Psychotic Disorders Clinical Trial
— ECHIONOfficial title:
Efficacy of an Online-Based Self-Help Intervention for Auditory Hallucinations in Persons With Psychotic Disorders (ECHION)
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).
Status | Recruiting |
Enrollment | 86 |
Est. completion date | December 15, 2025 |
Est. primary completion date | July 15, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Germany | Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin | Berlin |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency and distress of auditory hallucinations, PSYRATS | The frequency and distress of auditory hallucinations measured by the hallucination subscale of the Psychotic Symptom Rating Scales (PSYRATS). Comparison between the intervention and control group, considering changes from baseline to post-intervention. | At baseline and post-intervention at week 6 (T1). | |
Secondary | Beliefs about voices, BAVQ-R | Revised Beliefs About Voices Questionnaire (BAVQ-R), 35 items on a scale from 0 (disagree) to 3 (agree), including 5 subscales. | At baseline (T0) and post-intervention at week 6 (T1). | |
Secondary | Hallucinatory experiences, LSHS-R | Launay-Slade Hallucination Scale (LSHS-R), 12 items on a scale from 0 (certainly does not apply to me) to 4 (certainly applies to me). | At baseline (T0) and post-intervention at week 6 (T1). | |
Secondary | Negative Symptoms, SNS | Self-assessment of Negative Symptoms (SNS), 20 items on a scale from 0 (strongly disagree) to 2 (strongly agree). | At baseline (T0) and post-intervention at week 6 (T1). | |
Secondary | Positive and Negative Affect, PANAS | Positive and Negative Affect Schedule (PANAS), 20 items on a scale from 1 (not at all) to 5 (extremely). | At baseline (T0) and post-intervention at week 6 (T1). | |
Secondary | Characteristics of Voices, Thinking Scale | Thinking Scale (Moritz & Larøi, 2008), with 4 items addressing prevalent characteristics of voices (resemblances between imagined and real voices):
"Loudness", using the following scale: 1 = "The voices are as loud as real voices", 2 = "The voices are louder than real voices", 3 = "The voices are lower than real voices", 4 = "The voices are actually audible". "Ego-Stability", using the following scale: 1 = "The voices reflect my own inner self", 2 = "The voices are saying things I would never think of or feel this way", 3 = "The voices can be influenced just as little as real voices". "Reality", using the following scale: 1 = "The voices are not particularly real", 2 = "The voices are nearly real", 3 = "The voices are absolutely indistinguishable from real voices". "Under which circumstances do the voices occur?", free-text answer. |
At baseline (T0) and post-intervention at week 6 (T1). | |
Secondary | Patient Satisfaction, ZUF-8 | Patient Satisfaction Questionnaire (ZUF-8), 8 items on a 4-point scale. | At post-intervention at week 6 (T1) and only in the intervention group. |
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