Efficacy of an Online-Based Self-Help Intervention for Auditory Hallucinations in Persons With Psychotic Disorders (ECHION)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Frequency and distress of auditory hallucinations, PSYRATS
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: Online-Based Self-Help Intervention (Behavioral)
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.
结局指标
主要结局
Frequency and distress of auditory hallucinations, PSYRATS
时间窗: At baseline and post-intervention at week 6 (T1).
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.
次要结局
- 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).)
- Positive and Negative Affect, PANAS(At baseline (T0) and post-intervention at week 6 (T1).)
- Negative Symptoms, SNS(At baseline (T0) and post-intervention at week 6 (T1).)
- Patient Satisfaction, ZUF-8(At post-intervention at week 6 (T1) and only in the intervention group.)
- Characteristics of Voices, Thinking Scale(At baseline (T0) and post-intervention at week 6 (T1).)
研究者
Kerem Böge
Principal Investigator
Charite University, Berlin, Germany