U.S. Army Medical Research and Materiel Command Fort Detrick, Maryland

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1 AWARD NUMBER: W8XWH TITLE: Evaluating the Feasibility f RESCUE: An Adjunctive HAI-Based Interventin fr Veterans with PTSD PRINCIPAL INVESTIGATOR: Dr. Peter Tuerk CONTRACTING ORGANIZATION: Charlestn Research Institute Charlestn, SC REPORT DATE: May 206 TYPE OF REPORT: Annual PREPARED FOR: U.S. Army Medical Research and Materiel Cmmand Frt Detrick, Maryland DISTRIBUTION STATEMENT: Apprved fr Public Release; Distributin Unlimited The views, pinins and/r findings cntained in this reprt are thse f the authr(s) and shuld nt be cnstrued as an fficial Department f the Army psitin, plicy r decisin unless s designated by ther dcumentatin.

2 REPORT DOCUMENTATION PAGE Frm Apprved OMB N Public reprting burden fr this cllectin f infrmatin is estimated t average hur per respnse, including the time fr reviewing instructins, searching existing data surces, gathering and maintaining the data needed, and cmpleting and reviewing this cllectin f infrmatin. Send cmments regarding this burden estimate r any ther aspect f this cllectin f infrmatin, including suggestins fr reducing this burden t Department f Defense, Washingtn Headquarters Services, Directrate fr Infrmatin Operatins and Reprts ( ), 25 Jeffersn Davis Highway, Suite 204, Arlingtn, VA Respndents shuld be aware that ntwithstanding any ther prvisin f law, n persn shall be subject t any penalty fr failing t cmply with a cllectin f infrmatin if it des nt display a currently valid OMB cntrl number.. REPORT DATE May REPORT TYPE Annual 3. DATES COVERED 22 Apr 205-2Apr TITLE AND SUBTITLE 5a. CONTRACT NUMBER Evaluating the Feasibility f RESCUE: An Adjunctive HAI-Based Interventin fr Veterans with PTSD 6. AUTHOR(S) Dr. Peter Tuerk, Dr. Ursula Myers, and Ms. Kelsie H. Page 5b. GRANT NUMBER W8XWH c. PROGRAM ELEMENT NUMBER 5d. PROJECT NUMBER 5e. TASK NUMBER tuerk@musc.edu and kelly@chsri.cmcastbiz.net 5f. WORK UNIT NUMBER 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) 8. PERFORMING ORGANIZATION Charlestn Research Institute (CRI), 76-A Ashley Avenue, Charlestn, SC SPONSORING / MONITORING AGENCY NAME(S) AND ADDRESS(ES) 0. SPONSOR/MONITOR S ACRONYM(S) U.S. Army Medical Research and Materiel Cmmand Frt Detrick, MD SPONSOR/MONITOR S NUMBER(S) 2. DISTRIBUTION / AVAILABILITY STATEMENT Apprved fr Public Release; Distributin Unlimited 3. SUPPLEMENTARY NOTES: 4. ABSTRACT Due t award transfer and delayed funds n statin the start date was 2//6. This reprt dcuments accmplishment f the fllwing tasks:. Cnsultatin with and crdinatin amng experts in cmbat-related PTSD, evidence based treatment (EBT), scientific design, and therapeutic Human Animal Interactin (HAI); 2. Engagement f key stakehlders (e.g., Veteran supprt grups, animal rescue grups) as a means f identifying ptential barriers t study gals and t facilitate study recruitment; 3. Establishment f wrking relatinship with lcal shelter facility staff; 4. Review f prtcls/treatment materials; 5.Refinement f eligibility criteria, exclusin criteria, and screening prtcl; 6. Preparatin and submissin f prtcl t Charlestn VAMC R&D and MUSC IRB, (IRB pre-apprval btained: i.e., IRB apprval is secured pending submissin f shelter letters f supprt and apprval f ptential HRPO revisins); 7. Recruitment, hiring, and training f study independent evaluatrs (IEs) (training is nging). 5. SUBJECT TERMS psychtherapy; PTSD; Veterans; prlnged expsure 6. SECURITY CLASSIFICATION OF: 7. LIMITATION OF ABSTRACT 8. NUMBER OF PAGES 9a. NAME OF RESPONSIBLE PERSON USAMRMC a. REPORT U b. ABSTRACT U c. THIS PAGE U UU 9b. TELEPHONE NUMBER 2

3 Table f Cntents Page. Intrductin Keywrds Accmplishments Impact Changes/Prblems Prducts Participants & Other Cllabrating Organizatins.8 8. Special Reprting Requirements 3

4 . INTRODUCTION: PTSD is a cmmn mental health disrder amng Veterans. Currently, there are mre Veterans with PTSD wh d nt engage in r drp-ut f treatment than there are Veterans wh cmplete treatment. Recvery thrugh Engagement with Shelter Canines, Understanding, and Expsure (RESCUE), is an adjunctive, Human Animal Interactin (HAI) interventin that will be develped fr integratin int Prlnged Expsure (PE) treatment. The gal f RESCUE is t increase emtinal engagement and decrease emtinal numbing, an imprtant barrier t care, and thus imprve functining and EBT cmpletin rates. 2. KEYWORDS: psychtherapy; PTSD; Veterans; prlnged expsure 3. ACCOMPLISHMENTS: What were the majr gals f the prject? Majr Gal : Develpment f Recvery thrugh Engagement with Shelter Canines, Understanding, and Expsure (RESCUE) prvider manuals and patient handuts, Obtain apprvals frm versight bdies. Majr Gal 2: Cnduct a case series wherein Veterans (N=5) will be treated with the RESCUE/ PE prtcl t wrk ut any prtcl/lgistical difficulties and cllect initial feasibility/accessibility. Majr Gal 3: Test feasibility, acceptability, and initial efficacy f RESCUE/ PE in a pilt RCT cnducted with Veterans (N= 50) meeting Diagnstic and Statistical Manual Fifth Editin (DSM-V) criteria fr PTSD randmly assigned t RESCUE/ PE r t TAU/ Prlnged Expsure (PE) fllwed by RESCUE. What was accmplished under these gals?. a) Cnducted interviews, psted study psitins, and selected supprt staff persnnel fr the study, initiated training. b) Wrte and submitted IRB, applicatin number Pr , submitted n 03/04/206, Department preapprval btained n 07-MAR-206, Department Apprval Letter Issued n 08-MAR-206. IRB preapprval btained (full apprval pending submissin f shelter letters f supprt and review f ptential HRPO-related edits). c) Initiated cllabrative cntact with HRPO fficials t review initial IRB findings and requirements prir t HRPO submissin. d) Initiated cntact with partner shelters. e) Initiated cntact and cllabratin with Veteran stakehlder rganizatins. f) Initiated purchasing f study supplies. g) Gathering and creating study materials (fidelity frms, patient binders, MP, etc.) h) Initiated cnsultatin regarding Human Animal Interactin (HAI) i) Study presented at sympsium: Human-Animal Interactins in Treating Veterans with PTSD American Psychlgical Assciatin (APA) 23rd Annual Cnventin n 09-AUG-205, Trnt, Canada. See Chart fr specific aims related t reprting perid: 4

5 Specific Aim : Develpment f Recvery thrugh Engagement with Shelter Canines, Understanding, and Expsure (RESCUE) prvider manuals and patient handuts, Obtain apprvals frm versight bdies. Majr Task : Knwledge elicitatin frm cnsulting experts and key stakehlders. Cnsult experts in cmbat-related PTSD, Empirically Based Treatment (EBT), behavirism, and therapeutic Human Animal Interactin (HAI) Engage key stakehlders as a means f identifying ptential treatment barriers and t facilitate study recruitment later. Timeline/ Mnths % % Established/cntinue wrking relatinship with lcal SPCA facility staff % Majr Task 2: Finalize treatment and cntrl prtcls Review f prtcls/treatment materials by cnsulting experts in cmbat-related PTSD treatment and Human Animal Interactin (HAI) /animal behavirism fr theretical sundness, usability, and quality % Percentage Cmplete Majr Task 3: Obtain IRB apprval Develp eligibility criteria, exclusin criteria, and screening prtcl % Develp cnsent frm and human subjects prtcl % Prepare and submit prtcl t Charlestn VAMC R&D and MUSC IRB % Submit IRB prtcl t DOD/HRPO 0-4 0% Obtain IRB, R&D, and HRPO apprvals t mve frward % Submit amendments, adverse events and prtcl deviatins as needed % Submit annual IRB reprt fr cntinuing review (lcal) % Submit annual IRB reprt fr cntinuing review and reprts t HRPO as needed % Majr Task 4: Recruit & train IEs and study therapists Recruit, facilitate hiring, and train study independent evaluatrs (IEs) % Facilitate and crdinate training and PE certificatin, supervisin, % and fidelity checks as needed fr prject therapists. Specific Aim 2: A case series wherein Veterans (N=5) will be treated Majr Task : Finalize Thematic Interview Measures/Fcus grup prcedures Synthesize thematic interview based n scientific- and key stakehlder-knwledge % Majr Task 2: Recruit cmbat Veterans with PTSD fr case series Utilize PTSD Clinical Team (PCT) develped referral stream fr study recruitment % Majr Task 3: Cnduct pre-treatment evaluatins fr case series Screen, btain cnsent, assess, and enrll participants 6-8 0% Majr Task 4: Cnduct RESCUE/PE treatment with case series participants Cnduct and cmplete case series fr additinal refinements in design, lgistics, 6-0 0% Majr Task 5: Cnduct pst-treatment evaluatins fr case series participants Cmplete pst-treatment standardized evaluatins and clinical interviews % Cmplete pst-treatment 60-minute thematic interviews/fcus grups % Majr Task 6: Data review and Refinement f prtcl and materials Cnsulting experts review randmly selected sessins 8-0% Review and analysis f thematic interview utcmes 8-0% Review and analysis f quantitative case reprt measures 8-0% Prtcl refinement as indicated 0% 5

6 What pprtunities fr training and prfessinal develpment has the prject prvided? Nthing t reprt. Hw were the results disseminated t cmmunities f interest? Nthing t reprt. What d yu plan t d during the next reprting perid t accmplish the gals?. Submit IRB prtcl t DOD/HRPO 2. Finalize IRB, R&D, and HRPO apprvals t mve frward 3. Cntinue training study independent evaluatrs (IEs) 4. Facilitate and crdinate training and PE certificatin, supervisin, and fidelity checks as needed fr prject therapists. 5. Finalize thematic interview based n scientific- and key stakehlder-knwledge gained in Specific Aim. Cnstruct thematic interview prtcl in line with established prcedures fr best practices qualitative research. 6. Utilize PTSD Clinical Team (PCT) t develp referral stream fr study 7. Screen, btain cnsent, assess, and enrll participants fr pilt and RCT. 4. IMPACT: What was the impact n the develpment f the principal discipline(s) f the prject? Nthing t reprt. What was the impact n ther disciplines? Nthing t reprt. What was the impact n technlgy transfer? Nthing t reprt. What was the impact n sciety beynd science and technlgy? Nthing t reprt. 5. CHANGES/PROBLEMS: Changes in apprach and reasns fr change Nthing t reprt. Actual r anticipated prblems r delays and actins r plans t reslve them. Staff at area shelters turned ver and s new relatinships had t be frged, this is nt a significant issue. 2. We had riginally planned n submitting t HRPO in the first quarter but delays in getting funds n statin (funds will cver a start date f 0-FEB-206) and lnger than anticipated lcal IRB review has delayed this gal. We did prmptly submit t lcal IRB, btained preliminary apprval, and will cmmence HRPO review in the cming weeks. We have already established cntact with HRPO staff wh have been very respnsive and we d nt anticipate any difficulties in the cllabrative relatinship. 6

7 Changes that had a significant impact n expenditures First quarter funds were received in early April and will be used t cver staff effrt, cnsultatin services, and equipment/supplies. Our lcal research institute has drawn up subaward agreements and we expect them t be fully executed in the cming weeks. Once they are in place, we expect t be inviced fr salaries and fringe since February. Significant changes in use r care f human subjects, vertebrate animals, bihazards, and/r select agents Nthing t reprt. Significant changes in use r care f human subjects Nt applicable. Significant changes in use r care f vertebrate animals. Nt applicable. Significant changes in use f bihazards and/r select agents Nt applicable. 6. PRODUCTS: Publicatins, cnference papers, and presentatins Study presented at sympsium: Human-Animal Interactins in Treating Veterans with PTSD American Psychlgical Assciatin (APA) 23rd Annual Cnventin n 09-AUG-205, Trnt, Canada. Jurnal publicatins. Nthing t reprt. Bks r ther nn-peridical, ne-time publicatins. Nthing t reprt. Other publicatins, cnference papers, and presentatins. Nthing t reprt. Website(s) r ther Internet site(s) Nthing t reprt. Technlgies r techniques Nthing t reprt. Inventins, patent applicatins, and/r licenses Nthing t reprt. Other Prducts Nt applicable. 7

8 7. PARTICIPANTS & OTHER COLLABORATING ORGANIZATIONS Prject Rle: Nearest persn mnth wrked: Cntributin t Prject: What individuals have wrked n the prject? Dr. Peter Tuerk PI 3 Cnsulted with experts in therapeutic Human Animal Interactin (HAI). Engaged key stakehlders (e.g., Veteran supprt grups, animal rescue grups) as a means f identifying ptential treatment barriers and t facilitate study recruitment. Reviewed prtcls/treatment materials. Develped eligibility criteria, exclusin criteria, and screening prtcl. Prepared and submitted prtcl t Charlestn VAMC R&D and MUSC IRB. Recruited, facilitated hiring, and training study independent evaluatrs (IEs) (staff recruited, training is nging). Prject Rle: Researcher Identifier (e.g. ORCID ID): Nearest persn mnth wrked: Cntributin t Prject: Dr. Rnald Aciern C-I Prvided cnsultatin n MUSC IRB. Assisted with prtcl develpment. Prject Rle: Nearest persn mnth wrked: Cntributin t Prject: Dr. Dnald L. Myrick C-I Prvided cnsultatin n MUSC IRB. Assisted with prtcl develpment. Prject Rle: Nearest persn mnth wrked: Cntributin Prject: t Dr. Bethany Wangelin C-I Reviewed prtcls/treatment materials. Develped eligibility criteria, exclusin criteria, and screening prtcl. Prepared and submitted prtcl t Charlestn VAMC R&D and MUSC IRB. 8

9 Prject Rle: Nearest persn mnth wrked: Cntributin Prject: t Dr. Kristy Center C-I Engaged key stakehlders (e.g., Veteran supprt grups, animal rescue grups) as a means f identifying ptential treatment barriers and t facilitate study recruitment. Established wrking relatinship with lcal shelter facility staff. Prject Rle: Nearest persn mnth wrked: Cntributin Prject: t Dr. Brian Lzan C-I Reviewed prtcls/treatment materials. Develped eligibility criteria, exclusin criteria, and screening prtcl. Prepared and submitted prtcl t Charlestn VAMC R&D and MUSC IRB. Prject Rle: Nearest persn mnth wrked: Cntributin Prject: t Dr. Anuk Grubaugh C-I Cnsulted with experts in cmbat-related PTSD, Empirically Based Treatment (EBT), behavirism, and therapeutic Human Animal Interactin (HAI). Prject Rle: Nearest persn mnth wrked: Cntributin Prject: t Dr. Michael Klfer C-I Cnsultatin regarding human animal interactin (HAI) aspect f trial. Ursula Myers, M.S. Prject Rle: Lab crdinatr Nearest persn mnth wrked: Cntributin t Prepared and submitted prtcl t Charlestn VAMC R&D and MUSC IRB. Prject: 9

10 Bridgette Niepth, M.S. Prject Rle: Research Assistant II Nearest persn 6 mnth wrked: Cntributin t Prepared and submitted prtcl t Charlestn VAMC R&D and MUSC IRB. Prject: Has there been a change in the active ther supprt f the PD/PI(s) r senir/key persnnel since the last reprting perid? Dr. Tuerk has received additinal supprt n the fllwing grants: R42MH ; Tuerk (PI) 9/6/ - 8/3/7; 2.25 CM Pegasys VR: Integrating Virtual Humans in the Treatment f Child Scial Anxiety PT4078- USA MED RESEARCH ACQ ACTIVITY; Fa (PI) 09/30/5-09/29/8;.2 CM The Efficacy f 90-minute vs 60-minute sessins f Prlnged Expsure fr PTSD: A Randmized Cntrl Trial in Active Duty Military Persnnel. Funding n the fllwing grants has expired fr Dr. Tuerk: VA-CDA ; Tuerk (PI) 07/0/200-06/30/205; 9.0 CM Prlnged Expsure fr PTSD with and withut Yhimbine and the Crrelates f Trait Habituatin What ther rganizatins were invlved as partners? Nt applicable. 7. SPECIAL REPORTING REQUIREMENTS COLLABORATIVE AWARDS: Nt applicable. QUAD CHARTS: If applicable, the Quad Chart (available n shuld be updated and submitted with attachments. 8. APPENDICES: Nt applicable. 0

11 Evaluating the Feasibility f RESCUE: An Adjunctive HAI-Based Interventin fr Veterans with PTSD Lg Number: Award Number: W8XWH PI: Peter W. Tuerk, Ph.D. Org: Charlestn Research Institute/Ralph H. Jhnsn VAMC Award Amunt: $709,57 Study/Prduct Aim(s) T develp and pilt test feasibility, acceptability, and efficacy f RESCUE, an adjunct scalable human animal interactin (HAI) interventin invlving shelter dgs fr use with disseminated Empirically Based Treatments (EBT) fr psttraumatic stress disrder (PTSD) t increase treatment engagement and cmpletin. Apprach The prject is rganized int 3 sequential phases/aims. () Develpment f treatment prtcls; (2) A case series wherein 5 Veterans will be treated with Prlnged Expsure (PE) therapy in tandem with the experimental RESCUE cmpnent t wrk ut prtcl/lgistical difficulties and cllect initial feasibility and accessibility data; and (3) a randmized cntrlled trial using a crssver design with 50 Veterans (recruit 70) with PTSD randmized t PE simultaneusly with RESCUE r PE fllwed by RESCUE. Outcmes will include subjective PTSD assessments, bjective PTSD assessments, and qualitative interviews. Timeline and Cst Activities CY Develp treatment Pilt test treatment and revamp Cnduct RCT Analyze data Disseminate findings & study knwledge Estimated Budget ($K) $249,000 $230,000 $230,000 Updated: 5/23/6 Prlnged Expsure with RESCUE (n=35) Develp RESCUE Interventin Pilt Test (N=5) Imprve RESCUE Randmizatin (N=70) Analyze Data Prlnged Expsure fllwed by RESCUE (n=35) Disseminate data and if indicated RESCUE Prtcl Quantitative Measures and Qualitative Interviews Accmplishments: Recruited study staff, initiated develpment f RESCUE prtcl, created study materials, submitted t Internal Review Bard (IRB), initiated utreach t partner and stakehlder rganizatins. Gals/Milestnes CY6 Gals Treatment develpment & test pilt Develp treatment prtcls Develp thematic interviews Cnduct utreach t partner and stakehlder rganizatins Cmplete pilt case series Revamp prtcl as indicated by data CY7 Gals Randmized cntrlled trial f treatment (N=70) Recruit and cnsent 52 participants Cmplete treatment and assessments CY8 Gal Cmplete trial, analyze data, disseminate findings Recruit and cnsent 8 participants Cmplete treatment and assessments Analyze data Disseminate findings. Cmments/Challenges/Issues/Cncerns: Nne Budget Expenditure t Date: Have nt received funds n statin yet. Prjected Expenditure: Budget perid 2//206 - /3/207: $248,444