RecruitingNAINTERVENTIONAL

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

This research study is looking at how effective an online self-help program is for people who experience auditory hallucinations (hearing voices) as part of a psychotic disorder. The program combines two approaches: Metacognitive Training (MKT), which helps people think differently about their thoughts, and Mindfulness-Based Group Therapy (MBGT), which focuses on being present. Participants will use this online program for six weeks, and researchers will compare their progress to a group that doesn't immediately receive the program. The aim is to see if this online tool helps reduce the impact of hearing voices and if people find it helpful. You can continue your usual treatments during this study.

At a glance

Status

Recruiting

Phase

Sponsor

Charite University, Berlin, Germany

Enrolment target

Start

13 Jun 2024

Estimated completion

15 Dec 2025

Psychotic Disorders

What is this study about?

Imagine you're hearing voices that others can't. This can be a really challenging experience, and finding good support is important. This study is exploring a new way to help people who experience these 'auditory hallucinations' as part of conditions like schizophrenia. It’s an online self-help program you can do from home, designed to give you tools and strategies to manage these experiences better.

The program combines two helpful approaches. One is called Metacognitive Training, which helps you understand and change how you think about your experiences, empowering you to gain more control. The other is Mindfulness-Based Group Therapy, which teaches you to focus on the present moment, helping to reduce stress and improve your overall well-being. The researchers want to see if this online tool is effective and if people find it easy to use and beneficial.

Taking part would mean using the online program for about six weeks. Your regular treatment will continue as normal, and this study won’t interfere with that. Researchers will ask you to complete some online questionnaires at the beginning and end of the six weeks to see if the program has made a difference. Some participants will also have an interview to share their experiences in more detail.

Key takeaways

This study tests an online self-help program for hearing voices.
It uses coping skills and mindfulness techniques.
You can continue your regular mental health treatment.
Participation involves using an online program and completing questionnaires for six weeks.
The goal is to help people manage auditory hallucinations better.

Who may be eligible?

To join this study, you generally need to be between 18 and 75 years old and usually hear voices at least once a week. You should have a diagnosis of a psychotic disorder, such as schizophrenia, from a doctor. It’s also important that your current medication for your mental health condition has been stable for at least a month, though small adjustments are allowed.

You should be able to understand the study information and agree to take part. Being willing and able to use an online self-help program is also key, which means having a mobile device like a smartphone or tablet and internet access at home.

However, you wouldn't be able to join if you have certain neurological conditions, are currently experiencing thoughts of harming yourself, or if your auditory hallucinations are mainly due to other conditions like severe trauma or borderline personality disorder. Also, if you're currently abusing substances (other than nicotine or prescribed medicines), receiving electroconvulsive therapy, or are an inpatient or attending a day hospital program, this study wouldn't be suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 75 years old?
Do you hear voices at least once a week?
Do you have a diagnosis of a psychotic disorder (like schizophrenia)?
Has your current mental health medication been stable for at least one month?
Do you have a smartphone/tablet and internet access?
Are you willing to try an online self-help program?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a chat, either in person or over the phone, to make sure the study is right for you. If you're eligible and agree to participate, you'll sign an electronic consent form. You'll then be randomly placed into one of two groups: either the group that starts the online self-help program right away, or a 'waitlist' group that continues with their usual treatment for six weeks before potentially getting access to the program later.

Both groups will complete online questionnaires at the very beginning of the study and then again after six weeks. If you're in the group receiving the online program, you'll be using it for those six weeks. Some people in the group using the program will also be asked to have a chat (an interview) after the six weeks to talk about their experiences with hearing voices and how they found the program. The total duration of active participation for everyone is about six weeks for completing assessments, with some potentially doing an interview.

Potential risks and benefits

Participating in this study might offer you the benefit of learning new ways to cope with hearing voices through the online self-help program, which could improve your well-being. However, as with any new intervention, there's always a chance it might not be helpful for everyone. You might find completing the questionnaires or attending the interview (for some) takes up a little of your time. Your privacy is very important; all your information will be kept confidential and anonymised using special codes. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin
Verified postcode
Berlin, Germany· Recruiting

Common questions

What are auditory hallucinations?

Auditory hallucinations mean hearing sounds or voices when there's nothing actually there. It's an experience that can feel very real to the person experiencing it.

What is Metacognitive Training?

Metacognitive Training (MKT) is a talking therapy that helps people understand and change their thinking patterns, especially thoughts about their mental health experiences like hearing voices.

What is Mindfulness-Based Group Therapy?

Mindfulness-Based Group Therapy (MBGT) teaches people to pay attention to the present moment without judgment. This can help reduce stress and improve how you cope with difficult thoughts or feelings.

Will I still get my usual treatment?

Yes, you will continue with your regular medical treatment and support while taking part in this study. This study is designed to be an addition to your current care.

Do I have to come to a clinic?

Most of your participation will be online, including the self-help program and questionnaires. An initial screening might be in person or by phone.

How to find out more

Kerem Böge, PD Dr. Dr.

kerem.boege@charite.de (+49)30 - 450 517636 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.