Enhanced exposure therapy for combat-related Posttraumatic Stress Disorder (PTSD): Study protocol for a randomized controlled trial.
Humans
Clinical Trials, Phase III as Topic
Combined Modality Therapy
Cycloserine
/ administration & dosage
Implosive Therapy
/ methods
Multicenter Studies as Topic
Randomized Controlled Trials as Topic
Stress Disorders, Post-Traumatic
/ genetics
Veterans
/ psychology
Virtual Reality Exposure Therapy
/ methods
Combat Disorders
/ genetics
Augmentation strategies
D-cycloserine
Genetics
PTSD
Prolonged exposure therapy
Virtual reality
Journal
Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342
Informations de publication
Date de publication:
12 2019
12 2019
Historique:
received:
06
05
2019
revised:
25
09
2019
accepted:
02
10
2019
pubmed:
2
11
2019
medline:
24
10
2020
entrez:
1
11
2019
Statut:
ppublish
Résumé
PTSD, which has been identified in up to 23% of post-9-11 veterans, often results in a chronic, pernicious course. Thus, effective treatments are imperative. The Institute of Medicine (IOM) concluded that the only intervention for PTSD with sufficient evidence to conclude efficacy is exposure therapy. This Phase III trial compares the efficacy of exposure therapy for combat-related PTSD delivered in two different formats- via virtual reality exposure therapy (VRE) or prolonged exposure therapy (PE)- combined with D-Cycloserine (DCS), a cognitive enhancer shown to facilitate the extinction of fear. Military personnel of any duty status and civilians deployed to Iraq and Afghanistan were eligible. Participants were randomly assigned to 9 sessions of exposure therapy (VRE or PE) and medication (50 mg DCS or placebo). Participants were treated at three geographically diverse sites. Participants were re-assessed at 3-months post-treatment. The co-primary hypotheses are that (1) DCS will augment response to exposure therapy (both VRE and PE) on PTSD symptoms; (2) VRE will be associated with greater improvement than PE. Genetic and psychophysiological markers will be evaluated as potential moderators and mediators of treatment outcomes as well as secondary outcomes. This study is the first to compare the relative efficacy of DCS-augmented VRE versus PE on PTSD symptoms. The design has several advantages: participants received an active, effective treatment and predictors of response to treatment included genetic and psychobiological measures. The results may directly influence the future delivery of services, and contribute to the development of a standardized treatment protocol. NCT01352637.
Sections du résumé
BACKGROUND
PTSD, which has been identified in up to 23% of post-9-11 veterans, often results in a chronic, pernicious course. Thus, effective treatments are imperative. The Institute of Medicine (IOM) concluded that the only intervention for PTSD with sufficient evidence to conclude efficacy is exposure therapy. This Phase III trial compares the efficacy of exposure therapy for combat-related PTSD delivered in two different formats- via virtual reality exposure therapy (VRE) or prolonged exposure therapy (PE)- combined with D-Cycloserine (DCS), a cognitive enhancer shown to facilitate the extinction of fear.
METHODS/DESIGN
Military personnel of any duty status and civilians deployed to Iraq and Afghanistan were eligible. Participants were randomly assigned to 9 sessions of exposure therapy (VRE or PE) and medication (50 mg DCS or placebo). Participants were treated at three geographically diverse sites. Participants were re-assessed at 3-months post-treatment. The co-primary hypotheses are that (1) DCS will augment response to exposure therapy (both VRE and PE) on PTSD symptoms; (2) VRE will be associated with greater improvement than PE. Genetic and psychophysiological markers will be evaluated as potential moderators and mediators of treatment outcomes as well as secondary outcomes.
DISCUSSION
This study is the first to compare the relative efficacy of DCS-augmented VRE versus PE on PTSD symptoms. The design has several advantages: participants received an active, effective treatment and predictors of response to treatment included genetic and psychobiological measures. The results may directly influence the future delivery of services, and contribute to the development of a standardized treatment protocol.
TRIAL REGISTRATION
NCT01352637.
Identifiants
pubmed: 31669451
pii: S1551-7144(19)30572-5
doi: 10.1016/j.cct.2019.105857
pii:
doi:
Substances chimiques
Cycloserine
95IK5KI84Z
Banques de données
ClinicalTrials.gov
['NCT01352637']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, N.I.H., Extramural
Research Support, U.S. Gov't, Non-P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
105857Subventions
Organisme : NCATS NIH HHS
ID : UL1 TR002384
Pays : United States
Informations de copyright
Copyright © 2019 Elsevier Inc. All rights reserved.