search
Back to results

Cognitive Behavioral Social Skills Training in Early Onset Psychosis

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Psychosis NOS

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
CBT + SST
Psychoeducation, habits and healthy lifestyle
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

12 Years - 22 Years (Child, Adult)All SexesAccepts 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.

Sites / Locations

  • Department of Child and Adolescent Pyshicatry and PsychologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CBT + SST

Psychoeducation, habits and healthy lifestyle

Arm Description

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

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

Outcomes

Primary Outcome Measures

Psychosocial functioning
Change from baseline in social functioning questionnaires
Clinical symptoms
Change from baseline in Clinical scales

Secondary Outcome Measures

Biological stress markers
Change pre-post interventionbiological stress markers registered by blood analyses
Subjective stress
Change pre-post intervention in questionnaires of perceived stress

Full Information

First Posted
August 23, 2017
Last Updated
August 24, 2017
Sponsor
Hospital Clinic of Barcelona
Collaborators
University of California, San Diego
search

1. Study Identification

Unique Protocol Identification Number
NCT03261557
Brief Title
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

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 22, 2017 (Actual)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
Collaborators
University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Psychosis NOS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBT + SST
Arm Type
Experimental
Arm Description
The treatment group will receive the intervention according to the CBSST protocol, adapted to adolescents.
Arm Title
Psychoeducation, habits and healthy lifestyle
Arm Type
Active Comparator
Arm Description
The control group will receive 3 modules intervention: psychoeducation, habits and healthy lifestyle.
Intervention Type
Behavioral
Intervention Name(s)
CBT + SST
Intervention Description
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
Intervention Name(s)
Psychoeducation, habits and healthy lifestyle
Intervention Description
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 Measure Information:
Title
Psychosocial functioning
Description
Change from baseline in social functioning questionnaires
Time Frame
15 weeks
Title
Clinical symptoms
Description
Change from baseline in Clinical scales
Time Frame
15 weeks
Secondary Outcome Measure Information:
Title
Biological stress markers
Description
Change pre-post interventionbiological stress markers registered by blood analyses
Time Frame
15 weeks
Title
Subjective stress
Description
Change pre-post intervention in questionnaires of perceived stress
Time Frame
15 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olga Puig, PhD
Phone
93 227 99 74
Email
opuig@clinic.ub.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olga Puig, PhD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Child and Adolescent Pyshicatry and Psychology
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olga Puig, PhD
Phone
34 227
Ext
99 74
Email
opuig@clinic.ub.es

12. IPD Sharing Statement

Learn more about this trial

Cognitive Behavioral Social Skills Training in Early Onset Psychosis

We'll reach out to this number within 24 hrs