301. Enhancing prolonged exposure therapy for PTSD among veterans with oxytocin: Design of a multisite randomized controlled trial.
- Author
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Flanagan, Julianne C, Mitchell, Jennifer M, Baker, Nathaniel L, Woolley, Joshua, Wangelin, Bethany, Back, Sudie E, McQuaid, John R, Neylan, Thomas C, Wolfe, William R, and Brady, Kathleen T
- Subjects
Humans ,Oxytocin ,Treatment Outcome ,Stress Disorders ,Post-Traumatic ,Implosive Therapy ,Veterans ,PTSD ,Prolonged exposure therapy ,Psychophysiology ,Veteran ,Anxiety Disorders ,Mental Health ,Complementary and Integrative Health ,Cardiovascular ,Behavioral and Social Science ,Post-Traumatic Stress Disorder (PTSD) ,Clinical Trials and Supportive Activities ,Clinical Research ,Brain Disorders ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,6.6 Psychological and behavioural ,Mental health ,Good Health and Well Being ,Medical and Health Sciences ,General Clinical Medicine ,Public Health - Abstract
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.
- Published
- 2020