Transdiagnostic treatment in a face-to-face setting for emotional disorders in Arabic- and Farsi-speaking refugees: a randomized controlled study

Early Phase 1

Recruiting

Conditions: F32
F39
F41.1
F41.0
F40.0
F40.1
F43
F10
F19
F63

Registration Number: DRKS00033041

Lead Sponsor: Medical School Berlin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 130

Inclusion Criteria

Full legal age
-Primary diagnosis of a depressive disorder, post-traumatic stress disorder (PTSD), or an anxiety disorder (generalized anxiety disorder, panic disorder, agoraphobia, social anxiety disorder) according to DSM-5
-Arabic and/or Farsi language proficiency (spoken and written)
-Access to the Internet (smartphone or computer)
-Consent to the informed consent agreement

Exclusion Criteria

-Current psychotic or bipolar disorder
-Severe substance use disorder (AUDIT Score >15 for men, >13 for women; DUDIT Score >25)
-Acute suicidality (lack of or unclear distancing; no capacity for agreement)
-Suicide attempt in the last 12 months
-Ongoing psychotherapy or unstable medication with psychotropic drugs three months prior the start of the study

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the change in psychological distress, assessed using the total score of the HSCL-25 self-report version (from pre- to post-treatment).

Secondary Outcome Measures

Name	Time	Method
As secondary outcomes, depression will be assessed using the HSCL-25-Depression subscale, anxiety using the HSCL-25-Anxiety subscale, and post-traumatic symptoms using the PCL-5. Suicidality will be assessed through suicide screening during the diagnostic interviews over the phone. To evaluate alcohol consumption, the AUDIT will be employed and for drug consumption, the DUDIT will be used. The EQ-5D-5L will be utilized to measure quality of life and simultaneous somatic symptom burden. Treatment satisfaction will be assessed with the CSQ-I. Potential side effects will be recorded using the NEQ.