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Innovative Service Delivery for Secondary Prevention of PTSD

11 settembre 2015 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

280

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • South Carolina
      • Charleston, South Carolina, Stati Uniti, 29403
        • Medical University of South Carolina
      • Charleston, South Carolina, Stati Uniti, 29403
        • Ralph H. Johnson VAMC

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

21 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comparatore attivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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.
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Beck Depression Inventory-II (BDI-II)
Lasso di tempo: Linea di base
Linea di base
Beck Depression Inventory-II (BDI-II)
Lasso di tempo: 3 mesi
3 mesi
Scala PTSD amministrata dal medico (CAPS)
Lasso di tempo: 8 settimane
8 settimane
Clinician Administered PTSD Scale (CAPS)
Lasso di tempo: Baseline
Baseline
Clinician Administered PTSD Scale (CAPS)
Lasso di tempo: 3 months
3 months
Clinician Administered PTSD Scale (CAPS)
Lasso di tempo: 1 year
1 year
The Deployment Risk and Resiliency Inventory (DRRI)
Lasso di tempo: Baseline
Baseline
PTSD Checklist-Military (PCL-M)
Lasso di tempo: Baseline
Baseline
PTSD Checklist-Military (PCL-M)
Lasso di tempo: 4 weeks
4 weeks
PTSD Checklist-Military (PCL-M)
Lasso di tempo: 8 weeks
8 weeks
PTSD Checklist-Military (PCL-M)
Lasso di tempo: 3 months
3 months
PTSD Checklist-Military (PCL-M)
Lasso di tempo: 1 year
1 year
Beck Depression Inventory-II (BDI-II)
Lasso di tempo: 4 weeks
4 weeks
Beck Depression Inventory-II (BDI-II)
Lasso di tempo: 8 weeks
8 weeks
Beck Depression Inventory-II (BDI-II)
Lasso di tempo: 1 year
1 year
Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36)
Lasso di tempo: Baseline
Baseline
Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36)
Lasso di tempo: 4 weeks
4 weeks
Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36)
Lasso di tempo: 8 weeks
8 weeks
Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36)
Lasso di tempo: 3 months
3 months
Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36)
Lasso di tempo: 1 year
1 year
Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS-VA)
Lasso di tempo: 8 weeks
8 weeks
Service Delivery Perceptions Questionnaire
Lasso di tempo: 8 weeks
8 weeks
Prior Experience with Computer and Audiovisual Technology
Lasso di tempo: Baseline
Short measure to learn more about participants' prior experience and comfort level with computers and audiovisual technology
Baseline

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Ronald Acierno, PhD, VA Office of Research and Development

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 2008

Completamento primario (Effettivo)

1 agosto 2014

Completamento dello studio (Effettivo)

1 febbraio 2015

Date di iscrizione allo studio

Primo inviato

12 aprile 2010

Primo inviato che soddisfa i criteri di controllo qualità

5 agosto 2010

Primo Inserito (Stima)

9 agosto 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

14 settembre 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 settembre 2015

Ultimo verificato

1 settembre 2015

Maggiori informazioni

Termini relativi a questo studio

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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