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.
Age range
18 Years – 35 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Beck Depression Inventory (BDI-II) (Beck et al., 1996)
Timeframe: Baseline
Beck Depression Inventory (BDI-II) (Beck et al., 1996)
Timeframe: Immediatly after the intervention
Beck Depression Inventory (BDI-II) (Beck et al., 1996)
Timeframe: 3 month follow-up
Beck Anxiety Inventory (BAI) (Beck et al., 1993)
Timeframe: Baseline
Beck Anxiety Inventory (BAI) (Beck et al., 1993)
Timeframe: Immediatly after the intervention
Beck Anxiety Inventory (BAI) (Beck et al., 1993)
Timeframe: 3 months follow-up
PANAS Positive and Negative Affectiveness Scale (Watson et al., 1988)
Timeframe: Baseline
PANAS Positive and Negative Affectiveness Scale (Watson et al., 1988)
Timeframe: Inmediatly after the intervention
PANAS Positive and Negative Affectiveness Scale (Watson et al., 1988)
Timeframe: 3 month follow-up
Scale of Severity and Deterioration of Depression (ODSIS) (Bentley et al., 2013)
Timeframe: Baseline
Scale of Severity and Deterioration of Depression (ODSIS) (Bentley et al., 2013)
Timeframe: Immediatly after the intervention
Scale of Severity and Deterioration of Depression (ODSIS) (Bentley et al., 2013)
Timeframe: 3 months follow-up
General Scale of Severity and Anxiety Impairment (OASIS) (Norman et al., 2006).
Timeframe: Baseline
General Scale of Severity and Anxiety Impairment (OASIS) (Norman et al., 2006).
Timeframe: Immediatly after the intervention
General Scale of Severity and Anxiety Impairment (OASIS) (Norman et al., 2006).
Timeframe: 3 months follow-up
Difficulties in Emotion Regulation Scale (DERS) (Gratz et al., 2004)
Timeframe: Baseline
Difficulties in Emotion Regulation Scale (DERS) (Gratz et al., 2004)
Timeframe: Inmediatly afther the intervention
Difficulties in Emotion Regulation Scale (DERS) (Gratz et al., 2004)
Timeframe: 3 month follow-up