ACT-based EMI in College Students

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: Not yet recruiting
• Conditions: Healthy Participants Study
• Intervention / Treatment: Other: Mood monitoring; Behavioral: ACT-based ecological momentary intervention

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: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tao Zhang; Phone Number: +85294233827; Email: tao-t.zhang@connect.polyu.hk

Study Locations

• China
  • Hong Kong, China
    • The Hong Kong Polytechnic University
    • Contact: Bryant HUI; Phone Number: +852 2766 7744; Email: phhui@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	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	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.	post-intervention (one week after baseline)
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.	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).	Baseline (pre-intervention); Immediately after the intervention (1 week after baseline); 1-month follow-up (1 month after intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	During the 7-day intervention period, measurements are conducted twice per day.
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.	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.	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).	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).	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.	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).	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.	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.	Baseline (pre-intervention); Immediately after the intervention (1 week after baseline); 1-month follow-up (1 month after intervention)

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2025
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 20, 2025
• First Submitted That Met QC Criteria: February 20, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID 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