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Innovative Service Delivery for Secondary Prevention of PTSD

11. september 2015 opdateret af: Charleston Research Institute

Innovative Service Delivery for Secondary Prevention of PTSD in At-Risk OIF-OEF Service Men and Women

The purpose of this study is to determine whether therapy for Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) veterans with Post-traumatic Stress Disorder (PTSD) symptoms can be delivered effectively using videoconferencing technology ("telepsychology"), which allows a therapist and patient who are not in the same room as one another to communicate.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

OIF and OEF service men and women exposed to high levels of violence are at risk for developing mental health disorders including Post-traumatic Stress Disorder (PTSD) and Major Depressive Disorder (MDD). Even those with less severe symptoms who fail to meet diagnostic criteria for a mental health disorder may struggle to return to pre-deployment functioning. Studies suggest that a significant percentage of veterans may suffer from "subthreshold" PTSD; although their symptom presentation is less severe, these veterans experience emotional distress and reduced quality of life.

Given that Veterans Affairs (VA) mental-health service providers are faced with the important and challenging task of alleviating the emotional suffering of our service men and women while staying within budget confines, we need effective, practical, evidence-based treatments that can be delivered in an expedient and cost-effective manner. Thus, the current project has two primary objectives: 1) to develop, implement, and evaluate a treatment program (Behavioral Activation and Therapeutic Exposure, BATE) for OIF and OEF veterans with PTSD symptoms, and 2) to determine whether or not this program delivered via telepsychology will be as effective as in-person treatment. Secondary objectives include determining: 1) which treatment modality is more effective in terms of process variables (e.g., treatment satisfaction, session attendance), 2) which treatment modality is more cost-effective, and 3) whether treatment effects differ across race and gender. Study participants will be randomized to two treatment conditions, BATE delivered via telepsychology (BATE-T) and BATE delivered in-person (BATE-IP).

The current treatment protocol is based on two, research-supported therapeutic rationales, Behavioral Activation (BA) and Therapeutic Exposure (TE). Briefly, the treatment aims to increase the participant's engagement in healthy activities (i.e., activities that are naturally reinforcing and promote the participant's life values) and exposure activities (i.e., activities that target specific PTSD symptoms such as avoidance and hyperarousal). Treatment will be implemented in eight, one and half hour sessions. Although research supports the effectiveness of behavior- and exposure-based treatments for trauma-related mental health problems, a potential risk for any counseling program that targets avoidance symptoms is a temporary increase in emotional distress. Therapists will inform participants that this is a normal "side effect" of treatment. However, over the course of treatment should a participant's emotional distress rise to a level above what can be handled via outpatient counseling, the participant will be removed from the study and appropriate referrals will be made.

The anticipated duration of this study is four years. Based on results of the study, we will finalize the treatment manual. In terms of clinical applicability, we plan to present study findings at conferences and disseminate the treatment manual to VA mental health service providers in approximately four to five years. Study findings will address important gaps in the PTSD literature, yielding several contributions to the field. First, to the extent that BATE effectively reduces symptom severity, this investigational treatment may benefit individual OIF/OEF service men and women by alleviating emotional suffering and improving quality of life. Second, to the extent that BATE prevents the development of full-blown PTSD in subclinical military personnel, this investigational treatment may reduce attrition from the military due to untreated mental health problems. Third, only a small percentage of those who might benefit from counseling actually seek services due to barriers associated with traditional service delivery practices such as geographic distance from the VA hospital and stigma of psychological treatment. Thus, as telemedicine has been shown to circumvent these barriers to care, the current project has the potential to reach an otherwise underserved population: subclinical OIF and OEF service men and women who may be reluctant to seek care. Fourth, to the extent that BATE-T produces results comparable to BATE-IP, this study may potentially identify a cost-effective alternative to in-person treatment thereby reducing post-service treatment costs to VA's.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

280

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29403
        • Medical University of South Carolina
      • Charleston, South Carolina, Forenede Stater, 29403
        • Ralph H. Johnson VAMC

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

21 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Participants will be OIF/OEF military personnel,
  • age 21 and above, and
  • with symptoms of posttraumatic stress disorder (PTSD) assigned on the basis of the Clinician Administered PTSD Scale (CAPS) and PTSD Checklist-Military (PCL-M).

Exclusion Criteria:

  • Actively psychotic or demented persons,
  • individuals with both suicidal ideation and clear intent, and
  • individuals meeting criteria for substance dependence will be excluded from participation.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: BATE-T
Behavioral Activation Therapeutic Exposure done while the patient is at home via videoconferencing technology
This intervention combines Behavior Activation Therapy and Exposure Therapy to treat PTSD symptoms.
Aktiv komparator: BATE-IP
Behavioral Activation Therapeutic Exposure done in the therapist's office
This intervention combines Behavior Activation Therapy and Exposure Therapy to treat PTSD symptoms.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The major objective of this study is to determine if Behavioral Activation with Therapeutic Exposure (BATE) delivered via Telemedicine is as effective as BATE In Person.
Tidsramme: 1 year
This is measured in terms of (1) clinical (PTSD and Depression); (2) process (Treatment Satisfaction and Attrition); and (3) economic (Cost) outcomes.
1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Beck Depression Inventory-II (BDI-II)
Tidsramme: Baseline
Baseline
Beck Depression Inventory-II (BDI-II)
Tidsramme: 3 måneder
3 måneder
Kliniker administreret PTSD-skala (CAPS)
Tidsramme: 8 uger
8 uger
Clinician Administered PTSD Scale (CAPS)
Tidsramme: Baseline
Baseline
Clinician Administered PTSD Scale (CAPS)
Tidsramme: 3 months
3 months
Clinician Administered PTSD Scale (CAPS)
Tidsramme: 1 year
1 year
The Deployment Risk and Resiliency Inventory (DRRI)
Tidsramme: Baseline
Baseline
PTSD Checklist-Military (PCL-M)
Tidsramme: Baseline
Baseline
PTSD Checklist-Military (PCL-M)
Tidsramme: 4 weeks
4 weeks
PTSD Checklist-Military (PCL-M)
Tidsramme: 8 weeks
8 weeks
PTSD Checklist-Military (PCL-M)
Tidsramme: 3 months
3 months
PTSD Checklist-Military (PCL-M)
Tidsramme: 1 year
1 year
Beck Depression Inventory-II (BDI-II)
Tidsramme: 4 weeks
4 weeks
Beck Depression Inventory-II (BDI-II)
Tidsramme: 8 weeks
8 weeks
Beck Depression Inventory-II (BDI-II)
Tidsramme: 1 year
1 year
Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36)
Tidsramme: Baseline
Baseline
Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36)
Tidsramme: 4 weeks
4 weeks
Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36)
Tidsramme: 8 weeks
8 weeks
Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36)
Tidsramme: 3 months
3 months
Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36)
Tidsramme: 1 year
1 year
Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS-VA)
Tidsramme: 8 weeks
8 weeks
Service Delivery Perceptions Questionnaire
Tidsramme: 8 weeks
8 weeks
Prior Experience with Computer and Audiovisual Technology
Tidsramme: Baseline
Short measure to learn more about participants' prior experience and comfort level with computers and audiovisual technology
Baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Ronald Acierno, PhD, VA Office of Research and Development

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2008

Primær færdiggørelse (Faktiske)

1. august 2014

Studieafslutning (Faktiske)

1. februar 2015

Datoer for studieregistrering

Først indsendt

12. april 2010

Først indsendt, der opfyldte QC-kriterier

5. august 2010

Først opslået (Skøn)

9. august 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

14. september 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. september 2015

Sidst verificeret

1. september 2015

Mere information

Begreber relateret til denne undersøgelse

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med PTSD

Kliniske forsøg med Behavioral Activation Therapeutic Exposure (BATE)

Abonner