- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06832462
A Prospective and Experimental Study on the Effect of One-Day of Acceptance and Commitment Therapy (ACT) on Psychological Flexibility, Psychological Capital, Anxiety and Depression Among Undergraduate Students. (ACT)
The Effect of a One-Day Acceptance and Commitment Therapy (ACT) on Psychological Flexibility and Psychological Capital in Students With Anxiety and Depression : A RCT Study
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:-
- To what extent does the intervention affect psychological flexibility, psychological capital, anxiety, and depression as measured by Cohen's d?
- How does a one-day ACT intervention affect university students' psychological flexibility, psychological capital, anxiety, and depression over time?
- How does a one-day ACT intervention affect university students' psychological flexibility, psychological capital, anxiety, and depression between groups?
Participants will:
- 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).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a prospective and experimental study. A prospective study approach is used to examine the changes in outcome measures along with the data collection timeline. Data will be collected at four different points. Also, this is an experimental study, a randomised controlled trial study, and consists of two arms: a one-day ACT intervention and waitlist groups. The effect of a one-day ACT intervention will be evaluated using a randomised controlled trial approach by comparing the differences between intervention and waitlist groups.
(T0) - Screening phase - A set of questionnaires of the Beck Anxiety Inventory (BAI) and Beck Depression Inventory (BDI) will be distributed through the student portal for screening. Potential participants who score moderate and above will be invited to the One-Day ACT intervention. The details of potential participants will be recorded.
(T1) - During pre-intervention, participants will be divided into two groups: a waitlist and a group that will receive batteries of questionnaires. The questionnaires included the demographic survey, BAI, BDI, Acceptance and Action Questionnaire II (AAQ-II) and Psychological Capital Questionnaires (PCQ) for participants before receiving the ACT intervention. Those who answer the questionnaires will receive a One-Day ACT intervention. In addition, respondents will be fully informed regarding the objectives and procedure of this research, and consent information will be gathered.
One-Day Intervention: -
A one-day ACT intervention will be conducted in three sessions, each lasting 40 minutes. The intervention is based on a module developed by Shari et al. (2020) and aims to help respondents manage their issues, such as unpleasant thoughts and feelings. The first session will build a therapeutic relationship and icebreak, 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 importance of being present and aware of oneself. The final session, 'Get Moving', will connect values to practical action plans, using animated video (Values VS Goals) presentations to help respondents define their values and identify significant life steps.
(T2)-post-intervention, where a one-day ACT intervention has been completed and a set of questionnaires distributed to participants. The questionnaires include the BAI, BDI, AAQ-II, and PCQ.
(T3) - After one month of intervention, participants who received a one-day ACT intervention answered the BAI, BDI, AAQ-II and PCQ questionnaires.
Data analysis will be performed using SPSS version 30, including the calculation of effect sizes. To evaluate the research objectives, a repeated-measures MANOVA will be conducted.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Johor
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Johor Bahru, Johor, Malaysia, 81310
- Universiti Teknologi Malaysia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Local Malaysian Students
- 18 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
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.
|
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 |
|
Other: Waitlist Group
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.
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptance and Action Questionnaire-II
Time Frame: One hour before intervention, one hour after intervention, and 1 month after intervention
|
).
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
Time Frame: One hour before intervention, one hour after intervention, and 1 month after intervention
|
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
Time Frame: Screening phase, one hour before intervention, one hour after intervention, and 1 month after intervention
|
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
Time Frame: Screening phase, one hour before intervention, one hour after intervention, and 1 month after intervention
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychological capital and psychological flexibility.
Time Frame: Before and after participate the one-day acceptance and commitment therapy.
|
Psychological capital will be measured using the Psychological Capital Questionnaire (PCQ).
Meanwhile Psychological flexibility is measured by using the Acceptance and action questionnaire (AAQ II)
|
Before and after participate the one-day acceptance and commitment therapy.
|
|
Psychological flexibility mediates the mechanism through which ACT improves mental health issues among university students.
Time Frame: Before and after participate the one-day acceptance and commitment therapy.
|
Mediation analysis is calculated by using PROCESS macro Version 3.5 developed by Andrew F. Hayes.
Single mediator model will be used to analyse total, direct, and indirect effect of the mediator variables
|
Before and after participate the one-day acceptance and commitment therapy.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Video presentations are effective in improving understanding of the ACT concepts.
Time Frame: Before and after participate the one-day acceptance and commitment therapy.
|
The score from the survey of The Learning Acceptance Scale will be calculated to determine the efficacy of video presentations in enhancing the understanding of ACT concepts.
The score is...
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Before and after participate the one-day acceptance and commitment therapy.
|
|
A one-day ACT intervention is feasible to be implemented in enhancing mental health and psychological capital among university students
Time Frame: After participate a one-day acceptance and commitment therapy
|
The score for The Treatment Satisfaction Questionnaire and at T3 will be computed into the total score to determine the level of satisfaction toward the therapy and the therapist.
|
After participate a one-day acceptance and commitment therapy
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UTMREC-2024-83
- Q.J130000.3853.31J93 (Other Grant/Funding Number: UTMER)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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