Post-Traumatic Stress Disorder
Conditions
Keywords
Ketamine, Cognitive Behavioral Therapy, Online Cognitive Behavioral Therapy, Pharmacologically enhanced psychotherapy
Brief summary
An open label RCT assessing the efficacy of a combined treatment approach for PTSD, using Ketamine infusions and online Cognitive Behavioural Therapy.
Detailed description
OBJECTIVES (i) To introduce a previously untreated patient population with PTSD to new therapeutic options. (ii) To provide new insights into the functional role of Glutamate in affective disorders as well as in learning and memory. (iii) To explore the utility of pharmacologically-enhanced psychotherapy. OUTLINE The present study is an open label randomized control trial assessing the efficacy of a combined treatment of sub-anaesthetic IV Ketamine in conjunction with online CBT (eCBT). In the study, 16 participants with refractory PTSD will be assigned either to an experimental group receiving a combination of Ketamine and eCBT over 12 weeks, or they will be assigned to a 12-week control group. Both groups will be assessed for symptoms of PTSD and comorbid disorders before treatment, at 2 midway points (4 and 8 weeks), and at the end of the 12 week experimental period. Symptoms of PTSD and comorbid disorders for participants in the experimental group are expected to improve significantly more than participants in the control.
Interventions
DRUGKetamine
Patients will receive 6 sub-anesthetic IV ketamine infusions over 8 weeks, each one lasting 40 minutes.
BEHAVIORALOnline Trauma-Focused Cognitive Behavioural Therapy
Participants will enrol in a 12-week online CBT program mirroring in-person trauma-focused CBT.
Sponsors
Queen's University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants diagnosed with PTSD will be assigned either to the experimental treatment or a control. Data will be collected from participants in both groups at the same 4 time-points.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Scores on the Clinician Administered PTSD Scale for DSM-5 | 0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start | Assessment of PTSD symptoms for diagnosis and severity; score representing the mildest/lack of symptoms: 0; score representing the most severe symptoms: 120. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Scores on the Montgomery Asberg Depression Rating Scale | 0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start | Measure of depression; score representing the mildest/lack of symptoms: 0; score representing the most severe symptoms: 60. |
| Change in Scores on the Columbia Suicide Severity Rating Scale | 0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start | Measuring thoughts, feelings, and behaviours associated with suicide; score representing the mildest/lack of symptoms: 0; score representing the most severe symptoms: 6. |
| Change in Scores on the Sheehan Disabilities Scale | 0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start | A brief, patient rated measure of disability and impairment; score representing the mildest/lack of symptoms: 0; score representing the most severe symptoms: 44. |
| Change in Scores on the Global Assessment of Functioning | 0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start | Assessing the patient's overall capacity to handle life's challenges; score representing the mildest/lack of symptoms: 100; score representing the most severe symptoms: 1. |
Countries
Canada
Contacts
Primary ContactAaron E Philipp-Muller, B.Sc.
Outcome results
None listed