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

NCT07365787 | Not Yet Recruiting DMC

• 1 other identifier: JKEUPM-2025-330
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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; International Students; University Students

Outcome Measures

Primary Outcomes (3)

• 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%).

  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.

  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.

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

Secondary Outcomes (1)

• World Health Organization Quality of Life-BREF

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

Study Arms (2)

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.

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.

Interventions

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.

Experimental Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

Study Sites (1)

Universiti Putra Malaysia (UPM)

Serdang, Selangor, 43400, Malaysia

Location

Related Publications (4)

• 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.

  PMID: 15085902 BACKGROUND

• Hollon, 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

• 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.

  PMID: 11556941 BACKGROUND

• Spitzer 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.

  PMID: 16717171 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Prof. Dr. Firdaus Mukhtar

  Universiti Putra Malaysia

  STUDY CHAIR

Central Study Contacts

Shamsa Riaz, PhD Researcher

CONTACT

+60176929270; gs70161@student.upm.edu.my

Prof. Dr. Firdaus Mukhtar, PhD Clinical Psychology

CONTACT

+6012-302 6353; drfirdaus@upm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: January 26, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

MY (1)