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

Psychotic Disorders Clinical Trial

— ECHION  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06186570
• Other study ID #: ECHION2024
• Status: Recruiting
• Phase: N/A
• Start date: June 13, 2024
• Est. completion date: December 15, 2025

Study information

• Verified date: June 2024
• Source: Charite University, Berlin, Germany
• Contact: Kerem Böge, PD Dr. Dr.
• Phone: (+49)30 - 450 517636
• Email: kerem.boege[@]charite.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Hallucinations
• Mental Disorders
• Psychotic Disorders

Intervention

Behavioral:
• Online-Based Self-Help Intervention
See the description above.

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

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.