This study aims to evaluate the effectiveness of internet-based cognitive behavioral therapy (ICBT) combined with treatment as usual (TAU) for adults diagnosed with generalized anxiety disorder (GAD) or major depressive disorder (MDD) in Taiwan.
CBT is a proven treatment for anxiety and depression, but traditional face-to-face sessions require frequent clinic visits, which may be costly and time-consuming. ICBT delivers similar therapy content online, allowing participants to complete sessions at their own pace, reducing barriers such as travel and scheduling.
A total of 160 participants will be randomly assigned to receive either TAU alone or TAU plus an 8-week ICBT program delivered via a secure national research platform. The program includes 12 online modules covering cognitive restructuring, emotion regulation, and behavioral activation techniques. Participants will complete assessments before, during, and after the program, with follow-up at 3 months.
The results will help determine whether ICBT can improve symptoms, enhance treatment accessibility, and support the integration of digital mental health interventions into clinical practice in Taiwan.
Age between 20 and 65 years.
Diagnosis of Generalized Anxiety Disorder (GAD) confirmed by a psychiatrist.
Diagnosis of Major Depressive Disorder (MDD) confirmed by a psychiatrist, without acute suicidal risk (screened by PHQ-9 Item 9; score of 3 requires further clinical assessment to exclude active suicidal plan or recent self-harm).
For GAD ICBT participants
Current or past history of obsessive-compulsive disorder, panic disorder, bipolar disorder, eating disorder, schizophrenia, or substance abuse.
Severe depressive symptoms impairing daily functioning.
Current suicidal ideation.
Parallel
Internet-Based Cognitive Behavioral Therapy (ICBT)
BehavioralAn 8-week Internet-based Cognitive Behavioral Therapy (ICBT) program delivered via the National Health Research Institutes (NHRI) secure online platform. The program consists of 12 sequential modules released every 5 days, covering core CBT techniques such as cognitive restructuring, emotion regulation, behavioral activation, mindfulness, and self-compassion. Participants receive automated email notifications for new modules and supplementary review materials. Progress is monitored through the platform, and participants complete standardized self-report assessments at baseline, mid-intervention (week 5), post-intervention (week 9), and 3-month follow-up.
Treatment as Usual (TAU) Only
Other interventionRoutine clinical care provided by a psychiatrist, which may include pharmacological treatment, psychoeducation, and regular follow-up visits according to clinical judgment. No ICBT intervention is provided during the study period. Participants follow the same assessment schedule as the experimental group. After the 3-month follow-up, participants in this group may request access to the ICBT program.
Change in Generalized Anxiety Disorder symptoms (GAD-7 score) between intervention and control groups
The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report questionnaire assessing the severity of generalized anxiety symptoms over the past two weeks. Each item is scored from 0 ("not at all") to 3 ("nearly every day"), for a total score range of 0-21; higher scores indicate greater anxiety severity. The primary analysis will compare score changes from baseline to each follow-up point between the ICBT + Treatment as Usual (TAU) group and the TAU-only group.
Change in depressive symptoms (PHQ-9 score) between intervention and control groups
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report questionnaire assessing the severity of depressive symptoms over the past two weeks. Each item is scored from 0 ("not at all") to 3 ("nearly every day"), for a total score range of 0-27; higher scores indicate greater depression severity. The primary analysis will compare score changes from baseline to each follow-up point between the ICBT + TAU group and the TAU-only group.
Course completion rate
The percentage of participants who complete all 12 modules of the Internet-based Cognitive Behavioral Therapy (ICBT) program within the 8-week intervention period. Completion is defined as accessing and finishing all module activities.
Platform usage metrics
Total number of logins and cumulative time spent on the ICBT platform during the intervention period, as recorded by the system's usage tracking function.
Changes in perception of online psychological interventions (POPII score)
The Perception of Online Psychological Intervention Index (POPII) is a self-developed questionnaire assessing perceived emotional support, knowledge and skill acquisition, self-awareness, and self-care practices after participation in ICBT. Higher scores indicate greater perceived benefit.
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