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Not yet recruiting NCT07365787

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

No phase Interventional Anxiety Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DARE-Depression and Anxiety Regulation Program.
Who it may be relevant to
Registry conditions: Anxiety, Depression. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Malaysia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • Behavioral DARE-Depression and Anxiety Regulation Program
    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

Primary outcome measures

  • Generalized Anxiety Disorder Scale [Time frame: Baseline, post-intervention at 1 month, and follow-up at one month post-intervention.]
  • Patient Health Questionnaire [Time frame: Baseline, post-intervention at 1 month, and follow-up at one month post-intervention.]
  • Automatic Thoughts Questionnaire [Time frame: Baseline, post-intervention at 1 month, and follow-up at one month post-intervention.]
Secondary outcome measures (1)
  • World Health Organization Quality of Life-BREF [Time frame: Baseline, post-intervention at 1 month, and follow-up at one month post-intervention.]

Eligibility criteria

Inclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Malaysia · 1 center
  • Universiti Putra Malaysia (UPM) — Serdang

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. PMID 15085902
  • 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
  • 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
  • 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

Identifiers

NCT: NCT07365787 · JKEUPM-2025-330

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗