- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07671131
Chatbot Intervention Effects on Emotional Arousal in Anhedonia
Effects of a Chatbot-Based Intervention on Subjective Arousal and Neural Reactivity to Emotional Video Stimuli 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 affective arousal responses in college students with elevated anhedonia and depressive symptoms. Affective arousal is included because anhedonia may involve altered emotional reactivity and reduced subjective responses to affective stimuli, in addition to reduced pleasure. The emotional video task allows the study to assess subjective arousal responses and neural responses to positive, neutral, and negative affective stimuli. 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 an affective arousal video 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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Contacto:
- Benjamin Becker, Dr
- Número de teléfono: (852) 3917-5097
- Correo electrónico: bbecker@hku.hk
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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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Subjective Affective Arousal in Response to Video Stimuli
Periodo de tiempo: Baseline before the first chatbot interaction and Week 1 after completion of the chatbot intervention.
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Participants will view positive, neutral, and negative video stimuli before and after the intervention and report their subjective arousal after each video.
Mean arousal ratings will be calculated separately for each emotional condition, and pre-to-post changes will be compared across positive, neutral, and negative video conditions
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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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Activity in Brain Systems Supporting Affective Arousal Processing
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 viewing positive, negative, and neutral emotional videos.
Neural responses within predefined brain systems involved in arousal and valence processing will be estimated using a general linear model.
Beta contrast estimates will then be derived for positive versus neutral, negative versus neutral, and positive versus negative conditions.
These estimates will be used to evaluate changes 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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Colaboradores e Investigadores
Fechas de registro del estudio
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Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
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Publicado por primera vez (Actual)
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Última actualización enviada que cumplió con los criterios de control de calidad
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Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- BAM_lab_MI_02
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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