Cognitive Behavioral Social Skills Training in Early Onset Psychosis

Hospital Clinic of Barcelona

Status: Unknown

Conditions: Schizophrenia; Schizoaffective Disorder; Psychosis NOS

Treatments: Behavioral: Psychoeducation, habits and healthy lifestyle; Behavioral: CBT + SST

Study type: Interventional

Funder types: Other

Identifiers

NCT03261557

DN040595

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 12 to 22 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

CBT + SST

Experimental group

Description:

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

Treatment:

Behavioral: CBT + SST

Psychoeducation, habits and healthy lifestyle

Active Comparator group

Description:

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

Treatment:

Behavioral: Psychoeducation, habits and healthy lifestyle