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Psychotic DisordersECHIONNCT06186570

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

A study testing Online-Based Self-Help Intervention in people with Psychotic Disorders, run by Charite University, Berlin, Germany at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Psychotic Disorders
What is being tested?
Online-Based Self-Help Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
1 siteGermany
Study dates
13 Jun 2024to 26 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin

    Berlin, State of Berlin, 12203

Other trials in Germany

About this study

Official 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).

Read the detailed 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.

Being tested
Online-Based Self-Help Intervention
Keywords
psychotic disorders, auditory hallucinations, voices, psychotherapy, self-help
Medical subject headings
Psychotic Disorders, Hallucinations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online-Based Self-Help InterventionBehavioural

    See the description above.

Study groups in NCT06186570
Study groupRoleWhat they receive
Online-Based Self-Help InterventionExperimentalThe online-based self-help intervention is implemented as a six-week self-help intervention that is primarily based on Metacognitive Training (MKT), Mindfulness-Based Group Therapy (MBGT), and elements of cognitive behavioural therapy. It is conducted online and includes worksheets, audio, and interactive files. Participants work themselves through the intervention, based on their own needs and speed. All participants are allowed to continue parallel implemented standard scheduled treatment (TAU; for a description of TAU, see the section below).
Receives: Behavioral: Online-Based Self-Help Intervention
Waitlist-Control GroupNo interventionThe waitlist control group will not receive any additional intervention but is allowed to continue standard scheduled treatment (WL-TAU). This includes various forms of psychotherapeutic, pharmacologic, psychosocial, online, and other self-help interventions, either carried out individually or within a group. After study completion, participants in the waitlist-control group will equally receive the online-based self-help intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At baseline and post-intervention at week 6 (T1).

Secondary outcomes (6)

  1. 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.

    Measured: At baseline (T0) and post-intervention at week 6 (T1).

  2. 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).

    Measured: At baseline (T0) and post-intervention at week 6 (T1).

  3. Negative Symptoms, SNS

    Self-assessment of Negative Symptoms (SNS), 20 items on a scale from 0 (strongly disagree) to 2 (strongly agree).

    Measured: At baseline (T0) and post-intervention at week 6 (T1).

  4. Positive and Negative Affect, PANAS

    Positive and Negative Affect Schedule (PANAS), 20 items on a scale from 1 (not at all) to 5 (extremely).

    Measured: At baseline (T0) and post-intervention at week 6 (T1).

  5. Characteristics of Voices, Thinking Scale

    Thinking Scale (Moritz \& Larøi, 2008), with 4 items addressing prevalent characteristics of voices (resemblances between imagined and real voices):

    1. "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".
    2. "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".
    3. "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".
    4. "Under which circumstances do the voices occur?", free-text answer.

    Measured: At baseline (T0) and post-intervention at week 6 (T1).

  6. Patient Satisfaction, ZUF-8

    Patient Satisfaction Questionnaire (ZUF-8), 8 items on a 4-point scale.

    Measured: At post-intervention at week 6 (T1) and only in the intervention group.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2024
  2. Study start13 Jun 2024
  3. Primary completion26 Apr 2026
  4. Study completion26 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A randomized controlled trial with a parallel group design is used. The intervention group will receive the online-based self-help intervention immediately after the baseline assessment (T0), while the waitlist-control group will receive the online-based self-help intervention after study completion at T1. Both study conditions are allowed to continue standard scheduled treatment.
Masking
None (open label)
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06186570
Sponsor's protocol ID
ECHION2024
Acronym
ECHION
Status last verified
Jun 2026
First submitted
5 Dec 2023
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Online-Based Self-Help Intervention in people with Psychotic Disorders, run by Charite University, Berlin, Germany at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency and distress of auditory hallucinations, PSYRATS (time frame: At baseline and post-intervention at week 6 (T1).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06186570.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026; AzTrials last refreshed its copy on 1 Nov 2026.

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