Clinical trial NCT04929938: Application of UP for Transdiagnostic Treatment of Emotional Disorders for UHR for Psychosis Patients
Official title: Application of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders for Ultra High Risk for Psychosis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Emotional Dysfunction
Psychosis
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
Collaborators: name: Parc Sanitari Sant Joan de Déu
First posted: 2021-06-18
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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:

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Beck Depression Inventory (BDI-II) (Beck et al., 1996)
timeFrame: Baseline
measure: Beck Depression Inventory (BDI-II) (Beck et al., 1996)
timeFrame: Immediatly after the intervention
measure: Beck Depression Inventory (BDI-II) (Beck et al., 1996)
timeFrame: 3 month follow-up
measure: Beck Anxiety Inventory (BAI) (Beck et al., 1993)
timeFrame: Baseline
measure: Beck Anxiety Inventory (BAI) (Beck et al., 1993)
timeFrame: Immediatly after the intervention
measure: Beck Anxiety Inventory (BAI) (Beck et al., 1993)
timeFrame: 3 months follow-up
measure: PANAS Positive and Negative Affectiveness Scale (Watson et al., 1988)
timeFrame: Baseline
measure: PANAS Positive and Negative Affectiveness Scale (Watson et al., 1988)
timeFrame: Inmediatly after the intervention
measure: PANAS Positive and Negative Affectiveness Scale (Watson et al., 1988)
timeFrame: 3 month follow-up
measure: Scale of Severity and Deterioration of Depression (ODSIS) (Bentley et al., 2013)
timeFrame: Baseline
measure: Scale of Severity and Deterioration of Depression (ODSIS) (Bentley et al., 2013)
timeFrame: Immediatly after the intervention
measure: Scale of Severity and Deterioration of Depression (ODSIS) (Bentley et al., 2013)
timeFrame: 3 months follow-up
measure: General Scale of Severity and Anxiety Impairment (OASIS) (Norman et al., 2006).
timeFrame: Baseline
measure: General Scale of Severity and Anxiety Impairment (OASIS) (Norman et al., 2006).
timeFrame: Immediatly after the intervention
measure: General Scale of Severity and Anxiety Impairment (OASIS) (Norman et al., 2006).
timeFrame: 3 months follow-up
measure: Difficulties in Emotion Regulation Scale (DERS) (Gratz et al., 2004)
timeFrame: Baseline
measure: Difficulties in Emotion Regulation Scale (DERS) (Gratz et al., 2004)
timeFrame: Inmediatly afther the intervention
measure: Difficulties in Emotion Regulation Scale (DERS) (Gratz et al., 2004)
timeFrame: 3 month follow-up
Secondary outcomes:
measure: Socio-demographic questionnaire
timeFrame: Baseline
measure: Five Factor Personality Inventory (NEO-FFI) (Costa et al., 1999)
timeFrame: Baseline
measure: Five Factor Personality Inventory (NEO-FFI) (Costa et al., 1999)
timeFrame: 3 month follow-up
measure: Inadaptation Scale (EI) (Echeburúa et al., 2000). Resultados de traducción Scale of Inadaptation (EI) (Echeburúa et al. 2000)
timeFrame: Baseline
measure: Inadaptation Scale (EI) (Echeburúa et al., 2000). Resultados de traducción Scale of Inadaptation (EI) (Echeburúa et al. 2000)
timeFrame: Immediatly after the intervention
measure: Inadaptation Scale (EI) (Echeburúa et al., 2000). Resultados de traducción Scale of Inadaptation (EI) (Echeburúa et al. 2000)
timeFrame: 3 months follow-up
measure: Quality of Life Index (QLI-Sp) (Mezzich et al. 2000)
timeFrame: Baseline
measure: Quality of Life Index (QLI-Sp) (Mezzich et al. 2000)
timeFrame: Immediatly after the intervention
measure: Quality of Life Index (QLI-Sp) (Mezzich et al. 2000)
timeFrame: 3 months follow-up
measure: Cognitive Bias Questionnaire (CBQ) (Peters et al., 2013).
timeFrame: Baseline
measure: Cognitive Bias Questionnaire (CBQ) (Peters et al., 2013).
timeFrame: Immediatly after the intervention
measure: Cognitive Bias Questionnaire (CBQ) (Peters et al., 2013).
timeFrame: 3 months follow-up
measure: Beck Cognitive Insight Scale (BCIS) (Beck et al., 2004)
timeFrame: Baseline
measure: Beck Cognitive Insight Scale (BCIS) (Beck et al., 2004)
timeFrame: Immediatly after the intervention
measure: Beck Cognitive Insight Scale (BCIS) (Beck et al., 2004)
timeFrame: 3 months follow-up
measure: The Treatment Opinion Scale (TSO)
timeFrame: Immediatly after the intervention
measure: Mini International Neuropsychiatric Interview (MINI) 7.0.2. Spanish Version. (Sheehan, 2019)
timeFrame: Baseline
measure: Mini International Neuropsychiatric Interview (MINI) 7.0.2. Spanish Version. (Sheehan, 2019)
timeFrame: 3 months follow-up
measure: CAARMS (Yung et al., 2005).
timeFrame: Baseline
measure: CAARMS (Yung et al., 2005).
timeFrame: 3 months follow-up
Other outcomes:
Locations:
city: Sant Boi De Llobregat
country: Spain
facility: Parc Sanitari Sant Joan de Déu
state: Barcelona
city: Esplugues de Llobregat
country: Spain
facility: Fundació Sant Joan de Déu
Study officials:
affiliation: Parc Sanitari Sant Joan de Déu
name: Trini Peláez
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.