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Integrated Psychological Therapy for Chronic Schizophrenia

NCT03275909 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2017-09-08

No results posted yet for this study

Summary

Background: The chronic phase of schizophrenia (CS) that extremely affects the way people think, feel and act, underlines the need for effective interventions in patients affected by this disorder. The Integrated Psychological Therapy appears in clinical practice guidelines as the reference therapy in the treatment of this type of patients. In this paper authors propose to include in this program a new module focused on Emotional Management Therapy in order to reinforce its effectiveness. The aim of this study is to describe the design of a study protocol for a randomized controlled trial in which the objective is to assess the efficacy of this modified IPT program in patients with CS compared to treatment as usual (pharmacological treatment and social and leisure activities in a Day Care Center).

Methods/design: This is a randomized study with pre and post-treatment assessment and with a 6- and 12-month follow-up. Patients are to be randomly assigned to one of two treatments: (1) a experimental group: integrated psychological therapy in conjunction with emotional management therapy (IPT+EMT), composed of 2-hour biweekly 60 group sessions for 32 weeks, in addition to the treatment as usual (TAU), or (2) a control group (treatment as usual). Participants in both groups will be evaluated at baseline (pre-treatment) and at post-treatment after 8 months. The primary outcome will be that patients in the experimental group will show a greater improvement over participants in the control group in reducing symptoms and increasing emotional abilities, as well as in improving their quality of life. The secondary outcome will be that these results will maintain at the 6- and 12-month follow-up in the experimental group.

Conditions

  • Chronic Schizophrenia

Interventions

BEHAVIORAL

Integrated Psychological Therapy

The psychological treatment includes 50 sessions of integrated psychological therapy focused on attentional skills, social perception skills, verbal communication skills, social skills and interpersonal problems solving skills and 10 sessions of specific emotional management therapy , designed for this research. and based on the contents developed by Hodel, Kern and Brenner

Sponsors & Collaborators

  • Ministerio de Economía y Competitividad, Spain

    collaborator OTHER_GOV

  • University of the Basque Country (UPV/EHU)

    lead OTHER

Principal Investigators

  • Karmele Salaberria, Ph.D · Lecturer of School of Psychology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-01
Primary Completion
2013-07-30
Completion
2015-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03275909 on ClinicalTrials.gov