Ignite Creation Date:
2024-05-06 @ 1:20 AM
Last Modification Date:
2024-10-26 @ 11:02 AM
Study NCT ID:
NCT01783457
Status:
COMPLETED
Last Update Posted:
2016-01-26
First Post:
2013-01-23
Brief Title:
e-Learning Development of an Evidence-based Psychoeducational Programme for First Episode Psychosis
Sponsor:
Basque Health Service
Organization:
Basque Health Service
Study Overview
Official Title:
e-Learning Development of an Evidence-based Psychoeducational Programme for First Episode Psychosis
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None