Feasibility of a breath robot intervention to reduce sleep problems and hyperarousal in posttraumatic stress disorder
- Conditions
- F43.1Post-traumatic stress disorder
- Registration Number
- DRKS00031063
- Lead Sponsor
- MSH Medical School Hamburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 30
Diagnosis of at least subsyndromal PTSD (i.e., trauma exposure as defined by criterion A of the DSM-5 PTSD diagnosis AND PSSI-5 total score greater than 22 AND at least one intrusion symptom AND at least one arousal and reactivity symptom (PSSI-5);
Impaired sleep quality (Pittsburgh Sleep Quality Index; PSQI > 5)
Previously diagnosed organic sleep disorder (e.g., sleep apnoea, narcolepsy, restless legs syndrome);
Participation in psychotherapeutic treatment during the study period, except for the initial psychological consultations or probationary sessions to plan psychotherapeutic treatment.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome will be the feasibility to collect outcome data, i.e., the proportion of enrolled participants providing outcome data at post-treatment (T1). A proportion of >50% was considered as feasible.
- Secondary Outcome Measures
Name Time Method