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

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.

Study Overview

• Status: Completed
• Conditions: Psychotic Disorders; Schizophrenia; Schizoaffective Disorder
• Intervention / Treatment: Behavioral: Integrated Neurocognitive Therapy (INT); Behavioral: Integrated Psychological Therapy (IPT); Other: COGPACK

Detailed Description

Psychotic disorders, and particularly schizophrenia, are severe psychiatric disorders, characterized by psychotic symptoms (mainly hallucinations and delusions), disorganized speech, thought and behavior, and negative symptoms like blunted affect. People who have schizophrenia are chronically impaired. Schizophrenia is one of the first causes of disability worldwide with enormous direct and indirect costs.

The introduction of antipsychotics revolutionized the treatment and care of schizophrenia patients; remaining the cornerstone of schizophrenia treatment. Although new antipsychotics were introduced, they share the same mechanism of action (dopamine D2 antagonism). To date, nearly one-third to half of the patients still do not or respond poorly to antipsychotic treatment; furthermore, some core symptoms of the disorder are not fully addressed by this type of medication.

Parallel to pharmacological treatments, there has been a steady research in psychological interventions for schizophrenia. Current interventions had a more biologic understanding of the disorder and adopted a diathesis-stress model to explain symptoms and course, incorporating adaptation and adjustment through learned and practiced coping strategies. There are many psychological treatments for schizophrenia, although all are considered roughly equivalent, empirical data shows slight differences in efficacy; in particular, Cognitive Behavioural Therapy (CBT) yields small to medium sized effects in addition to psychopharmacological treatment.

There are several available manualized psychological group interventions for patients with a schizophrenic psychosis. One the is the "Integrated Psychological Therapy for Schizophrenia Patients (IPT)", it was developed and introduced into clinical practice almost 30 years ago. It combines neurocognitive and social cognitive interventions with social skills and problem- solving approaches, it has been extensively evaluated by several independent groups, in inpatient and outpatient settings as well, showing an overall improvement in participants.

During the last decade, the cognitive section of IPT was further developed, with the "Integrated Neurocognitive Therapy for schizophrenia patients (INT)" was the final result of this process, with the peculiarity that it was designed to fit the needs of outpatients. While IPT focuses predominantly on the domains of speed of processing, attention, reasoning, and problem-solving as well as on emotion and social perception; INT in contrast targets all 11 neuro- and social-cognitive MATRICS-domains. Furthermore, INT uses computerized neurocognitive exercises for restitution. Initial trials seem to confirm INT as a feasible and efficient group therapy approach with the potential to improve functional outcome in schizophrenia outpatients

The investigators, plan investigational trial to assess the efficacy and feasibility of INT for patients with schizophrenia in an inpatient setting. Therefore, an 8-week, randomized, controlled, assessor-blind, three-parallel-arm trial is planned with patients diagnosed with a schizophrenic psychosis. Following baseline assessment, patients will be randomly assigned to either IPT, INT or a control intervention.

All study interventions, i.e.: the experimental intervention, the psychological control intervention, and the control condition will occur simultaneously twice a week to avoid participants from involuntarily switch groups. Therapists of the psychological experimental and control intervention, as well as trainers involved in the control condition, are not involved in the recruitment, assessment, and assignment of participants of the study. Study interventions will be held in group sessions with 6 to 8 participants each; we plan to conduct five such batches till we reach our sample size of at least 30 participants in each intervention arm.

Patients undergoing psychological interventions should have some prerequisites and conditions which make them suitable for the intervention; this, however, is not fully compatible with a random allocation of participants. Through randomization there is the possibility that participants are not able to cope with their assigned treatment; therefore in a pragmatic way patients will be allowed to switch in another treatment arm. Accordingly after two weeks; patients will be reassessed; reallocation will be followed according to predefined criteria for excessive demands or under requirement.

Participants which switch groups should complete the 8-week intervention in the second assigned group. The assessment at week two will be considered their baseline, with subsequent measures eight weeks later analog to those who did not switch treatment groups. For the final analysis and to preserve randomization the data from those who did not switch treatment groups will be analyzed: however data from the switching groups will be analyzed separately in an ITT fashion.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland, 8032
    • Psychiatrische Universitätsklinik Zürich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Symptomatology at 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.	Baseline, 2 Weeks, 10 Weeks, 6 Months, and 12 Months.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Psychiatric University Hospital, Zurich

Publications and helpful links

General Publications

• Redlich Bossy M, Mueller D, Seifritz E, Vetter S, Egger ST. Feasibility and Efficacy of a Psychological Therapy for Patients With a Schizophrenic Psychosis in an Inpatient Setting: Study Protocol of a Randomized Switch Controlled Trial. Front Public Health. 2020 Aug 12;8:391. doi: 10.3389/fpubh.2020.00391. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: October 2, 2017
• First Submitted That Met QC Criteria: October 17, 2017
• First Posted (Actual): October 20, 2017

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 15, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: schizophrenia; schizoaffective disorder; cognitive behavioural therapy; psychological intervention; psychotic disorder
• Additional Relevant MeSH Terms: Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Disease; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: CBTSZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No