Integrated Psychological Therapy for Chronic Schizophrenia

Chronic Schizophrenia Clinical Trial

Official title: Integrated Psychological Therapy (IPT) + Emotional Management Therapy (EMT) in Chronic Schizophrenia: Study Protocol for a Randomized Controlled Trial

Status Completed

Clinical Trial 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.

Clinical Trial Description

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 (IPT) 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 (EMT) 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.

Discussion: This study provides the description of a clinical trial based on specific psychological intervention (IPT+EMT) for patients with chronic schizophrenia, aiming to improve lasting clinical and functional outcome. ;

Related Conditions & MeSH terms

• Chronic Schizophrenia
• Schizophrenia

• NCT number: NCT03275909
• Study type: Interventional
• Source: Basque Country University
• Status: Completed
• Phase: N/A
• Start date: July 1, 2011
• Completion date: December 31, 2015