- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07333365
Efficacy of Interactive Audio-based Mindfulness ChatGPT-Powered Intervention on Well-being
Brief mindfulness intervention is a short form is a form of short-duration practice, typically delivered for around 30 minutes or less (Howarth et al., 2019). It can be conducted in various formats, including a short breathing exercise or body scan (Palascha et al., 2021), and are increasingly offered through digital platforms, including app-based formats.
Empirical evidence has examined the efficacy of brief mindfulness intervention and yielded mixed results. For some studies, positive effects were found, while some studies found no supporting evidence. Such inconsistencies may be due to the several current limitations of brief mindfulness intervention. Firstly, the duration of the intervention is too short. Given this brevity, these short practices may not offer the same immersion and depth that traditional mindfulness may offer. Secondly, most brief mindfulness utilised audio-based formats, which tend to be passive in nature and may not fully engage participants. Lastly, for brief mindfulness delivered through app-based platforms, these applications adopt a self-help approach, which may lower engagement and user commitment. Moreover, these applications also relied on audio guides which lacks the student-facilitator engagement found in traditional classes.
To address the current limitations within the literature, a between-within-subjects experiment will be conducted where participants will be randomly assigned to one of the three conditions: (1) an interactive brief mindfulness breathing ChatGPT-powered intervention, (2) an interactive mind-wandering ChatGPT-powered control, or (3) a mindfulness breathing audio control. We hypothesise that the brief mindfulness breathing ChatGPT-powered intervention group will have significant improvements in well-being outcomes as compared to the other two control groups. By exploring the potential of an interactive ChatGPT-powered intervention, this study aims to understand its efficacy in improving well-being.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Xun Ci Soh
- Phone Number: +65 83994980
- Email: xunci.soh.2024@msps.smu.edu.sg
Study Locations
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-
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Singapore, Singapore
- Recruiting
- Singapore Management University
-
Contact:
- Xun Ci Soh
- Phone Number: +65 83994980
- Email: xunci.soh.2024@msps.smu.edu.sg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants who are aged 18 to 30 (inclusive)
Exclusion Criteria:
- Not applicable
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Interactive Mind Wandering (ChatGPT)
The intervention is a ChatGPT-powered mind wandering bot configured using a 15-minute guided exercise adapted from Hafenbrack et al. (2014), Clinton et al. (2018), and Arch and Craske (2006).
The session is divided into one-minute segments: the first minute provides settling instructions (for example, inviting participants to adopt a comfortable position), followed by step-by-step guidance of the mindfulness breathing exercise.
To foster reflection and encourage active engagement, the chatbot was trained to interact with the participants using interactive prompts.
This includes asking questions, such as "When you are ready, please share...What feeling or memory stood out most clearly as your mind wandered?",
"When you are ready, please share...where did your attention drift... to just now?".
|
The intervention is a ChatGPT-powered mind wandering bot configured using a 15-minute guided exercise adapted from Hafenbrack et al. (2014), Clinton et al. (2018), and Arch and Craske (2006).
The session is divided into one-minute segments: the first minute provides settling instructions (for example, inviting participants to adopt a comfortable position), followed by step-by-step guidance of the mindfulness breathing exercise.
To foster reflection and encourage active engagement, the chatbot was trained to interact with the participants using interactive prompts.
This includes asking questions, such as "When you are ready, please share...What feeling or memory stood out most clearly as your mind wandered?",
"When you are ready, please share...where did your attention drift... to just now?".
|
|
Experimental: Interactive Mindfulness Breathing (ChatGPT)
The intervention is a ChatGPT-powered mindfulness breathing bot configured using a 15-minute guided exercise adapted from Hafenbrack et al. (2014), Clinton et al. (2018), and Arch and Craske (2006).
The session is divided into one-minute segments: the first minute provides settling instructions (for example, inviting participants to adopt a comfortable position), followed by step-by-step guidance of the mindfulness breathing exercise.
To foster reflection and encourage active engagement, the chatbot was trained to interact with the participants using interactive prompts.
This includes asking questions, such as " Share what this present moments feel like for you", "What sensations do you notice in your abdomen as you place your hand there?", "Share what stood out to you as you noticed your thoughts, feelings, or sensations just now.".
|
The intervention is a ChatGPT-powered mindfulness breathing bot configured using a 15-minute guided exercise adapted from Hafenbrack et al. (2014), Clinton et al. (2018), and Arch and Craske (2006).
The session is divided into one-minute segments: the first minute provides settling instructions (for example, inviting participants to adopt a comfortable position), followed by step-by-step guidance of the mindfulness breathing exercise.
To foster reflection and encourage active engagement, the chatbot was trained to interact with the participants using interactive prompts.
This includes asking questions, such as " Share what this present moments feel like for you", "What sensations do you notice in your abdomen as you place your hand there?", "Share what stood out to you as you noticed your thoughts, feelings, or sensations just now.".
|
|
Active Comparator: Mindfulness Breathing Audio
This intervention consists of listening to a 15-minute mindfulness breathing audio-only exercise, adapted from Hafenbrack et al. (2014), Clinton et al. (2018), and Arch and Craske (2006).
There will be no verbal interactions in this intervention.
|
This intervention consists of listening to a 15-minute mindfulness breathing audio-only exercise, adapted from Hafenbrack et al. (2014), Clinton et al. (2018), and Arch and Craske (2006).
There will be no verbal interactions in this intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stress
Time Frame: Change from pre-intervention (baseline, before intervention) to immediately post-intervention (after the 15-minute session)
|
Participants' current stress levels will be measured with a single item ("How stressed do you feel right now?"), rated on an 11-point scale (0 = No stress, 10 = Extreme stress).
|
Change from pre-intervention (baseline, before intervention) to immediately post-intervention (after the 15-minute session)
|
|
Positive and Negative Affect
Time Frame: Change from pre-intervention (baseline) to immediately post-intervention (after the 15-minute session)
|
Participants' affective states will be measured using the 18-item Circumplex Model of Affect Scale (Russell, 1980), which assesses emotional states across two separate dimensions: positive affect (PA) and negative affect (NA).
Participants are required to indicate the extent to which they currently experience each emotion on a 5-point Likert scale (1 = Not at all, 5 = Extremely), in response to the question, "Overall, how do you feel right now?".
|
Change from pre-intervention (baseline) to immediately post-intervention (after the 15-minute session)
|
|
State Anxiety
Time Frame: Change from pre-intervention (baseline) to immediately post-intervention (after the 15-minute session).
|
Participants' state anxiety levels will be measured with the 6-item Spielberger State-Trait Anxiety Inventory (STAI; Marteau & Bekker, 1992), rated on a 4-point Likert scale (1 = Not at all, 4 = Very much).
Participants are required to rate how they generally feel in response to statements presented (e.g., "I feel calm", "I am tense", "I feel upset").
|
Change from pre-intervention (baseline) to immediately post-intervention (after the 15-minute session).
|
|
Self-control Capacity
Time Frame: Change from pre-intervention (baseline) to immediately post-intervention (after the 15-minute session).
|
Participants' self-control capacity will be measured with the 5-item Brief State Self-Control Capacity Scale (SMS-5; Ciarocco et al., 2009; Linder et al., 2015), rated on a 7-point Likert scale (1 = Very untrue of me, 7 = Very true of me).
Participants are required to rate how they feel in response to the statements presented (e.g., "I feel drained now", "I feel lazy now", "I feel like my willpower is gone now").
|
Change from pre-intervention (baseline) to immediately post-intervention (after the 15-minute session).
|
|
State Mindfulness Attention
Time Frame: Change from pre-intervention (baseline) to immediately post-intervention (after the 15-minute session).
|
Mindful Attention State.
Participants' state mindfulness attention levels will be measured with the 21-item State Mindfulness Scale (SMS; Tanya & Bernstein, 2013; Ruimi et al., 2022), on a 5-point Likert scale (1 = Not at all, 5 = Very well).
Participants are required to rate how they feel in response to the statements presented (e.g., "I was aware of different emotions that arose in me", "I noticed many small details of my experience", "I felt that I was experiencing the present moment fully").
|
Change from pre-intervention (baseline) to immediately post-intervention (after the 15-minute session).
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-25-212-A172-M2(1125)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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