Negative Type; SchizophrenicMoNSSNCT04793438
Motive-specific Intervention for Negative Symptoms in Schizophrenia
A study testing Motive-specific intervention and Supportive conversations in people with Negative Type; Schizophrenic and Anhedonia, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Negative Type; Schizophrenic, Anhedonia, Apathy
- What is being tested?
- Motive-specific intervention and Supportive conversations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Psychiatric University Hospital
Zurich, Canton of Zurich, 8032
Birgit Kleim, Prof. Dr., +41 44 384 23 51, birgit.kleim@uzh.ch
About this study
Official title: 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.
Read the 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.
- Conditions
- Negative Type; Schizophrenic, Anhedonia, Apathy
- Being tested
- Motive-specific intervention, Supportive conversations
- Keywords
- Negative symptoms, Psychosis, Schizophrenia, Psychotherapy, Inpatients, Apathy, Anhedonia, Avolition
- Medical subject headings
- Anhedonia, Lethargy, Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motive-specific interventionBehavioural
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.
Supportive conversationsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Motive-specific intervention; three appointments within two weeks, 30-45 minutes per session. Receives: Behavioral: Motive-specific intervention |
| Control group | Active comparator | Supportive conversations; three appointments within two weeks; 30-45 minutes per session. Receives: Behavioral: Supportive conversations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 4 weeks after end of the psychotherapeutic intervention
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Negative Type; SchizophrenicStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Birgit Kleim, Prof. Dr., Principal investigator, Psychiatric University Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793438
- Sponsor's protocol ID
- 2018-00916
- Other IDs
- 2018
- Acronym
- MoNSS
- Status last verified
- Mar 2021
- First submitted
- 6 Sep 2018
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Negative Symptoms of Schizophrenia With a Motive-specific Intervention: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04793438
- Acronym / sponsor ID
- MoNSS / 2018-00916
- Conditions
- Negative Type; Schizophrenic, Anhedonia, Apathy
- Keywords
- Negative symptoms, Psychosis, Schizophrenia, Psychotherapy, Inpatients, Apathy, Anhedonia, Avolition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Motive-specific interventionMotive-specific intervention; three appointments within two weeks, 30-45 minutes per session. |
| Control group | Active comparator | Behavioral: Supportive conversationsSupportive conversations; three appointments within two weeks; 30-45 minutes per session. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motive-specific interventionThree 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. | Behavioural | Intervention group |
| Supportive conversationsSince 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. | Behavioural | Control group |
Primary outcome
Reduction of negative symptoms measured with the Brief Negative Symptom Scale (BNSS)
Time frame: Baseline
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)
Time frame: 4 weeks after end of the psychotherapeutic intervention
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).
2 secondary outcomes
Correlation between the severity of negative symptoms and explicit motives measured with the Questionnaire for the Zurich Model of Social Motivation
Time frame: Baseline
Correlation between the severity of negative symptoms and implicit motives measured with the Multi Motive Gitter
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Birgit Kleim, Prof. Dr. principal investigator
Psychiatric University Hospital, Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motive-specific intervention and Supportive conversations in people with Negative Type; Schizophrenic and Anhedonia, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kleim Birgit, Prof. Dr. (+41 44 384 21 11, birgit.kleim@pukzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of negative symptoms measured with the Brief Negative Symptom Scale (BNSS) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.