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Completed

NCT Number: NCT01783457

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

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.

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Key information

Conditions

Psychosis Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinic de Barcelona, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control

Other

Usual treatment: pharmacological treatment + regular sessions with their psychiatrist.

Other names: Usual treatment

Individual psychoeducation

Other

Usual treatment + individual psychoeducational programme, consisting of 14 sessions of 60 minutes every other week for six months, focused on improving patient awareness of their condition, adherence to treatment, identification of prodromes, early intervention in potential relapses, anxiety management techniques, social skills, healthy lifestyle habits and problem solving.

Programme of sessions available upon request.

Primary outcomes

  1. 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

  1. Score on clinical scales assessing functionality.

    Time frame: 6 months

    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, using different scales for clinical assessment of FUNCTIONALITY (Positive and Negative Syndrome Scale (PANSS), SUMD, Morisky-Green Scale, STAI, Hamilton Rating scale for Depression, LSAS, WHOQOL-BREF, EuroQoL) and PROGNOSIS (Strauss Carpenter Scale, GAF, Functional Assessment Staging Test-FAST).

  2. Score of participating psychotherapists on a specific test after online training.

    Time frame: 6 months

    To analyse the effectiveness of online training of psychotherapist who will provide psychoeducation to patients, all therapists carried out a specific tests after each one of the sessions to confirm if they had delivered the session as specified in the protocol.

  3. Biological Parameters: blood levels of BDNF.

    Time frame: 6 months

    To analyse BDNF biological parameter at baseline and during re-assessment at six months (after completion of treatment): BDNF levels in plasma will be measured by ELISA techniques with a kit based on the Sandwich technique used according to the manufacturer´s instructions (CYT306 from Chemicon). The standard curves will be characterised using plasma duplicates and the absorption determined with a microplate reader (BIO-TEK, Sinergy HT) using a wavelength of 450 nm.

  4. Biological Parameters: levels oxidative stress indicators in blood.

    Time frame: 6 months

    To analyse OXIDATIVE STRESS indicators at baseline and during re-assessment at six months (after completion of treatment): Levels of the following OXIDATIVE STRESS INDICATORS will be measured in red blood cell haemolysates: lipid peroxidation (TBARS), nitrites and superoxide dismutase enzyme, total antioxidant ability, glutathione peroxidase and catalase.

Sponsors and collaborators

Lead sponsor

Basque Health Service

Other Gov

Collaborators

  • Carlos III Health Institute

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Feb 5, 2013
Registry last updated
Jan 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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