Motivational Intervention for Patients With Schizophrenia

NCT07853079 | Not Yet Recruiting DMC

• 1 other identifier: 2024-01743
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Conditions

Schizo-affective Disorder; Non Organic Psychosis; Schizophenia Disorder

Keywords

Schizophrenia; PEPS; fMRI; Negative symptoms; Apathy; Group psychotherapy

Outcome Measures

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.

  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

  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

  Baseline, and within 2 weeks after the end of the 8-week intervention or treatment-as-usual period.

• Fronto-limbic connectivity during emotion processing

  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

  Baseline, and within 2 weeks after the end of the 8-week intervention or treatment-as-usual period.

• Resting-state functional connectivity

  Baseline, and within 2 weeks after the end of the 8-week intervention or treatment-as-usual period.

Study Arms (2)

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.

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.

Interventions

Positive Emotion Program for Schizophrenia (PEPS), a psychotherapeutic intervention, BEHAVIORAL

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.

Positive Emotions Program for Schizophrenia (PEPS) group psychotherapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Swiss National Science Foundation: collaborator
• University Hospital, Geneva: collaborator
• University of Geneva, Switzerland: lead

Related Publications (1)

• 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.

  PMID: 30783071 BACKGROUND

MeSH Terms

Conditions

Psychotic Disorders; Mental Disorders; Schizophrenia; Lethargy

Interventions

Leucyl Aminopeptidase

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminopeptidases; Exopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloexopeptidases; Metalloproteases

Central Study Contacts

Stefan Kaiser, MD

CONTACT

+41 (0)22 305 51 04; stefan.kaiser@hug.ch

Rachel Goldstein, MA

CONTACT

+41 (0)22 379 0958; Rachel.Goldstein@unige.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor- Investigator

Study Record Dates

• First Submitted: September 27, 2026
• First Posted: October 1, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2029
• Last Updated: October 1, 2026

Record last verified: 2026-09