Mental health specialist video consultations for patients with depression or anxiety disorders in primary care: A randomised controlled feasibility trial
- Conditions
- F00-F99Mental and behavioural disorders
- Registration Number
- DRKS00015812
- Lead Sponsor
- niversitätsklinikum Heidelberg Klinik für Allgemeine Innere Medizin und Psychosomatik
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
Inclusion criteria for GP offices and practice teams:
- Primary practice (specialist in general medicine or internal medicine)
- Team that introduces patients in video consultations
- Psychotherapist requires at least intermediate examination and experience amounting to 1200 hours of treatment
- written informed informed consent
Inclusion criteria for patients:
- Clinically significant depressive or anxious symptoms (PHQ-9 / GAD-7)
- currently no or as yet insufficient therapy or difficulty with adherence
- written informed informed consent
- Ability to consent
- completed 18 years of age
Exclusion criteria for GP offices or practice teams:
- Lack of space to protect the video consultations
- lack of internet access or bandwidth limitations (<384 kbps)
Exclusion criteria for patients:
Substance abuse / dependence that limits treatment adherence
- Active suicidal thoughts or active thoughts to do violence to others
- Immediately required other or inpatient acute treatment
- acute psychotic condition pictures
- Dementia and / or severe cognitive impairment
- Significant hearing and / or visual impairment
- Pregnancy in the 2nd or 3rd trimester
- insufficient German language skills
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method o secondary endpoint is defined in the conventional sense. In addition to feasibility, the following endpoints are evaluated:<br>- Mental symptom burden (Patient Health Questionnaire 9, PHQ-9, for Generalized Anxiety Disorder Scale, GAD-7, for anxiety disorders)<br>Recovery (Recovery Assessment Scale, RAS-G)<br>- Quality of life (EQ-5D)<br>- Patient Assessment of Chronic Illness Care (PACIC)<br>- adverse effects (quantitative on the inventory for negative effects of psychotherapy, INEP and qualitative in the process evaluation)<br>- health economic parameters (Questionnaire for the Assessment of Medical and non Medical Resource Utilisation in Mental Disorders, FIMPsy)