F43.1
Conditions
Interventions
Group 1: PRIMA-Plus is a pilot study testing a short version of narrative exposure therapy adapted for general practice (GP) for patients with symptoms of post-traumatic stress disorder (PTSD) followi
Sponsors
Institut für Allgemeinmedizin der LMU München
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Traumatic birth experience in the 12 months prior to the start of the study • Live birth in a hospital with an existing birth record • PTSD-like symptoms with a Posttraumatic Diagnostic Scale for DSM-5 total score =15 and <70 points • Ability to comply with study procedures • Sufficient knowledge of the German language • Written consent
Exclusion criteria
Exclusion criteria: • Psychiatric and psychotherapeutic care during the last 12 months, existing or planned participation in trauma-focused psychotherapy at the start of the study • Severe symptoms of PTSD (PDS-5 > 70) • Acute suicidality • Taking high-dose antidepressant/antipsychotic/ anticholinergic medication • Inability to give informed consent • Severe physical or psychiatric illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility assessment using the RE-AIM framework • Reach: Target group vs. participating patients, profile of participating doctors, survey of demographic data of participating patients and data from doctors • Effectiveness: Changes in secondary endpoints (see below) • Adoption: Reasons for or against participation (survey using qualitative questionnaire after the end of the study, survey of both patients and doctors) • Implementation: Implementation of planned steps of the intervention, duration of each session, time-benefit ratio (survey using a qualitative questionnaire after the end of the study, both among patients and doctors; in addition, questionnaire for patients after each therapy session, asking about the duration of the session and whether all elements were included) • Maintenance: question about maintenance of the intervention (survey using a qualitative questionnaire after the end of the study among doctors) | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptom questionnaires before the start of the study (baseline, time point T0) and post-intervention (time point T1) • Posttraumatic Diagnostic Scale for DSM-5, PDS-5 (post-traumatic stress disorder, PTSD) • City Birth Trauma Scale, City BiTS (post-traumatic stress disorder after childbirth) • Patient Health Questionnaire-9, PHQ-9 (depression) • Overall Anxiety Severity and Impairment Scale, OASIS (anxiety) • Postpartum Bonding Questionnaire, PBQ (mother-child bonding) • Patient Health Questionnaire-15, PHQ-15 (somatisation) | — |
Countries
Germany
Contacts
Public ContactSophie Schneider
Institut für Allgemeinmedizin der LMU München
Outcome results
None listed