Pilot Study to Evaluate the Effectiveness of an Acceptance and Commitment Therapy (ACT)-Based Treatment Approach With Inpatient Group Therapy Interventions for Patients With Psychosis Spectrum Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Positive and Negative Syndrome Scale (PANSS)
研究概览
简要总结
The pilot study that will serve as the basis for the larger project - a multicenter randomized controlled single-blinded trial (RCT) will focus on testing the feasibility and efficacy of an inpatient group ACT treatment program and its effects on symptom severity and patient satisfaction in patients with psychosis spectrum disorder. The ACT-specific treatment program for inpatients with psychosis spectrum disorder is designed to enable patients to deal with their disease in an accepting manner over the long term, to promote self-determined and positive attitudes toward treatment and support options, and thus to reduce rehospitalization rates.
详细描述
Inpatient hospitalization is an important time to provide patients with psychosis spectrum disorder with skills to better manage symptoms and improve functioning after discharge. The long-term goal is to reduce the negative consequences of these disorders and to have a lasting positive impact on the course of the disease. Against this background, the aim of a larger-scale future study project is to evaluate a specific ACT-based four-week treatment program providing inpatient group therapy interventions for patients with psychosis spectrum disorder. The ACT-specific treatment program is designed to enable patients to deal with their disease in an accepting manner over the long term, to promote self-determined and positive attitudes toward treatment and support options, and thus to reduce rehospitalization rates. The pilot study will focus on testing the feasibility and efficacy of the inpatient group ACT treatment program and its effects on symptom severity and patient satisfaction in patients with psychosis spectrum disorder. Here, treatment will include a high-frequency four-week inpatient ACT group therapy program with a focus on the core ACT process of mindfulness in addition to standard inpatient treatment. Within the scope of the survey, possible side effects of the intervention will also be recorded and mapped by conducting qualitative individual interviews and documenting serious adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with psychosis spectrum disorder with the following diagnoses according to the Diagnostic and Statistical Manual Diploma in Social Medicine 5 ("Schizophrenia Spectrum and Other Psychotic Disorders"):
- •Schizophrenia
- •Schizophreniform disorder
- •Schizoaffective disorder
- •Delusional disorder
- •Brief psychotic disorder
- •Psychotic disorder due to another disorder
- •Substance-induced/medication-induced psychotic disorder
- •Depressive episode with psychotic symptoms
- •Manic or bipolar episode with psychotic symptoms
排除标准
- •Patients decline to participate in the treatment program
- •Language or intellectual abilities insufficient for study participation
结局指标
主要结局
Positive and Negative Syndrome Scale (PANSS)
时间窗: T0 Baseline Examinations: Before the start of the intervention at study enrollment T1 Final examinations: After the end of the four-week intervention (week 5) T2 Follow-up examinations: 6 months after the end of the intervention
The primary endpoint symptom severity is assessed using the German version of the established Positive and Negative Syndrome Scale (PANSS). The PANSS consists of a third-party assessment interview in which 30 symptoms are rated using a seven-point scale ranging from 1 (nonexistent) to 7 (extreme symptom). Symptoms are assigned to three scales: The Positive Scale, the Negative Scale, and the General Psychopathology Scale. The PANSS is widely used and is considered the gold standard for assessing psychopathology in people with psychotic disorders because of its good reliability and validity.
次要结局
- Fragebogen zur Messung der Patientenzufriedenheit (ZUF-8)(T1 Final Examinations: After the end of the four-week intervention (week 5))
- World Health Organization Quality of Life Brief Version (WHOQOL-BREF)(T0 Baseline Examinations: Before the start of the intervention at study enrollment T1 Final Examinations: After the end of the four-week intervention (week 5) T2 Follow-up Examinations: 6 months after the end of the intervention)
- Fragebogen für Akzeptanz und Handeln (FAH-II)(T0 Baseline Examinations: Before the start of the intervention at study enrollment T1 Final Examinations: After the end of the four-week intervention (week 5) T2 Follow-up Examinations: 6 months after the end of the intervention)
- Cognitive Fusion Questionnaire (CFQ-D)(T0 Baseline Examinations: Before the start of the intervention at study enrollment T1 Final Examinations: After the end of the four-week intervention (week 5) T2 Follow-up Examinations: 6 months after the end of the intervention)
- Comprehensive Inventory of Mindfulness Experiences (CHIME)(T0 Baseline Examinations: Before the start of the intervention at study enrollment T1 Final Examinations: After the end of the four-week intervention (week 5) T2 Follow-up Examinations: 6 months after the end of the intervention)
- Global Assessment of Functioning (GAF)(T0 Baseline Examinations: Before the start of the intervention at study enrollment T1 Final Examinations: After the end of the four-week intervention (week 5) T2 Follow-up Examinations: 6 months after the end of the intervention)
- Questionnaire about the Process of Recovery (QPR)(T0 Baseline Examinations: Before the start of the intervention at study enrollment T1 Final Examinations: After the end of the four-week intervention (week 5) T2 Follow-up Examinations: 6 months after the end of the intervention)
研究者
Prof. Dr. Andreas Bechdolf
Head of Psychiatry Vivantes Klinikum Am Urban and Klinikum im Friedrichshain
Vivantes Netzwerk für Gesundheit GmbH