Enhancing prolonged exposure therapy for PTSD among veterans with oxytocin: Design of a multisite randomized controlled trial.

Humans Implosive Therapy Oxytocin Stress Disorders, Post-Traumatic / drug therapy Treatment Outcome Veterans
Oxytocin PTSD Prolonged exposure therapy Psychophysiology Veteran

Journal

Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342

Informations de publication

Date de publication:
08 2020
Historique:
received: 06 03 2020
revised: 06 06 2020
accepted: 12 06 2020
pubmed: 21 6 2020
medline: 25 9 2021
entrez: 21 6 2020
Statut: ppublish

Résumé

Posttraumatic stress disorder (PTSD) is the most highly prevalent mental health disorder among U.S. military Veterans. Prolonged Exposure (PE) therapy is one of the most widely used evidence-based treatments for PTSD, but there is substantial room for improvement in outcomes and retention rates. Accumulating data suggest that oxytocin offers a promising pharmacological approach towards achieving this goal. Therefore, the primary objective of this two-site Phase II study is to examine the ability of oxytocin (vs. placebo) administration combined with PE therapy to (1) reduce PTSD symptom severity, (2) accelerate the rate of PTSD symptom improvement, and (3) improve PE adherence and retention rates. To accomplish these objectives, we will employ a randomized, double-blind, placebo-controlled trial and use standardized, repeated dependent measures of change at five time points (baseline, mid-treatment, end of treatment, and 3 and 6 month follow-up). Intranasal oxytocin (40 IU) will be administered directly prior to each PE therapy session. Findings from this study will provide critical new information regarding the efficacy of oxytocin to augment psychosocial treatment for PTSD, as well as information regarding the physiological mechanisms underlying PTSD and positive treatment response. ClinicalTrials.gov Identifier: NCT04228289.

Identifiants

DOI: 10.1016/j.cct.2020.106074 PMID: 32561468 PMC: PMC7484278
pubmed: 32561468
pii: S1551-7144(20)30152-X
doi: 10.1016/j.cct.2020.106074
pmc: PMC7484278
mid: NIHMS1619474
pii:
doi:

Substances chimiques

Oxytocin 50-56-6

Banques de données

ClinicalTrials.gov
['NCT04228289']

Types de publication

Clinical Trial, Phase II Journal Article Randomized Controlled Trial Research Support, N.I.H., Extramural Research Support, U.S. Gov't, Non-P.H.S.

Langues

eng

Sous-ensembles de citation

IM

Pagination

106074

Subventions

Organisme : CSRD VA
ID : I01 CX001962
Pays : United States
Organisme : NIAAA NIH HHS
ID : K23 AA023845
Pays : United States

Informations de copyright

Copyright © 2020 Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of Competing Interest The authors have no financial conflicts of interest to declare.

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Auteurs

Julianne C Flanagan (JC)

Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: hellmuth@musc.edu.

Jennifer M Mitchell (JM)

Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA; Department of Neurology, University of California San Francisco, San Francisco, CA, USA; San Francisco Veterans Affairs Health Care System, San Francisco, CA, USA. Electronic address: jennifer.mitchell@ucsf.edu.

Nathaniel L Baker (NL)

Department of Public Health Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: bakern@musc.edu.

Joshua Woolley (J)

Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA; San Francisco Veterans Affairs Health Care System, San Francisco, CA, USA. Electronic address: josh.woolley@ucsf.edu.

Bethany Wangelin (B)

Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: bethany.wangelin@va.gov.

Sudie E Back (SE)

Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: backs@musc.edu.

John R McQuaid (JR)

Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA; San Francisco Veterans Affairs Health Care System, San Francisco, CA, USA. Electronic address: john.mcquaid@va.gov.

Thomas C Neylan (TC)

Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA; Department of Neurology, University of California San Francisco, San Francisco, CA, USA; San Francisco Veterans Affairs Health Care System, San Francisco, CA, USA. Electronic address: thomas.neylan@ucsf.edu.

William R Wolfe (WR)

Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA; San Francisco Veterans Affairs Health Care System, San Francisco, CA, USA. Electronic address: william.wolfe@ucsf.edu.

Kathleen T Brady (KT)

Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: bradykt@musc.edu.

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Classifications MeSH

questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Enhancing prolonged exposure therapy for PTSD...
questionsmedicales.fr › Disciplines et activités comportementales › Psychothérapie › Thérapie comportementale › Désensibilisation psychologique › Thérapie implosive › Enhancing prolonged exposure therapy for PTSD...
questionsmedicales.fr › Acides aminés, peptides et protéines › Peptides › Hormones peptidiques › Hormones hypophysaires › Hormones post-hypophysaires › Ocytocine › Enhancing prolonged exposure therapy for PTSD...
questionsmedicales.fr › Troubles mentaux › Troubles liés aux traumatismes et au stress › Troubles de stress traumatique › Troubles de stress post-traumatique › Enhancing prolonged exposure therapy for PTSD...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Évaluation des résultats et des processus en soins de santé › Évaluation de résultat (soins) › Résultat thérapeutique › Enhancing prolonged exposure therapy for PTSD...
questionsmedicales.fr › Personnes › Anciens combattants › Enhancing prolonged exposure therapy for PTSD...