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

NCT04929938 | Unknown

• 1 other identifier: AR202003
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Emotional Dysfunction; Psychosis

Outcome Measures

Primary Outcomes (18)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (20)

• Socio-demographic questionnaire

  Baseline

• Five Factor Personality Inventory (NEO-FFI) (Costa et al., 1999)

  Baseline

• 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)

  Baseline

• Inadaptation Scale (EI) (Echeburúa et al., 2000). Resultados de traducción Scale of Inadaptation (EI) (Echeburúa et al. 2000)

  Immediatly after the intervention

Study Arms (2)

Inmediate UP plus Treatment As Usual

EXPERIMENTAL

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.

Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Waiting list plus Treatment As Usual

ACTIVE COMPARATOR

A waiting list for treatment with delayed UP after 7 months while receiving the treatment as usual (WL + TAU).

Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Interventions

Unified Protocol for Transdiagnostic Treatment of Emotional Disorders BEHAVIORAL

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).

Inmediate UP plus Treatment As Usual; Waiting list plus Treatment As Usual

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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 4. Fluently speaking in spanish and/or catalan. 5. Sign informed consent (IC).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundació Sant Joan de Déu: lead
• Parc Sanitari Sant Joan de Déu: collaborator

Study Sites (2)

Parc Sanitari Sant Joan de Déu

Sant Boi de Llobregat, Barcelona, Spain

RECRUITING

Fundació Sant Joan de Déu

Esplugues de Llobregat, Spain

RECRUITING

Related Publications (1)

• Pelaez T, Lopez-Carrillero R, Ferrer-Quintero M, Ochoa S, Osma J. Application of the unified protocol for the transdiagnostic treatment of comorbid emotional disorders in patients with ultra-high risk of developing psychosis: A randomized trial study protocol. Front Psychol. 2022 Sep 1;13:976661. doi: 10.3389/fpsyg.2022.976661. eCollection 2022.

  PMID: 36118431 DERIVED

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Trini Peláez

  Parc Sanitari Sant Joan de Déu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Trini Peláez

CONTACT

+34 93.640.63.50; mtrinidad.pelaez@sjd.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The evaluator will be blind to the condition that owns the patients included
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized clinical trial in wich a group will receive inmediate UP plus standard intervention and the other one will be in a waiting list plus standard care at PIPPEP.

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: June 18, 2021
• Study Start: September 6, 2021
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 15, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)