NCT06832462

Brief Summary

The goal of this study is to examine the effect of a one-day ACT intervention on psychological flexibility and psychological capital among undergraduate students at UTM who have anxiety and depression. Undergraduate students who scored moderate or above on anxiety and depression questionnaires during screening and volunteered to participate will be invited to a one-day ACT intervention. The participants will be randomly divided into two groups, which are the intervention and waitlist groups. Assessment of psychological flexibility, psychological capital, anxiety, and depression levels will be given online at the pre-intervention phase (T1), post-intervention phase (T2), and follow-up after one month phase (T3). The main questions it aims to answer are the following:-

  • The intervention group will participate in a one-day Acceptance and Commitment Therapy (ACT) intervention during data collection while the waitlist group receives it after the data completion.
  • Answer set of questionnaires during pre-intervention (T1), post-intervention (T2) and follow-up after one month (T3).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Mar 2024

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 18, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

July 6, 2026

Status Verified

July 1, 2026

Enrollment Period

1.6 years

First QC Date

February 13, 2025

Last Update Submit

July 1, 2026

Conditions

Keywords

Acceptance and Commitment Therapy (ACT)University studentpsychological flexibilitypsychological capital

Outcome Measures

Primary Outcomes (4)

  • Acceptance and Action Questionnaire-II

    ). The AAQ-II is a 7-item self-report measure of psychological flexibility. Participants respond using a 7-point Likert scale, with higher scores reflecting greater psychological inflexibility.

    One hour before intervention, one hour after intervention, and 1 month after intervention

  • Psychological Capital Questionnaire

    Psychological capital will be measured using the Psychological Capital Questionnaire (PCQ) developed by Luthans (2007). The questionnaire consists of 22 items, divided into 6 existing scales, with answers ranging from "strongly disagree" to "strongly agree". In this scale, 6 items represent each dimension of PsyCap: hope, self-efficacy, resilience, and optimism. The final score indicated a person's level of positive PsyCap.

    One hour before intervention, one hour after intervention, and 1 month after intervention

  • Beck Anxiety Inventory

    The Beck Anxiety Inventory (BAI) will be used to measure anxiety. The BAI score is divided into 4 categories: 0-7 indicates minimal anxiety, 8-15 indicates mild anxiety, 16-25 indicates moderate anxiety, and 26-63 indicates severe anxiety.

    Screening phase, one hour before intervention, one hour after intervention, and 1 month after intervention

  • Beck Depression Inventory

    The Beck depression inventory (BDI) is used to measure depression level. The total score of the BDI is divided into 4 categories: 0-13 indicates minimal, 14-19 indicates mild, 20-28 indicates moderate, and 29-63 indicates severe depression

    Screening phase, one hour before intervention, one hour after intervention, and 1 month after intervention

Study Arms (2)

Intervention

EXPERIMENTAL

This group will receive one-day Acceptance and Commitment Therapy (ACT). The therapy includes 4 sessions that explain and guide participants to understand the concept of ACT and apply it in their daily lives for the purpose of increasing their psychological flexibility.

Behavioral: Acceptance and Commitment Therapy

Waitlist Group

OTHER

After data completion, the waitlist group will receive a similar one-day ACT intervention. During data collection, this group did not receive any intervention in order to compare the level of psychological flexibility, psychological capital, anxiety and depression between the intervention group and the waitlist group.

Behavioral: Acceptance and Commitment Therapy

Interventions

A one-day Acceptance and Commitment Therapy (ACT) will be held with three (3) sessions. The sessions start with ice breaking, and follow by, The first session will build a therapeutic relationship and icebreaking, using animated video (unwanted guest) presentations to explain how ACT can help manage issues. The second session will focus on acceptance and defusion concepts, emphasizing the importance of letting go of unproductive emotion-control techniques by using animated video (response ability) The third session, 'Show Up', will increase awareness of undesirable thoughts and feelings through structured mindfulness exercises and observing surroundings. The therapist will explain the metaphor of dropping the anchor and emphasize the

InterventionWaitlist Group

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Local Malaysian Students
  • years old and above
  • Students who scored moderate or above for the Beck Depression Inventory (BDI) or Beck Anxiety Inventory (BAI) during the screening phase.

You may not qualify if:

  • International UTM students, due to the intervention being conducted in Bahasa Malaysia
  • Students who have a neurodevelopmental condition or those currently receiving psychiatric treatment or attending psychotherapy sessions, including ACT-based interventions
  • Students with a clinically diagnosed psychotic disorder confirmed by a psychiatrist.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiti Teknologi Malaysia

Johor Bahru, Johor, 81310, 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
TREATMENT
Intervention Model
PARALLEL
Model Details: There are two group: intervention and waitlist
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate Student

Study Record Dates

First Submitted

February 13, 2025

First Posted

February 18, 2025

Study Start

March 1, 2024

Primary Completion

September 30, 2025

Study Completion

February 28, 2026

Last Updated

July 6, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

In the inform consent, we agreed to keep the information private and confidential.

Locations