Metacognitive Training in Depression (D-MKT) for the Target Group of Asylum Seekers (Refugees): Feasibility Study (Proof of Concept)

Not Applicable

Recruiting

• Conditions: F32; F33; Depressive episode; Recurrent depressive disorder

• Registration Number: DRKS00017754
• Lead Sponsor: Asklepios Klinik Nord-Ochsenzoll

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Written consent to participate in the study, ages 18-65 years, criteria for depressive disorder (major depression, dysthymia, recurrent depressive disorder) according to clinical judgement and PHQ 9, language skills in German, Arabic or Farsi / Dari. The patients have applied for asylum within the last 5 years. A parallel psychopharmacological therapy is possible, is documented on the course of studies and controlled for possible effects on the outcome parameters.

Exclusion Criteria

Presence of bipolar disorder, acute psychotic symptoms, current substance dependence, dementia or acute suicidality (SBQ-R = 7), age under 18 years or over 65 years. Patients who have not applied for asylum.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validation of the diagnoses is performed with the help of the clinical assessment and the assigned diagnosis(s) of the main practitioner (t0). The change of the depressive symptoms (primary outcome) to t0, t1 and t2 (3-month follow-up) will then be determined by means of the PHQ-9 in the respective language version. The 9-item Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer & Williams, 2001) is freely available in more than 30 languages and has been recommended by the DSM-5 Working Group of the American Psychiatric Association as a tool for measuring the severity of major depression according to the new DSM-5 criteria. The positive results from psychometric studies on the cultural equivalence of PHQ-9 in different ethnic groups suggest good cultural equivalence (Glaesmer, Brähler & von Lersner, 2012). The results are compared with a waiting control group of n = 20 Arabic or Farsi/Dari speaking patients who are also asked about t0, t1 and t2.