Cognitive Behavioral Social Skills Training in Early Onset Psychosis

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

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.

Study Overview

• Status: Unknown
• Conditions: Schizophrenia; Schizoaffective Disorder; Psychosis NOS
• Intervention / Treatment: Behavioral: CBT + SST; Behavioral: Psychoeducation, habits and healthy lifestyle

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Catalunya
    • Barcelona, Catalunya, Spain, 08036
      • Recruiting
      • Department of Child and Adolescent Pyshicatry and Psychology
      • Contact: Olga Puig, PhD; Phone Number: 99 74 34 227; Email: opuig@clinic.ub.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 22 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBT + SST; The treatment group will receive the intervention according to the CBSST protocol, adapted to adolescents.	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.
Active Comparator: Psychoeducation, habits and healthy lifestyle; The control group will receive 3 modules intervention: psychoeducation, habits and healthy lifestyle.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychosocial functioning	Change from baseline in social functioning questionnaires	15 weeks
Clinical symptoms	Change from baseline in Clinical scales	15 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biological stress markers	Change pre-post interventionbiological stress markers registered by blood analyses	15 weeks
Subjective stress	Change pre-post intervention in questionnaires of perceived stress	15 weeks

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Collaborators: University of California, San Diego
• Investigators: Principal Investigator: Olga Puig, PhD, Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2017
• Primary Completion (Anticipated): February 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: August 23, 2017
• First Submitted That Met QC Criteria: August 24, 2017
• First Posted (Actual): August 25, 2017

Study Record Updates

• Last Update Posted (Actual): August 25, 2017
• Last Update Submitted That Met QC Criteria: August 24, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: DN040595

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No