Motivational Intervention for Patients With Schizophrenia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Geneva, Switzerland
About this trial
The goal of this clinical trial is to learn if a group therapy called the Positive Emotions Program for Schizophrenia (PEPS) can reduce apathy in adults aged 18 to 60 who have schizophrenia or a related psychotic disorder. Apathy means having little motivation or drive and getting less pleasure from daily life. The trial will also look at how the brain responds to this therapy.
The main questions it aims to answer are:
Do people who take part in PEPS have less apathy after the therapy than people who continue with their usual care? Does PEPS increase activity in a brain areas important for motivation? Are changes in brain activity linked to changes in apathy?
Researchers will compare PEPS with usual care (regular visits with the treating psychiatrist and nurse, without PEPS) to see if PEPS reduces apathy. They will also compare brain scans of people with schizophrenia to those of healthy volunteers, to see whether brain activity after PEPS becomes more similar to that of people without the illness.
Participants with schizophrenia will:
* Be placed by chance into one of two groups: PEPS or usual care * Have an interview and questionnaires about their symptoms * Have an MRI brain scan while doing computer tasks * In the PEPS group, attend 8 weekly group sessions of 1 hour led by a psychologist. They will learn skills to notice, enjoy and look forward to pleasant moments, to question discouraging thoughts, and to share positive feelings with others. They will also do short exercises at home. * In the usual-care group, continue their usual care for 8 weeks. They will be offered PEPS after the study ends. * Repeat the interview and the brain scan within 2 weeks after the 8-week period
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18-60 years old
Capacity to give informed consent
Clinically diagnosis of schizophrenia, schizoaffective disorder or unspecified nonorganic psychosis
Clinically stable as judged by the treating psychiatrist and no hospitalization or change of medication two weeks prior to study entry
Disqualifiers
Current major depressive episode
Psychotic symptoms with major impact on the daily life of the patient based on the clinician's judgment.
Current diagnosis of neurological disease,
Extrapyramidal symptoms with major impact on the daily life of the patient based on the clinician's judgment
Trial design
Design model
Parallel
Treatments tested in this trial
Positive Emotion Program for Schizophrenia (PEPS), a psychotherapeutic intervention,
BehavioralPEPS is a manualized group intervention delivered over eight weekly sessions. Groups include four to eight participants and each session lasts approximately one hour. The intervention focuses on four main domains: * identifying and savouring positive experiences; * emotional expression; * challenging negative beliefs related to performance; and maximise positive experiences * anticipating and recognizing positive moments in daily life. The intervention uses standardized materials and home exercises to ensure consistency and encourage real-life application.
Treatment groups
88 Participants
are divided into 2 treatment groupsGroup A: Positive Emotions Program for Schizophrenia (PEPS) group psychotherapyExperimental treatment 1 intervention
Group B: Treatment as usual (TAU)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Apathy score on the Brief Negative Symptom Scale (BNSS)
Apathy is measured with the BNSS apathy composite score. The score is the sum of seven items: three for anhedonia (intensity of pleasure during activities, frequency of pleasurable activities, intensity of expected pleasure from future activities), two for asociality (behaviour and internal experience), and two for avolition (behaviour and internal experience). Each item is rated from 0 to 6 in a clinical interview by a blinded rater. The total score ranges from 0 to 42, and higher scores mean more severe apathy. The post-intervention score is compared between the PEPS and treatment-as-usual groups, adjusted for the baseline score.
Time frame
Baseline, and within 2 weeks after the end of the 8-week intervention or treatment-as-usual periodSecondary outcomes
1
Ventral striatal activation during reward anticipation
Brain activity (fMRI BOLD signal) in the ventral striatum during reward anticipation in the Monetary Incentive Delay task. Post-intervention activation is compared between the PEPS and treatment-as-usual groups, adjusted for baseline activation.
Time frame
Baseline, and within 2 weeks after the end of the 8-week intervention or treatment-as-usual period.2
Association between change in ventral striatal activation and change in apathy
Relationship between post-intervention ventral striatal activation during reward anticipation (Monetary Incentive Delay task) and post-intervention apathy (BNSS apathy composite score). Both are adjusted for their baseline values.
Time frame
Baseline, and within 2 weeks after the end of the 8-week intervention or treatment-as-usual period.3
Fronto-limbic connectivity during emotion processing
Task-related functional connectivity (psychophysiological interaction) between the dorsolateral prefrontal cortex, caudate nucleus, anterior cingulate cortex and amygdala during the Variable Affective Attention Task. Post-intervention connectivity is compared between groups, adjusted for baseline.
Time frame
Baseline, and within 2 weeks after the end of the 8-week intervention or treatment-as-usual period.4
Prefrontal activation and fronto-striatal connectivity during social decision-making
Prefrontal activation and prefrontal-striatal functional connectivity (fMRI) during a social-context decision-making task. Post-intervention values are compared between groups, adjusted for baseline.
Time frame
Baseline, and within 2 weeks after the end of the 8-week intervention or treatment-as-usual period.Locations
Sponsors and contacts
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University of Geneva, Switzerland
Lead sponsor
Swiss National Science Foundation
Collaborator
University Hospital, Geneva
Collaborator
Source ClinicalTrials.gov
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