F32 F41 F45
Conditions
Interventions
Group 1: Intervention group: Transdiagnostic intervention (adapted from the Unified Protocol) for the treatment of mental health problems, delivered by general practitioners
- 4 sessions of 20 minutes
session 2: concept of cognitive flexibility
session 3: concept of emotion-based behaviour
session 4: summary and outlook
Group 2: Active control group: Improved treatment as usual according to the official German guidelines for the treatment of a depression, anxiety or somatoform disorder
Sponsors
LMU Institut für Allgemeinmedizin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Fluency in the German language (2) Psychological distress, assessed by the general practitioner (3) Digital informed consent
Exclusion criteria
Exclusion criteria: (1) Life expectancy = 12 months (2) Known substance abuse (3) Increased risk of suicidality (4) Pronounced cognitive impairment (5) Serious mental disorder (6) Psychotherapy at the start of the study (7) Change in psychotropic medication 6 weeks before the start of the study (8) Lack of opportunity to visit the GP's practice in person
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| What? Feasibility and acceptability of the newly developed transdiagnostic treatment approach When? For patients: After individual treatment completion (t1 = at the latest 12 weeks from baseline t0) For GPs: After completion of all treatments (t2) How? Administration of questionnaires (developed specifically for the study); one questionnaire for patients and one for GPs; the degree of agreement will be monitored on a 4-point Likert scale (“strongly disagree” – “strongly agree”) regarding statements related to treatment recruitment, delivery, response, effectiveness, unintended consequences and maintenance, as well as on two 3-point Likert scales concerning treatment duration (“too short”, “adequate duration”, “too long”) and the number/amount of sessions (“too few”, “adequate number”, “too many”); treatment fidelity will be measured on a percentage scale (0%: “no adherence” – 100%: “full adherence”); the overall satisfaction with the treatment will be assessed with school grades (1: very good – 6: very bad) | — |
Secondary
| Measure | Time frame |
|---|---|
| What? Assessment of the potential effectiveness of the transdiagnostic intervention compared to improved treatment as usual using diagnosis-specific and transdiagnostic questionnaires When? Only patients: Before treatment start (t0) and after treatment completion (t1) How? (1) Diagnosis-specific questionnaires: Patient Health Questionnaire-9 (PHQ-9); Generalised Anxiety Disorder-7 (GAD-7); Patient Health Questionnaire-15 (PHQ-15); Primary Care Post Traumatic Stress Disorder-5 (PC-PTSD-5; only at t0) (1) Transdiagnostic questionnaires: Emotion Beliefs Questionnaire (EBQ); Emotion Regulation Questionnaire (ERQ); Brief Experiential Avoidance Questionnaire (BEAQ); Modified Personality Inventory for DSM 5 (PID-5-BF+M) (only negative affectivity); Kessler Psychological Distress Scale-6 (K-6; only at t0) | — |
Countries
Germany
Contacts
Public ContactKirsten Lochbühler
LMU Institut für Allgemeinmedizin
Outcome results
None listed