F00-F99
Conditions
Interventions
Group 1: The intervention group will receive either two or five video consultations with psychotherapists depending on their level of symptoms. The consultations will be carried out via the web portal
Sponsors
Universitätsklinikum Heidelberg Klinik für Allgemeine Innere Medizin und Psychosomatik
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion criteria for the general practices or treatment teams in these practices: - general practioners' activity of the practice (specialist in general medicine or internal medicine) - completed 18th year of life - team that introduces patients to videoconsultations - study therapist at least after intermediate examination and with experience amounting to 1200 treatment hours - written Informed Consent/Informed Consent Form. Inclusion criteria for patients: - somatic symptom disorder (determined via combined use of Somatic Symptom Disorder-B Criteria Scale (SSD-12) and Somatic Symptom Scale-8 (SSS-8) threshold scores) - currently no therapy, insufficient therapy or difficulties with adherence - Informed Consent documented in writing. - ability to give consent - completed 18th year of life
Exclusion criteria
Exclusion criteria: Exclusion criteria for general practices practices or treatment teams in practices: - No available room to conduct video consultations in a protected environment - No access to internet or insufficient bandwidth (< 384 KBit/s). Patient exclusion criteria: - active suicidal ideation or active thoughts of inflicting violence onto others - Immediate need for other acute inpatient or rehabilitation treatment (e.g. immediate diagnostic clarification of severe physical illnesses) - acute psychosis (as measured by Module B of the SCID-5) - dementia and/or severe cognitive impairment - significant hearing and/or visual impairment - pregnancy in the 2nd or 3rd trimester - insufficient German language skills
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study evaluates the feasibility of the following aspects: sufficiency and efficiency of recruitment strategies for intervention and control group, recruitment and attrition rates for intervention and control group, patient and provider acceptance of outcome measurements, feasibility of study procedures (e.g. patient and provider acceptance of randomisation and outcome measurements), feasibility of intervention procedures (including the necessary documentation, implementation loyalty, patient acceptance of video consultations, patient safety). | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary endpoint is defined in the conventional sense. In addition to feasibility, the following endpoints are evaluated: - Mental symptom burden (Somatic Symptom Disorder–B Criteria Scale (SSD-12) and Somatic Symptom Scale-8 (SSS-8) for Somatic Symptom Disorder, Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) for Depression and for anxiety disorders) Recovery (Recovery Assessment Scale, RAS-G) - Quality of life (SF-12) - patient satisfaction (EUROPEP) - adverse effects (quantitative on the inventory for negative effects of psychotherapy, INEP and qualitative in the process evaluation) - health economic parameters (Questionnaire for the Assessment of Medical and non Medical Resource Utilisation in Mental Disorders, FIMPsy) | — |
Countries
Germany
Contacts
Public ContactMarkus Haun
Universitätsklinikum Heidelberg
Outcome results
None listed