AnxietyACTNCT06832462
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.
A study testing Acceptance and Commitment Therapy in people with Anxiety and Depression, run by Universiti Teknologi Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Mar 2024to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:-
Read more
- 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).
Read the 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.
- Conditions
- Anxiety, Depression
- Being tested
- Acceptance and Commitment Therapy
- Keywords
- Acceptance and Commitment Therapy (ACT), University student, psychological flexibility, psychological capital
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Acceptance and Commitment Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Screening phase, one hour before intervention, one hour after intervention, and 1 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start1 Mar 2024
- Primary completion30 Sep 2025
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two group: intervention and waitlist
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Teknologi Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akmar Nabila Binti A Bakar, Universiti Teknologi Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832462
- Sponsor's protocol ID
- UTMREC-2024-83
- Other IDs
- Q.J130000.3853.31J93
- Acronym
- ACT
- Status last verified
- Jul 2026
- First submitted
- 13 Feb 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In the inform consent, we agreed to keep the information private and confidential.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06832462
- Acronym / sponsor ID
- ACT / UTMREC-2024-83
- Conditions
- Anxiety, Depression
- Keywords
- Acceptance and Commitment Therapy (ACT), University student, psychological flexibility, psychological capital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Universiti Teknologi MalaysiaUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- There are two group: intervention and waitlist
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Acceptance and Commitment TherapyThis 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. |
| Waitlist Group | Other | Behavioral: Acceptance and Commitment TherapyAfter 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. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment TherapyA 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 | Behavioural | Intervention, Waitlist Group |
Primary outcome
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.
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.
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No. In the inform consent, we agreed to keep the information private and confidential.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy in people with Anxiety and Depression, run by Universiti Teknologi Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance and Action Questionnaire-II (time frame: One hour before intervention, one hour after intervention, and 1 month after intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.