Psilocybin-Assisted Psychotherapy for Veterans With PTSD (PsiVet)
Psilocybin-Assisted Psychotherapy for Posttraumatic Stress Disorder in Military Veterans: A Pilot Feasibility Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Posttraumatic stress disorder (PTSD) is a severe and debilitating mental health condition that significantly impacts patients' lives, leading to functional impairments, strained relationships, and high healthcare costs. About half of the patients with PTSD do not benefit from current evidence-based psychotherapy and available pharmacological treatments offer only limited benefits. Therefore, there is a high need for novel therapeutic approaches in the treatment of PTSD.
Psilocybin-assisted psychotherapy is a promising approach combining the pharmacological effects of psilocybin, a serotonergic psychedelic, with psychotherapy. Psilocybin-assisted psychotherapy has shown promising effects in several phase 2 studies in the treatment of mental health conditions such as depression and end-of-life anxiety, with two phase 3 studies underway for treatment-resistant depression. Building on these initial promising results, psilocybin-assisted psychotherapy is increasingly being studied for other psychiatric indications, including PTSD.
Many of psilocybin's potential therapeutic mechanisms appear to be transdiagnostic in nature. For example, studies suggest that psilocybin can enhance introspection, emotional processing, and psychological flexibility, all of which could facilitate psychotherapeutic processes. Psilocybin has also been shown to reduce avoidance and promote neural plasticity and cognitive reappraisal, which could be particularly relevant for addressing core symptoms of PTSD, such as persistent avoidance and rigid negative thought patterns. Furthermore, its ability to foster a sense of connectedness aligns well with the therapeutic need of individuals with PTSD who face challenges related to social isolation.
Preliminary findings from an initial Phase 2 trial suggest that psilocybin-assisted psychotherapy may be safe and associated with clinically meaningful improvements in PTSD symptoms. However, this study differed from the present study in several important aspects. Participants were not required to have had previous unsuccessful evidence-based psychotherapies for PTSD, and psilocybin administration was not embedded within psychotherapeutic treatment. The current open-label pilot study will focus on veterans with treatment-refractory PTSD, a patient population that frequently shows partial or no response to standard evidence-based PTSD treatment. In addition, psilocybin administration will be part of an extensive psychotherapeutic treatment protocol. This study aims to collect data on the feasibility, preliminary efficacy and safety of psilocybin-assisted psychotherapy in this population, to inform a potential future randomized controlled trial.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Annika Wirsching, MSc
- Número de teléfono: +31 088 330 5699
- Correo electrónico: a.wirsching@arq.org
Ubicaciones de estudio
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Oegstgeest, Países Bajos, 2342 EG
- ARQ National Psychotrauma Centre / ARQ Centrum'45
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Are between 18 and 70 years old.
- Able to provide written informed consent.
- Fluent in speaking and reading Dutch.
- Is a veteran of the Dutch Armed Forces.
- Able to swallow pills.
- Have a body mass index (kg/m2) of >18.0.
- Meet DSM-5 criteria for current PTSD.
- Meet criteria for treatment-refractory PTSD.
- Agree to have study visits audiovisually recorded.
- Able to provide a contact (relative, spouse, close friend, or other support person) who is willing and able to be reached by the investigators in the event of the participant becoming unwell or unreachable.
Exclusion Criteria:
- Has a history of any medical condition that could make receiving psilocybin harmful because of temporary increases in blood pressure and heart rate.
- Has a medical or psychiatric condition that could interfere with study participation or pose a risk to the participant's safety or well-being.
- Has uncontrolled hypertension.
- Unable or unwilling to safely taper-off prohibited psychiatric medication.
- Has been exposed to electroconvulsive therapy (ECT) within 12 weeks of enrollment.
- Has any current problem which, in the opinion of the investigator, might interfere with study participation.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Psilocybin-assisted psychotherapy
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Two psilocybin sessions (15 mg psilocybin in the first session; 25 mg psilocybin in the second session) embedded in a psychotherapeutic framework with three preparatory sessions and six integrative sessions.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)
Periodo de tiempo: From Baseline to 1 month after final integrative psychotherapy session
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The last month CAPS-5-R is a semi-structured interview that assesses index history of DSM-5-defined traumatic event exposure, including the most distressing event and time since exposure, and rates intrusion symptoms (intrusive thoughts or memories), avoidance, cognitive and mood symptoms, arousal and reactivity symptoms, duration and degree of distress and dissociation.
The CAPS-5-R will be administered by a study independent CAPS-5-R rater.
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From Baseline to 1 month after final integrative psychotherapy session
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Semi-structured interview
Periodo de tiempo: One month after final integrative psychotherapy session
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Comprehensive qualitative information about participants' evaluation of the feasibility, acceptability and efficacy of psilocybin-assisted psychotherapy for PTSD will be collected through a semi-structured interview.
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One month after final integrative psychotherapy session
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Treatment Acceptability/Adherence Scale Modified (TAAS-M)
Periodo de tiempo: One month after final integrative psychotherapy session
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A modified 10-item version of the Treatment Acceptability and Adherence Scale (TAAS-M) will be used to describe acceptability and adherence to psilocybin-assisted psychotherapy.
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One month after final integrative psychotherapy session
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Feasibility of participant screening and study retention
Periodo de tiempo: From screening until one month after the final integrative psychotherapy session.
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The feasibility of participant screening and study retention will be assessed by documenting the number and proportion of participants who fail screening, the number and proportion of enrolled participants who discontinue the intervention, and the reasons for screen failure and discontinuation.
All measures will be summarized descriptively.
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From screening until one month after the final integrative psychotherapy session.
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Concomitant medication use
Periodo de tiempo: From screening until one month after the final integrative psychotherapy session.
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Concomitant medication use during study participation will be recorded.
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From screening until one month after the final integrative psychotherapy session.
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Columbia Suicide Severity Rating Scale (C-SSRS)
Periodo de tiempo: Measured at several timepoints from screening to one month after the final integrative psychotherapy session.
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The C-SSRS is a clinician-administered measure of suicidal behavior devised to detect potential suicidal thoughts or behaviors during a clinical trial.
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Measured at several timepoints from screening to one month after the final integrative psychotherapy session.
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Adverse events
Periodo de tiempo: From screening until one month after the final integrative psychotherapy session.
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Severity, incidence and frequency of AEs and serious adverse events (SAEs).
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From screening until one month after the final integrative psychotherapy session.
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Blood pressure
Periodo de tiempo: At several timepoints between screening and one month after the final integrative psychotherapy session, including during psilocybin administration.
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Systiloc and diastolic blood pressure (mmHg) will be monitored.
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At several timepoints between screening and one month after the final integrative psychotherapy session, including during psilocybin administration.
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Heart rate
Periodo de tiempo: At several timepoints between screening and one month after the final integrative psychotherapy session, including during psilocybin administration.
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Heart rate (beats per minute) will be monitored.
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At several timepoints between screening and one month after the final integrative psychotherapy session, including during psilocybin administration.
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Body temperature
Periodo de tiempo: At several timepoints between screening and one month after the final integrative psychotherapy session, including during psilocybin administration.
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Body temperature (°C) will be monitored.
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At several timepoints between screening and one month after the final integrative psychotherapy session, including during psilocybin administration.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Sheehan Disability Scale
Periodo de tiempo: Change from Baseline to one month after final integrative psychotherapy session
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The Sheehan Disability Scale is a 3-item assessment of functional impairment.
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Change from Baseline to one month after final integrative psychotherapy session
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Beck Depression Inventory-II (BDI-II)
Periodo de tiempo: Change from baseline to one month after final integrative psychotherapy session
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The BDI-II is a 21-item self-report measure for depression symptom severity.
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Change from baseline to one month after final integrative psychotherapy session
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Eric Vermetten, MD, PhD, Leiden University Medical Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2025-521488-11-00
- 2025 (Subvención/contrato del NIH de EE. UU.: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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