Cognitive Behavioral Social Skills Training in Early Onset Psychosis

Schizophrenia Clinical Trial

Official title:

Cognitive Behavioral Social Skills Training in Early-onset Psychosis: Efficacy in Psychotic Symptoms, Psyshosocial Functioning and Neurobiological and Epigenetic Stress Markers.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03261557
• Other study ID #: DN040595
• Status: Recruiting
• Phase: N/A
• First received: August 23, 2017
• Last updated: August 24, 2017
• Start date: February 22, 2017
• Est. completion date: September 2020

Study information

• Verified date: August 2017
• Source: Hospital Clinic of Barcelona
• Contact: Olga Puig, PhD
• Phone: 93 227 99 74
• Email: opuig[@]clinic.ub.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cognitive-behavioral therapy (CBT) and social skills training (SST) are recommended psychological interventions to improve symptomatology and functional recovery in psychosis. In addition, CBT may reduce hyperactivation of the brain structures responsible for the stress response. In patients with early onset psychotic disorder (EOP) there are not any previous controlled study that has analyzed the efficacy of this type of intervention.

The aim of this study is to investigate efficacy of CBT + SST in symptomatic and functional improvement after the treatment in patients with EOP. The study will also examine the potential effect of the intervention on neurobiological stress markers.

Description:

Early-onset of psychotic disorders (EOP), and especially Schizophrenia, is associated with a worse clinical and psychosocial evolution than in the adult form of the illness. In the case of patients with EOP, international and national clinical guidelines recommend the combination of pharmacological treatment with CBT. However there are not any previous controlled study that has analyzed the efficacy of this type of psychological intervention.

A controlled randomized study will be carry out of CBT + SST intervention compared to a control intervention of the same duration, format and contact with a therapist. The sample will be 30 participants with a diagnosis of schizophrenia, Schizoaffective disorder or psychotic disorder not otherwise specified diagnosed between 9 and 18 years. Patiens have to be in the early phase of the disease (first 5 years after the onset) and in non-acute treatment. All participants will be evaluated before and after the intervention with clinical scales, neuropsychological battery and blood test(...). 20 healthy subjects paired by age, puberal stage and sex will be also recruited and evaluated only at baseline point. The evaluations will be carried out by blind evaluators. Intention-to-treat analysis will be carry out using the statistical package SPSS v 20.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 22 Years

Eligibility

Inclusion Criteria:

• Subjects with a diagnosis of non-affective psychotic disorder diagnosed between age of 9 and 18 (Schizophrenia, schizoaffective disorder or psychotic disorder not otherwise specified according to DSM-V criteria).

• Critical period after the first psychotic episode (which covers the first 5 years) and in non-acute treatment

Exclusion Criteria:

• IQ <70

• Toxic dependence comorbid disorder

• Presence of Neurological disorder.

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis NOS
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Behavioral:
• CBT + SST
It will consist of 1 individual sessions and 15 weekly periodicity group sessions distributed in 3 modules: cognitive skills module, which includes the basic principles of CBT for psychosis; Social skills module, which includes the usual strategies in HHSS training; and problem solving module. All patients will receive pharmacological treatment and will be followed up by their referral psychiatrist habitual.
• Psychoeducation, habits and healthy lifestyle
Patients randomized to the control treatment will receive the same number of Individual and group sessions, with the same periodicity and format: 1 individual sessions and 15 weekly periodicity group sessions distributed in 3 modules: psychoeducation, habits and healthy lifestyle. All patients will receive pharmacological treatment and will be followed up by their referral psychiatrist habitual.

Locations

Country	Name	City	State
Spain	Department of Child and Adolescent Pyshicatry and Psychology	Barcelona	Catalunya

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	University of California, San Diego

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychosocial functioning	Change from baseline in social functioning questionnaires	15 weeks
Primary	Clinical symptoms	Change from baseline in Clinical scales	15 weeks
Secondary	Biological stress markers	Change pre-post interventionbiological stress markers registered by blood analyses	15 weeks
Secondary	Subjective stress	Change pre-post intervention in questionnaires of perceived stress	15 weeks