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NCT Number: NCT06843395

ACT-based EMI in College Students

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACT-based ecological momentary intervention

Behavioral

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 monitoring

Other

Participants do not receive any intervention. During the intervention period, they only need to complete ecological momentary assessments twice a day.

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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).

  5. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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).

  5. 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).

  6. 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.

  7. 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).

  8. 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.

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tao Zhang

CONTACT

[email protected]

+85294233827

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 25, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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