higher scores indicate worse outcome. | Mean | Standard Deviation | T-score |
|
| PROMIS Companionship | Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Companionship 6a; T-score range 24 to 64; 50 indicates the population mean with a standard deviation of 10; higher scores indicate better outcome | Mean | Standard Deviation | T-score |
|
| PROMIS Social Activities | Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Ability to Participate in Social Roles and Activities 8a; T-score range 25 to 65; 50 indicates the population mean with a standard deviation of 10; higher scores indicate better outcome. | Mean | Standard Deviation | T-score |
|
| VR-12 MCS | Veterans Rand 12-item Health Survey (VR-12) - Mental Health Component; range 0-100; higher scores indicate better outcome. | Mean | Standard Deviation | units on a scale |
|
| BSPW | Bradburn Scale of Psychological Wellbeing (BSPW); range -5 to 5; higher scores indicate better outcome. | Mean | Standard Deviation | units on a scale |
|
| SWLS | Satisfaction with Life Scale (SLS); range 3-35; higher scores indicate better outcome. | Mean | Standard Deviation | units on a scale |
|
| CD-RISC-10 | Connor-Davidson Resilience Scale (CDRS); range 0-40; higher scores indicate better outcome. | Mean | Standard Deviation | units on a scale |
|
| PROMIS Anger | Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.1 - Emotional Distress - Anger 5a; T-score range 32-82; 50 indicates the population mean with a standard deviation of 10; higher scores indicate worse outcome. | Mean | Standard Deviation | T-score |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | PTSD Severity and Symptoms Via Clinician Rating | Clinician-Administered PTSD Assessment for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition DSM-V (CAPS-5); range 0-80; higher scores indicate worse outcome. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
|
| Primary | Depression | Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Depression 8a; T-score range 38 to 81; 50 indicates the population mean with a standard deviation of 10; minimally important difference greater than or equal to 3 points; higher scores indicate worse outcome. | Posted | Mean | Standard Deviation | T-score | 3 months |
|
|
|
|
| Primary | Anxiety | Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Anxiety 8a; T-score range 37 to 83; 50 indicates the population mean with a standard deviation of 10; minimally important difference greater than or equal to 3 points; higher scores indicate worse outcome. | Posted | Mean | Standard Deviation | T-score | 3 months |
|
|
|
|
| Secondary | Social Isolation | Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Social Isolation 8a; T-score range 33 to 76; 50 indicates the population mean with a standard deviation of 10; higher scores indicate worse outcome. | Posted | Mean | Standard Deviation | T-score | 3 months |
|
|
|
|
| Secondary | Companionship | Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Companionship 6a; T-score range 24 to 64; 50 indicates the population mean with a standard deviation of 10; higher scores indicate better outcome | Posted | Mean | Standard Deviation | T-score | 3 months |
|
|
|
|
| Secondary | Ability to Participate in Social Activities | Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Ability to Participate in Social Roles and Activities 8a; T-score range 25 to 65; 50 indicates the population mean with a standard deviation of 10; higher scores indicate better outcome. | Posted | Mean | Standard Deviation | T-score | 3 months |
|
|
|
|
| Secondary | Mental Health Quality of Life | Veterans Rand 12-item Health Survey (VR-12) - Mental Health Component; range 0-100; higher scores indicate better outcome. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
|
| Secondary | Psychological Well-being | Bradburn Scale of Psychological Wellbeing (BSPW); range -5 to 5; higher scores indicate better outcome. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
|
| Secondary | Life Satisfaction | Satisfaction with Life Scale (SLS); range 3-35; higher scores indicate better outcome. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
|
| Secondary | Resilience | Connor-Davidson Resilience Scale (CDRS); range 0-40; higher scores indicate better outcome. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
|
| Secondary | Anger | Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.1 - Emotional Distress - Anger 5a; T-score range 32-82; 50 indicates the population mean with a standard deviation of 10; higher scores indicate worse outcome. | Posted | Mean | Standard Deviation | T-score | 3 months |
|
|
|
|
| Secondary | Daily Socio-emotional Experiences | Ecological momentary assessment (EMA) Social interaction quality; range 0-6; higher score indicates better outcome. | This analysis was conducted with all participants who had available data based on initial group assignment. It differs from the other analyses in that it was done prior to the primary outcomes analysis and does not follow the same modified intent-to-treat analysis as conducted with the other outcomes. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
|
| Other Pre-specified | Work and Activity Participation | Work Productivity and Activity Impairment Questionnaire (WPAIQ) | Not Posted | 3 months | Participants |
| Other Pre-specified | Suicidal Ideation | Columbia Suicide Severity Rating Scale (CSSRS) | Not Posted | 3 months | Participants |
| Other Pre-specified | Sleep Quality | Pittsburgh Sleep Quality Assessment (PSQI) | Not Posted | 3 months | Participants |
| Other Pre-specified | Sleep Disturbance | Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Sleep Disturbance 8a | Not Posted | 3 months | Participants |
| Other Pre-specified | Sleep Actigraphy | Actiwatch 2 (Philips Respironics) | Not Posted | 3 months | Participants |
| Other Pre-specified | Salivary Cortisol Awakening Response | Passive drool method (Salimetrics) | Not Posted | 3 months | Participants |
| Other Pre-specified | Electrodermal Activity (Skin Conductance) | Embrace wristband (Empatica, Inc.) | Not Posted | 3 months | Participants |
| 0 |
| 81 |
| 4 |
| 81 |
| 1 |
| 81 |
| EG001 | Waitlist Control | Participants in the control arm received unrestricted, non-study usual care, while on the waitlist for a service dog. | 0 | 75 | 6 | 75 | 0 | 75 |
|
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