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

8 kwietnia 2022 zaktualizowane przez: Fundació Sant Joan de Déu

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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Oczekiwany)

42

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Hiszpania
      • Esplugues de Llobregat, Hiszpania
        • Rekrutacyjny
        • Fundació Sant Joan de Déu
        • Kontakt:
        • Pod-śledczy:
          • Raquel López-Carrillero
        • Pod-śledczy:
          • Marta Ferrer
        • Pod-śledczy:
          • Marta Núñez
        • Pod-śledczy:
          • Romans Carlota
    • Barcelona
      • Sant Boi De Llobregat, Barcelona, Hiszpania
        • Rekrutacyjny
        • Parc Sanitari Sant Joan de Deu
        • Kontakt:
          • Susana Ochoa, PhD
          • Numer telefonu: 12538 +34 93 6406350
          • E-mail: sochoa@pssjd.org

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 35 lat (Dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: 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).
Aktywny komparator: 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).
Behawioralne: 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).

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Beck Depression Inventory (BDI-II) (Beck et al., 1996)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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.
3 month follow-up

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Socio-demographic questionnaire
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Fundació Sant Joan de Déu

Współpracownicy

Parc Sanitari Sant Joan de Déu

Śledczy

  • Główny śledczy: Trini Peláez, Parc Sanitari Sant Joan de Deu

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

6 września 2021

Zakończenie podstawowe (Oczekiwany)

1 października 2023

Ukończenie studiów (Oczekiwany)

1 grudnia 2023

Daty rejestracji na studia

Pierwszy przesłany

10 czerwca 2021

Pierwszy przesłany, który spełnia kryteria kontroli jakości

16 czerwca 2021

Pierwszy wysłany (Rzeczywisty)

18 czerwca 2021

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

15 kwietnia 2022

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

8 kwietnia 2022

Ostatnia weryfikacja

1 grudnia 2021

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • AR202003

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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