F43.1
Conditions
Interventions
Group 1: Intervention group: 4-week application of a robotic intervention with simulation of human breathing.
Group 2: Control group: 4-week application of robotic intervention without simulation of h
Sponsors
MSH Medical School Hamburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Eligibility rate (proportion of included participants out of all screened individuals); Recruitment speed (number of participants recruited in 6 months); Uptake (proportion of participants who started the robot intervention out of those randomized in the intervention arm); Retention (proportion of participants in the intervention arm received at least 10 robot sessions); Treatment adherence (proportion of days the robot was used, daily duration of robot use in minutes); Dropout rate (rate of participants that were randomized but terminated study before completion of T1; Satisfaction with the intervention: Client Satisfaction Questionnaire (CSQ-8) Efficacy outcomes: Efficacy outcomes will be measured as between-group change from T0 to T1: Sleep quality (Pittsburgh Sleep Quality Index, PSQI); severity of PTSD symptoms (Posttraumatic Stress Scale-Interview, PSSI-5), stress symptoms by using the Perceived Stress Scale-10 (PSS-10), and well-being by using the World Health Organization Well-Being Index (WHO-5) all assessed at t0 and t1. Participant experiences: Qualitative interview at T1. Participants’ views on the feasibility, acceptability and efficacy of the intervention and trial design. | — |
Countries
Germany
Contacts
Public ContactIsabelle Laskowsky
MSH Medical School Hamburg
Outcome results
None listed