Integrated Psychological Therapy for Chronic Schizophrenia
Condition: Chronic Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Integrated Psychological Therapy
Intervention type(s): Behavioral
Intervention description(s): 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
Other intervention name(s): Emotional Management Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic schizophrenia; Emotional Management Therapy; Integrated Psychological Therapy