Cognitive-behavioral Therapy for Treatment of Post-traumatic Stress Disorder and Related Problems (NCT03019497) | Clinical Trial Compass
CompletedNot Applicable
Cognitive-behavioral Therapy for Treatment of Post-traumatic Stress Disorder and Related Problems
Canada92 participantsStarted 2017-01
Plain-language summary
The purpose of this study is to evaluate the efficacy of a form of cognitive behavioral therapy (CBT) in a population of individuals with PTSD and common related problems (depression, anxiety or sleep disorders, pain, psychosocial stressors, low social support, substance use disorder). Half of the participants will receive a cognitive behavioral therapy with specific modules for the treatment of related problems (CBT-E) and the other half of participants will receive therapy without specific modules (CBT-C).
The main assumption is that participants treated in the CBT-E condition will present a lower level of symptom intensity of PTSD and a higher remission rate than those in the CBT-C condition during the post-treatment assessment. As a secondary objective, an analysis of the different parameters of effectiveness of the two forms of CBT (e.g., average number of sessions required to reach remission, treatment strategies used) will be performed.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Exposed to a traumatic event at an adult age
* Primary PTSD diagnosis according to the DSM-5 criteria
* At least one PTSD related problem (depressive, anxiety or sleep disorders, pain, psychosocial stressors, inadequate social support, substance use disorder)
* Being fluent in French.
Exclusion Criteria:
* Schizophrenia diagnostic, current or past psychotic episodes, bipolar disorder, organic cerebral disorder or intellectual deficiency
* Presence of a trouble linked to a substance developed prior to the traumatic event
* Physical condition preventing participation in the study (e.g. cerebral trauma)
* Presence of active suicide ideas.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; Weathers et al., 2013)
Timeframe: Baseline, changes from baseline at 1 week post-treatment, 3 months post-treatment, and 6 months post-treatment