- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07665242
Chatbot Intervention Effects on Social and Monetary Incentive Processing in Anhedonia
Effects of a Chatbot-Based Intervention on Behavioral Responsiveness and Neural Anticipation of Social and Monetary Incentives in Individuals With Anhedonia
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Anhedonia represents a core characteristic of depression and is characterized by reduced experience of pleasure. It is closely related to decreased motivation, altered reward processing, changes in affective responsiveness, and alterations in intrinsic brain network function. Anhedonia is not specifically targeted by currently available pharmacological interventions. Initial evidence indicates that an increased willingness to change and implementation of change in daily life can alleviate anhedonia.
The present study aims to examine whether a Motivational Interviewing-based AI chatbot can lead to changes in social incentive processing in college students with elevated anhedonia and depressive symptoms. Social incentive processing is included because social approval, social feedback, and interpersonal reward are important sources of motivation in daily life and may be altered in individuals with elevated anhedonia. The Social Incentive Delay Task allows the study to examine behavioral and neural responses during the anticipation and receipt of social incentives. To this end, eligible participants with a total score of 22 or higher on the Snaith-Hamilton Pleasure Scale and a score of 14 or higher on the Beck Depression Inventory will undergo a randomized, between-subjects, active-control intervention study. Participants will be assigned to either a Motivational Interviewing-based chatbot group or an active control chatbot group for 1 week. Pre- and post-intervention assessments will include self-report questionnaires and the Social Incentive Delay Task during functional magnetic resonance imaging to examine psychological, behavioral, and neural effects of the intervention.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Benjamin Becker, Dr
- Número de teléfono: (852) 3917-5097
- Correo electrónico: bbecker@hku.hk
Ubicaciones de estudio
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Sichuan
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Chengdu, Sichuan, Porcelana
- Reclutamiento
- University of Electronic Science and Technology of China
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- 18-40 years
- Right-handed
- Normal or corrected normal visual acuity
- Participants must show elevated anhedonia and depressive symptoms at screening, defined as a total score of 22 or higher on the Snaith-Hamilton Pleasure Scale and a score of 14 or higher on the Beck Depression Inventory
Exclusion Criteria:
- History of major central nervous system disorders, such as epilepsy, traumatic brain injury, stroke, or brain tumors.
- History of severe mental illness, including schizophrenia spectrum disorders, bipolar disorder, or other psychotic disorders.
- History of substance or alcohol use disorder or substance or alcohol misuse within the past 12 months that may affect study participation or outcome assessment.
- Individuals currently at high risk of suicide, severe self-harm, or experiencing an acute psychiatric crisis.
- Individuals who are currently using psychiatric medications or have undergone psychotherapy within the past 4 weeks that may significantly affect mood, motivation, or reward processing.
- Severe vision or hearing impairments that cannot be corrected and would interfere with task performance.
- Contraindications to MRI scanning, including metallic implants, pacemakers, severe claustrophobia, or other conditions incompatible with MRI.
- Pregnancy or breastfeeding.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Motivational Interviewing-based AI chatbot group
Motivational Interviewing-based AI chatbot intervention
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The experimental chatbot is designed to use principles of Motivational Interviewing to support participants in exploring their personal values, motivation for change, and daily behavioral goals related to pleasure, engagement, and reward-seeking.
During the intervention period, participants will interact with the chatbot regularly through brief text-based conversations.
The chatbot will provide empathic, non-judgmental responses, encourage reflection on current difficulties, and help participants identify small, feasible actions that may increase daily engagement and positive experiences.
It will not provide diagnosis, crisis counseling, or medical treatment.
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Comparador activo: Active control chatbot group
Active control nature-story chatbot intervention
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Participants will interact with a chatbot matched in format and frequency of use.
This chatbot will provide neutral nature-related stories or general natural history content.
It will be designed to maintain participant engagement while avoiding therapeutic techniques, motivational interviewing strategies, behavioral activation guidance, or personalized mental health advice.
This active control condition will help control for nonspecific effects of chatbot interaction, attention, expectancy, and digital engagement.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Neural Activity During Social Incentive Anticipation
Periodo de tiempo: Baseline before the first chatbot interaction and Week 1 after completion of the chatbot intervention.
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Participants will undergo task-based BOLD fMRI while completing the Social Incentive Delay Task.
Neural responses during the anticipation of social incentive cues will be compared with responses to neutral cues using a general linear model.
Pre-to-post intervention changes will be evaluated from the resulting beta contrast estimates.
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Baseline before the first chatbot interaction and Week 1 after completion of the chatbot intervention.
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Neural Activity During Monetary Incentive Anticipation
Periodo de tiempo: Baseline before the first chatbot interaction and Week 1 after completion of the chatbot intervention.
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Task-based BOLD fMRI data will be acquired while participants perform the Monetary Incentive Delay Task.
Neural responses associated with the anticipation of monetary reward and punishment will be estimated using a general linear model.
Beta contrast estimates will be calculated for monetary reward versus neutral and monetary punishment versus neutral conditions.
These estimates will be used to assess changes between baseline and post-intervention.
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Baseline before the first chatbot interaction and Week 1 after completion of the chatbot intervention.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Behavioral Responsiveness to Social Incentive Cues
Periodo de tiempo: Baseline before the first chatbot interaction and Week 1 after completion of the chatbot intervention.
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Reaction time, accuracy, and hit rate will be calculated separately for social incentive cue conditions and neutral cue conditions in the Social Incentive Delay Task before and after the intervention.
Behavioral differences between social incentive and neutral cue conditions will also be derived and compared from baseline to post-intervention.
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Baseline before the first chatbot interaction and Week 1 after completion of the chatbot intervention.
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Behavioral responsiveness to monetary incentives
Periodo de tiempo: Baseline before the first chatbot interaction and Week 1 after completion of the chatbot intervention.
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The Monetary Incentive Delay Task will be administered before and after the intervention.
Reaction time, accuracy, and hit rate will be extracted separately for monetary incentive cue conditions and neutral cue conditions, and changes in behavioral differences between monetary incentive and neutral cue conditions will be calculated.
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Baseline before the first chatbot interaction and Week 1 after completion of the chatbot intervention.
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Colaboradores e Investigadores
Fechas de registro del estudio
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Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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Palabras clave
Otros números de identificación del estudio
- BAM_lab_MI_03
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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