Schizo-affective DisorderNCT07853079
Motivational Intervention for Patients With Schizophrenia
A study testing Positive Emotion Program for Schizophrenia (PEPS), a psychotherapeutic intervention, in people with Schizo-affective Disorder and Non Organic Psychosis, run by University of Geneva, Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizo-affective Disorder, Non Organic Psychosis, Schizophenia Disorder
- What is being tested?
- Positive Emotion Program for Schizophrenia (PEPS), a psychotherapeutic intervention,
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
- At least on negative symptom at a moderate level (3 on the BNSS) based on the clinician's judgment.
Who cannot join
- 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
- Stimulant, opiate or alcohol use disorder
- Contra-indication for MRI (e.g. Pregnancy, Pacemaker)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of a Motivational Intervention on the Neural Mechanisms of Apathy in Patients With Schizophrenia - a Randomized Controlled 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:
Read more
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
Read the detailed description
Background: Negative symptoms of schizophrenia, particularly apathy (avolition, asociality, anhedonia), are a major cause of poor functional outcome, and no pharmacological treatment adequately improves them. The Positive Emotions Program for Schizophrenia (PEPS) is a group psychotherapy that targets deficits in anticipating and maintaining positive emotions. It has reduced apathy and anhedonia compared with treatment as usual in a previous randomized trial (Favrod et al., 2019). The neural mechanisms of this effect are unknown. Ventral striatal hypoactivation during reward anticipation, which is associated with apathy, is a candidate response biomarker.
Objectives: The primary objective is to test the efficacy of PEPS on apathy compared with treatment as usual (TAU). Secondary objectives are to test whether PEPS changes ventral striatal activation during reward anticipation, whether neural changes are associated with clinical improvement, and whether PEPS affects emotion processing, social decision-making and resting-state networks.
Design: This is a single-centre, rater-blinded randomized controlled trial at the Geneva University Hospitals. Eighty-eight outpatients with schizophrenia, schizoaffective disorder or unspecified nonorganic psychosis (aged 18-60, clinically stable, with at least one moderate negative symptom) are randomized 1:1, stratified by sex, to PEPS or TAU. PEPS consists of eight weekly 1-hour group sessions, with about four participants per group. TAU is routine outpatient care, and TAU participants are offered PEPS after completing the study. Thirty healthy controls are also recruited, without randomization or intervention, to provide test-retest benchmarks. All participants undergo clinical assessment and fMRI at baseline and within 2 weeks after the 8-week intervention or waiting period.
- Being tested
- Positive Emotion Program for Schizophrenia (PEPS), a psychotherapeutic intervention,
- Keywords
- Schizophrenia, PEPS, fMRI, Negative symptoms, Apathy, Group psychotherapy
- Medical subject headings
- Psychotic Disorders, Mental Disorders, Schizophrenia, Lethargy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Emotion Program for Schizophrenia (PEPS), a psychotherapeutic intervention,Behavioural
PEPS 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.
| Study group | Role | What they receive |
|---|---|---|
| Positive Emotions Program for Schizophrenia (PEPS) group psychotherapy | Experimental | Patients receive the Positive Emotions Program for Schizophrenia (PEPS) in addition to their usual outpatient care. PEPS consists of eight weekly 1-hour group sessions led by a psychologist. Sessions train skills to anticipate, savour, express and share positive emotions, and to challenge defeatist beliefs, with home exercises between sessions. Receives: Behavioral: Positive Emotion Program for Schizophrenia (PEPS), a psychotherapeutic intervention, |
| Treatment as usual (TAU) | No intervention | Patients continue their usual outpatient care for 8 weeks without PEPS. Usual care includes regular follow-up by their psychiatrist and nurse, antipsychotic medication, and non-specific group activities. None of these specifically targets negative symptoms. Patients are offered PEPS after completing the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, and within 2 weeks after the end of the 8-week intervention or treatment-as-usual period
Secondary outcomes (8)
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.
Measured: Baseline, and within 2 weeks after the end of the 8-week intervention or treatment-as-usual period.
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.
Measured: Baseline, and within 2 weeks after the end of the 8-week intervention or treatment-as-usual period.
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.
Measured: Baseline, and within 2 weeks after the end of the 8-week intervention or treatment-as-usual period.
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.
Measured: Baseline, and within 2 weeks after the end of the 8-week intervention or treatment-as-usual period.
Resting-state functional connectivity
Functional connectivity between brain regions measured with resting-state fMRI, including network (graph-theory) measures. Post-intervention connectivity is compared between groups, adjusted for baseline.
Measured: Baseline, and within 2 weeks after the end of the 8-week intervention or treatment-as-usual period.
Positive symptoms on the Positive and Negative Syndrome Scale (PANSS)
PANSS positive factor score, the sum of six items (delusions, hallucinatory behaviour, grandiosity, suspiciousness, unusual thought content, lack of judgement and insight). The post-intervention score is compared between groups, adjusted for baseline.
Measured: Baseline, and within 2 weeks after the end of the 8-week intervention or treatment-as-usual period.
Self-rated negative symptoms (Self-evaluation of Negative Symptoms, SNS)
Total score on the SNS, a 20-item self-report questionnaire covering anhedonia, avolition, social withdrawal, blunted affect and alogia. The post-intervention score is compared between groups, adjusted for baseline.
Measured: Baseline, and within 2 weeks after the end of the 8-week intervention or treatment-as-usual period.
Cognition (Brief Assessment of Cognition in Schizophrenia, BACS)
BACS composite score across verbal memory, working memory, motor speed, verbal fluency, attention and processing speed, and executive function. The post-intervention score is compared between groups, adjusted for baseline.
Measured: Baseline, and within 2 weeks after the end of the 8-week intervention or treatment-as-usual period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Schizo-affective DisorderStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Geneva, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, University Hospital, Geneva
- Responsible party
- Principal investigator, Stefan Kaiser, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853079
- Sponsor's protocol ID
- 2024-01743
- Status last verified
- Sep 2026
- First submitted
- 27 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sharing of anonymized individual participant data is possible only if the participant has agreed to this option in the informed consent form.
Publications
Favrod J, Nguyen A, Chaix J, Pellet J, Frobert L, Fankhauser C, Ismailaj A, Brana A, Tamic G, Suter C, Rexhaj S, Golay P, Bonsack C. Improving Pleasure and Motivation in Schizophrenia: A Randomized Controlled Clinical Trial. Psychother Psychosom. 2019;88(2):84-95. doi: 10.1159/000496479. Epub 2019 Feb 18.
PubMed 30783071
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Motivational Intervention on the Neural Mechanisms of Apathy in Patients With Schizophrenia - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07853079
- Acronym / sponsor ID
- 2024-01743
- Keywords
- Schizophrenia, PEPS, fMRI, Negative symptoms, Apathy, Group psychotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- University of Geneva, SwitzerlandUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, University Hospital, Geneva
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 1 Oct 2026 (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 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
Detailed description
Background: Negative symptoms of schizophrenia, particularly apathy (avolition, asociality, anhedonia), are a major cause of poor functional outcome, and no pharmacological treatment adequately improves them. The Positive Emotions Program for Schizophrenia (PEPS) is a group psychotherapy that targets deficits in anticipating and maintaining positive emotions. It has reduced apathy and anhedonia compared with treatment as usual in a previous randomized trial (Favrod et al., 2019). The neural mechanisms of this effect are unknown. Ventral striatal hypoactivation during reward anticipation, which is associated with apathy, is a candidate response biomarker.
Objectives: The primary objective is to test the efficacy of PEPS on apathy compared with treatment as usual (TAU). Secondary objectives are to test whether PEPS changes ventral striatal activation during reward anticipation, whether neural changes are associated with clinical improvement, and whether PEPS affects emotion processing, social decision-making and resting-state networks.
Design: This is a single-centre, rater-blinded randomized controlled trial at the Geneva University Hospitals. Eighty-eight outpatients with schizophrenia, schizoaffective disorder or unspecified nonorganic psychosis (aged 18-60, clinically stable, with at least one moderate negative symptom) are randomized 1:1, stratified by sex, to PEPS or TAU. PEPS consists of eight weekly 1-hour group sessions, with about four participants per group. TAU is routine outpatient care, and TAU participants are offered PEPS after completing the study. Thirty healthy controls are also recruited, without randomization or intervention, to provide test-retest benchmarks. All participants undergo clinical assessment and fMRI at baseline and within 2 weeks after the 8-week intervention or waiting period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive Emotions Program for Schizophrenia (PEPS) group psychotherapy | Experimental | Behavioral: Positive Emotion Program for Schizophrenia (PEPS), a psychotherapeutic intervention,Patients receive the Positive Emotions Program for Schizophrenia (PEPS) in addition to their usual outpatient care. PEPS consists of eight weekly 1-hour group sessions led by a psychologist. Sessions train skills to anticipate, savour, express and share positive emotions, and to challenge defeatist beliefs, with home exercises between sessions. |
| Treatment as usual (TAU) | No intervention | –Patients continue their usual outpatient care for 8 weeks without PEPS. Usual care includes regular follow-up by their psychiatrist and nurse, antipsychotic medication, and non-specific group activities. None of these specifically targets negative symptoms. Patients are offered PEPS after completing the study. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
- At least on negative symptom at a moderate level (3 on the BNSS) based on the clinician's judgment.
Key exclusion criteria (6 listed)
- 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
- Stimulant, opiate or alcohol use disorder
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 |
|---|---|---|
| Positive Emotion Program for Schizophrenia (PEPS), a psychotherapeutic intervention,PEPS 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. | Behavioural | Positive Emotions Program for Schizophrenia (PEPS) group psychotherapy |
Primary outcome
Apathy score on the Brief Negative Symptom Scale (BNSS)
Time frame: Baseline, and within 2 weeks after the end of the 8-week intervention or treatment-as-usual period
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.
8 secondary outcomes
Ventral striatal activation during reward anticipation
Time frame: Baseline, and within 2 weeks after the end of the 8-week intervention or treatment-as-usual period.
Association between change in ventral striatal activation and change in apathy
Time frame: Baseline, and within 2 weeks after the end of the 8-week intervention or treatment-as-usual period.
Fronto-limbic connectivity during emotion processing
Time frame: Baseline, and within 2 weeks after the end of the 8-week intervention or treatment-as-usual period.
Prefrontal activation and fronto-striatal connectivity during social decision-making
Time frame: Baseline, and within 2 weeks after the end of the 8-week intervention or treatment-as-usual period.
Resting-state functional connectivity
Time frame: Baseline, and within 2 weeks after the end of the 8-week intervention or treatment-as-usual period.
Positive symptoms on the Positive and Negative Syndrome Scale (PANSS)
Time frame: Baseline, and within 2 weeks after the end of the 8-week intervention or treatment-as-usual period.
Self-rated negative symptoms (Self-evaluation of Negative Symptoms, SNS)
Time frame: Baseline, and within 2 weeks after the end of the 8-week intervention or treatment-as-usual period.
Cognition (Brief Assessment of Cognition in Schizophrenia, BACS)
Time frame: Baseline, and within 2 weeks after the end of the 8-week intervention or treatment-as-usual period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Background: PubMed 30783071Favrod J, Nguyen A, Chaix J, Pellet J, Frobert L, Fankhauser C, Ismailaj A, Brana A, Tamic G, Suter C, Rexhaj S, Golay P, Bonsack C. Improving Pleasure and Motivation in Schizophrenia: A Randomized Controlled Clinical Trial. Psychother Psychosom. 2019;88(2):84-95. doi: 10.1159/000496479. Epub 2019 Feb 18.
- Individual participant dataSharing planned: Undecided. Sharing of anonymized individual participant data is possible only if the participant has agreed to this option in the informed consent form.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Emotion Program for Schizophrenia (PEPS), a psychotherapeutic intervention, in people with Schizo-affective Disorder and Non Organic Psychosis, run by University of Geneva, 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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefan Kaiser, MD (+41 (0)22 305 51 04, stefan.kaiser@hug.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apathy score on the Brief Negative Symptom Scale (BNSS) (time frame: Baseline, and within 2 weeks after the end of the 8-week intervention or treatment-as-usual period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07853079, which also lists 1 linked publication.
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 1 Oct 2026.