Combined Ketamine and eCBT Intervention for PTSD
Open-label, non-randomised parallel-group study (n=16) testing six sub-anaesthetic IV ketamine infusions plus 12-week online CBT versus treatment as usual in participants with refractory PTSD.
Detailed Description
Open-label, non-randomised parallel-group study comparing six sub-anaesthetic IV ketamine infusions combined with a 12-week asynchronous online trauma-focused CBT programme against treatment as usual in participants with refractory PTSD; assessments at baseline, 4, 8 and 12 weeks.
Primary aims are to evaluate clinical efficacy of the combined intervention, explore glutamatergic mechanisms in affective disorders, and assess the utility of pharmacologically-enhanced psychotherapy.
Study Protocol
Preparation
Dosing
Integration
Therapeutic Protocol
Study Arms & Interventions
Ketamine + eCBT
experimentalSix sub-anaesthetic IV ketamine infusions plus a 12-week online trauma-focused CBT programme.
Interventions
- Ketaminevia IV• six infusions over 8 weeks• 6 doses total
Sub-anaesthetic IV infusions; each infusion ~40 minutes.
- Compoundvia Other• 12-week programme• 12 doses total
Asynchronous online trauma-focused CBT (TF-CBT).
Control
waitlistTreatment as usual for 12 weeks; no change in treatment regimen.
Interventions
- Compound• treatment as usual
Participants continue usual care and do not receive the experimental interventions during the 12-week period.
Participants
Inclusion Criteria
- Diagnosis of PTSD by a psychiatrist on the team using the Clinician Administered PTSD Scale (CAPS-5) with a score of at least 50 and a medium presentation.
- Patients will have received at least 2 different types of prior treatment, both of which produced less than a 50% reduction in the participant's symptoms.
- Participants with hypertension or cardiovascular disease must be receiving stable treatment to participate.
- Participants must speak and read English, and will have consistent and reliable access to the internet.
- Patients with suicidal ideation will be included.
- Patients with a history of substance abuse will be included (except for opioid use disorder).
Exclusion Criteria
- Hypomanic/manic episodes, bipolar disorder, acute psychosis, opioid use disorder, treatment with Naltrexone, pregnancy, postpartum, breastfeeding, untreated hypertension, cardiovascular disease, ASPD, active homicidal ideation, and general noncompliance with the study protocol.