RUFUS - a Randomized Mixed Methods Pilot Clinical Trial Investigating the Relevance and Feasibility of Rumination-focused Cognitive Behavioral Therapy in the Treatment of Patients With Emergent Psychosis Spectrum Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- the Brief Negative Symptoms Scale (BNSS)
研究概览
简要总结
Abstract - --
Introduction:
Psychosis spectrum disorders are characterized by both positive and negative symptoms, but whereas there is good effect of treatment on positive symptoms, there is still a scarcity of effective interventions aimed at reducing negative symptoms. Rumination has been proposed as an important and fundamental factor in the development and maintenance of symptoms across psychiatric diagnoses, and there is a need to develop effective interventions targeting rumination behaviors and negative symptoms in patients with psychotic disorders. The aim of the current study is to investigate the feasibility and acceptability of group rumination-focused cognitive behavioral therapy (RFCBT) in the treatment of young people with psychosis spectrum disorders as well as investigating potential indications of treatment efficacy.
Methods and analysis: The study is a mixed-method clinical randomized controlled pilot trial with a target sample of 60 patients, who are randomized to either receive 13 weeks of group CFCBT or 13 weeks of treatment as usual (TAU). All patients are examined at the start of the project and at the 13-week follow-up. The researcher will compare changes in outcomes from baseline to posttreatment between group CFCBT and TAU. In addition, qualitative analyzes are carried out to explore feasibility and acceptability and to uncover the patients' experience of receiving the intervention.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 37 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with a psychosis spectrum disorder (ICD-10 F2x)
- •At least 8 months left of their OPUS treatment
- •The presence of rumination behavior as assessed by a score of minimum 30 on the Perseverative Thinking Questionnaire (PTQ)
- •Danish-speaking
排除标准
- •Substance abuse or positive symptoms that make participation in therapy difficult
- •Severe suicidal thoughts/behavior
- •Lacks capacity to consent
- •Mild, moderate, or severe intellectual disability (IQ ˂ 70)
- •Planned adjustment of antidepressant and/or antipsychotic treatment (noted in the patient's medical record)
结局指标
主要结局
the Brief Negative Symptoms Scale (BNSS)
时间窗: up to 20 weeks
Assessment of negative symptoms on a scale from 0-78
次要结局
- Perseverative Thinking Questionnaire (PTQ)(up to 20 weeks)
- Social Functioning Scale (SFS)(up to 20 weeks)
- Calgary depression scale (CDS)(up to 20 weeks)
- Behavior Rating Inventory of Executive Function (BRIEF)(up to 20 weeks)
- Ruminative Response Scale (RRS)(up to 20 weeks)
- Scale for the assessment of positive symptoms (SAPS)(up to 20 weeks)
