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Mental health specialist video consultations for patients with depression or anxiety disorders in primary care: A randomised controlled feasibility trial

Mental health specialist video consultations for patients with depression or anxiety disorders in primary care: A randomised controlled feasibility trial - PROVIDE-B

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00015812
Enrollment
50
Registered
2019-02-22
Start date
2019-03-06
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F00-F99

Interventions

Group 1: The intervention group will receive up to five video consultations with psychotherapists directly in the GP's practice. The consultations will be carried out via the web portal of a certifie

Sponsors

Universitätsklinikum Heidelberg Klinik für Allgemeine Innere Medizin und Psychosomatik
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime 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

MeasureTime frame
No secondary endpoint is defined in the conventional sense. In addition to feasibility, the following endpoints are evaluated: - Mental symptom burden (Patient Health Questionnaire 9, PHQ-9, for Generalized Anxiety Disorder Scale, GAD-7, for anxiety disorders) Recovery (Recovery Assessment Scale, RAS-G) - Quality of life (EQ-5D) - Patient Assessment of Chronic Illness Care (PACIC) - 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 ContactJustus Tönnies

Universitätsklinikum Heidelberg

justus.toennies@med.uni-heidelberg.de06221 56 32781

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 2, 2026