Clinical trial NCT03261557: Cognitive Behavioral Social Skills Training in Early Onset Psychosis
Official title: Cognitive Behavioral Social Skills Training in Early-onset Psychosis: Efficacy in Psychotic Symptoms, Psyshosocial Functioning and Neurobiological and Epigenetic Stress Markers.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Psychosis NOS
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: University of California, San Diego
First posted: 2017-08-25
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Psychosocial functioning
timeFrame: 15 weeks
measure: Clinical symptoms
timeFrame: 15 weeks
Secondary outcomes:
measure: Biological stress markers
timeFrame: 15 weeks
measure: Subjective stress
timeFrame: 15 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Department of Child and Adolescent Pyshicatry and Psychology
state: Catalunya
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Olga Puig, PhD
role: PRINCIPAL_INVESTIGATOR
References: