NCT07665216

Brief Summary

The main aim of the present study is to investigate the effects of a Motivational Interviewing-based artificial intelligence chatbot on resting-state brain function in college students with elevated anhedonia and depressive symptoms. The study will use a randomized active-control intervention design with pre- and post-intervention resting-state functional magnetic resonance imaging assessments.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for not_applicable healthy

Timeline
30mo left

Started Jun 2026

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Jun 2026Dec 2028

First Submitted

Initial submission to the registry

June 17, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

June 20, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

July 9, 2026

Status Verified

June 1, 2026

Enrollment Period

2 years

First QC Date

June 17, 2026

Last Update Submit

July 7, 2026

Conditions

Keywords

reward processingfMRIAI interaction

Outcome Measures

Primary Outcomes (1)

  • Intervention-Related Changes in Resting-State Functional Connectivity After the Intervention

    Resting-state fMRI will be used to examine functional connectivity among predefined regions involved in reward, social, and self-referential processing. Connectivity will be estimated from Pearson correlations between regional BOLD time series and then converted using the Fisher z transformation. Changes from baseline to post-intervention will be reported as dimensionless Fisher z values.

    Baseline before the first chatbot interaction and Week 1 after completion of the chatbot intervention.

Secondary Outcomes (1)

  • Intervention-Related Changes in Spontaneous Activity After the Intervention

    Baseline before the first chatbot interaction and Week 1 after completion of the chatbot intervention.

Study Arms (2)

Motivational Interviewing-based AI chatbot group

EXPERIMENTAL

Motivational Interviewing-based AI chatbot intervention

Behavioral: MI Chatbot Interaction

Active control chatbot group

ACTIVE COMPARATOR

Active control nature-story chatbot intervention

Behavioral: Active Control Chatbot Interaction

Interventions

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.

Active control chatbot group

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.

Motivational Interviewing-based AI chatbot group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Electronic Science and Technology of China

Chengdu, Sichuan, China

RECRUITING

Central Study Contacts

Benjamin Becker

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Between-subject randomized controlled trial comparing a Motivational Interviewing-based AI chatbot intervention with an active control chatbot intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 17, 2026

First Posted

June 24, 2026

Study Start

June 20, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

July 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Corresponding individual level data will be made available upon request.

Locations