Cognitive Behavioral Social Skills Training in Early Onset Psychosis

NCT ID: NCT03261557

Last Updated: 2017-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-22
• Study Completion Date: 2020-09-30

Brief 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.

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.

Conditions

Schizophrenia; Schizoaffective Disorder; Psychosis NOS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CBT + SST

The treatment group will receive the intervention according to the CBSST protocol, adapted to adolescents.

Group Type: EXPERIMENTAL

CBT + SST

Intervention Type: BEHAVIORAL

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

The control group will receive 3 modules intervention: psychoeducation, habits and healthy lifestyle.

Group Type: ACTIVE_COMPARATOR

Psychoeducation, habits and healthy lifestyle

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Diego

OTHER

Sponsor Role: collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Olga Puig

Clinical psychologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Olga Puig, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Locations

Department of Child and Adolescent Pyshicatry and Psychology

Barcelona, Catalonia, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Olga Puig, PhD

Role: CONTACT

opuig@clinic.ub.es

93 227 99 74

Facility Contacts

Olga Puig, PhD

Role: primary

opuig@clinic.ub.es

34 227 ext. 99 74

Other Identifiers

DN040595

Identifier Type: -

Identifier Source: org_study_id