The PROBAS-Study: Developing a Process-based and Modular Group Therapy for Acute Psychiatric Patients With Psychotic Symptoms: a Single-arm Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Eligibility rate
研究概览
简要总结
The purpose of this single-arm feasibility study is to develop and pilot test a novel process-based and modular group therapy approach for patients with acute psychotic symptoms in an inpatient setting.
详细描述
Due to the enormous economic and social costs of psychotic-spectrum disorders, increasing the effectiveness of treatment options has become an important subject for psychiatric research. Latest findings in the field of psychotherapy for psychosis show some promising results for so-called Process-based Therapies (PBT) such as the Metacognitive Training (MCT) and Acceptance and Commitment Therapy (ACT) (Barnicot et al., 2020). Instead of trying to change the content of psychotic symptoms such as hallucinations and delusions, PBT directly address cognitive processes, which have been found to maintain the disorder's symptomatology (Hayes et al., 2020). While MCT focusses on changing patients' cognitive biases by inducing metacognition (Moritz & Woodward, 2007), ACT works with psychological processes such as mindfulness, willingness and cognitive distancing (Gaudiano & Herbert, 2006). There is a growing study base for PBT in a psychotic outpatient setting, research in non-ambulatory settings though is rare (Barnicot et al., 2020). Therefore, the aim of the current study is to develop and test the feasibility and safety of a new process-based group therapy program for acute psychotic patients. The five-week treatment approach will consist of three different modules combining interventions from both MCT and ACT (Module I: Psychoeducation, Module II: Metacognition, Module III: Cognitive Defusion). First preliminary effectiveness and process measures (PANSS, BPRS, WHO-DAS, CGI, BCIS and CFQ) will also be included in order to inform the design of future research. Thus, the study will give valuables insights in the feasibility and effectiveness of an innovative psychotherapy approach and breaks new ground in the field of psychotherapy research for psychosis.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main diagnosis of a mental disorder with psychotic symptoms according to ICD-10 criteria currently experiencing delusions and hallucinations (F20, F21, F22, F23, F24, F25, F28, F29, F30.2, F31.2, F31.5, F32.3, F33.3) indicated by diagnostic assessment of attending MD
- •Age between 18 and 70 years
- •Informed consent to the study procedures and assessments (in written form)
排除标准
- •Severe neurological or internal concomitant diseases
- •IQ < 80; severe learning disability, brain damage or pervasive developmental disorder
- •Missing eligibility for psychotherapy because of missing language skills/hostile or uncooperative behaviour.
- •No further constraints will be imposed in order to collect data in a representative clinical sample.
结局指标
主要结局
Eligibility rate
时间窗: assessed from study start in May 2021 until study completition in May 2022, up to 1 year
proportion of those eligible to participate as a percentage of those screened
Semi-structured interviews
时间窗: after completing Module III in week 5
conducted with one randomly selected patient out of every therapy cycle after completion; selected patients will be asked in detail about feasibility and perceived efficacy of the group program
Consent rate
时间窗: assessed from study start in May 2021 until study completition in May 2022, up to 1 year
proportion of those who signed the informed consent as a percentage of those who where approached to participate
Completion rate
时间窗: assessed from study start in May 2021 until study completition in May 2022, up to 1 year
proportion of assessments completed at each time point including screening, baseline, intervention and final meeting and reasons for missing data; subjective patient feedback on frequency, duration, delivery, method and content of the assesments
Drop out rate
时间窗: assessed from study start in May 2021 until study completition in May 2022, up to 1 year
proportion of patients who entered the trial, attended at least one therapy session after baseline but decided to drop out as well as reasons for the drop out
Adverse events
时间窗: assessed from study start in May 2021 until study completition in May 2022, up to 1 year
number and nature of adverse events
Acceptability of Module II
时间窗: after completion of Module II in week 3
self-rating on subjective effectiveness and acceptability of Module II (four sessions Metacognition). The questionnaire will be designed in a manner similar to session feedback forms developed by Moritz and Woodward (2007) including likert-scaled items on satisfaction, effectiveness, usefulness, applicability and transparency of the aim as well as open-ended feedback
Trial entry rate
时间窗: assessed from study start in May 2021 until study completition in May 2022, up to 1 year
proportion of those who consented and completed baseline measures
Missing data rate
时间窗: assessed from study start in May 2021 until study completition in May 2022, up to 1 year
proportion of missing data for each time point including screening, baseline, intervention and final meeting
Acceptability of Module I
时间窗: after completion of Module I in week 1
self-rating on subjective effectiveness and acceptability of Module I (one session Psychoeducation). The questionnaire will be designed in a manner similar to session feedback forms developed by Moritz and Woodward (2007) including likert-scaled items on satisfaction, effectiveness, usefulness, applicability and transparency of the aim as well as open-ended feedback
Acceptability of Module III
时间窗: after completion of Module III in week 5
self-rating on subjective effectiveness and acceptability of Module III (four sessions Cognitive Defusion). The questionnaire will be designed in a manner similar to session feedback forms developed by Moritz and Woodward (2007) including likert-scaled items on satisfaction, effectiveness, usefulness, applicability and transparency of the aim as well as open-ended feedback
Patient engagement
时间窗: assessed from study start in May 2021 until study completition in May 2022, up to 1 year
frequency of unattended sessions per patient as well as the reason for non-attendance
次要结局
- Psychopathological in general and positive and negative psychotic symptoms (BPRS)(before session 1 in week 1 and after completing the therapy in week 5)
- Psychopathological in general and positive and negative psychotic symptoms (PANSS)(before session 1 in week 1 and after completing the therapy in week 5)
- Therapy processes of metacognition (BCIS)(before starting Module II in week 2 and after completing Module II in week 3)
- Positive symptoms (hallucinatiosn and delusions) and their severity, intensity and frequency (PSYRATS)(before session 1 in week 1 and after completing the therapy in week 5)
- Patient's improvement (CGI)(The patient's supervising MD will rate CGI's severity scale for each patient in week 1 and week 5, and the improvement scale only after week 5)
- Social functioning (WHODAS)(in week 1 and week 5)
- Degree of Cognitive fusion (CFQ)(before starting Module III in week 4 and after completing Module II in week 5)