NCT07256093

Brief Summary

The goal of this clinical trial is to learn if Acceptance and Commitment Therapy (ACT) can reduce dysfunctional attitudes and difficulties in emotion regulation among university students in Malaysia.The main questions it aims to answer are:

  • Will participants who receive ACT show statistically significant reduction in dysfunctional attitudes scores compared to those in the control group?
  • Will participants who receive ACT show statistically significant reduction in difficulties in emotion regulation scores compared to those in the control group?
  • Will participants who receive ACT show statistically significant reduction in dysfunctional attitudes scores from pre-test to intermediate-test and from pre-test to post-test?
  • Will participants who receive ACT show statistically significant reduction in difficulties in emotion regulation scores from pre-test to intermediate test and from pre-test to post-test? Researchers will compare ACT group to a waitlist control group to see if ACT work to reduce dysfunctional attitudes and difficulties in emotion regulation. Participants in the ACT group will
  • attend six weekly individual sessions of ACT intervention (1 hour per session) conducted online
  • complete the outcome measures at three different time points (week 1, week 3, and week 6) Meanwhile, participants in the waitlist control group
  • will not receive any intervention during the data collection period
  • will be asked to complete same outcome measures at three different time points (week 1, week 3, and week 6)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 10, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 1, 2025

Completed
Last Updated

April 30, 2026

Status Verified

October 1, 2025

Enrollment Period

1 month

First QC Date

November 19, 2025

Last Update Submit

April 28, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Difficulties in Emotion Regulation

    It is measured as the total score on the Difficulties in Emotion Regulation Scale-18 Malay, where a higher score indicates a greater degree of difficulties in emotion regulation.

    Baseline, Week 3, and Week 6

  • Dysfunctional Attitudes

    It is measured as the total score on the Dysfunctional Attitude Scale-Malay, where a higher score indicates a greater degree of dysfunctional attitude.

    Baseline, Week 3, and Week 6

Study Arms (2)

ACT Intervention Group

EXPERIMENTAL

Participants in the intervention group attended six weekly individual sessions of ACT intervention (1 hour per session) conducted online via the Webex platform.

Other: Acceptance and Commitment Therapy (ACT)

Waitlist Control Group

NO INTERVENTION

Participants in the control group were placed on a waitlist and completed the same outcome measures at three different time points (week 1, week 3, and week 6). After the completion of data collection, they were then divided into two groups and attended two group sessions of ACT (1.5 hours per session), each covering three of the six ACT main components.

Interventions

Six sessions of ACT were conducted Session 1: Introduction. Theme: Broaden your horizon. Values and value-based actions. Identifying what matters the most in your life and acting accordingly. Session 2: Theme: Present moment. Mindfully notice your internal and external experiences, notice the movement of your breath. Live in the present moment. To address difficulties in emotion regulation. Session 3: Theme: Cognitive defusion. The power of thoughts. Identify your unwanted thoughts and emotions and learn to describe, name, and welcome them. To address dysfunctional attitudes. Session 4: Theme: The observer's stance. Learn to view your thoughts and emotions from an observer's stance. To address difficulties in emotion regulation. Session 5: Theme: Toward an attitude of acceptance. Let go of your struggle and learn acceptance towards your wakefulness and unwanted thoughts. To address dysfunctional attitudes. Session 6: Theme: Summary of the programme. Plans committed action.

ACT Intervention Group

Eligibility Criteria

Age18 Years - 32 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Malaysian citizens
  • currently enrolled as a university student
  • be proficient in both Malay and English languages
  • aged between 18 and 32 years old
  • reported mild to moderate depression, anxiety, and/or stress levels according to the DASS-21

You may not qualify if:

  • reported severe depression, anxiety, and/or stress on the DASS-21
  • expected to graduate before study ends
  • had been diagnosed with any psychological disorder prior to the study
  • were currently receiving psychotherapeutic medication and/or psychological interventions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiti Sains Malaysia

Kuala Lumpur, Malaysia

Location

MeSH Terms

Conditions

Anxiety DisordersDepression

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr

Study Record Dates

First Submitted

November 19, 2025

First Posted

December 1, 2025

Study Start

February 10, 2025

Primary Completion

March 20, 2025

Study Completion

April 25, 2025

Last Updated

April 30, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations