Emotional DysfunctionNCT04929938
Application of UP for Transdiagnostic Treatment of Emotional Disorders for UHR for Psychosis Patients
A study testing Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in people with Emotional Dysfunction and Psychosis, run by Fundació Sant Joan de Déu at 2 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Emotional Dysfunction, Psychosis
- What is being tested?
- Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesSpain
- Study dates
- 6 Sep 2021to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Fundació Sant Joan de Déu
Esplugues de Llobregat
Susana Ochoa, PhD, sochoa@pssjd.org
Raquel López-Carrillero
- Recruiting
Parc Sanitari Sant Joan de Déu
Sant Boi de Llobregat, Barcelona
Susana Ochoa, PhD, +34 93 6406350 ext. 12538, sochoa@pssjd.org
About this study
Official title: 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).
Read more
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.
Read the detailed 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:
- 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.
- Conditions
- Emotional Dysfunction, Psychosis
- Being tested
- Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unified Protocol for Transdiagnostic Treatment of Emotional DisordersBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 month follow-up
Secondary outcomes (20)
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: 3 month follow-up
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).
Measured: Baseline
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).
Measured: Immediatly after the intervention
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).
Measured: 3 months follow-up
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.
Measured: Baseline
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.
Measured: Immediatly after the intervention
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.
Measured: 3 months follow-up
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.
Measured: Baseline
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.
Measured: Immediatly after the intervention
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.
Measured: 3 months follow-up
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.
Measured: Baseline
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.
Measured: Immediatly after the intervention
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.
Measured: 3 months follow-up
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.
Measured: Immediatly after the intervention
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.
Measured: Baseline
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.
Measured: 3 months follow-up
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.
Measured: Baseline
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.
Measured: 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start6 Sep 2021
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emotional DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Collaborators
- Parc Sanitari Sant Joan de Déu
- Responsible party
- Sponsor
- Investigators
- Trini Peláez, Principal investigator, Parc Sanitari Sant Joan de Déu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929938
- Sponsor's protocol ID
- AR202003
- Status last verified
- Dec 2021
- First submitted
- 10 Jun 2021
- Last updated
- 15 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36118431
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders for Ultra High Risk for Psychosis Patients
- ClinicalTrials.gov ID
- NCT04929938
- Acronym / sponsor ID
- AR202003
- Conditions
- Emotional Dysfunction, Psychosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Collaborators
- Parc Sanitari Sant Joan de Déu
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Inmediate UP plus Treatment As Usual | Experimental | Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional DisordersTreatment 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. |
| Waiting list plus Treatment As Usual | Active comparator | Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional DisordersA waiting list for treatment with delayed UP after 7 months while receiving the treatment as usual (WL + TAU). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unified Protocol for Transdiagnostic Treatment of Emotional DisordersThis 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). | Behavioural | Inmediate UP plus Treatment As Usual, Waiting list plus Treatment As Usual |
Primary outcome
Beck Depression Inventory (BDI-II) (Beck et al., 1996)
Time frame: 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.
Beck Depression Inventory (BDI-II) (Beck et al., 1996)
Time frame: 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.
Beck Depression Inventory (BDI-II) (Beck et al., 1996)
Time frame: 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.
Beck Anxiety Inventory (BAI) (Beck et al., 1993)
Time frame: Baseline
It is a self-applied scale of 21 items that assess the presence and severity of anxiety.
Beck Anxiety Inventory (BAI) (Beck et al., 1993)
Time frame: Immediatly after the intervention
It is a self-applied scale of 21 items that assess the presence and severity of anxiety.
Beck Anxiety Inventory (BAI) (Beck et al., 1993)
Time frame: 3 months follow-up
It is a self-applied scale of 21 items that assess the presence and severity of anxiety.
PANAS Positive and Negative Affectiveness Scale (Watson et al., 1988)
Time frame: 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.
PANAS Positive and Negative Affectiveness Scale (Watson et al., 1988)
Time frame: 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.
PANAS Positive and Negative Affectiveness Scale (Watson et al., 1988)
Time frame: 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.
Scale of Severity and Deterioration of Depression (ODSIS) (Bentley et al., 2013)
Time frame: 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
Scale of Severity and Deterioration of Depression (ODSIS) (Bentley et al., 2013)
Time frame: 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
Scale of Severity and Deterioration of Depression (ODSIS) (Bentley et al., 2013)
Time frame: 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
General Scale of Severity and Anxiety Impairment (OASIS) (Norman et al., 2006).
Time frame: 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.
General Scale of Severity and Anxiety Impairment (OASIS) (Norman et al., 2006).
Time frame: 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.
General Scale of Severity and Anxiety Impairment (OASIS) (Norman et al., 2006).
Time frame: 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.
Difficulties in Emotion Regulation Scale (DERS) (Gratz et al., 2004)
Time frame: 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.
Difficulties in Emotion Regulation Scale (DERS) (Gratz et al., 2004)
Time frame: 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.
Difficulties in Emotion Regulation Scale (DERS) (Gratz et al., 2004)
Time frame: 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.
20 secondary outcomes
Socio-demographic questionnaire
Time frame: Baseline
Five Factor Personality Inventory (NEO-FFI) (Costa et al., 1999)
Time frame: Baseline
Five Factor Personality Inventory (NEO-FFI) (Costa et al., 1999)
Time frame: 3 month follow-up
Inadaptation Scale (EI) (Echeburúa et al., 2000). Resultados de traducción Scale of Inadaptation (EI) (Echeburúa et al. 2000)
Time frame: Baseline
Inadaptation Scale (EI) (Echeburúa et al., 2000). Resultados de traducción Scale of Inadaptation (EI) (Echeburúa et al. 2000)
Time frame: Immediatly after the intervention
Inadaptation Scale (EI) (Echeburúa et al., 2000). Resultados de traducción Scale of Inadaptation (EI) (Echeburúa et al. 2000)
Time frame: 3 months follow-up
Quality of Life Index (QLI-Sp) (Mezzich et al. 2000)
Time frame: Baseline
Quality of Life Index (QLI-Sp) (Mezzich et al. 2000)
Time frame: Immediatly after the intervention
Quality of Life Index (QLI-Sp) (Mezzich et al. 2000)
Time frame: 3 months follow-up
Cognitive Bias Questionnaire (CBQ) (Peters et al., 2013).
Time frame: Baseline
Cognitive Bias Questionnaire (CBQ) (Peters et al., 2013).
Time frame: Immediatly after the intervention
Cognitive Bias Questionnaire (CBQ) (Peters et al., 2013).
Time frame: 3 months follow-up
Beck Cognitive Insight Scale (BCIS) (Beck et al., 2004)
Time frame: Baseline
Beck Cognitive Insight Scale (BCIS) (Beck et al., 2004)
Time frame: Immediatly after the intervention
Beck Cognitive Insight Scale (BCIS) (Beck et al., 2004)
Time frame: 3 months follow-up
The Treatment Opinion Scale (TSO)
Time frame: Immediatly after the intervention
Mini International Neuropsychiatric Interview (MINI) 7.0.2. Spanish Version. (Sheehan, 2019)
Time frame: Baseline
Mini International Neuropsychiatric Interview (MINI) 7.0.2. Spanish Version. (Sheehan, 2019)
Time frame: 3 months follow-up
CAARMS (Yung et al., 2005).
Time frame: Baseline
CAARMS (Yung et al., 2005).
Time frame: 3 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Derived from this study: PubMed 36118431Pelaez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trini Peláez principal investigator
Parc Sanitari Sant Joan de Déu
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in people with Emotional Dysfunction and Psychosis, run by Fundació Sant Joan de Déu at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Trini Peláez (+34 93.640.63.50 ext. 28605, mtrinidad.pelaez@sjd.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory (BDI-II) (Beck et al., 1996) (time frame: Baseline). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04929938, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.