Integrated Psychological Therapy for Chronic Schizophrenia

NCT03275909 | Completed DMC

• 1 other identifier: PSI2011-27590
• Study Type: interventional
• Target: 77
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Chronic schizophrenia; Emotional Management Therapy; Integrated Psychological Therapy

Outcome Measures

Primary Outcomes (1)

• Frankfurt Complaint Questionnaire (FBF-3)

  (Assessing change)This is a self-report test composed of 98 items measuring the presence of the "basic" symptoms of schizophrenia. These are subjectively experienced disturbances at different domains including perception, thought, processing, language and attention that it could be the neurobiological features of schizophrenia. It contains 10 subscales and 4 factors. We will use a validated version for the Spanish population, in which Cronbach's alpha was above .95 and the test-retest reliability was above .60

  Pretreatment-Posttreatment (8months)-1 month-3 months-6 months-12 months follow-up

Secondary Outcomes (5)

• Screen for Cognitive Impairment in Psychiatry (SCIP)

  Pretreatment-Posttreatment (8 months)-1 month-3 months-6 months-12 months follow-up

• Wechsler Adult Intelligence Scale-Third Edition (WAIS-III)

  Pretreatment-Posttreatment (8 months)-1 month-3 months-6 months-12 months follow-up

• Wisconsin Card Sorting Test (WCST)

  Pretreatment-Posttreatment (8 months)-1 month-3 months-6 months-12 months follow-up

• Social Functioning Scale (SFS)

  Pretreatment-Posttreatment-1 month (8 months)-3 months-6 months-12 months follow-up

• Lancashire Quality of Life Profile (LQoLP)

  Pretreatment-Posttreatment (8 months)-1 month-3 months-6 months-12 months follow-up

Study Arms (2)

Study procedure

EXPERIMENTAL

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

Behavioral: Integrated Psychological Therapy

Treatment as usual

NO INTERVENTION

The treatment as usual is pharmacological treatment and activities in a Day Care Center.

Interventions

Integrated Psychological Therapy BEHAVIORAL

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

Also known as: Emotional Management Therapy

Study procedure

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having ≥ 5 years since disease onset and aged between 25 and 65 years.
• Being in a stable phase of the illness and under psychopharmacological treatment.
• Having negative or attenuated positive symptoms.
• Failing to achieve premorbid functioning in terms of education, work and/or social life.
• Agreeing to participate in the study and giving written informed consent.

You may not qualify if:

• \. Presenting organic brain pathology. 2. Presenting intellectual developmental disorder according to DSM-5 criteria.

Sponsors & Collaborators

• University of the Basque Country (UPV/EHU): lead
• Ministerio de Economía y Competitividad, Spain: collaborator

Study Officials

• Karmele Salaberria, Ph.D

  Lecturer of School of Psychology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd.-Lecturer

Study Record Dates

• First Submitted: July 10, 2017
• First Posted: September 8, 2017
• Study Start: July 1, 2011
• Primary Completion: July 30, 2013
• Study Completion: December 31, 2015
• Last Updated: September 8, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 2011/2017
• Access Criteria: Researchers