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Clinical Trials/NCT01783457
NCT01783457
Completed
Not Applicable

e-Learning & Development of an Evidence-based Psychoeducational Programme for First Episode Psychosis

Basque Health Service6 sites in 1 country177 target enrollmentJanuary 2011
ConditionsPsychosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Psychosis
Sponsor
Basque Health Service
Enrollment
177
Locations
6
Primary Endpoint
Prognosis of patients.
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

Treatment delay in psychosis usually lead to slower recovery, an increase in associated comorbidity and greater deterioration in social and family life of patients. Previous studies indicate that an early intervention with guidelines for increasing adherence to treatment, disease awareness and condition management leads to better progression of the disorder and is therefore related to a better prognosis.

Several studies have found that the rate of relapse is higher in patients with pharmacological treatment alone compared to those also receiving psychoeducation, who tend to improve their adherence to treatment and reduce toxic drugs dosage.

Hypotheses:

  • Individual psychoeducation will be effective as complementary therapy to pharmacological treatment in patients with a first psychotic episode, improving disease evolution.
  • BDNF levels will increase more in the patients receiving individual therapy compared to those without it.
  • Psychoeducation can be performed similarly in all participating centers if the therapists receive the same training and use the same psychoeducation material.
  • The use of telemedicine for the follow-up of the patients will help improve the welfare work and therefore the disease evolution.

Detailed Description

Treatment delay in psychosis usually lead to slower recovery, an increase in associated comorbidity and greater deterioration in social and family life of patients. Previous studies indicate that an early intervention with guidelines for increasing adherence to treatment, disease awareness and condition management leads to better progression of the disorder and is therefore related to a better prognosis. Several studies have found that the rate of relapse is higher in patients with pharmacological treatment alone compared to those also receiving psychoeducation, who tend to improve their adherence to treatment and reduce toxic drugs dosage. Hypotheses: * Individual psychoeducation will be effective as complementary therapy to pharmacological treatment in patients with a first psychotic episode, improving the disease evolution. * BDNF levels will increase more in the patients receiving individual therapy compared to those without it. * Psychoeducation can be performed similarly in all participating centers if the therapists receive the same training and use the same psychoeducation material. * The use of telemedicine for the follow-up of the patients will help improve the welfare work and therefore the disease evolution. Primary Objective: * To assess the effectiveness of individual psychoeducation together with telemedicine (telephone assistance) as an adjuvant therapy in the pharmacological treatment of patients with first episode psychosis, regarding functionality of patients and positive and negative symptoms. Secondary Objectives: * To analyse certain biological parameters (BDNF and oxidative stress) in both arms (intervention and control) at baseline and during re-assessment (at six months and after completion of treatment). * To analyse the effectiveness of online training of psychotherapists who will provide psychoeducation to patients with first episode psychosis.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
June 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Basque Health Service
Responsible Party
Principal Investigator
Principal Investigator

Ana María González-Pinto

Ph.D. in Medicine, Psychiatrist, Lecturer at University of the Basque Country, Chief of Psychiatry Department at Araba University Hospital

Basque Health Service

Eligibility Criteria

Inclusion Criteria

  • patients who have suffered a first psychotic episode (diagnosis IV-TR) in the last five years,
  • age between 18 and 45 years,
  • patients who have given written informed consent to participate.

Exclusion Criteria

  • patients with a comorbid disorder that interferes with their ability to communicate,
  • patients who received psychoeducation previous to inclusion in study.

Outcomes

Primary Outcomes

Prognosis of patients.

Time Frame: 6 months

To assess the prognosis of patients by registering the number of relapses and the number of psychiatric hospital admissions.

Secondary Outcomes

  • Score on clinical scales assessing functionality.(6 months)
  • Score of participating psychotherapists on a specific test after online training.(6 months)
  • Biological Parameters: blood levels of BDNF.(6 months)
  • Biological Parameters: levels oxidative stress indicators in blood.(6 months)

Study Sites (6)

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