Application of UP for Transdiagnostic Treatment of Emotional Disorders for UHR for Psychosis Patients
Application of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders for Ultra High Risk for Psychosis Patients
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.
研究概览
详细说明
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).
The first group will receive immediate intervention with UP in online group format (UP + TAU) with a total of 15 sessions of 2 hours of weekly frequency in addition to the usual treatment in PIPPEP. The sessions will have a group format of 5-8 patients per group. An additional follow-up sessios will be held at 3 months after the end of the treatment sessions. The sessions will work on the 8 modules of UP for the transdiagnostic treatment of Emotional Disorders.
Treatment as usual on PIPPEP is a multidisciplinary treatment in which psychiatric sessions, nursing, social work and psychology are performed applying cognitive-behavioral psychotherapy. The frequency of visits can be weekly or fortnightly in the case of psychotherapy and the focus of the intervention would be the sub-threshold positive symptoms. Traditional cognitive-behavioral techniques such as behavioral experiments, cognitive restructuring, or exposure will be used as outlined in manuals created for this purpose. The usual duration of the visits will be one hour and the format will be individual.
Due to the restrictions arising from the pandemic situation by COVID-19, the group intervention will be in video conferencing format with a secure platform to maintain data protection. To ensure the adequacy of the GE intervention, the number of patients will be between 5-8.
The videoconferencing method will be secure and the personal data of the participants will be protected. The platform method that the Foundation San Joan de Deu will use is appropriate and contemplates the data protection regulations.
Patients will be randomized for inclusion in the experimental or control group using a list of random numbers and will be assigned according to the order of collection. The evaluator will be blind to the group to which the evaluated patient belongs.
Fidelity to the PU treatment protocol will be guaranteed through regular supervision with an accredited therapist.
The psychiatric medication prescribed for the patients in the study will be monitored, as well as any changes that may be made during the time of the study.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Trini Peláez
- 电话号码：28605 +34 93.640.63.50
- 邮箱：mtrinidad.pelaez@sjd.es
学习地点
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Esplugues de Llobregat、西班牙
- 招聘中
- Fundació Sant Joan de Déu
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接触：
- Susana Ochoa, PhD
- 邮箱：sochoa@pssjd.org
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副研究员：
- Raquel López-Carrillero
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副研究员：
- Marta Ferrer
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副研究员：
- Marta Núñez
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副研究员：
- Romans Carlota
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Barcelona
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Sant Boi De Llobregat、Barcelona、西班牙
- 招聘中
- Parc Sanitari Sant Joan de Deu
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接触：
- Susana Ochoa, PhD
- 电话号码：12538 +34 93 6406350
- 邮箱：sochoa@pssjd.org
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
1. Have a diagnosis of UHR for psychosis in the last 3 years and have been included in the Early Intervention of Psychosis Program.
3. Having comorbid emotional symptoms 4. Fluently speaking in spanish and/or catalan. 5. Sign informed consent (IC).
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Inmediate UP plus Treatment As Usual
Treatment As Usual Plus Inmediate Virtual group Therapy applying the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders.
The treatment consists in 15 weekly sessions of 120 minutes that combines cognitive-behavioural techniques to improve emotional self-regulation skills.
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This is a combination of cognitive-behavioural techniques oriented to improve the emotional regulation.
The Unified Protocol is comprised of 8 modules and it is applied following The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders Manual (Barlow, 2017).
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有源比较器：Waiting list plus Treatment As Usual
A waiting list for treatment with delayed UP after 7 months while receiving the treatment as usual (WL + TAU).
|
This is a combination of cognitive-behavioural techniques oriented to improve the emotional regulation.
The Unified Protocol is comprised of 8 modules and it is applied following The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders Manual (Barlow, 2017).
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Beck Depression Inventory (BDI-II) (Beck et al., 1996)
大体时间：Baseline
|
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.
|
Baseline
|
|
Beck Depression Inventory (BDI-II) (Beck et al., 1996)
大体时间：Immediatly after the intervention
|
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.
|
Immediatly after the intervention
|
|
Beck Depression Inventory (BDI-II) (Beck et al., 1996)
大体时间：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.
|
3 month follow-up
|
|
Beck Anxiety Inventory (BAI) (Beck et al., 1993)
大体时间：Baseline
|
It is a self-applied scale of 21 items that assess the presence and severity of anxiety.
|
Baseline
|
|
Beck Anxiety Inventory (BAI) (Beck et al., 1993)
大体时间：Immediatly after the intervention
|
It is a self-applied scale of 21 items that assess the presence and severity of anxiety.
|
Immediatly after the intervention
|
|
Beck Anxiety Inventory (BAI) (Beck et al., 1993)
大体时间：3 months follow-up
|
It is a self-applied scale of 21 items that assess the presence and severity of anxiety.
|
3 months follow-up
|
|
PANAS Positive and Negative Affectiveness Scale (Watson et al., 1988)
大体时间：Baseline
|
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.
|
Baseline
|
|
PANAS Positive and Negative Affectiveness Scale (Watson et al., 1988)
大体时间：Inmediatly after the intervention
|
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.
|
Inmediatly after the intervention
|
|
PANAS Positive and Negative Affectiveness Scale (Watson et al., 1988)
大体时间：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.
|
3 month follow-up
|
|
Scale of Severity and Deterioration of Depression (ODSIS) (Bentley et al., 2013)
大体时间：Baseline
|
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
|
Baseline
|
|
Scale of Severity and Deterioration of Depression (ODSIS) (Bentley et al., 2013)
大体时间：Immediatly after the intervention
|
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
|
Immediatly after the intervention
|
|
Scale of Severity and Deterioration of Depression (ODSIS) (Bentley et al., 2013)
大体时间：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
|
3 months follow-up
|
|
General Scale of Severity and Anxiety Impairment (OASIS) (Norman et al., 2006).
大体时间：Baseline
|
This is a short 5-item questionnaire that continuously assesses the severity of symptoms and deteriorating anxiety.
Can be used in multiple anxiety disorders.
|
Baseline
|
|
General Scale of Severity and Anxiety Impairment (OASIS) (Norman et al., 2006).
大体时间：Immediatly after the intervention
|
This is a short 5-item questionnaire that continuously assesses the severity of symptoms and deteriorating anxiety.
Can be used in multiple anxiety disorders.
|
Immediatly after the intervention
|
|
General Scale of Severity and Anxiety Impairment (OASIS) (Norman et al., 2006).
大体时间：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.
|
3 months follow-up
|
|
Difficulties in Emotion Regulation Scale (DERS) (Gratz et al., 2004)
大体时间：Baseline
|
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.
|
Baseline
|
|
Difficulties in Emotion Regulation Scale (DERS) (Gratz et al., 2004)
大体时间：Inmediatly afther the intervention
|
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.
|
Inmediatly afther the intervention
|
|
Difficulties in Emotion Regulation Scale (DERS) (Gratz et al., 2004)
大体时间：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.
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3 month follow-up
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Socio-demographic questionnaire
大体时间：Baseline
|
This questionnaire collects basic information such as gender and clinical aspects like age of onset, number of admissions, treatment received and substance use.
|
Baseline
|
|
Five Factor Personality Inventory (NEO-FFI) (Costa et al., 1999)
大体时间：Baseline
|
It is the reduced version of the NEO-PI-R and consists of 60 items that evaluate the personality according to 5 factors: Neuroticism, Extraversion, Openness, Kindness and Responsibility.
|
Baseline
|
|
Five Factor Personality Inventory (NEO-FFI) (Costa et al., 1999)
大体时间：3 month follow-up
|
It is the reduced version of the NEO-PI-R and consists of 60 items that evaluate the personality according to 5 factors: Neuroticism, Extraversion, Openness, Kindness and Responsibility.
|
3 month follow-up
|
|
Inadaptation Scale (EI) (Echeburúa et al., 2000). Resultados de traducción Scale of Inadaptation (EI) (Echeburúa et al. 2000)
大体时间：Baseline
|
It consists of 6 items that measure the impact that the current problems of the subjects have in different areas of their daily life (work, social life, leisure time, relationships, family life and globally).
|
Baseline
|
|
Inadaptation Scale (EI) (Echeburúa et al., 2000). Resultados de traducción Scale of Inadaptation (EI) (Echeburúa et al. 2000)
大体时间：Immediatly after the intervention
|
It consists of 6 items that measure the impact that the current problems of the subjects have in different areas of their daily life (work, social life, leisure time, relationships, family life and globally).
|
Immediatly after the intervention
|
|
Inadaptation Scale (EI) (Echeburúa et al., 2000). Resultados de traducción Scale of Inadaptation (EI) (Echeburúa et al. 2000)
大体时间：3 months follow-up
|
It consists of 6 items that measure the impact that the current problems of the subjects have in different areas of their daily life (work, social life, leisure time, relationships, family life and globally).
|
3 months follow-up
|
|
Quality of Life Index (QLI-Sp) (Mezzich et al. 2000)
大体时间：Baseline
|
It is a 10-item questionnaire that assesses various aspects of health-related quality of life (physical disability, emotional well-being, self-care and independent functioning, occupational functioning, interpersonal functioning, etc.).
It is scored on a scale of 1-10 points, with the highest scores corresponding to a higher quality of life.
|
Baseline
|
|
Quality of Life Index (QLI-Sp) (Mezzich et al. 2000)
大体时间：Immediatly after the intervention
|
It is a 10-item questionnaire that assesses various aspects of health-related quality of life (physical disability, emotional well-being, self-care and independent functioning, occupational functioning, interpersonal functioning, etc.).
It is scored on a scale of 1-10 points, with the highest scores corresponding to a higher quality of life.
|
Immediatly after the intervention
|
|
Quality of Life Index (QLI-Sp) (Mezzich et al. 2000)
大体时间：3 months follow-up
|
It is a 10-item questionnaire that assesses various aspects of health-related quality of life (physical disability, emotional well-being, self-care and independent functioning, occupational functioning, interpersonal functioning, etc.).
It is scored on a scale of 1-10 points, with the highest scores corresponding to a higher quality of life.
|
3 months follow-up
|
|
Cognitive Bias Questionnaire (CBQ) (Peters et al., 2013).
大体时间：Baseline
|
It consists of 30 statements which pose situations in the form of vignettes and measure the presence of 5 cognitive biases: intentionality, catastrophism, dichotomous thinking, hasty conclusions, and reasoning based on emotions.
|
Baseline
|
|
Cognitive Bias Questionnaire (CBQ) (Peters et al., 2013).
大体时间：Immediatly after the intervention
|
It consists of 30 statements which pose situations in the form of vignettes and measure the presence of 5 cognitive biases: intentionality, catastrophism, dichotomous thinking, hasty conclusions, and reasoning based on emotions.
|
Immediatly after the intervention
|
|
Cognitive Bias Questionnaire (CBQ) (Peters et al., 2013).
大体时间：3 months follow-up
|
It consists of 30 statements which pose situations in the form of vignettes and measure the presence of 5 cognitive biases: intentionality, catastrophism, dichotomous thinking, hasty conclusions, and reasoning based on emotions.
|
3 months follow-up
|
|
Beck Cognitive Insight Scale (BCIS) (Beck et al., 2004)
大体时间：Baseline
|
It is a self-administered scale of 15 items with 4 response options.
Collects information on the ability to correct erroneous judgments on two subscales: self-reflection and self-certainty.
|
Baseline
|
|
Beck Cognitive Insight Scale (BCIS) (Beck et al., 2004)
大体时间：Immediatly after the intervention
|
It is a self-administered scale of 15 items with 4 response options.
Collects information on the ability to correct erroneous judgments on two subscales: self-reflection and self-certainty.
|
Immediatly after the intervention
|
|
Beck Cognitive Insight Scale (BCIS) (Beck et al., 2004)
大体时间：3 months follow-up
|
It is a self-administered scale of 15 items with 4 response options.
Collects information on the ability to correct erroneous judgments on two subscales: self-reflection and self-certainty.
|
3 months follow-up
|
|
The Treatment Opinion Scale (TSO)
大体时间：Immediatly after the intervention
|
This is a questionnaire created ad hoc to assess patients satisfaction with the treatment "Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders" created by Jorge Osma and collaborators in a Spanish sample of patients with Emotional Disorders of the public health system.
|
Immediatly after the intervention
|
|
Mini International Neuropsychiatric Interview (MINI) 7.0.2. Spanish Version. (Sheehan, 2019)
大体时间：Baseline
|
This is a brief and high structured interview of the main psychiatric disorders of the IDC -10 and DSM-IV in order to be employed by psychiatrists and physicians not psychiatrists afterwards short time training.
|
Baseline
|
|
Mini International Neuropsychiatric Interview (MINI) 7.0.2. Spanish Version. (Sheehan, 2019)
大体时间：3 months follow-up
|
This is a brief and high structured interview of the main psychiatric disorders of the IDC -10 and DSM-IV in order to be employed by psychiatrists and physicians not psychiatrists afterwards short time training.
|
3 months follow-up
|
|
CAARMS (Yung et al., 2005).
大体时间：Baseline
|
It is a semi-structured interview that assesses subclinical psychotic symptoms in the previous year.
The intensity and frequency of symptoms are recorded to distinguish between a non-risk state and a High Risk Mental State or a First Psychotic Episode.
|
Baseline
|
|
CAARMS (Yung et al., 2005).
大体时间：3 months follow-up
|
It is a semi-structured interview that assesses subclinical psychotic symptoms in the previous year.
The intensity and frequency of symptoms are recorded to distinguish between a non-risk state and a High Risk Mental State or a First Psychotic Episode.
|
3 months follow-up
|
合作者和调查者
调查人员
- 首席研究员：Trini Peláez、Parc Sanitari Sant Joan de Deu
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- AR202003
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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