Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07365787

Internet-Based Group CBT for Anxiety and Depression Among International Students

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universiti Putra Malaysia (UPM)

Serdang, Selangor, 43400, Malaysia

Location contact

Ethics Committee for Research Involving Human Subjects (JKEUPM

CONTACT

[email protected]

03-97691244/1421/1438/1439

School of Graduate Studies (SGS), UPM

CONTACT

[email protected]

+603-9769 1000

Shamsa Riaz, PhD Candidate

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • International students.
  • 18 and 60 years of age.
  • Moderate to severe symptoms of anxiety and depression.
  • Fluent in the English language.

Treatment and study plan

DARE-Depression and Anxiety Regulation Program

Behavioral

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.

Primary outcomes

  1. 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%).

  2. 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.

  3. 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.

Secondary outcomes

  1. World Health Organization Quality of Life-BREF

    Time frame: Baseline, post-intervention at 1 month, and follow-up at one month post-intervention.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Prof. Dr. Firdaus Mukhtar, PhD Clinical Psychology

CONTACT

[email protected]

+6012-302 6353

Shamsa Riaz, PhD Researcher

CONTACT

[email protected]

+60176929270

Sponsors and collaborators

Lead sponsor

Universiti Putra Malaysia

Other

Registry information

Official study title

Effectiveness of Internet-Based Group Cognitive Behaviour Therapy (GCBT) for Anxiety and Depression Among International Students Studying in Malaysia: A Randomized Controlled Trial

Acronym: DARE Program

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 26, 2026
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.