Clinical trial NCT01783457: e-Learning & Development of an Evidence-based Psychoeducational Programme for First Episode Psychosis
Official title: e-Learning & Development of an Evidence-based Psychoeducational Programme for First Episode Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychosis
Keywords: First psychotic episode
Individual psychoeducation
Telemedicine
BDNF
Oxidative stress
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
Collaborators: name: Carlos III Health Institute
First posted: 2013-02-05
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Prognosis of patients.
timeFrame: 6 months
Secondary outcomes:
measure: Score on clinical scales assessing functionality.
timeFrame: 6 months
measure: Score of participating psychotherapists on a specific test after online training.
timeFrame: 6 months
measure: Biological Parameters: blood levels of BDNF.
timeFrame: 6 months
measure: Biological Parameters: levels oxidative stress indicators in blood.
timeFrame: 6 months
Other outcomes:
Locations:
city: Hospitalet Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
state: Barcelona
city: Bilbao
country: Spain
facility: Universidad del País Vasco
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Valencia
country: Spain
facility: Fundación Clínico Valencia INCLIVA
city: Valencia
country: Spain
facility: Universidad de Valencia
city: Vitoria
country: Spain
facility: Araba University Hospital-Santiago
state: Álava
Study officials:
affiliation: Santiago Hospital - Basque Health Service
name: Patricia Vega, Psychologist
role: STUDY_CHAIR
References:
citation: 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.