Application of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders for Ultra High Risk for Psychosis Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 42
- 试验地点
- 3
- 主要终点
- Beck Depression Inventory (BDI-II) (Beck et al., 1996)
研究概览
简要总结
The principal aim of the study is to assess the efficacy of the Unified Protocol (UP) for the treatment of the comorbid symptomatology of patients with Ultra High Risk (UHR) for psychosis. The secondary aims would be to assess the effects of the intervention with the UP on the subthreshold positive symptoms and the transition to psychosis rates at 3 months follow-up, insight, positive and negative emotions, emotion regulation skills, personality, quality of life, cognitive distortions, psychosocial functioning and the maintenance of the effects at the 3 months of follow-up.
The study is a randomised controlled trial in which a group will receive inmediate UP plus standard intervention and the other one will be in a waiting list plus standard care at our Early Psychosis Program (PIPPEP).
The evaluator will be blind to the group that owns every patients. The sample will be 42 patients with UHR for psychosis with comorbid emotional symptoms and are visited at the PIPPEP of the CSMA Ripollet (PSSJD).
The assessment will be performed at baseline, at the end of treatment and at three months follow-up and will include: general psychopathology (SCID), anxiety and depression (BDI-II, BAI), positive and negative emotions (PANAS), emotional disregulation (DERS), personality (NEO-FFI), functionality (EEASL, MI), quality of life (QLI-sp), cognitive distortions (CBQ), insight (BCIS) and a scale of satisfaction created ad-hoc. At the end of each session with the UP we will assess depression and anxiety during the last week (ODSIS, OASIS). Treatment with the UP will consist in 15 group sessions of 8 patients, 120 minutes in addition to the treatment as usual.
详细描述
Main goal:
To evaluate the efficacy of UP in a group format for the treatment of comorbid symptoms present in UHR for psychosis.
Secondary goals:
- Evaluate the effects of UP intervention on subthreshold positive symptoms
- Evaluate the rates of transition to psychosis at 3 months in patients in the inmediate UP+TAU group intervention and compare them with those in the WL+TAU.
- Evaluate the effect of UP treatment on quality of life.
- Evaluate the effect of treatment on cognitive distortions and disease awareness.
- Evaluate the effect of treatment on positive and negative emotions.
- Evaluate the effect of treatment on emotion regulation skills.
- Evaluate the effect of UP treatment on psychosocial functioning.
- To know the levels of neuroticism and extraversion in UHR patients and to study if they constitute a modulating factor of the response to treatment with UP.
- Evaluate in the medium term the maintenance of the effects of treatment with PU.
- Evaluate the satisfaction of patients with the UP intervention.
The present study is a randomized controlled trial in which participants will be assigned to a treatment group that will receive immediate group treatment with UP in addition to the treatment as usual (UP + TAU) and the other group will be placed on a waiting list for treatment with delayed UP after 7 months while receiving the treatment as usual (WL + TAU).
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)
盲法说明
The evaluator will be blind to the condition that owns the patients included
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of UHR for psychosis in the last 3 years and have been included in the Early Intervention of Psychosis Program.
- •Having comorbid emotional symptoms
- •Fluently speaking in spanish and/or catalan.
- •Sign informed consent (IC).
排除标准
- •Having a current or past frank psychotic episode.
- •Having an intellectual disability
- •Having an organic problem that better explains the symptoms presented by the subjects.
结局指标
主要结局
Beck Depression Inventory (BDI-II) (Beck et al., 1996)
时间窗: 3 month follow-up
This self-applied scale consists of 21 items and assesses the severity (symptomatic intensity) of the depression with each item containing several self-assessment phrases.
PANAS Positive and Negative Affectiveness Scale (Watson et al., 1988)
时间窗: 3 month follow-up
It is a self-administered scale consisting of 20 items that describe positive and negative emotions. Each item is answered with a 5-point Likert-type scale where 0 is the minimum score and 5 is the maximum.
Beck Anxiety Inventory (BAI) (Beck et al., 1993)
时间窗: 3 months follow-up
It is a self-applied scale of 21 items that assess the presence and severity of anxiety.
Difficulties in Emotion Regulation Scale (DERS) (Gratz et al., 2004)
时间窗: 3 month follow-up
It is a 28-item scale that measures emotional dysregulation in 5 dimensions:Non acceptance of Emotions, Difficulties Engaging in Goal-Directed Behavior When Distressed, Lack of Emotional Clarity, Lack of Emotional Awareness, Limited Access to Emotion Regulation Strategies and Impulse Control Difficulties.
General Scale of Severity and Anxiety Impairment (OASIS) (Norman et al., 2006).
时间窗: 3 months follow-up
This is a short 5-item questionnaire that continuously assesses the severity of symptoms and deteriorating anxiety. Can be used in multiple anxiety disorders.
Scale of Severity and Deterioration of Depression (ODSIS) (Bentley et al., 2013)
时间窗: 3 months follow-up
This is a short 5-item questionnaire that continuously assesses the severity of symptoms and the deterioration of depression. Can be used in different depressive disorders
次要结局
- Socio-demographic questionnaire(Baseline)
- The Treatment Opinion Scale (TSO)(Immediatly after the intervention)
- Five Factor Personality Inventory (NEO-FFI) (Costa et al., 1999)(3 month follow-up)
- Inadaptation Scale (EI) (Echeburúa et al., 2000). Resultados de traducción Scale of Inadaptation (EI) (Echeburúa et al. 2000)(3 months follow-up)
- Quality of Life Index (QLI-Sp) (Mezzich et al. 2000)(3 months follow-up)
- Beck Cognitive Insight Scale (BCIS) (Beck et al., 2004)(3 months follow-up)
- Cognitive Bias Questionnaire (CBQ) (Peters et al., 2013).(3 months follow-up)
- Mini International Neuropsychiatric Interview (MINI) 7.0.2. Spanish Version. (Sheehan, 2019)(3 months follow-up)
- CAARMS (Yung et al., 2005).(3 months follow-up)