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L'essai clinique NCT07009158 pour Douleur chronique, Trouble de stress post-traumatique (TSPT) est pas encore en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
Ketamine Assisted Psychotherapy for Treating Comorbid Chronic Pain and PTSD Phase I, Phase II 30 Exercice
Ketamine Assisted Psychotherapy to Improve Quality of Life in Veterans and Civilians With Comorbid Chronic Pain and Posttraumatic Stress Disorder: an Open-label Randomized Controlled Trial.
- TRAQ-6043701
Phase II
Mindfulness-based Cognitive Therapy
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalKAP group The Ketamine-assisted psychotherapy (KAP) group will receive 4 ketamine infusion treatments and 8 sessions of mindfulness therapy. | Perfusion de kétamine Ketamine hydrochloride (DIN: 02246795, 02246796) will be administered over 40-min intravenous (IV) infusion twice per week on non-consecutive days for the first two weeks of study treatment (four treatment sessions in total). We will use a standard dose of 0.5mg/kg which has demonstrated efficacy in safety in individuals with PTSD. Thérapie cognitive basée sur la pleine conscience The Mindfulness-based cognitive therapy (MBCT) will be an 8-week group program adapted from a protocol developed to treat PTSD to include psychoeducation about chronic pain and mutual maintenance factors through which chronic pain and PTSD facilitate each other. The MBCT group will be delivered by trained professionals in weekly 2-hour sessions through Microsoft Teams. The 8-week program will include 1) mindfulness t...Afficher plus |
Comparateur actifMT group The mindfulness therapy (MT) group will receive only the psychotherapy treatment (8 sessions mindfulness therapy). | Thérapie cognitive basée sur la pleine conscience The Mindfulness-based cognitive therapy (MBCT) will be an 8-week group program adapted from a protocol developed to treat PTSD to include psychoeducation about chronic pain and mutual maintenance factors through which chronic pain and PTSD facilitate each other. The MBCT group will be delivered by trained professionals in weekly 2-hour sessions through Microsoft Teams. The 8-week program will include 1) mindfulness t...Afficher plus |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Health-Related Quality of Life | Measured using the Short-Form-12 Health Survey (SF-12v2) | Enrollment, 1 week pre-treatment, mid-treatment (1month), post-treatment (2months) and follow-up (3months) |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Depressive symptoms | Measured using the Montgomery-Asberg Depression Rating Scale (MADRS) | At enrollment, 1 week pre-treatment, mid-treatment (1 month), post-treatment (2 month), follow-up (3 months) |
Suicide risk | Suicide risk will be measured using the Columbia-Suicide Severity Rating Scale (C-SSRS) | At enrollment, 1 week pre-treatment, mid-treatment (1 month), post-treatment (2 month), follow-up (3 months) |
PTSD symptoms | Measured using the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5). | At enrollment, 1 week pre-treatment, mid-treatment (1 month), post-treatment (2 month), follow-up (3 months) |
Pain Severity | Pain Severity will be measured using the Brief Pain Inventory - Short Form (BPI) | At enrollment, 1 week pre-treatment, mid-treatment (1 month), post-treatment (2 month), follow-up (3 months) |
Pain Interference | Pain Interference will be measured using the Brief Pain Inventory - Short Form (BPI) | At enrollment, 1 week pre-treatment, mid-treatment (1 month), post-treatment (2 month), follow-up (3 months) |
Disability | Measured using the WHO Disability Assessment Schedule (WHODAS 2.0- 12 items) | At enrollment, 1 week pre-treatment, mid-treatment (1 month), post-treatment (2 month), follow-up (3 months) |
Adverse events | Measured using a adverse events form. | From enrollment to 1 month after the end of the 8-week treatment period |
i) A current DSM-5 diagnosis of PTSD (confirmed by the Mini International Neuropsychiatric Interview (66)) ii) Chronic pain (> 4/10 average pain reported for longer than 3 months (per (67)).
iii) 18-65 years of age. iv) Capacity to consent
ii) Meeting DSM-5 criteria for substance abuse disorder within the past month or lifetime history of ketamine abuse.
iii) Concomitant unstable major medical or neurological conditions, or laboratory/imaging results as considered by the study treating physician to interfere with trial participation (e.g. poorly controlled blood pressure, BMI >35).
iv) Pregnancy or the intention to become pregnant and breastfeeding during the study as confirmed by self-report. Participants must be willing to use a medically acceptable method of birth control which include abstinence, hormonal (birth control pills, patch, hormone injections or implants), diaphragm with spermicide or cervical cap, IUD, condom used together with spermicide, surgical sterilization (hysterectomy or partner's vasectomy) and post-menopausal more than 2 years.
v) DSM-5 diagnosis of bipolar disorder, psychotic disorder, or a severe personality disorder which may interfere with the trial. Patients with lifelong diagnosis of Bipolar Disorder, Schizophrenia or Schizoaffective disorder will be excluded. Patients with primary Obsessive Compulsive Disorder, Substance Use Disorder (dependence and abuse), Seasonal Affective Disorder, or Generalized Anxiety Disorder at time of assessment will be excluded. Primary severe borderline personality disorder and any other personality disorders that potentially may interfere with treatment administration will also be excluded.
vi) Deemed to be high suicidal risk during the baseline assessment as per treating physician. Chronic persistent suicidality is not an exclusion.
vii) Use of medications that might interfere with ketamine efficacy such as benzodiazepines with a dose equivalent to lorazepam 2mg/day or higher, and anti-convulsant (except for pregabalin and gabapentin).
viii) Deemed not appropriate to engage in group psychotherapy. ix) Inability to communicate in spoken and written English fluently enough to complete the required study assessments or a non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete clinical assessments).
x) Cognitive or physical impairment severe enough to interfere with IV ketamine administration and the subject's ability to stay in the same place for a 2-hr monitoring supervision.
xi) Inability to secure a responsible adult to accompany them back home after ketamine sessions.
xii) Inability to take part in virtual care, no valid email address. xiii) Inability to safely secure IV access.
Queen's University- Kingston Health Sciences Centre
- Providence Care Hospital, Kingston, ON, Canada