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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Online-Based Self-Help Intervention | Behavioral | See the description above. |
|
| 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). |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin | Berlin | State of Berlin | 12203 | Germany |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D006212 | Hallucinations |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
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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.
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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):
| 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. |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |