Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2025-12-31 @ 8:13 AM
Study NCT ID:
NCT01783457
Status:
COMPLETED
Last Update Posted:
2016-01-26
First Post:
2013-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
e-Learning & Development of an Evidence-based Psychoeducational Programme for First Episode Psychosis
Sponsor:
Basque Health Service
Organization:
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:
False
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?: