Online self-help for auditory hallucinations in psychotic disorders
Efficacy of an Online-Based Self-Help Intervention for Auditory Hallucinations in Persons With Psychotic Disorders (ECHION)
NA · Charite University, Berlin, Germany · NCT06186570
This study tests whether an online self-help program that combines mindfulness and metacognitive training can help people with psychotic disorders who hear voices feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany (other) |
| Locations | 1 site (Berlin) |
| Trial ID | NCT06186570 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of an online-based self-help intervention designed for individuals experiencing auditory hallucinations associated with psychotic disorders. The intervention combines Metacognitive Training and Mindfulness-Based Group Therapy, and participants will be randomly assigned to either the intervention group or a waitlist-control group while continuing their standard treatment. The study will assess the efficacy and participant satisfaction through self-reported measures collected before and after the 6-week intervention period, along with qualitative interviews to explore individual experiences with the intervention.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with schizophrenia-spectrum disorders who experience auditory hallucinations at least once a week and have stable psychiatric medication.
Not a fit: Patients with neurological disorders affecting cognitive function or those experiencing acute suicidality may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could provide a novel, accessible therapeutic option for individuals struggling with auditory hallucinations.
How similar studies have performed: Other studies have shown promise in using online interventions for mental health conditions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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 screening procedures. * auditory hallucinations in the context of other primary diagnoses e.g., post-traumatic stress disorder or borderline personality disorder. * acute substance abuse other than nicotine and prescribed medication. * current electroconvulsive therapy. * current inpatient or day-care treatment.
Where this trial is running
Berlin
- Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin — Berlin, Germany (RECRUITING)
Study contacts
- Study coordinator: Kerem Böge, PD Dr. Dr.
- Email: kerem.boege@charite.de
- Phone: (+49)30 - 450 517636
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Psychotic Disorders, psychotic disorders, auditory hallucinations, voices, psychotherapy, self-help