NCT06843395

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

April 15, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 11, 2025

Status Verified

February 1, 2025

Enrollment Period

4 months

First QC Date

February 20, 2025

Last Update Submit

March 6, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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 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)

  • 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 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)

  • 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)

Secondary Outcomes (9)

  • State anxiety and depression

    During the 7-day intervention period, measurements are conducted twice per day.

  • State stress

    During the 7-day intervention period, measurements are conducted twice per day.

  • State well-being

    During the 7-day intervention period, measurements are conducted twice per day.

  • State subjective happiness

    During the 7-day intervention period, measurements are conducted twice per day.

  • State affect

    During the 7-day intervention period, measurements are conducted twice per day.

  • +4 more secondary outcomes

Study Arms (2)

Mood monitoring condition

PLACEBO COMPARATOR

Only pre- and post-assessments and ecological momentary assessment (EMA) measurements are conducted.

Other: Mood monitoring

ACT-based EMI group

EXPERIMENTAL

Participants are required to complete a 7-day ecological momentary intervention (EMI).

Behavioral: ACT-based ecological momentary intervention

Interventions

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.

ACT-based EMI group

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

Mood monitoring condition

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, China

Location

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2025

First Posted

February 25, 2025

Study Start

April 15, 2025

Primary Completion

August 1, 2025

Study Completion

December 31, 2025

Last Updated

March 11, 2025

Record last verified: 2025-02

Locations