Psilocybin-Assisted Psychotherapy for Veterans With PTSD
ConditionPosttraumatic Stress Disorder (PTSD)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorARQ National Psychotrauma Centre
About this trial
This study will evaluate the feasibility, safety and preliminary efficacy of psilocybin-assisted psychotherapy in military veterans with treatment-refractory posttraumatic stress disorder (PTSD).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Psilocybin-assisted Psychotherapy
DrugTwo 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.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Psilocybin-assisted psychotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)
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.
Time frame
From Baseline to 1 month after final integrative psychotherapy session2
Semi-structured interview
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.
Time frame
One month after final integrative psychotherapy session3
Treatment Acceptability/Adherence Scale Modified (TAAS-M)
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.
Time frame
One month after final integrative psychotherapy session4
Feasibility of participant screening and study retention
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.
Time frame
From screening until one month after the final integrative psychotherapy session.Secondary outcomes
1
Sheehan Disability Scale
The Sheehan Disability Scale is a 3-item assessment of functional impairment.
Time frame
Change from Baseline to one month after final integrative psychotherapy session2
Beck Depression Inventory-II (BDI-II)
The BDI-II is a 21-item self-report measure for depression symptom severity.
Time frame
Change from baseline to one month after final integrative psychotherapy sessionSponsors and contacts
Click on the lead sponsor to view all of their trials.
ARQ National Psychotrauma Centre
Lead sponsor
National Healthcare System for Veterans / Landelijk Zorgsysteem voor Veteranen (LZV)
Collaborator
Leiden University Medical Center
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: