NCT03261557

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

August 25, 2017

Status Verified

August 1, 2017

Enrollment Period

2.9 years

First QC Date

August 23, 2017

Last Update Submit

August 24, 2017

Conditions

SchizophreniaSchizoaffective DisorderPsychosis NOS

Outcome Measures

Primary Outcomes (2)

  • Psychosocial functioning

    Change from baseline in social functioning questionnaires

    15 weeks

  • Clinical symptoms

    Change from baseline in Clinical scales

    15 weeks

Secondary Outcomes (2)

  • Biological stress markers

    15 weeks

  • Subjective stress

    15 weeks

Study Arms (2)

CBT + SST

EXPERIMENTAL

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

Behavioral: CBT + SST

Psychoeducation, habits and healthy lifestyle

ACTIVE COMPARATOR

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

Behavioral: Psychoeducation, habits and healthy lifestyle

Interventions

CBT + SSTBEHAVIORAL

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.

CBT + SST
Psychoeducation, habits and healthy lifestyleBEHAVIORAL

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.

Psychoeducation, habits and healthy lifestyle

Eligibility Criteria

Age12 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • IQ \<70
  • Toxic dependence comorbid disorder
  • Presence of Neurological disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Child and Adolescent Pyshicatry and Psychology

Barcelona, Catalonia, 08036, Spain

RECRUITING

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersMental Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

  • Olga Puig, PhD

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olga Puig, PhD

CONTACT

93 227 99 74opuig@clinic.ub.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical psychologist

Study Record Dates

First Submitted

August 23, 2017

First Posted

August 25, 2017

Study Start

February 22, 2017

Primary Completion

February 1, 2020

Study Completion

September 1, 2020

Last Updated

August 25, 2017

Record last verified: 2017-08

Locations

ES(1)