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Evaluation of the effectiveness of the reconsolidation therapy in a clinical population suffering from post-traumatic stress disorder
EU CTIS ID: 2022-500870-32-02
What this study is testing
To verify the effectiveness of reconsolidation therapy in patients with a chronic and severe form of PTSD requiring hospital care. This verification will be carried out by comparing reconsolidation therapy to prolonged exposure therapy (Foa et al., 2000), recommended by the guidelines (APA, 2017; NICE, 2018) and the therapy "usually" offered within of the psychiatric care unit. To check if propranolol has an action of facilitator of extinction of the fear conditioning by including in the methodology a therapeutic group where patients would benefit prolonged exposure therapy plus propranolol intake to be compared with a therapeutic group where patients would benefit prolonged exposure therapy (without propranolol).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Aged 18 to 65
- Hospitalized in a psychiatric care unit
- French mother tongue
- Diagnosed with a state of post-traumatic stress marked by one or more traumas. Patients with PTSD who present with behavioral disorders characterized by difficulty regulating emotions, impulsivity, interpersonal difficulties, feelings of chronic emptiness and abandonment as well as dissociative symptoms are also included in the protocol of research.
- Women of childbearing potential must be on hormonal contraception or a non-hormonal intrauterine device. Contraception must be maintained throughout the clinical sessions. Inclusion will be after a negative high sensitivity pregnancy test.
You likely can't join if
- Participants with unstabilized bipolar disorder and/or unstabilized substance dependance and/or with psychiatric disorders like schizophrenia.
- All contraindications mentioned in section 4.3 of the SmPC.
- Patients with neurological disorders or cognitive deficits measured by an M.M.S.E. score of less than 27 were not included in the study.
- Pregnant or lactating women
- Asthma, heart problems, diabetes
- Basal systolic blood pressure < 100mm Hg
See the full eligibility criteria
- Aged 18 to 65
- Hospitalized in a psychiatric care unit
- French mother tongue
- Diagnosed with a state of post-traumatic stress marked by one or more traumas. Patients with PTSD who present with behavioral disorders characterized by difficulty regulating emotions, impulsivity, interpersonal difficulties, feelings of chronic emptiness and abandonment as well as dissociative symptoms are also included in the protocol of research.
- Women of childbearing potential must be on hormonal contraception or a non-hormonal intrauterine device. Contraception must be maintained throughout the clinical sessions. Inclusion will be after a negative high sensitivity pregnancy test.
- Participants with unstabilized bipolar disorder and/or unstabilized substance dependance and/or with psychiatric disorders like schizophrenia.
- All contraindications mentioned in section 4.3 of the SmPC.
- Patients with neurological disorders or cognitive deficits measured by an M.M.S.E. score of less than 27 were not included in the study.
- Pregnant or lactating women
- Asthma, heart problems, diabetes
- Basal systolic blood pressure < 100mm Hg
- Basal heart rate <55 beats per minute
- Previous adverse reaction to a beta-blocker or use of another beta-blocker
- Participants are also evaluated by a psychiatrist to rule out any dangerous interaction between taking psychotropic drugs and propranolol.
- Participants meet with a general physician in order to carry out medical check-up and to exclude any risk to taking propranolol
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.