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

Treating Negative Symptoms of Schizophrenia With a Motive-specific Intervention: A Randomised Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Anhedonia; Apathy; Negative Type; Schizophrenic
• Intervention / Treatment: Behavioral: Motive-specific intervention; Behavioral: Supportive conversations

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kleim Birgit, Prof. Dr.; Phone Number: +41 44 384 21 11; Email: birgit.kleim@pukzh.ch
• Study Contact Backup: Name: Rahel Horisberger, M.Sc.; Phone Number: +41 44 384 26 52; Email: rahel.horisberger@pukzh.ch

Study Locations

• Switzerland
  • Zurich
    • Zürich, Zurich, Switzerland, 8032
      • Recruiting
      • Psychiatric University Hospital
      • Contact: Birgit Kleim, Prof. Dr.; Phone Number: +41 44 384 23 51; Email: birgit.kleim@uzh.ch

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention group; Motive-specific intervention; three appointments within two weeks, 30-45 minutes per session.	Behavioral: Motive-specific intervention; 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.
ACTIVE_COMPARATOR: Control group; Supportive conversations; three appointments within two weeks; 30-45 minutes per session.	Behavioral: Supportive conversations; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline
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).	4 weeks after end of the psychotherapeutic intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline
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.	Baseline

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Birgit Kleim, Prof. Dr., Psychiatric University Hospital, Zurich

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2021
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): June 30, 2022

Study Registration Dates

• First Submitted: September 6, 2018
• First Submitted That Met QC Criteria: March 8, 2021
• First Posted (ACTUAL): March 11, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 11, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Schizophrenia; Psychosis; Inpatients; Negative symptoms; Psychotherapy; Avolition; Anhedonia; Apathy
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Anhedonia
• Other Study ID Numbers: 2018-00916

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