Motive-specific Intervention for Negative Symptoms in Schizophrenia

NCT ID: NCT04793438

Last Updated: 2021-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2022-06-30

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.

Conditions

Negative Type; Schizophrenic; Anhedonia; Apathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

Motive-specific intervention

Intervention Type: BEHAVIORAL

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.

Control group

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

Group Type: ACTIVE_COMPARATOR

Supportive conversations

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Birgit Kleim, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Psychiatric University Hospital, Zurich

Locations

Psychiatric University Hospital

Zurich, Canton of Zurich, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Kleim Birgit, Prof. Dr.

Role: CONTACT

birgit.kleim@pukzh.ch

+41 44 384 21 11

Rahel Horisberger, M.Sc.

Role: CONTACT

rahel.horisberger@pukzh.ch

+41 44 384 26 52

Facility Contacts

Birgit Kleim, Prof. Dr.

Role: primary

birgit.kleim@uzh.ch

+41 44 384 23 51

Other Identifiers

2018-00916

Identifier Type: -

Identifier Source: org_study_id