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

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).

Study Overview

• Status: Recruiting
• Conditions: Psychotic Disorders
• Intervention / Treatment: Behavioral: Online-Based Self-Help Intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 86
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kerem Böge, PD Dr. Dr.; Phone Number: (+49)30 - 450 517636; Email: kerem.boege@charite.de
• Study Contact Backup: Name: Laura Fässler, M.Sc.; Phone Number: (+49)30 - 450 517549; Email: laura.faessler@charite.de

Study Locations

• Germany
  • Berlin, Germany, 12203
    • Recruiting
    • Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin
    • Contact: Kerem Böge, Dr. Dr.; Phone Number: 49 30 450 517 789; Email: Kerem.boege@charite.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Online-Based Self-Help Intervention; The 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).	Behavioral: Online-Based Self-Help Intervention; See the description above.
No Intervention: Waitlist-Control Group; The 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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).
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).
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).
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).
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Suicidal Intentions, SBQ-R	Revised Suicide Behaviours Questionnaire (SBQ-R) to examine potential suicidal intentions (see exclusion criteria), 4 items on different scales (higher scores indicate worse outcomes.): "Have you ever thought about or tried to take your own life?", on a scale from 1 = "never" to 6 = " I tried to kill myself and I really wanted to die".; "How often have you thought about killing yourself in the last 12 months?", on a scale from 1 = "Never" to 5 = "Often (5 times or more often)".; "Have you ever told anyone that you are going to kill yourself or that you might want to take your own life?", on a scale from 1 = "No" to 5 = "Yes, more than one time and I really wanted to kill myself".; "How likely is it that you will take your own life one day?", on a scale from 1 = "Never" to 7 = "Very likely".	At baseline (T0).

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: Elsa-Neumann scholarship of the federal state of Berlin, Doctoral funding.; Charité - University Medicine Berlin, Medical scientist program.

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2024
• Primary Completion (Estimated): July 15, 2025
• Study Completion (Estimated): December 15, 2025

Study Registration Dates

• First Submitted: December 5, 2023
• First Submitted That Met QC Criteria: December 29, 2023
• First Posted (Actual): January 2, 2024

Study Record Updates

• Last Update Posted (Actual): June 14, 2024
• Last Update Submitted That Met QC Criteria: June 13, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: psychotherapy; auditory hallucinations; self-help; psychotic disorders; voices
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Schizophrenia Spectrum and Other Psychotic Disorders; Perceptual Disorders; Psychotic Disorders; Mental Disorders; Hallucinations
• Other Study ID Numbers: ECHION2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No