e-Learning & Development of an Evidence-based Psychoeducational Programme for First Episode Psychosis
Condition: Psychosis
MeSH terms: Psychotic Disorders; Mental Disorders
Study type: Interventional

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.
    

Intervention name(s): Control; Individual psychoeducation
Intervention type(s): Other; Other
Intervention description(s): Usual treatment: pharmacological treatment + regular sessions with their psychiatrist.; 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.
Other intervention name(s): Usual treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: First psychotic episode; Individual psychoeducation; Telemedicine; BDNF; Oxidative stress