Evaluation of a transdiagnostic intervention in primary care: a pilot study

Not Applicable

Recruiting

Conditions: F32
F45
F41
Depressive episode
Other anxiety disorders
Somatoform disorders

Registration Number: DRKS00033386

Lead Sponsor: MU Institut für Allgemeinmedizin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

(1) Fluency in the German language
(2) Psychological distress, assessed by the general practitioner
(3) Digital informed consent

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
What?<br>Feasibility and acceptability of the newly developed transdiagnostic treatment approach<br><br>When?<br>For patients: After individual treatment completion (t1 = at the latest 12 weeks from baseline t0)<br>For GPs: After completion of all treatments (t2)<br> <br>How?<br>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”) and two 3-point Likert scales (too short”, adequate duration”, too long”; too few”, adequate number”, too many”, respectively) regarding statements on treatment condition related recruitment, delivery, response, effectiveness, unintended consequences and maintenance; treatment fidelity will be measured on a percentage scale (0%: no adherence” – 100%: full adher-ence”); the overall satisfaction with the treatment will be assessed with school grades (1: very good – 6: very bad)

Secondary Outcome Measures

Name	Time	Method
What? <br>Assessment of the potential effectiveness of the transdiagnostic intervention compared to improved treatment as usual using diagnosis-specific and transdiagnostic questionnaires <br><br>When?<br>Only patients: Before treatment start (t0) and after treatment completion (t1)<br><br>How?<br>(1) Diagnosis-specific questionnaires:<br>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<br><br>(1) Transdiagnostic questionnaires:<br>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)