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

Primary Purpose

Psychosis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Control
Individual psychoeducation
Sponsored by
Basque Health Service
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis focused on measuring First psychotic episode, Individual psychoeducation, Telemedicine, BDNF, Oxidative stress

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Universitario de Bellvitge
  • Universidad del País Vasco
  • Hospital Clinic de Barcelona
  • Fundación Clínico Valencia INCLIVA
  • Universidad de Valencia
  • Araba University Hospital-Santiago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Individual psychoeducation

Control

Arm 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.

Usual treatment

Outcomes

Primary Outcome Measures

Prognosis of patients.
To assess the prognosis of patients by registering the number of relapses and the number of psychiatric hospital admissions.

Secondary Outcome Measures

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).
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.
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.
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.

Full Information

First Posted
January 23, 2013
Last Updated
January 25, 2016
Sponsor
Basque Health Service
Collaborators
Carlos III Health Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01783457
Brief Title
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

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Basque Health Service
Collaborators
Carlos III Health Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis
Keywords
First psychotic episode, Individual psychoeducation, Telemedicine, BDNF, Oxidative stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
177 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individual psychoeducation
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Usual treatment
Intervention Type
Other
Intervention Name(s)
Control
Other Intervention Name(s)
Usual treatment
Intervention Description
Usual treatment: pharmacological treatment + regular sessions with their psychiatrist.
Intervention Type
Other
Intervention Name(s)
Individual psychoeducation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Prognosis of patients.
Description
To assess the prognosis of patients by registering the number of relapses and the number of psychiatric hospital admissions.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Score on clinical scales assessing functionality.
Description
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).
Time Frame
6 months
Title
Score of participating psychotherapists on a specific test after online training.
Description
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.
Time Frame
6 months
Title
Biological Parameters: blood levels of BDNF.
Description
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.
Time Frame
6 months
Title
Biological Parameters: levels oxidative stress indicators in blood.
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Vega, Psychologist
Organizational Affiliation
Santiago Hospital - Basque Health Service
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Universitario de Bellvitge
City
Hospitalet Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Universidad del País Vasco
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48940
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Fundación Clínico Valencia INCLIVA
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Universidad de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Araba University Hospital-Santiago
City
Vitoria
State/Province
Álava
ZIP/Postal Code
01004
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
25348346
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.
Results Reference
derived

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

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