NCT01433094

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2011

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 13, 2011

Completed
12 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 11, 2017

Status Verified

September 1, 2017

Enrollment Period

3.7 years

First QC Date

August 20, 2011

Last Update Submit

September 6, 2017

Conditions

Patient Non-ComplianceSchizophrenia and Related Disorders

Keywords

AdherencePsychoeducationPharmacotherapySchizophreniaFamily support

Outcome Measures

Primary Outcomes (1)

  • Adherence

    Adherence will be checked with a triple method of assessment: patient's self-report, patient's replies to a four-query interview, and assessment of blood levels of the prescribed drug.

    Change from baseline in adherence to treatment at 6 months

Secondary Outcomes (4)

  • Psychotic symptoms

    Changes from baseline in levels of psychotic symptoms at 6 months, with effects maintained at12 months and 18 months

  • General level of psychopathology

    Changes from baseline in levels of general psychopathology at 6 months, with effects maintained at 12 and 18 months

  • Changes in the social functioning

    Changes from baseline in social functioning at 6 months, maintained at 12 and 18 months

  • Readmission

    Occurrence of episodes of readmission over 27 months

Study Arms (2)

Falloon et al. Psychoeducation Program

EXPERIMENTAL

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

Behavioral: Falloon et al. Psychoeducation Program

Generic Treatment

ACTIVE COMPARATOR

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).

Behavioral: Generic Treatment

Interventions

Falloon et al. Psychoeducation ProgramBEHAVIORAL

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).

Also known as: Family psychoeducation
Falloon et al. Psychoeducation Program
Generic TreatmentBEHAVIORAL

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).

Generic Treatment

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • diagnosis of psychosis in the spectrum of schizophrenia (ICD-10: F20 to F29); -age from 18 to 55;
  • being in care for 2 years or more.

You may not qualify if:

  • mental retardation, or any severe cognitive impairment;
  • psychosis due to substance abuse or to a medical condition;
  • affective psychosis;
  • comorbid substance dependence;
  • patient does not understand Italian language;
  • pharmacotherapy with depot.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Università Degli Studi Di Urbino "Carlo Bo"

Urbino, Urbino/Pesaro, Italy

Location

Università Degli Studi Di Bari

Bari, Italy

Location

Fatebenefratelli Irccs

Brescia, Italy

Location

Azienda Universitaria Ospedaliera Cagliari

Cagliari, Italy

Location

Università Degli Studi Di Cagliari

Cagliari, Italy

Location

Ausl 3 Centro Molise Di Campobasso

Campobasso, Italy

Location

Università Degli Studi Di Catania

Catania, Italy

Location

Azienda Ospedaliera Universitaria Policlinico Martino Di Messina

Messina, Italy

Location

Related Publications (3)

  • Falloon IR, Boyd JL, McGill CW, Williamson M, Razani J, Moss HB, Gilderman AM, Simpson GM. Family management in the prevention of morbidity of schizophrenia. Clinical outcome of a two-year longitudinal study. Arch Gen Psychiatry. 1985 Sep;42(9):887-96. doi: 10.1001/archpsyc.1985.01790320059008.

    PMID: 2864032BACKGROUND

  • Petretto DR, Preti A, Zuddas C, Veltro F, Rocchi MB, Sisti D, Martinelli V, Carta MG, Masala C; SPERA-S group. Study on psychoeducation enhancing results of adherence in patients with schizophrenia (SPERA-S): study protocol for a randomized controlled trial. Trials. 2013 Oct 7;14:323. doi: 10.1186/1745-6215-14-323.

    PMID: 24099414BACKGROUND

  • Petretto DR, Lussu C, Zuddas C, Pistis I, Piras P, Preti A, et al. Meta-Review of Systematic and Meta-Analytic Reviews on Family Psychoeducation for Schizophrenia. Austin J Clin Neurol 2017; 4(2): 1107.

    BACKGROUND

MeSH Terms

Conditions

Patient ComplianceSchizophrenia

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorSchizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • donatella rita petretto, PhD eq

    Department of Psychology, State University of Cagliari

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 20, 2011

First Posted

September 13, 2011

Study Start

September 1, 2012

Primary Completion

May 1, 2016

Study Completion

December 1, 2016

Last Updated

September 11, 2017

Record last verified: 2017-09

Locations

IT(8)