Effectiveness of Internet-Based Group Cognitive Behaviour Therapy (GCBT) for Anxiety and Depression Among International Students Studying in Malaysia: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Universiti Putra Malaysia
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- Generalized Anxiety Disorder Scale
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •International students.
- •18 and 60 years of age.
- •Moderate to severe symptoms of anxiety and depression.
- •Fluent in the English language.
Exclusion Criteria
- Not provided
Arms & Interventions
Waitlist Control Group
The waitlist control group will be provided with 4 weeks intervention, one hour each, followed by one booster session at 1 month post-intervention.
Experimental Group
The experimental group will be provided with 4 weeks intervention, one hour each, followed by one booster session at 1 month post-intervention.
Intervention: DARE-Depression and Anxiety Regulation Program (Behavioral)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- World Health Organization Quality of Life-BREF(Baseline, post-intervention at 1 month, and follow-up at one month post-intervention.)
Investigators
Shamsa Riaz
PhD Candidate
Universiti Putra Malaysia