Efficacy of an Online-Based Self-Help Intervention for Auditory Hallucinations in Persons With Ps… (NCT06186570) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of an Online-Based Self-Help Intervention for Auditory Hallucinations in Persons With Psychotic Disorders
Germany86 participantsStarted 2024-06-13
Plain-language 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).
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency and distress of auditory hallucinations, PSYRATS
Timeframe: At baseline and post-intervention at week 6 (T1).