None listed
Conditions
Brief summary
We aim to determine if a 6-session course of reconsolidation blockade (i.e., oral propranolol treatment combined with script-driven trauma recall) is efficacious in reducing PTSD symptom frequency and severity in adults 18years +. We will also examine the psychosocial, neurocognitive, neurobiological, neuroimaging and physiological effects of reconsolidation blockade treatment in adult participants with PTSD. Our research questions include: 1. Primary question: Will a 6-session reconsolidation blockade treatment be efficacious in reducing core PTSD symptoms frequency and severity? 2. Secondary question: Are there psycho-social, cognitive, and biological markers (genetic, circulating, and neural) that can predict treatment response to reconsolidation blockade treatment?
Interventions
6-session course of reconsolidation blockade (i.e., oral propranolol treatment combined with script-driven trauma recall)
Once all eligibility criteria has been established, participants will be enrolled into the study, and provided with a participant ID number and card. Participants will be advised that they will be placed on a 4-week waitlist before starting the intervention phase to allow for participants to be their own control (i.e., within subjects control condition). If participants wait
6-session course of reconsolidation blockade (i.e., oral propranolol treatment combined with script-driven trauma recall) Once all eligibility criteria has been established, participants will be enrolled into the study, and provided with a participant ID number and card. Participants will be advised that they will be placed on a 4-week waitlist before starting the intervention phase to allow for participants to be their own control (i.e., within subjects control condition). If participants wait for 4 weeks before starting the intervention, their PTSD symptoms measured during the waitlist period reflect the "no-treatment" state. After completing the treatment, any improvements beyond what occurred during the waitlist period can be attributed more confidently to the intervention. Drug Trial Low-dose oral tablet propranolol (Inderal®) treatment (40mg) administered once per week, for 6 weeks, approximately 90 minutes before each session. Session 1 will take approximately 50 minutes and be delivered by a trained mental health clinician (i.e., psychologist/mental health social worker). Session 1 involves orienting the participant to the reconsolidation blockage processes and what to expect over the next 6 weeks of treatment. Participants will have been advised to take their first dose of propranolol on arrival, and the study General Practitioner will be onsite should any adverse events occur. The participant and practitioner will work together to identify the core trauma memory for the intervention and the participant will be invited to complete a script driven recall of the event. Once completed, the participant will be advised of their scheduled appointments and reminded of any key information to complete before their next session (i.e., when to take the dose of propranolol). If no adverse effects were observed or reported, the participant can leave the premises. Sessions 2-6 will last approximately 25 minutes and involve a script recall exercise to activate the specific trauma memory targeted for that session. All participants attendances/non-attendances will be captured using a session attendance checklist.
Sponsors
Dr Alain Brunet - University of the Sunshine Coast
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria: - Persons aged 18 years + - Participants must be able to understand Research Project Information Sheet (RPIS) and provide written informed consent on the Participant Informed Consent Form (PICF) (including both adequate intellectual capacity and fluency in English language) - Diagnosis of PTSD - Participants must undertake psychological, cognitive, and biological assessments, tolerate propranolol and not be taking any drugs that could contraindicate propranolol. - Participants must have a current treating team who is managing their mental health diagnosis - Persons of child-bearing potential must agree to use a *highly effective method of contraception Highly effective methods of contraception are listed below: - Hormonal methods of contraception including oral contraceptives containing combined estrogen and progesterone, a vaginal ring, injectable and implantable hormonal contraceptives, intrauterine hormone-releasing system (e.g. Mirena) and progestogen-only hormonal contraception associated with inhibition of ovulation o Nonhormonal intrauterine device (IUD) - Bilateral tubal occlusion - Vasectomised participant/partner with documented azoospermia 90 days after procedure, if that partner is the sole sexual partner. - Abstinence from heterosexual intercourse: when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, postovulation methods) and withdrawal are not acceptable methods of contraception. Persons in the following categories are not considered persons of childbearing potential - Person without a uterus - Premenarchal - Premenopausal with permanent infertility due to 1 of the following: - Documented hysterectomy - Documented bilateral salpingectomy - Documented bilateral oophorectomy - Postmenopausal - A postmenopausal state is defined as no menses for 12 months without an alternative medical cause
Exclusion criteria
Exclusion criteria: - Complex PTSD - Significant psychiatric condition: psychosis, bipolar disorder, personality disorder, substance use disorder - Any contraindication to propranolol as determined by the study physician - Development of serious, adverse, or unexpected events/reactions during the trial - Previous allergy or reaction to propranolol, or other beta-adrenergic blocking agent - Participation in any other clinical study at the time of enrolment, or having received any investigation product within 30 days of the day of enrolment onto the study - Currently pregnant, breastfeeding or intending to become pregnant during the course of the study. - Any other condition that, in the opinion of the investigator, may adversely impact the safety of the participant or the accuracy of the study data
Outcome results
None listed