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

NCT06186570 | Recruiting

• 1 other identifier: ECHION2024
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Psychotic Disorders

Keywords

psychotic disorders; auditory hallucinations; voices; psychotherapy; self-help

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (6)

• Beliefs about voices, BAVQ-R

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

• Hallucinatory experiences, LSHS-R

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

• Negative Symptoms, SNS

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

• Positive and Negative Affect, PANAS

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

• Characteristics of Voices, Thinking Scale

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

Study Arms (2)

Online-Based Self-Help Intervention

EXPERIMENTAL

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

Waitlist-Control Group

NO INTERVENTION

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.

Interventions

Online-Based Self-Help Intervention BEHAVIORAL

See the description above.

Online-Based Self-Help Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin

Berlin, 12203, Germany

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders; Hallucinations

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kerem Böge, PD Dr. Dr.

CONTACT

(+49)30 - 450 517636; kerem.boege@charite.de

Laura Fässler, M.Sc.

CONTACT

(+49)30 - 450 517549; laura.faessler@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: January 2, 2024
• Study Start: June 13, 2024
• Primary Completion: July 15, 2025
• Study Completion: December 15, 2025
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)