Clinical trial NCT06843395: ACT-based EMI in College Students
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy Participants Study
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall mental health
timeFrame: Baseline (pre-intervention); Immediately after the intervention (1 week after baseline); 1-month follow-up (1 month after intervention)
measure: Psychological distress
timeFrame: Baseline (pre-intervention); Immediately after the intervention (1 week after baseline); 1-month follow-up (1 month after intervention)
measure: Mental well-being
timeFrame: Baseline (pre-intervention); Immediately after the intervention (1 week after baseline); 1-month follow-up (1 month after intervention)
measure: Psychological flexibility and inflexibility
timeFrame: Baseline (pre-intervention); Immediately after the intervention (1 week after baseline); 1-month follow-up (1 month after intervention)
measure: Acceptability
timeFrame: post-intervention (one week after baseline)
Secondary outcomes:
measure: State anxiety and depression
timeFrame: During the 7-day intervention period, measurements are conducted twice per day.
measure: State stress
timeFrame: During the 7-day intervention period, measurements are conducted twice per day.
measure: State well-being
timeFrame: During the 7-day intervention period, measurements are conducted twice per day.
measure: State subjective happiness
timeFrame: During the 7-day intervention period, measurements are conducted twice per day.
measure: State affect
timeFrame: During the 7-day intervention period, measurements are conducted twice per day.
measure: State psychological flexibility
timeFrame: During the 7-day intervention period, measurements are conducted twice per day.
measure: State psychological inflexibility
timeFrame: During the 7-day intervention period, measurements are conducted twice per day.
measure: State suicide ideation
timeFrame: During the 7-day intervention period, measurements are conducted twice per day.
measure: Suicide ideation
timeFrame: Baseline (pre-intervention); Immediately after the intervention (1 week after baseline); 1-month follow-up (1 month after intervention)
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The Hong Kong Polytechnic University
Study officials:
References: