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Integrated Psychological Therapy for Chronic Schizophrenia

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ClinicalTrials.gov Identifier: NCT03275909
Recruitment Status : Completed
First Posted : September 8, 2017
Last Update Posted : September 8, 2017
Sponsor:
Collaborator:
Ministerio de Economía y Competitividad, Spain
Information provided by (Responsible Party):
Karmele Salaberria Irizar, Basque Country University

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.


Condition or disease Intervention/treatment Phase
Chronic Schizophrenia Behavioral: Integrated Psychological Therapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Integrated Psychological Therapy (IPT) + Emotional Management Therapy (EMT) in Chronic Schizophrenia: Study Protocol for a Randomized Controlled Trial
Actual Study Start Date : July 1, 2011
Actual Primary Completion Date : July 30, 2013
Actual Study Completion Date : December 31, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Study procedure
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
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 Name: Emotional Management Therapy

No Intervention: Treatment as usual
The treatment as usual is pharmacological treatment and activities in a Day Care Center.



Primary Outcome Measures :
  1. Frankfurt Complaint Questionnaire (FBF-3) [ Time Frame: Pretreatment-Posttreatment (8months)-1 month-3 months-6 months-12 months follow-up ]
    (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


Secondary Outcome Measures :
  1. Screen for Cognitive Impairment in Psychiatry (SCIP) [ Time Frame: Pretreatment-Posttreatment (8 months)-1 month-3 months-6 months-12 months follow-up ]
    (Assessing change)This test assesses cognitive impairment through five areas: immediate and delayed verbal learning, working memory, verbal fluency and information processing speed. It is used for identifying cognitive impairment. The test-retest reliability ranged from 74 to 90 and Cronbach's alpha was 73.

  2. Wechsler Adult Intelligence Scale-Third Edition (WAIS-III) [ Time Frame: Pretreatment-Posttreatment (8 months)-1 month-3 months-6 months-12 months follow-up ]
    (Assessing change)Short forms of this scale have been designed for patients with schizophrenia . It assess cognitive functioning. Scores on these short forms are correlated (0.91) with the overall intelligence quotient (IQ) of the full scale in clinical patients.

  3. Wisconsin Card Sorting Test (WCST) [ Time Frame: Pretreatment-Posttreatment (8 months)-1 month-3 months-6 months-12 months follow-up ]
    (Assessing change)This test assesses attention span, planning and execution, and hence is considered a valid measure of executive function. We used the version of the test standardised and benchmarked for the Spanish population by TEA Editions.

  4. Social Functioning Scale (SFS) [ Time Frame: Pretreatment-Posttreatment-1 month (8 months)-3 months-6 months-12 months follow-up ]
    (Assessing change)We will use the short version of the scale, validated in a Spanish clinical sample, with a Cronbach's alpha of 0.76.

  5. Lancashire Quality of Life Profile (LQoLP) [ Time Frame: Pretreatment-Posttreatment (8 months)-1 month-3 months-6 months-12 months follow-up ]
    (Assessing change)This instrument assesses patient satisfaction with various aspects of their life, work, leisure time, religion, finances, living situation, safety, family relations, social relations, and health, as well as global wellbeing and self-esteem.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03275909


Sponsors and Collaborators
Basque Country University
Ministerio de Economía y Competitividad, Spain
Investigators
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Principal Investigator: Karmele Salaberria, Ph.D Lecturer of School of Psychology
  Study Documents (Full-Text)

Documents provided by Karmele Salaberria Irizar, Basque Country University:
Informed Consent Form  [PDF] July 30, 2013
Statistical Analysis Plan  [PDF] July 30, 2013
Study Protocol  [PDF] July 30, 2013


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Responsible Party: Karmele Salaberria Irizar, Phd.-Lecturer, Basque Country University
ClinicalTrials.gov Identifier: NCT03275909     History of Changes
Other Study ID Numbers: PSI2011-27590
First Posted: September 8, 2017    Key Record Dates
Last Update Posted: September 8, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: to share the study protocol and the clinical study report
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: 2011/2017
Access Criteria: Researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karmele Salaberria Irizar, Basque Country University:
Chronic schizophrenia
Emotional Management Therapy
Integrated Psychological Therapy
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders