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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03261557
Other study ID # DN040595
Secondary ID
Status Recruiting
Phase N/A
First received August 23, 2017
Last updated August 24, 2017
Start date February 22, 2017
Est. completion date September 2020

Study information

Verified date August 2017
Source Hospital Clinic of Barcelona
Contact Olga Puig, PhD
Phone 93 227 99 74
Email opuig@clinic.ub.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date September 2020
Est. primary completion date February 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 22 Years
Eligibility 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.

Study Design


Intervention

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.
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.

Locations

Country Name City State
Spain Department of Child and Adolescent Pyshicatry and Psychology Barcelona Catalunya

Sponsors (2)

Lead Sponsor Collaborator
Hospital Clinic of Barcelona University of California, San Diego

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Psychosocial functioning Change from baseline in social functioning questionnaires 15 weeks
Primary Clinical symptoms Change from baseline in Clinical scales 15 weeks
Secondary Biological stress markers Change pre-post interventionbiological stress markers registered by blood analyses 15 weeks
Secondary Subjective stress Change pre-post intervention in questionnaires of perceived stress 15 weeks
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