AnxietyDARE ProgramNCT07365787
Internet-Based Group CBT for Anxiety and Depression Among International Students
A study testing DARE-Depression and Anxiety Regulation Program in people with Anxiety and Depression, run by Universiti Putra Malaysia at 1 site in Malaysia.
Trial summary
The goal of this RCT trial is to learn if internet-based group cognitive behaviour therapy delivered via the Zoom application works to treat anxiety and depression among international students. It will also learn about the predictive factors of the intervention's effectiveness. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- DARE-Depression and Anxiety Regulation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jun 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- International students.
- 18 and 60 years of age.
- Moderate to severe symptoms of anxiety and depression.
- Fluent in the English language.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site
Universiti Putra Malaysia (UPM)
Serdang, Selangor, 43400
School of Graduate Studies (SGS), UPM, +603-9769 1000, pspk@upm.edu.my
Ethics Committee for Research Involving Human Subjects (JKEUPM, 03-97691244/1421/1438/1439, jkeupm@upm.edu.my
About this study
Official title: Effectiveness of Internet-Based Group Cognitive Behaviour Therapy (GCBT) for Anxiety and Depression Among International Students Studying in Malaysia: A Randomized Controlled Trial
The goal of this RCT trial is to learn if internet-based group cognitive behaviour therapy delivered via the Zoom application works to treat anxiety and depression among international students. It will also learn about the predictive factors of the intervention's effectiveness. The main questions it aims to answer are:
- Does participating in internet-based GCBT reduce the symptoms of anxiety among international students in Malaysia?
- Does participating in internet-based GCBT reduce the symptoms of depression among international students in Malaysia?
Read more
Researchers will compare students who take part in the intervention program with students in a waitlist control group to understand whether the intervention is associated with changes in anxiety and depression symptoms.
Participants will:
- Be randomly assigned to either the intervention program or a waitlist control group
- Attend four sessions of one hour each, including 1) psychoeducation, 2) cognitive techniques, 3) behaviour techniques, and 4) support and relapse prevention. A booster session and a follow-up assessment will be done1 month post intervention.
- Conditions
- Anxiety, Depression
- Being tested
- DARE-Depression and Anxiety Regulation Program
- Keywords
- Anxiety, Depression, Anxiety and Depression, Internet-based Group Cognitive Behaviour Therapy, Internet-based Group CBT, Internet-based Group CBT Intervention, iGCBT, Internet-based GCBT, International Students, University Students
- 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.
DARE-Depression and Anxiety Regulation ProgramBehavioural
Participants assigned to this intervention will receive a structured, manual-based online GCCBT intervention delivered via Zoom. The program consists of four weekly group sessions, each lasting approximately 60 minutes, followed by a booster session conducted one month after completion of the intervention.
Sessions will be conducted by the researcher, a clinical psychologist, under the supervision of a senior clinical psychologist with formal training and expertise in group Cognitive Behavioral Therapy (GCBT). The intervention follows a structured progression beginning with psychoeducation, followed by cognitive skill development and behavioural techniques. The later sessions emphasise consolidation of learnt skills, peer support, and relapse-prevention planning.
The content and delivery of the intervention are designed to be relevant and sensitive to the experiences of international university students.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The experimental group will be provided with 4 weeks intervention, one hour each, followed by one booster session at 1 month post-intervention. Receives: Behavioral: DARE-Depression and Anxiety Regulation Program |
| Waitlist Control Group | No intervention | The waitlist control group will be provided with 4 weeks intervention, one hour each, followed by one booster session at 1 month post-intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generalized Anxiety Disorder Scale
The GAD-7 is a 7-item self-report measure used to assess the frequency and severity of anxiety symptoms in clients 11 and older. Aligned with the DSM-V-TR criteria for Generalized Anxiety Disorder (GAD) the results of this measure can support accurate diagnoses, establishment of treatment goals based on symptom severity, and guide effective clinical interventions.
Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.
Using the threshold score of 10, the GAD-7 has a sensitivity of 89% and a specificity of 82% for GAD. It is moderately good at screening three other common anxiety disorders - panic disorder (sensitivity 74%, specificity 81%), social anxiety disorder (sensitivity 72%, specificity 80%) and post-traumatic stress disorder (sensitivity 66%, specificity 81%).
Measured: Baseline, post-intervention at 1 month, and follow-up at one month post-intervention.
Patient Health Questionnaire
The PHQ-9 is a widely recognized self-report questionnaire used to screen for depression severity. It's a simple yet powerful tool, comprising nine questions that mirror the nine diagnostic criteria for major depressive disorder from the DSM-IV. Understanding how to score phq 9 is the first step in interpreting your results.
A score of ≥10 is considered a sensitive and specific cut-off for major depressive disorder. Whereas, a score ≥15 strongly indicates the presence of clinically significant depression.
Measured: Baseline, post-intervention at 1 month, and follow-up at one month post-intervention.
Automatic Thoughts Questionnaire
The ATQ is a psychological assessment tool designed to measure the frequency of negative automatic thoughts, particularly in individuals with depression.
ATQ consists of 30 items, each describing a common negative automatic thought relevant to depression, such as "I am a failure" or "I can't cope." Respondents rate how frequently they have experienced each thought over a specified period, typically the past week, using a structured Likert scale. This systematic approach transforms fleeting internal experiences into quantifiable data points.
Measured: Baseline, post-intervention at 1 month, and follow-up at one month post-intervention.
Secondary outcomes (1)
World Health Organization Quality of Life-BREF
WHOQOL-BREF is a self-report questionnaire that contains 26 items and addresses 4 QOL domains: physical health (7 items), psychological health (6 items), social relationships (3 items) and environment (8 items). Two other items measure overall QOL and general health.
Items are rated on a 5-point Likert scale (low score of 1 to high score of 5) to determine a raw item score. Subsequently, the mean score for each domain is calculated, resulting in a mean score per domain that is between 4 and 20. Finally, this mean domain score is then multiplied by 4 in order to transform the domain score into a scaled score, with a higher score indicating a higher QOL.
Measured: Baseline, post-intervention at 1 month, and follow-up at one month post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shamsa Riaz, Universiti Putra Malaysia
- Investigators
- Prof. Dr. Firdaus Mukhtar, Study chair, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07365787
- Sponsor's protocol ID
- JKEUPM-2025-330
- Acronym
- DARE Program
- Status last verified
- Jan 2026
- First submitted
- 16 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified individual participant data (IPD) will not be shared publicly at this stage. The study is part of a doctoral research project, and data access is restricted to the primary research team to protect participant confidentiality and comply with institutional ethics approval. Any future data sharing would require additional ethical clearance and participant consent.
Publications
Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.
PubMed 15085902Hollon, S. D., & Kendall, P. C. (1980). Cognitive self-statements in depression: Development of an automatic thoughts questionnaire. Cognitive Therapy and Research, 4(4), 383-395. https://doi.org/10.1007/BF01178214
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Internet-Based Group Cognitive Behaviour Therapy (GCBT) for Anxiety and Depression Among International Students Studying in Malaysia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07365787
- Acronym / sponsor ID
- DARE Program / JKEUPM-2025-330
- Conditions
- Anxiety, Depression
- Keywords
- Anxiety, Depression, Anxiety and Depression, Internet-based Group Cognitive Behaviour Therapy, Internet-based Group CBT, Internet-based Group CBT Intervention, iGCBT, Internet-based GCBT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 26 Jan 2026 (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 RCT trial is to learn if internet-based group cognitive behaviour therapy delivered via the Zoom application works to treat anxiety and depression among international students. It will also learn about the predictive factors of the intervention's effectiveness. The main questions it aims to answer are:
- Does participating in internet-based GCBT reduce the symptoms of anxiety among international students in Malaysia?
- Does participating in internet-based GCBT reduce the symptoms of depression among international students in Malaysia?
Researchers will compare students who take part in the intervention program with students in a waitlist control group to understand whether the intervention is associated with changes in anxiety and depression symptoms.
Participants will:
- Be randomly assigned to either the intervention program or a waitlist control group
- Attend four sessions of one hour each, including 1) psychoeducation, 2) cognitive techniques, 3) behaviour techniques, and 4) support and relapse prevention. A booster session and a follow-up assessment will be done1 month post intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: DARE-Depression and Anxiety Regulation ProgramThe experimental group will be provided with 4 weeks intervention, one hour each, followed by one booster session at 1 month post-intervention. |
| Waitlist Control Group | No intervention | –The waitlist control group will be provided with 4 weeks intervention, one hour each, followed by one booster session at 1 month post-intervention. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- International students.
- 18 and 60 years of age.
- Moderate to severe symptoms of anxiety and depression.
- Fluent in the English language.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| DARE-Depression and Anxiety Regulation ProgramParticipants assigned to this intervention will receive a structured, manual-based online GCCBT intervention delivered via Zoom. The program consists of four weekly group sessions, each lasting approximately 60 minutes, followed by a booster session conducted one month after completion of the intervention. Sessions will be conducted by the researcher, a clinical psychologist, under the supervision of a senior clinical psychologist with formal training and expertise in group Cognitive Behavioral Therapy (GCBT). The intervention follows a structured progression beginning with psychoeducation, followed by cognitive skill development and behavioural techniques. The later sessions emphasise consolidation of learnt skills, peer support, and relapse-prevention planning. The content and delivery of the intervention are designed to be relevant and sensitive to the experiences of international university students. | Behavioural | Experimental Group |
Primary outcome
Generalized Anxiety Disorder Scale
Time frame: Baseline, post-intervention at 1 month, and follow-up at one month post-intervention.
The GAD-7 is a 7-item self-report measure used to assess the frequency and severity of anxiety symptoms in clients 11 and older. Aligned with the DSM-V-TR criteria for Generalized Anxiety Disorder (GAD) the results of this measure can support accurate diagnoses, establishment of treatment goals based on symptom severity, and guide effective clinical interventions. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater. Using the threshold score of 10, the GAD-7 has a sensitivity of 89% and a specificity of 82% for GAD. It is moderately good at screening three other common anxiety disorders - panic disorder (sensitivity 74%, specificity 81%), social anxiety disorder (sensitivity 72%, specificity 80%) and post-traumatic stress disorder (sensitivity 66%, specificity 81%).
Patient Health Questionnaire
Time frame: Baseline, post-intervention at 1 month, and follow-up at one month post-intervention.
The PHQ-9 is a widely recognized self-report questionnaire used to screen for depression severity. It's a simple yet powerful tool, comprising nine questions that mirror the nine diagnostic criteria for major depressive disorder from the DSM-IV. Understanding how to score phq 9 is the first step in interpreting your results. A score of ≥10 is considered a sensitive and specific cut-off for major depressive disorder. Whereas, a score ≥15 strongly indicates the presence of clinically significant depression.
Automatic Thoughts Questionnaire
Time frame: Baseline, post-intervention at 1 month, and follow-up at one month post-intervention.
The ATQ is a psychological assessment tool designed to measure the frequency of negative automatic thoughts, particularly in individuals with depression. ATQ consists of 30 items, each describing a common negative automatic thought relevant to depression, such as "I am a failure" or "I can't cope." Respondents rate how frequently they have experienced each thought over a specified period, typically the past week, using a structured Likert scale. This systematic approach transforms fleeting internal experiences into quantifiable data points.
1 secondary outcome
World Health Organization Quality of Life-BREF
Time frame: Baseline, post-intervention at 1 month, and follow-up at one month post-intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Background: PubMed 15085902Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.
- BackgroundHollon, S. D., & Kendall, P. C. (1980). Cognitive self-statements in depression: Development of an automatic thoughts questionnaire. Cognitive Therapy and Research, 4(4), 383-395. https://doi.org/10.1007/BF01178214
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Individual participant dataSharing planned: Undecided. De-identified individual participant data (IPD) will not be shared publicly at this stage. The study is part of a doctoral research project, and data access is restricted to the primary research team to protect participant confidentiality and comply with institutional ethics approval. Any future data sharing would require additional ethical clearance and participant consent.
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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.
Prof. Dr. Firdaus Mukhtar study chair
Universiti Putra Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DARE-Depression and Anxiety Regulation Program in people with Anxiety and Depression, run by Universiti Putra 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 4 inclusion and 0 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: opening soon, as of the sponsor's last update on 30 Jan 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shamsa Riaz, PhD Researcher (+60176929270, gs70161@student.upm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generalized Anxiety Disorder Scale (time frame: Baseline, post-intervention at 1 month, and follow-up at one month post-intervention.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07365787, which also lists 4 linked publications.
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 30 Jan 2026.