Application of UP for Transdiagnostic Treatment of Emotional Disorders for UHR for Psychosis Patients

Psychosis Clinical Trial

Official title:

Application of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders for Ultra High Risk for Psychosis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04929938
• Other study ID #: AR202003
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2021
• Est. completion date: December 2023

Study information

• Verified date: December 2021
• Source: Fundació Sant Joan de Déu
• Contact: Trini Peláez
• Phone: +34 93.640.63.50
• Email: mtrinidad.pelaez[@]sjd.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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:

1. Evaluate the effects of UP intervention on subthreshold positive symptoms

2. 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.

3. Evaluate the effect of UP treatment on quality of life.

4. Evaluate the effect of treatment on cognitive distortions and disease awareness.

5. Evaluate the effect of treatment on positive and negative emotions.

6. Evaluate the effect of treatment on emotion regulation skills.

7. Evaluate the effect of UP treatment on psychosocial functioning.

8. 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.

9. Evaluate in the medium term the maintenance of the effects of treatment with PU.

10. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: December 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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:

1. Having a current or past frank psychotic episode.

2. Having an intellectual disability

3. Having an organic problem that better explains the symptoms presented by the subjects.

Related Conditions & MeSH terms

• Emotional Dysfunction
• Mental Disorders
• Psychosis
• Psychotic Disorders

Intervention

Behavioral:
• Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
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).

Locations

Country	Name	City	State
Spain	Fundació Sant Joan de Déu	Esplugues de Llobregat
Spain	Parc Sanitari Sant Joan de Déu	Sant Boi De Llobregat	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Sant Joan de Déu	Parc Sanitari Sant Joan de Déu

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beck Depression Inventory (BDI-II) (Beck et al., 1996)	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
Primary	Beck Depression Inventory (BDI-II) (Beck et al., 1996)	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
Primary	Beck Depression Inventory (BDI-II) (Beck et al., 1996)	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
Primary	Beck Anxiety Inventory (BAI) (Beck et al., 1993)	It is a self-applied scale of 21 items that assess the presence and severity of anxiety.	Baseline
Primary	Beck Anxiety Inventory (BAI) (Beck et al., 1993)	It is a self-applied scale of 21 items that assess the presence and severity of anxiety.	Immediatly after the intervention
Primary	Beck Anxiety Inventory (BAI) (Beck et al., 1993)	It is a self-applied scale of 21 items that assess the presence and severity of anxiety.	3 months follow-up
Primary	PANAS Positive and Negative Affectiveness Scale (Watson et al., 1988)	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
Primary	PANAS Positive and Negative Affectiveness Scale (Watson et al., 1988)	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
Primary	PANAS Positive and Negative Affectiveness Scale (Watson et al., 1988)	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
Primary	Scale of Severity and Deterioration of Depression (ODSIS) (Bentley et al., 2013)	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
Primary	Scale of Severity and Deterioration of Depression (ODSIS) (Bentley et al., 2013)	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
Primary	Scale of Severity and Deterioration of Depression (ODSIS) (Bentley et al., 2013)	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
Primary	General Scale of Severity and Anxiety Impairment (OASIS) (Norman et al., 2006).	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
Primary	General Scale of Severity and Anxiety Impairment (OASIS) (Norman et al., 2006).	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
Primary	General Scale of Severity and Anxiety Impairment (OASIS) (Norman et al., 2006).	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
Primary	Difficulties in Emotion Regulation Scale (DERS) (Gratz et al., 2004)	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
Primary	Difficulties in Emotion Regulation Scale (DERS) (Gratz et al., 2004)	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
Primary	Difficulties in Emotion Regulation Scale (DERS) (Gratz et al., 2004)	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.	3 month follow-up
Secondary	Socio-demographic questionnaire	This questionnaire collects basic information such as gender and clinical aspects like age of onset, number of admissions, treatment received and substance use.	Baseline
Secondary	Five Factor Personality Inventory (NEO-FFI) (Costa et al., 1999)	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
Secondary	Five Factor Personality Inventory (NEO-FFI) (Costa et al., 1999)	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
Secondary	Inadaptation Scale (EI) (Echeburúa et al., 2000). Resultados de traducción Scale of Inadaptation (EI) (Echeburúa et al. 2000)	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
Secondary	Inadaptation Scale (EI) (Echeburúa et al., 2000). Resultados de traducción Scale of Inadaptation (EI) (Echeburúa et al. 2000)	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
Secondary	Inadaptation Scale (EI) (Echeburúa et al., 2000). Resultados de traducción Scale of Inadaptation (EI) (Echeburúa et al. 2000)	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
Secondary	Quality of Life Index (QLI-Sp) (Mezzich et al. 2000)	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
Secondary	Quality of Life Index (QLI-Sp) (Mezzich et al. 2000)	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
Secondary	Quality of Life Index (QLI-Sp) (Mezzich et al. 2000)	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
Secondary	Cognitive Bias Questionnaire (CBQ) (Peters et al., 2013).	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
Secondary	Cognitive Bias Questionnaire (CBQ) (Peters et al., 2013).	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
Secondary	Cognitive Bias Questionnaire (CBQ) (Peters et al., 2013).	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
Secondary	Beck Cognitive Insight Scale (BCIS) (Beck et al., 2004)	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
Secondary	Beck Cognitive Insight Scale (BCIS) (Beck et al., 2004)	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
Secondary	Beck Cognitive Insight Scale (BCIS) (Beck et al., 2004)	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
Secondary	The Treatment Opinion Scale (TSO)	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
Secondary	Mini International Neuropsychiatric Interview (MINI) 7.0.2. Spanish Version. (Sheehan, 2019)	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
Secondary	Mini International Neuropsychiatric Interview (MINI) 7.0.2. Spanish Version. (Sheehan, 2019)	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
Secondary	CAARMS (Yung et al., 2005).	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
Secondary	CAARMS (Yung et al., 2005).	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