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

NCT ID: NCT01783457

Last Updated: 2016-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 177 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2015-06-30

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.

Conditions

Psychosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Individual psychoeducation

Intervention Type: 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.

Control

Usual treatment

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

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

Interventions

Control

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

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Usual treatment

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carlos III Health Institute

OTHER_GOV

Sponsor Role: collaborator

Basque Health Service

OTHER_GOV

Sponsor Role: lead

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patricia Vega, Psychologist

Role: STUDY_CHAIR

Santiago Hospital - Basque Health Service

Locations

Hospital Clinic de Barcelona

Barcelona, Barcelona, Spain

Hospital Universitario de Bellvitge

Hospitalet Llobregat, Barcelona, Spain

Fundación Clínico Valencia INCLIVA

Valencia, Valencia, Spain

Universidad de Valencia

Valencia, Valencia, Spain

Universidad del País Vasco

Bilbao, Vizcaya, Spain

Araba University Hospital-Santiago

Vitoria-Gasteiz, Álava, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 25348346 (View on PubMed)

Other Identifiers

PsychEd-FEP

Identifier Type: -

Identifier Source: org_study_id