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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Basque Health Service
Sponsor:
Collaborator:
Carlos III Health Institute
Information provided by (Responsible Party):
Ana María González-Pinto, Basque Health Service
ClinicalTrials.gov Identifier:
NCT01783457
First received: January 23, 2013
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

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.

Condition Intervention
Psychosis
Other: Control
Other: Individual psychoeducation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: e-Learning & Development of an Evidence-based Psychoeducational Programme for First Episode Psychosis

Resource links provided by NLM:


Further study details as provided by Basque Health Service:

Primary Outcome Measures:
  • Prognosis of patients. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To assess the prognosis of patients by registering the number of relapses and the number of psychiatric hospital admissions.


Secondary Outcome Measures:
  • Score on clinical scales assessing functionality. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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).

  • Score of participating psychotherapists on a specific test after online training. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Biological Parameters: blood levels of BDNF. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Biological Parameters: levels oxidative stress indicators in blood. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 260
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Individual psychoeducation
Usual treatment + individual psychoeducational intervention (14 sessions). The psychoeducational programme consists 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.
Other: Individual psychoeducation

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.

Active Comparator: Control
Usual treatment
Other: Control
Usual treatment: pharmacological treatment + regular sessions with their psychiatrist.
Other Name: Usual treatment

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.
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01783457

Contacts
Contact: Ana María González-Pinto, Psychiatrist +34 945 007617 ANAMARIA.GONZALEZ-PINTOARRILLAGA@osakidetza.net

Locations
Spain
Hospital Universitario de Bellvitge Recruiting
Hospitalet Llobregat, Barcelona, Spain, 08907
Contact: Jose Manuel Crespo       jmcrespo@bellvitgehospital.cat   
Principal Investigator: Jose Manuel Crespo         
Universidad del País Vasco Active, not recruiting
Bilbao, Vizcaya, Spain, 48940
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Francesc Colom       FCOLOM@clinic.ub.es   
Principal Investigator: Francesc Colom         
Fundación Clínico Valencia INCLIVA Recruiting
Valencia, Spain, 46010
Contact: Ester Lorente       esterlorente@hotmail.com   
Principal Investigator: Ester Lorente         
Universidad de Valencia Recruiting
Valencia, Spain, 46010
Contact: Vicent Balanzá       Vicente.Balanza@uv.es   
Principal Investigator: Vicent Balanzá         
Araba University Hospital-Santiago Recruiting
Vitoria, Álava, Spain, 01004
Contact: Ana María González-Pinto, Psychiatrist    +34 945 007617    ANAMARIA.GONZALEZ-PINTOARRILLAGA@osakidetza.net   
Contact: Patricia Vega, Psychologist    +34 945 007617    PATRICIA.VEGAPEREZ@osakidetza.net   
Principal Investigator: Ana María González-Pinto, Psychiatrist         
Sponsors and Collaborators
Basque Health Service
Carlos III Health Institute
Investigators
Study Chair: Patricia Vega, Psychologist Santiago Hospital - Basque Health Service
  More Information

No publications provided

Responsible Party: 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
ClinicalTrials.gov Identifier: NCT01783457     History of Changes
Other Study ID Numbers: PsychEd-FEP
Study First Received: January 23, 2013
Last Updated: February 1, 2013
Health Authority: Spain: Ethics Committee

Keywords provided by Basque Health Service:
First psychotic episode
Individual psychoeducation
Telemedicine
BDNF
Oxidative stress

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on August 21, 2014