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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
86
See the description above.
Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin
Berlin, Germany
RECRUITINGFrequency 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.
Time frame: At baseline and post-intervention at week 6 (T1).
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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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): 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.
Time frame: 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.
Time frame: At post-intervention at week 6 (T1) and only in the intervention group.
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