Chatbot-based Mindfulness Programme for Depressive University Students: Pilot Intervention Study

NCT06440941 | Completed

• 1 other identifier: HSEARS20221027007
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate the feasibility, acceptability, safety and preliminary efficacy of a chatbot-based mindfulness-based stress reduction (MBSR) intervention for university students with depressive symptoms. A rule-based MBSR chatbot will be developed and evaluated with a single-group pretest-posttest study for university students aged 18 or above in Hong Kong reporting depressive symptoms, followed by the collection of their subjective feedback. The intervention will last eight weeks. The primary clinical outcome is depression levels, with a range of secondary outcomes including stress, anxiety and mindfulness levels.

Conditions

Depression

Keywords

Mindfulness; Chatbot; Depression; University Student

Outcome Measures

Primary Outcomes (1)

• Patient Health Questionnaire (PHQ-9)

  The depression levels of the participants will be assessed using the Patient Health Questionnaire (PHQ-9) in Chinese. Items are rated on a scale from 0 (not at all) to 3 (nearly every day), with total scores categorizing depression severity: 5-9 (mild), 10-14 (moderate), 15-19 (moderately severe), and ≥20 (severe). Higher scores mean a worse outcome.

  The pre-intervention/baseline assessment using this measure will be conducted one week before the start of the intervention. The post-intervention assessment using this measure will be conducted upon the completion of the 8-week intervention.

Secondary Outcomes (3)

• Generalized Anxiety Disorder Scale (GAD-7)

  The pre-intervention/baseline assessment using this measure will be conducted one week before the start of the intervention. The post-intervention assessment using this measure will be conducted upon the completion of the 8-week intervention.

• Perceived Stress Scale (PSS-14)

  The pre-intervention/baseline assessment using this measure will be conducted one week before the start of the intervention. The post-intervention assessment using this measure will be conducted upon the completion of the 8-week intervention.

• Five-Facet Mindfulness Questionnaire (FFMQ-39)

  The pre-intervention/baseline assessment using this measure will be conducted one week before the start of the intervention. The post-intervention assessment using this measure will be conducted upon the completion of the 8-week intervention.

Study Arms (1)

one arm pre-post test

EXPERIMENTAL

This study consists of two phases. In the first phase, a rule-based automated chatbot will be developed to facilitate mindfulness-based stress reduction (MBSR) interventions. The second phase will employ a single-group pretest-posttest design to evaluate the feasibility, acceptability, safety and preliminary efficacy of the chatbot-based MBSR intervention for university students with self-reported depressive symptoms. The study will be guided by the 'CONSORT 2010 checklist of information to include when reporting a pilot or feasibility trial'. This study specifically targets university students in Hong Kong and the intervention lasts eight weeks.

Other: chatbot-based mindfulness-based stress reduction

Interventions

chatbot-based mindfulness-based stress reduction OTHER

During the intervention, participants will be involved in a developed chatbot and undergo a single-item assessment to verify the stability of their mental states for subsequent mindfulness-based stress reduction (MBSR) sessions, deemed stable if rated as excellent, very good, or good; They will then engage in conversations with the chatbot, responding to prompts like What is the most recent thing that made you happy? to foster interactive communication and relaxation. Subsequently, participants need to follow guided MBSR sessions and are encouraged to interact with the chatbot for at least one hour daily; all interactions will be monitored and recorded. After eight weeks, a post-intervention assessment will be conducted, followed by pre-post statistical analyses. A total of ten participants with the most and least significant changes in depression levels will be selected for an open-ended questionnaire.

one arm pre-post test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• University students aged over 18 years
• University students pursuing a bachelor degree, associate degree, or higher diploma in Hong Kong
• University students with self-reported depressive symptoms (The depressive symptoms are assessed pre-intervention using the 9-item Patient Health Questionnaire, with cumulative scores of 5 or higher indicating at least mild depressive symptoms.)
• Be able to provide informed consent, read Chinese, listen to Cantonese
• Ensure internet access during the study

You may not qualify if:

• University students who have been diagnosed with a clinical psychotic condition pre-intervention
• University students who are currently involved in any mindfulness-based or other psychosocial interventions

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

School of Nursing, The Hong Kong Polytechnic Unviersity

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2024
• First Posted: June 4, 2024
• Study Start: December 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: June 30, 2023
• Last Updated: June 4, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)