Healthy Participants StudyNCT06843395
ACT-based EMI in College Students
A study testing ACT-based ecological momentary intervention and Mood monitoring in people with Healthy Participants Study, run by The Hong Kong Polytechnic University at 1 site in China.
Trial summary
This study aims to evaluate the acceptability and effectiveness of a transdiagnostic, Acceptance and Commitment Therapy (ACT)-based ecological momentary intervention (EMI) among college students. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants Study
- What is being tested?
- ACT-based ecological momentary intervention and Mood monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Participants in our study are healthy college students
- have smartphone, and have access to the internet
Who cannot join
- currently participating in another research
- have significant cognitive impairment that prevents participation in the research
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Hong Kong Polytechnic University
Hong Kong
Bryant Hui, +852 2766 7744, phhui@polyu.edu.hk
About this study
Official title: Assessing the Feasibility, Acceptability and Effectiveness of an Transdiagnostic Acceptance and Commitment Therapy-based Ecological Momentary Intervention in College Students: a Pilot Randomized Controlled Trial
This study aims to evaluate the acceptability and effectiveness of a transdiagnostic, Acceptance and Commitment Therapy (ACT)-based ecological momentary intervention (EMI) among college students. A mixed-methods pilot randomized controlled trial (RCT) will be conducted to assess its impact on psychological flexibility, well-being and mental health outcomes.
Read the detailed description
Mental health issues are prevalent among college students, yet traditional interventions often face barriers related to accessibility and engagement. This study explores the feasibility, acceptability, and preliminary effectiveness of a transdiagnostic ACT-based EMI designed to deliver in-the-moment psychological support via digital platforms. A mixed-methods pilot RCT will be conducted, with participants randomly assigned to either the ACT-based EMI group or a mood monitoring group. Quantitative measures will assess changes in psychological flexibility, stress, anxiety, depression, and well-being, while qualitative interviews will provide insights into user experience, engagement, and perceived benefits or barriers. Findings from this study will inform the optimization of ACT-based digital interventions for college students and contribute to the growing field of personalized, technology-assisted mental health care.
- Conditions
- Healthy Participants Study
- Being tested
- ACT-based ecological momentary intervention, Mood monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-based ecological momentary interventionBehavioural
The intervention is based on Acceptance and Commitment Therapy (ACT) and includes the six core processes (being present, acceptance, defusion, self-as-content, values, and taking action). It is delivered in the form of an ecological momentary intervention (EMI), lasting for 7 days with two sessions per day. The intervention aims to enhance mental health, well-being, and psychological flexibility.
Mood monitoringOther
Participants do not receive any intervention. During the intervention period, they only need to complete ecological momentary assessments twice a day.
| Study group | Role | What they receive |
|---|---|---|
| Mood monitoring condition | Placebo comparator | Only pre- and post-assessments and ecological momentary assessment (EMA) measurements are conducted. Receives: Other: Mood monitoring |
| ACT-based EMI group | Experimental | Participants are required to complete a 7-day ecological momentary intervention (EMI). Receives: Behavioral: ACT-based ecological momentary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall mental health
Overall mental health will be measured using the 12-item General Health Questionnaire (GHQ-12). Each item is rated on a 4-point Likert scale, with total scores ranging from 0 to 36. Higher scores indicate greater mental health difficulty.
Measured: Baseline (pre-intervention); Immediately after the intervention (1 week after baseline); 1-month follow-up (1 month after intervention)
Psychological distress
Psychological distress will be measured using the 21-item Depression Anxiety Stress Scale. They ask about depressive symptoms, anxiety symptoms, and general stress symptoms. Each item is rated on a 4-point Likert scale from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). Higher scores indicate more psychological distress
Measured: Baseline (pre-intervention); Immediately after the intervention (1 week after baseline); 1-month follow-up (1 month after intervention)
Mental well-being
The 14-item Mental Health Continuum-Short Form (MHC-SF) will be used to measure mental well-being during the past month. This scale has 3 dimensions: emotional well-being (EWB), psychological well-being (PWB), and social well-being (SWB). Each item is rated on a 6-point scale from 0 (never) to 5 (every day), with a higher score indicating greater well-being.
Measured: Baseline (pre-intervention); Immediately after the intervention (1 week after baseline); 1-month follow-up (1 month after intervention)
Psychological flexibility and inflexibility
The multidimensional psychological flexibility inventory short form (MPFI-24) is a 24-item scale assessing psychological flexibility. The scale consists of a flexibility subscale and an inflexibility subscale, divided into 12 dimensions, with 2 entries for each dimension, a total of 24 entries, and scored at levels 1 (never true) to 6 (always true).
Measured: Baseline (pre-intervention); Immediately after the intervention (1 week after baseline); 1-month follow-up (1 month after intervention)
Acceptability
The 8-item Client Satisfaction Questionnaire (CSQ-8) is employed to measure client satisfaction. Each item is rated on a 4-point Likert scale. Higher scores reflect better client satisfaction.
Measured: post-intervention (one week after baseline)
Secondary outcomes (9)
State anxiety and depression
State anxiety and depression will be measured with the four-item Patient Health Questionnaire for Depression and Anxiety (PHQ-4). Responses are scored as 0 ("not at all"), 1 ("several days"), 2 ("more than half the days"), or 3 ("nearly every day"), with the total score on this composite measure ranging from 0 to 12.
Measured: During the 7-day intervention period, measurements are conducted twice per day.
State stress
State stress will be measured using a single item adapted from the Psychological Stress Measure (PSM-9). Participants will rate their state stress level on a sliding scale from 0 (not stressed at all) to 100 (very stressed), with higher scores indicating greater perceived stress.
Measured: During the 7-day intervention period, measurements are conducted twice per day.
State well-being
State well-being will be measured with one item inspired by the Well-Being Manifestations Measure Scale using a sliding scale ranging from 0 (not good at all) to 100 (very good).
Measured: During the 7-day intervention period, measurements are conducted twice per day.
State subjective happiness
State subjective happiness will be measured by the 2-item Subjective Happiness Scale with each item rated on a 7-point Likert scale from 1 (not a very happy person) to 7 (a very happy person).
Measured: During the 7-day intervention period, measurements are conducted twice per day.
State affect
State affect will be tapped by the 9-item Emmons Mood Indicator. Participants indicate their momentary feelings on a 7-point Likert scale ranging from 1 (not at all) to 7 (extremely), for NA (e.g., depressed, worried/anxious, and unhappy) and PA (e.g., joyful, happy, and enjoyment/fun).
Measured: During the 7-day intervention period, measurements are conducted twice per day.
State psychological flexibility
State psychological flexibility will be measured with Psy-Flex, a short self-report measure which covers all aspects of psychological flexibility. Items are rated on a scale from 5 ("very often") to 1 ("very rarely") and then summed. The score is then inter-preted such that higher scores represent higher psychological flexibility.
Measured: During the 7-day intervention period, measurements are conducted twice per day.
State psychological inflexibility
State psychological inflexibility will be measured with six item adapted from the Multidimensional psychological flexibility inventory using a sliding scale ranging from 1 (never true) to 6 (always true).
Measured: During the 7-day intervention period, measurements are conducted twice per day.
State suicide ideation
State suicide ideation will be assessed using a single item. Participants will respond on a 0 to 4 scale, with higher scores indicating greater suicidal ideation.
Measured: During the 7-day intervention period, measurements are conducted twice per day.
Suicide ideation
Suicide ideation will be measured using the 5-item Beck Scale for Suicide Ideation (BSS-5). Each item is rated on a three-point scale, with higher scores indicating greater suicidal ideation.
Measured: Baseline (pre-intervention); Immediately after the intervention (1 week after baseline); 1-month follow-up (1 month after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start15 Apr 2025 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Participants StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843395
- Sponsor's protocol ID
- HSEARS20250214003
- Status last verified
- Feb 2025
- First submitted
- 20 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility, Acceptability and Effectiveness of an Transdiagnostic Acceptance and Commitment Therapy-based Ecological Momentary Intervention in College Students: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06843395
- Acronym / sponsor ID
- HSEARS20250214003
- Conditions
- Healthy Participants Study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the acceptability and effectiveness of a transdiagnostic, Acceptance and Commitment Therapy (ACT)-based ecological momentary intervention (EMI) among college students. A mixed-methods pilot randomized controlled trial (RCT) will be conducted to assess its impact on psychological flexibility, well-being and mental health outcomes.
Detailed description
Mental health issues are prevalent among college students, yet traditional interventions often face barriers related to accessibility and engagement. This study explores the feasibility, acceptability, and preliminary effectiveness of a transdiagnostic ACT-based EMI designed to deliver in-the-moment psychological support via digital platforms. A mixed-methods pilot RCT will be conducted, with participants randomly assigned to either the ACT-based EMI group or a mood monitoring group. Quantitative measures will assess changes in psychological flexibility, stress, anxiety, depression, and well-being, while qualitative interviews will provide insights into user experience, engagement, and perceived benefits or barriers. Findings from this study will inform the optimization of ACT-based digital interventions for college students and contribute to the growing field of personalized, technology-assisted mental health care.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mood monitoring condition | Placebo comparator | Other: Mood monitoringOnly pre- and post-assessments and ecological momentary assessment (EMA) measurements are conducted. |
| ACT-based EMI group | Experimental | Behavioral: ACT-based ecological momentary interventionParticipants are required to complete a 7-day ecological momentary intervention (EMI). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Participants in our study are healthy college students
- have smartphone, and have access to the internet
Key exclusion criteria (2 listed)
- currently participating in another research
- have significant cognitive impairment that prevents participation in the research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT-based ecological momentary interventionThe intervention is based on Acceptance and Commitment Therapy (ACT) and includes the six core processes (being present, acceptance, defusion, self-as-content, values, and taking action). It is delivered in the form of an ecological momentary intervention (EMI), lasting for 7 days with two sessions per day. The intervention aims to enhance mental health, well-being, and psychological flexibility. | Behavioural | ACT-based EMI group |
| Mood monitoringParticipants do not receive any intervention. During the intervention period, they only need to complete ecological momentary assessments twice a day. | Other | Mood monitoring condition |
Primary outcome
Overall mental health
Time frame: Baseline (pre-intervention); Immediately after the intervention (1 week after baseline); 1-month follow-up (1 month after intervention)
Overall mental health will be measured using the 12-item General Health Questionnaire (GHQ-12). Each item is rated on a 4-point Likert scale, with total scores ranging from 0 to 36. Higher scores indicate greater mental health difficulty.
Psychological distress
Time frame: Baseline (pre-intervention); Immediately after the intervention (1 week after baseline); 1-month follow-up (1 month after intervention)
Psychological distress will be measured using the 21-item Depression Anxiety Stress Scale. They ask about depressive symptoms, anxiety symptoms, and general stress symptoms. Each item is rated on a 4-point Likert scale from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). Higher scores indicate more psychological distress
Mental well-being
Time frame: Baseline (pre-intervention); Immediately after the intervention (1 week after baseline); 1-month follow-up (1 month after intervention)
The 14-item Mental Health Continuum-Short Form (MHC-SF) will be used to measure mental well-being during the past month. This scale has 3 dimensions: emotional well-being (EWB), psychological well-being (PWB), and social well-being (SWB). Each item is rated on a 6-point scale from 0 (never) to 5 (every day), with a higher score indicating greater well-being.
Psychological flexibility and inflexibility
Time frame: Baseline (pre-intervention); Immediately after the intervention (1 week after baseline); 1-month follow-up (1 month after intervention)
The multidimensional psychological flexibility inventory short form (MPFI-24) is a 24-item scale assessing psychological flexibility. The scale consists of a flexibility subscale and an inflexibility subscale, divided into 12 dimensions, with 2 entries for each dimension, a total of 24 entries, and scored at levels 1 (never true) to 6 (always true).
Acceptability
Time frame: post-intervention (one week after baseline)
The 8-item Client Satisfaction Questionnaire (CSQ-8) is employed to measure client satisfaction. Each item is rated on a 4-point Likert scale. Higher scores reflect better client satisfaction.
9 secondary outcomes
State anxiety and depression
Time frame: During the 7-day intervention period, measurements are conducted twice per day.
State stress
Time frame: During the 7-day intervention period, measurements are conducted twice per day.
State well-being
Time frame: During the 7-day intervention period, measurements are conducted twice per day.
State subjective happiness
Time frame: During the 7-day intervention period, measurements are conducted twice per day.
State affect
Time frame: During the 7-day intervention period, measurements are conducted twice per day.
State psychological flexibility
Time frame: During the 7-day intervention period, measurements are conducted twice per day.
State psychological inflexibility
Time frame: During the 7-day intervention period, measurements are conducted twice per day.
State suicide ideation
Time frame: During the 7-day intervention period, measurements are conducted twice per day.
Suicide ideation
Time frame: Baseline (pre-intervention); Immediately after the intervention (1 week after baseline); 1-month follow-up (1 month after intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT-based ecological momentary intervention and Mood monitoring in people with Healthy Participants Study, run by The Hong Kong Polytechnic University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tao Zhang (+85294233827, tao-t.zhang@connect.polyu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall mental health (time frame: Baseline (pre-intervention); Immediately after the intervention (1 week after baseline); 1-month follow-up (1 month after intervention)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.