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

Basque Health Service

Status: Completed

Conditions: Psychosis

Treatments: Other: Control; Other: Individual psychoeducation

Study type: Interventional

Funder types: Other

Identifiers

NCT01783457

PsychEd-FEP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 177 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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177 participants in 2 patient groups

Individual psychoeducation

Experimental group

Description:

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.

Treatment:

Other: Individual psychoeducation

Control

Active Comparator group

Description:

Usual treatment

Treatment:

Other: Control