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Trial record 6 of 846 for:    Not yet recruiting Studies | Psychotic Disorders

Assessment of Efficacy of a Psychological Therapy in Inpatients With a Schizophrenic Psychosis (CBTSZ)

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ClinicalTrials.gov Identifier: NCT03316664
Recruitment Status : Not yet recruiting
First Posted : October 20, 2017
Last Update Posted : October 20, 2017
Sponsor:
Information provided by (Responsible Party):
Stephan T. Egger, Psychiatric University Hospital, Zurich

Brief Summary:
This randomised three-arm study aims to evaluate the efficacy and feasibility of a cognitive behavioral therapy (INT-Integrated Neurocognitive Therapy for Schizophrenia Patients) in the treatment of schizophrenia patients in an inpatient setting. The intervention will be compared with an active comparator (IPT- Integrated Psychological Therapy) and a control condition. Overall the study will include 90 patients (30 in each arm). Each patient will receive at least 16 sessions of the respective treatment. Baseline and follow up assessments up to 12 months after the intervention will investigate the stability of treatment.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Psychotic Disorders Behavioral: Integrated Neurocognitive Therapy (INT) Behavioral: Integrated Psychological Therapy (IPT) Other: COGPACK Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: An 8-week, randomized, controlled, assessor-blind, three-parallel-arm trial is planned with patients diagnosed with a schizophrenic psychosis.
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of Efficacy of a Psychological Therapy in Inpatients With a Schizophrenic Psychosis
Estimated Study Start Date : December 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: INT
Integrated Neurocognitive Therapy (INT) is a manualized psychological intervention that consists of 30 sessions administered by a therapist and a co-therapist in an open group of 6-8 patients. Sessions will take place twice a week, and each session should last 90 min.
Behavioral: Integrated Neurocognitive Therapy (INT)
Information already included in arm/group description.

Active Comparator: IPT
Integrated Psychological Therapy (IPT) is a manualized psychological intervention that consists of 5 modules which can be completed in a variable number of sessions that will be administered by a therapist and a co-therapist in an open group of 6- 8 patients. Sessions will take place twice a week, and each session should last 60 to 90 min.
Behavioral: Integrated Psychological Therapy (IPT)
Information already included in arm/group description.

CoC
COGPACK is a computer-based neuropsychological cognitive training program. It will be administered by a trainer in an open group of 6- 8 patients. Sessions will take place twice a week, and each session will last 45 - 60 minutes.
Other: COGPACK
Information already included in arm/group description.




Primary Outcome Measures :
  1. Change from Baseline Symptomatology at 12 Months. [ Time Frame: Baseline, 2 Weeks, 10 Weeks, 6 Months, and 12 Months. ]
    The "Positive and Negative Syndrome Scale" (PANSS) was designed to measure the severity of psychopathology in adult patients with a psychotic disorder, mainly schizophrenia and schizoaffective disorder.


Secondary Outcome Measures :
  1. Change from Baseline Symptomatology at 12 Months. [ Time Frame: Baseline, 2 Weeks, 10 Weeks, 6 Months, and 12 Months. ]
    The Mini-ICF (mICF) was developed to classify disorders according to the level of functioning and capacity in an abbreviated version.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants are competent to give informed consent.
  • Diagnosis of Schizophrenia or Schizoaffective Disorder (ICD-10).
  • Participants are between 18 and 65 years of age.
  • Fulfillment of regular compulsory education.
  • German language proficiency as a native speaker or level B1

Exclusion Criteria:

  • Unwilling or unable to comply with study instructions.
  • Low Intelligence as stated by failure to accomplish regular compulsory education.
  • Currently in another psychotherapeutic treatment, either in individual or group sessions.
  • Current consumption of Alcohol or illicit Drugs.

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): NCT03316664


Contacts
Contact: Stephan T Egger +41523049340 stephan.egger@puk.zh.ch

Locations
Switzerland
Psychiatrische Universitätsklinik Zürich Not yet recruiting
Zürich, Switzerland, 8032
Contact: Stephan T Egger, MD    +4152304940    stephan.egger@puk.zh.ch   
Contact: Godehard Weniger    +41523049221    godehard.weniger@puk.zh.ch   
Sub-Investigator: Mona Redlich Bossy         
Sponsors and Collaborators
Psychiatric University Hospital, Zurich

Responsible Party: Stephan T. Egger, MD, Psychiatric University Hospital, Zurich
ClinicalTrials.gov Identifier: NCT03316664     History of Changes
Other Study ID Numbers: CBTSZ
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Stephan T. Egger, Psychiatric University Hospital, Zurich:
cognitive behavioural therapy
psychotic disorder
schizophrenia
schizoaffective disorder
psychological intervention

Additional relevant MeSH terms:
Disease
Schizophrenia
Psychotic Disorders
Mental Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders