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Recruiting NCT06186570

Efficacy of an Online-Based Self-Help Intervention for Auditory Hallucinations in Persons With Psychotic Disorders

Trial Parameters

Condition Psychotic Disorders
Sponsor Charite University, Berlin, Germany
Study Type INTERVENTIONAL
Phase N/A
Enrollment 86
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2024-06-13
Completion 2025-07-15
Interventions
Online-Based Self-Help Intervention

Brief Summary

The proposed clinical trial aims to examine the efficacy of an online-based self-help intervention for auditory hallucinations in persons with psychotic disorders. The intervention is primarily based on Metacognitive Training (MKT) and Mindfulness-Based Group Therapy (MBGT). The investigators will utilize a mixed-method study design within a randomized controlled trial. The intervention group will be compared with a waitlist-control group (WL-TAU). Both study conditions are allowed to continue standard scheduled treatment. The aim is to analyze the efficacy of and the subjective satisfaction with the intervention, based on self-report assessments evaluated from baseline (T0) to post-intervention after 6 weeks (T1).

Eligibility Criteria

Inclusion Criteria: * current experience of auditory hallucinations that appear at least once a week (measured over the PSYRATS). * diagnosis of a schizophrenia-spectrum disorder according to the Diagnostical and Statistical Manual (5th edition) and/or the International Statistical Classification of Diseases and Related Health Problems (ICD-10), code F2x.x. In case of a suspected diagnosis or missing clinical diagnostic, we will apply the Mini-International Neuropsychiatric Interview (M.I.N.I.). * stable psychiatric medication over at least one month, slight changes of dosage are allowed and will be evaluated by a trained psychiatrist. * ability to give informed consent. * willingness and ability to engage in the psychotherapeutic self-help intervention. * availability of a mobile device and internet access. Exclusion Criteria: * neurological disorders that may affect cognitive functioning and condition after severe traumatic brain injury. * acute suicidality, assessed at the previous

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