ACT-based EMI in College Students

March 6, 2025 updated by: The Hong Kong Polytechnic University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Hong Kong, China
        • The Hong Kong Polytechnic University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participants in our study are healthy college students
  • have smartphone, and have access to the internet

Exclusion Criteria:

  • currently participating in another research
  • have significant cognitive impairment that prevents participation in the research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Mood monitoring condition
Only pre- and post-assessments and ecological momentary assessment (EMA) measurements are conducted.
Other: Mood monitoring
Participants do not receive any intervention. During the intervention period, they only need to complete ecological momentary assessments twice a day.
Experimental: ACT-based EMI group
Participants are required to complete a 7-day ecological momentary intervention (EMI).
Behavioral: ACT-based ecological momentary intervention
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (pre-intervention); Immediately after the intervention (1 week after baseline); 1-month follow-up (1 month after intervention)
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
Baseline (pre-intervention); Immediately after the intervention (1 week after baseline); 1-month follow-up (1 month after intervention)
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.
post-intervention (one week after baseline)
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.
Baseline (pre-intervention); Immediately after the intervention (1 week after baseline); 1-month follow-up (1 month after intervention)
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).
Baseline (pre-intervention); Immediately after the intervention (1 week after baseline); 1-month follow-up (1 month after intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
State affect
Time Frame: During the 7-day intervention period, measurements are conducted twice per day.
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).
During the 7-day intervention period, measurements are conducted twice per day.
State anxiety and depression
Time Frame: During the 7-day intervention period, measurements are conducted twice per day.
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.
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 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.
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 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).
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 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).
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 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.
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 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).
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.
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.
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)
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.
Baseline (pre-intervention); Immediately after the intervention (1 week after baseline); 1-month follow-up (1 month after intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSEARS20250214003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings