Study on Psychoeducation Enhancing Results of Adherence in Schizophrenia
Condition: Patient Non-Compliance; Schizophrenia and Related Disorders
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Background: Psychosis in the spectrum of schizophrenia (PSS) are severe mental disorders,
      with a high impact on disability and participation. Poor adherence to pharmacotherapy
      negatively impacts on the course and outcome of PSS.

      Non-adherence in these patients is 41 to 50%, and it is predictive of a higher risk of
      relapse and readmission up to 5-time higher than in adherent patients. Falloon et al.
      developed a Psychoeducation Program (FPP) aimed at improving communication and
      problem-solving abilities in patients and their families. Past studies reported a
      statistically significant reduction of the risk of relapse in patients receiving the FPP, but
      did not take into account effects on adherence.

      Objectives: To evaluate changes in adherence to pharmacotherapy in a sample of patients
      diagnosed with PSS (ICD-10: F20 to F29), by comparing a group exposed to the FPP with another
      group exposed to a treatment with generic informative prospects on the disorders provided
      with same attendance frequency as the FPP (Generic Treatment - GT).

      Methods: 340 patients with PSS, from 10 participating units distributed in the territory of
      the Italian National Health System, will be enrolled, with allocation 1:1. The sample will be
      randomized into an exposed group (to FPP) and an unexposed group. Adherence will be assessed
      on a three-monthly basis with blood levels of the primary prescribed drug by High Pressure
      Liquid Chromatography, with a self-report, the Medication Adherence Questionnaire, and
      concurrently with the administration of a 4-item interview, based on a modified version of
      the Adherence Interview. Survival analyses will be performed using Kaplan-Meier method,
      followed by Log-rank test, defining as terminal events both the start of non-adherence and/or
      the first relapse or readmission episode. Intention-to-treat will be applied in considering
      the primary and secondary outcomes. Multiple imputations will be applied to integrate missing
      data.

      Expected results: Median prevalence of non-adherence to pharmacotherapy in patients already
      in contact with a psychiatric service is 47%; effect size of psychosocial treatment on
      various outcomes, including relapse, readmission and adherence to drug is 0.48 of the
      standard deviation (SD), with 95% C.I.=0.10 to 0.85. The intervention is expected to produce
      a change in the prevalence of non-adherence to drug in the exposed group with an effect size
      of 0.45 SD.
    


Intervention name(s): Falloon et al. Psychoeducation Program; Generic Treatment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention aims to improve communication and problem-solving abilities in patients and their families by sessions focused on: assessment of the individual's and the family's strengths, weaknesses, and goals; education about schizophrenia and treatment; communication skills training; problem-solving training; and special problems (Falloon et al. 1985). Treatment sessions are provided on a weekly basis for months (1 hour for each session) (groups of about 8-9 persons - patients and caregivers).; The comparator is a treatment with generic informative prospect on the disorders and with the same frequencies as the Intervention. Treatment sessions are provided on a weekly basis for 6 months (1 hour for each session) (groups of about 8-9 persons - patients and caregivers).
Other intervention name(s): Family psychoeducation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adherence; Psychoeducation; Pharmacotherapy; Schizophrenia; Family support