Sleep's Influence on the Treatment of Intrusive Emotional (NCT05678361) | Clinical Trial Compass
CompletedNot Applicable
Sleep's Influence on the Treatment of Intrusive Emotional
Switzerland42 participantsStarted 2018-08-01
Plain-language summary
Intrusive memories represent a debilitating core feature of PTSD, one of the most prevalent psychiatric disorders following trauma. Exposure therapy is amongst the most successful treatments of PTSD that is recommended by most of the current national and international guidelines. The current study aims to test whether sleep as adjunct to written exposure sessions, a type of exposure- based treatment for PTSD, may boost the effectiveness of the therapy.
Who can participate
Age range
18 Years – 65 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:
* DSM V criteria of PTSD (at least moderate symptoms in two categories)
* Currently receiving Written Exposure Therapy at one of the psychotherapy centers at the Psychiatric University Clinic (PUC).
* Not more than moderate alcohol consumption (not more than 5 alcoholic drinks/week).
* Ability to understand the study instructions
Exclusion Criteria:
* Travel over \> 3 time zones in \< 3 months
* head injury
* shift work
* current substance abuse
* neurological disease
* drug addiction
* Current suicidality
Specific exclusion criteria for the fMRI:
* Acute psychotic symptoms
* Pregnancy
* Claustrophobia
* Magnetic resonance imaging incompatibility:
* Cardiac pacemaker or other metallic implants (e.g. metallic cardiac valve, insulin pump)
* Metallic foreign particles (e.g. after bullet wound, shell splinter, clips, metal prostheses)
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
Clinician- assessed Posttraumatic stress symptom severity at 1 week
Timeframe: One week post- treatment
2
Self-reported Posttraumatic stress symptom severity at 1 week
Timeframe: One week post- treatment
3
Clinician- assessed Posttraumatic stress symptom severity at 1 month
Timeframe: One month post- treatment
4
Self-reported Posttraumatic stress symptom severity at 1 month