e-Learning & Development of an Evidence-based Psychoeducational Programme for First Episode Psychosis
1 other identifier
interventional
177
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2011
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 23, 2013
CompletedFirst Posted
Study publicly available on registry
February 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedJanuary 26, 2016
January 1, 2016
4.4 years
January 23, 2013
January 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prognosis of patients.
To assess the prognosis of patients by registering the number of relapses and the number of psychiatric hospital admissions.
6 months
Secondary Outcomes (4)
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 Arms (2)
Individual psychoeducation
EXPERIMENTALUsual 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.
Control
ACTIVE COMPARATORUsual treatment
Interventions
Usual treatment: pharmacological treatment + regular sessions with their psychiatrist.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- patients with a comorbid disorder that interferes with their ability to communicate,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Basque Health Servicelead
- Carlos III Health Institutecollaborator
Study Sites (6)
Hospital Clinic de Barcelona
Barcelona, Barcelona, 08036, Spain
Hospital Universitario de Bellvitge
Hospitalet Llobregat, Barcelona, 08907, Spain
Fundación Clínico Valencia INCLIVA
Valencia, Valencia, 46010, Spain
Universidad de Valencia
Valencia, Valencia, 46010, Spain
Universidad del País Vasco
Bilbao, Vizcaya, 48940, Spain
Araba University Hospital-Santiago
Vitoria-Gasteiz, Álava, 01004, Spain
Related Publications (1)
Barbeito S, Vega P, Ruiz de Azua S, Balanza-Martinez V, Colom F, Lorente E, Luengo A, Cerrillo E, Crespo JM, Gonzalez Pinto A. Integrated treatment of first episode psychosis with online training (e-learning): study protocol for a randomised controlled trial. Trials. 2014 Oct 27;15:416. doi: 10.1186/1745-6215-15-416.
PMID: 25348346DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Patricia Vega, Psychologist
Santiago Hospital - Basque Health Service
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ph.D. in Medicine, Psychiatrist, Lecturer at University of the Basque Country, Chief of Psychiatry Department at Araba University Hospital
Study Record Dates
First Submitted
January 23, 2013
First Posted
February 5, 2013
Study Start
January 1, 2011
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
January 26, 2016
Record last verified: 2016-01