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Cognitive Behavioral Social Skills Training in Early Onset Psychosis

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ClinicalTrials.gov Identifier: NCT03261557
Recruitment Status : Recruiting
First Posted : August 25, 2017
Last Update Posted : August 25, 2017
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
Olga Puig, Hospital Clinic of Barcelona

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.


Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Psychosis NOS Behavioral: CBT + SST Behavioral: Psychoeducation, habits and healthy lifestyle Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Social Skills Training in Early-onset Psychosis: Efficacy in Psychotic Symptoms, Psyshosocial Functioning and Neurobiological and Epigenetic Stress Markers.
Actual Study Start Date : February 22, 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03261557


Contacts
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Contact: Olga Puig, PhD 93 227 99 74 opuig@clinic.ub.es

Locations
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Spain
Department of Child and Adolescent Pyshicatry and Psychology Recruiting
Barcelona, Catalunya, Spain, 08036
Contact: Olga Puig, PhD    34 227 ext 99 74    opuig@clinic.ub.es   
Sponsors and Collaborators
Hospital Clinic of Barcelona
University of California, San Diego
Investigators
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Principal Investigator: Olga Puig, PhD Hospital Clinic of Barcelona

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Responsible Party: Olga Puig, Clinical psychologist, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT03261557     History of Changes
Other Study ID Numbers: DN040595
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders