Somatoform and functional disorders
Conditions
Interventions
Phase I:
1. The intervention involves the establishment of a health network (Sofu-Net) of PCPs, psychotherapists, inpatient clinics and an outpatient clinic, offering special consultations for patient
Sponsors
Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung) (BMBF) (Germany)
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: Phase I and Phase II: Inclusion criteria for screening questionnaire: 1. Patients aged 18 years and above 2. Patients that attend one of the PCP practices that collaborate with Sofu-Net 3. Patients that give oral informed consent for screening Inclusion criteria for further assessment: 4. Patients that screen positive on the initial screening questionnaire for somatoform and functional disorders, i.e. patients with severe somatic symptoms (Patient Health Questionnaire-15; PHQ-15 sum score of = 15 points) or with moderate somatoform/ functional symptoms (PHQ-15 sum score of 10-15 points) in combination with moderate symptoms of anxiety (Generalized Anxiety Disorder Scale-7; GAD-7 sum score of = 10 points) and/or moderate symptoms of depression (Patient Health Questionnaire-9; PHQ-9 sum score of = 10 points)
Exclusion criteria
Exclusion criteria: Phase I and Phase II: Exclusion criteria for screening questionnaire: 1. Patients under the age of 18 years 2. Patients with insufficient language skills Exclusion criteria for further assessment: 3. Patients with severe physical impairments or severe psychological disorders that impede study participation 4. Patients with cognitive impairments 5. Patients with acute suicidal ideation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: At this stage of network implementation a hierarchy of primary and secondary outcomes is not defined. The following measures are considered equally important in order to evaluate the network: 1. Outcomes related to diagnostic processes: 1.1. The number of patients who are discussing psychological distress with their PCP?s 1.2. The percentage of correct detection of somatoform and functional disorders by PCP?s 2. Outcomes related to treatment recommendations: 2.1. The percentage of patients who are referred to a psychotherapist 3. Outcomes related to health care utilization 3.1. The amount of appointments with PCP?s and with specialized psychiatric and psychological services 3.2. Attempts to initiate psychotherapy Phase II: The effectiveness of Sofu-Net will be assessed with the following outcome measures: 1. Outcomes related to adequate treatment and symptom change: 1.1. The percentage of patients attending a Sofu-Net PCP practice who have commenced with appropriate treatment (i.e. psychotherapy) since implementation of Sofu-Net/since the initial screening 6 months post recruitment, when compared to the number of patients attending a regular PCP practice who have commenced with appropriate treatment at these points in time 1.2. Severity of somatic symptoms (PHQ-15) 2. Outcomes related to health care utilization: 2.1. The amount of health care utilization and costs (e.g., outpatient appointments, emergency appointments, inpatient appointments) in patients attending a Sofu-Net PCP practice when compared to health care utilization and costs in patients attending a regular PCP practice | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I: See comment above: Primary outcome measures - Phase I Phase II: In addition to the primary outcomes, patients in the Sofu-Net PCP practices will be compared to patients in regular PCP practices with regards to their outcomes on the measures below: 1. The amount of sickness-leave and self-reported inability to work (measured in days) 2. Health anxiety (Whiteley Index-7; WI-7) 3. Depression (PHQ-9) 4. Anxiety (GAD-7) 5. Health related quality of life/Health status (European Quality of Life-5 Dimensions; EQ-5D) 6. Patient satisfaction with treatment 7. Comorbidity of somatoform and functional symptoms and other psychopathological symptoms as assessed with the PCP checklist | — |
Countries
Germany
Outcome results
None listed