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

Psychosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01783457
• Other study ID #: PsychEd-FEP
• Status: Completed
• Phase: N/A
• First received: January 23, 2013
• Last updated: January 25, 2016
• Start date: January 2011
• Est. completion date: June 2015

Study information

• Verified date: January 2016
• Source: Basque Health Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders

Intervention

Other:
• Control
Usual treatment: pharmacological treatment + regular sessions with their psychiatrist.
• 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.

Locations

Country	Name	City	State
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Universidad del País Vasco	Bilbao	Vizcaya
Spain	Hospital Universitario de Bellvitge	Hospitalet Llobregat	Barcelona
Spain	Fundación Clínico Valencia INCLIVA	Valencia
Spain	Universidad de Valencia	Valencia
Spain	Araba University Hospital-Santiago	Vitoria	Álava

Sponsors (2)

Lead Sponsor	Collaborator
Basque Health Service	Carlos III Health Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prognosis of patients.	To assess the prognosis of patients by registering the number of relapses and the number of psychiatric hospital admissions.	6 months	No
Secondary	Score on clinical scales assessing functionality.	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).	6 months	No
Secondary	Score of participating psychotherapists on a specific test after online training.	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.	6 months	No
Secondary	Biological Parameters: blood levels of BDNF.	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.	6 months	No
Secondary	Biological Parameters: levels oxidative stress indicators in blood.	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.	6 months	No