Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin
Berlin, State of Berlin, 12203, Germany
NCT Number: NCT06186570
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).
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Berlin, State of Berlin, 12203, Germany
The investigators will identify eligible participants at various outpatient departments, suitable support groups, online platforms, and social media. An eligibility screening (in person or by telephone) to ensure the inclusion criteria and to introduce the study is held by the study assistant. All participants must sign an informed electronic consent after written and verbal study clarification. If persons are eligible for participation, they will be randomized according to a randomization plan by the electronic database RedCap. Due to the psychotherapeutic nature of the study, there will be no blinding. Participants in both study conditions will carry out self-reported measurements (online) at baseline (T0) and after the intervention phase of 6 weeks (T1). With an anticipated n = 25 of persons from the intervention group, there will be additionally conducted semi-structured interviews at T1 that aim to examine specific patterns of auditory hallucinations and satisfaction with the intervention. The final sample of the qualitative research part will be determined according to the principle of saturation (content-related). The data management plan includes standard procedures for data-handling such as using anonymized identification codes for patient data. Besides, the participants have the right to access their data, and the right to claim an annihilation. The data is being saved in an online database, only allowing researchers involved in the study to access the data.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
See the description above.
Time frame: At baseline and post-intervention at week 6 (T1).
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.
Time frame: At baseline (T0) and post-intervention at week 6 (T1).
Revised Beliefs About Voices Questionnaire (BAVQ-R), 35 items on a scale from 0 (disagree) to 3 (agree), including 5 subscales.
Time frame: At baseline (T0) and post-intervention at week 6 (T1).
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).
Time frame: At baseline (T0) and post-intervention at week 6 (T1).
Self-assessment of Negative Symptoms (SNS), 20 items on a scale from 0 (strongly disagree) to 2 (strongly agree).
Time frame: At baseline (T0) and post-intervention at week 6 (T1).
Positive and Negative Affect Schedule (PANAS), 20 items on a scale from 1 (not at all) to 5 (extremely).
Time frame: At baseline (T0) and post-intervention at week 6 (T1).
Thinking Scale (Moritz & Larøi, 2008), with 4 items addressing prevalent characteristics of voices (resemblances between imagined and real voices):
Time frame: At post-intervention at week 6 (T1) and only in the intervention group.
Patient Satisfaction Questionnaire (ZUF-8), 8 items on a 4-point scale.
Charite University, Berlin, Germany
Other
Efficacy of an Online-Based Self-Help Intervention for Auditory Hallucinations in Persons With Psychotic Disorders (ECHION)
Acronym: ECHION
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