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Completed

NCT Number: NCT03261557

Cognitive Behavioral Social Skills Training in Early Onset Psychosis

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.

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Key information

Age range

12 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Child and Adolescent Pyshicatry and Psychology

Barcelona, Catalonia, 08036, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CBT + SST

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

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.

Primary outcomes

  1. Psychosocial functioning

    Time frame: 15 weeks

    Change from baseline in social functioning questionnaires

  2. Clinical symptoms

    Time frame: 15 weeks

    Change from baseline in Clinical scales

Secondary outcomes

  1. Biological stress markers

    Time frame: 15 weeks

    Change pre-post interventionbiological stress markers registered by blood analyses

  2. Subjective stress

    Time frame: 15 weeks

    Change pre-post intervention in questionnaires of perceived stress

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

  • University of California, San Diego

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 25, 2017
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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