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Motive-specific Intervention for Negative Symptoms in Schizophrenia (MoNSS)

Primary Purpose

Negative Type; Schizophrenic, Anhedonia, Apathy

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Motive-specific intervention
Supportive conversations
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Negative Type; Schizophrenic focused on measuring Negative symptoms, Psychosis, Schizophrenia, Psychotherapy, Inpatients, Apathy, Anhedonia, Avolition

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Informed Consent as documented by signature
  • Male and female inpatients between 18 and 65 years of age
  • ICD-10 diagnosis of psychosis (F2)
  • Clinical relevant negative symptoms
  • Ability to judge with regard to decisions on study participation
  • Fluent in German and able to understand the instructions

Exclusion Criteria:

  • Florid positive psychotic symptoms (measured with PANSS; that is any positive-subscale item score higher than five)
  • Post-schizophrenic depression (ICD: F20.4)
  • Organic schizophrenia-like disorder (ICD: F0.6)
  • Known or suspected non-compliance, drug or alcohol abuse during treatment
  • Cognitive impairments: strongly below average values in cognitive tests
  • Complete stop or restart of taking antipsychotic medication during the study (dose adjustments are not a reason for exclusion)
  • Previous enrolment in the current study
  • Enrolment of the investigator, his/her family members, employees and other dependent persons.

Sites / Locations

  • Psychiatric University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Control group

Arm Description

Motive-specific intervention; three appointments within two weeks, 30-45 minutes per session.

Supportive conversations; three appointments within two weeks; 30-45 minutes per session.

Outcomes

Primary Outcome Measures

Reduction of negative symptoms measured with the Brief Negative Symptom Scale (BNSS)
The primary outcome criterion is the change and expected reduction of the severity of the negative symptoms in schizophrenia patients before and after the three-week motive-specific intervention. We compare the change of severity between the patients of the intervention group and those in the control group. Negative symptoms are measured with the Brief Negative Symptom Scale (BNSS) and items are rated on a 7-point-scale (0 = absent, 6 = severe).
Long-term Reduction of negative symptoms measured with the Brief Negative Symptom Scale (BNSS)
Another primary outcome criterion is the change of the severity of the negative symptoms in schizophrenia patients who have received the motive-specific intervention compared to the control group patients in a follow-up appointment four weeks after termination of the intervention. Negative symptoms are measured with the Brief Negative Symptom Scale (BNSS) and items are rated on a 7-point-scale (0 = absent, 6 = severe).

Secondary Outcome Measures

Correlation between the severity of negative symptoms and explicit motives measured with the Questionnaire for the Zurich Model of Social Motivation
Secondary outcome criterion is the statistical significance and quality of the relationship between negative symptoms (measured with the Brief Negative Symptom Scale; items are rated on a 7-point-scale with 0 = absent and 6 = severe) and explicit reported motives.
Correlation between the severity of negative symptoms and implicit motives measured with the Multi Motive Gitter
Another secondary outcome criterion is the statistical significance and quality of the relationship between negative symptoms (measured with the Brief Negative Symptom Scale; items are rated on a 7-point-scale with 0 = absent and 6 = severe) and implicit motives.

Full Information

First Posted
September 6, 2018
Last Updated
March 8, 2021
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT04793438
Brief Title
Motive-specific Intervention for Negative Symptoms in Schizophrenia
Acronym
MoNSS
Official Title
Treating Negative Symptoms of Schizophrenia With a Motive-specific Intervention: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to test a therapeutic intervention to reduce negative symptomatic among schizophrenia patients. Since the intervention can take place within an inpatient stay, it is a short intervention. Three appointments are made with the patients within two weeks. With an adaptation of the Autobiographical Memory Test (AMT) participants will be asked to recall events from the past and to imagine future events. Patients are additionally asked to complete tasks between the sessions. One pre- and one post-measurement of negative symptoms, motives, level of functioning, hope for recovery and other co-variables are part of the study. A follow-up appointment four weeks later is intended to provide information on the longer-term impact.
Detailed Description
Clinically relevant negative symptoms are present in almost 60% of all patients suffering from schizophrenia. Motivational deficits seem to be one of the main barriers in the process of "functional recovery" among those patients and have been shown to be very treatment resistant. Effects of pharmacological compounds are at best moderate. There are some psychotherapeutic intervention studies that show promise but further controlled trials are needed to clarify the specific treatment effects. Therefore, patients shall be encouraged to remember memories that stand in an association with specific motives. Motives are conscious and unconscious affect-based needs that are activated by behavior and influence behavior toward specific incentives in specific circumstances. They influence the selection of everyday goals and have influence on the degree of the progress people are making towards these goals. The intervention is based on the assumption that a positive expectation of the future is constituted among others by positive experiences from the past and at the same time increases the motivation for future behaviour. The activation of specific, motive-associated memories from autobiographical memory and their transformation into images of the future by means of imaginative methods could be a possible way of strengthening certain motives and thus increasing motivation for certain behaviour. This is mainly because there is evidence that psychosis patients have difficulties specifically remembering memories, i.e. those that happened on only one day. In addition, there is a diminished ability to create specific images of their personal future.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Negative Type; Schizophrenic, Anhedonia, Apathy
Keywords
Negative symptoms, Psychosis, Schizophrenia, Psychotherapy, Inpatients, Apathy, Anhedonia, Avolition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Motive-specific intervention; three appointments within two weeks, 30-45 minutes per session.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Supportive conversations; three appointments within two weeks; 30-45 minutes per session.
Intervention Type
Behavioral
Intervention Name(s)
Motive-specific intervention
Intervention Description
Three appointments are made with the patients of the intervention group within two weeks. With an adaptation of the Autobiographical Memory Test (AMT) participants will be asked to recall events from the past and to imagine future events. The time frame of 45 minutes for each intervention must be strictly adhered to. Patients are additionally asked to complete tasks between the sessions. All appointments take place in the Psychiatric University Hospital directly on the ward.
Intervention Type
Behavioral
Intervention Name(s)
Supportive conversations
Intervention Description
Since we want to check whether the patients benefit from the specific intervention and not only from getting more speaking time, patients without the motive-specific intervention should also be given three sessions, in which no intervention takes place. They will be carried out in the sense of supportive conversations (i.e. conversations that do not follow a specific psychotherapy concept). All appointments take place in the Psychiatric University Hospital directly on the ward.
Primary Outcome Measure Information:
Title
Reduction of negative symptoms measured with the Brief Negative Symptom Scale (BNSS)
Description
The primary outcome criterion is the change and expected reduction of the severity of the negative symptoms in schizophrenia patients before and after the three-week motive-specific intervention. We compare the change of severity between the patients of the intervention group and those in the control group. Negative symptoms are measured with the Brief Negative Symptom Scale (BNSS) and items are rated on a 7-point-scale (0 = absent, 6 = severe).
Time Frame
Baseline
Title
Long-term Reduction of negative symptoms measured with the Brief Negative Symptom Scale (BNSS)
Description
Another primary outcome criterion is the change of the severity of the negative symptoms in schizophrenia patients who have received the motive-specific intervention compared to the control group patients in a follow-up appointment four weeks after termination of the intervention. Negative symptoms are measured with the Brief Negative Symptom Scale (BNSS) and items are rated on a 7-point-scale (0 = absent, 6 = severe).
Time Frame
4 weeks after end of the psychotherapeutic intervention
Secondary Outcome Measure Information:
Title
Correlation between the severity of negative symptoms and explicit motives measured with the Questionnaire for the Zurich Model of Social Motivation
Description
Secondary outcome criterion is the statistical significance and quality of the relationship between negative symptoms (measured with the Brief Negative Symptom Scale; items are rated on a 7-point-scale with 0 = absent and 6 = severe) and explicit reported motives.
Time Frame
Baseline
Title
Correlation between the severity of negative symptoms and implicit motives measured with the Multi Motive Gitter
Description
Another secondary outcome criterion is the statistical significance and quality of the relationship between negative symptoms (measured with the Brief Negative Symptom Scale; items are rated on a 7-point-scale with 0 = absent and 6 = severe) and implicit motives.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Informed Consent as documented by signature Male and female inpatients between 18 and 65 years of age ICD-10 diagnosis of psychosis (F2) Clinical relevant negative symptoms Ability to judge with regard to decisions on study participation Fluent in German and able to understand the instructions Exclusion Criteria: Florid positive psychotic symptoms (measured with PANSS; that is any positive-subscale item score higher than five) Post-schizophrenic depression (ICD: F20.4) Organic schizophrenia-like disorder (ICD: F0.6) Known or suspected non-compliance, drug or alcohol abuse during treatment Cognitive impairments: strongly below average values in cognitive tests Complete stop or restart of taking antipsychotic medication during the study (dose adjustments are not a reason for exclusion) Previous enrolment in the current study Enrolment of the investigator, his/her family members, employees and other dependent persons.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kleim Birgit, Prof. Dr.
Phone
+41 44 384 21 11
Email
birgit.kleim@pukzh.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Rahel Horisberger, M.Sc.
Phone
+41 44 384 26 52
Email
rahel.horisberger@pukzh.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgit Kleim, Prof. Dr.
Organizational Affiliation
Psychiatric University Hospital, Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatric University Hospital
City
Zürich
State/Province
Zurich
ZIP/Postal Code
8032
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Birgit Kleim, Prof. Dr.
Phone
+41 44 384 23 51
Email
birgit.kleim@uzh.ch

12. IPD Sharing Statement

Plan to Share IPD
No

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Motive-specific Intervention for Negative Symptoms in Schizophrenia

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