Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:03 PM
Ignite Modification Date:
2025-12-24 @ 7:03 PM
NCT ID:
NCT06412757
Eligibility Criteria:
Inclusion Criteria:
1. Aged 18 years or over.
2. Fluent in English.
3. Meet DSM-5 criteria for PTSD, irrespective of occupation (e.g. first responder, police officer, ex-military or civilian), determined using the Mini International Neuropsychiatric Interview 7.0.2.
4. Have a score on the PTSD Checklist for DSM-5 (PCL-5) equal to or over 33.
Exclusion Criteria:
1. Are currently serving in the Australian Defence Force
2. Lifetime history of a psychotic or bipolar disorder, or dissociative identity disorder.
3. Moderate or severe alcohol or other substance use disorder within 3 months of screening.
4. Active suicidal or homicidal ideation.
5. Borderline Personality Disorder (BPD).
6. Acute or unstable medical illness or other significant medical condition, that would make participation in the trial unsafe or inappropriate.
7. Pregnancy, lactation or unwillingness to use an acceptable method of contraception (required for both males and females who are of reproductive potential and sexually active with partners of the opposite sex) through the duration of participants' involvement in the study up to and including week 16. Participants will also be advised not to donate eggs or sperm during the study period.
8. Commencement of a trauma-focussed psychotherapy (including Prolonged Exposure, Cognitive Processing Therapy and Eye Movement Desensitisation and Reprocessing) within 3 months of screening.
9. Commencement or change in dose of psychoactive medications within 4 weeks of screening.
10. Participants will be asked not to initiate psychotherapy or change the dose of psychoactive medications during the course of the study except in clinically urgent circumstances; if this becomes necessary, a decision will be made on a case-by-case basis with regard to retaining the participant or terminating their participation.
11. Severe acquired brain injury.
12. Individual is not eligible for public mental health services due to their visa status in Australia or for any other reason.
13. Any other condition that in the opinion of the research team is likely to make completion of the trial requirements infeasible.
14. Inability to understand or speak English to the extent necessary to give informed consent and complete the trial (researcher or clinician-determined).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06412757
Study Brief:
Protocol Section:
NCT06412757