Status:
NOT_YET_RECRUITING
Internet-Based Cognitive Behavioral Therapy With Treatment as Usual for Generalized Anxiety Disorder and Major Depressive Disorder in Taiwan (ICBT-TW)
Lead Sponsor:
National Health Research Institutes, Taiwan
Conditions:
Generalized Anxiety Disorder (GAD)
Major Depressive Disorder (MDD)
Eligibility:
All Genders
20-65 years
Phase:
NA
Brief Summary
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) ...
Detailed Description
This randomized controlled trial will assess the efficacy and feasibility of a locally adapted internet-based cognitive behavioral therapy (ICBT) program for patients with generalized anxiety disorder...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
- Experiencing acute life stressors (e.g., domestic violence, ongoing treatment for serious physical illness).
- Currently receiving psychological counseling or psychotherapy.
- Other serious factors limiting participation (e.g., intellectual disability, significant cognitive impairment, severe vision or hearing impairment).
- For MDD ICBT participants
- Diagnosis of bipolar disorder, eating disorder, schizophrenia, psychotic symptoms, or substance abuse.
- Current suicidal ideation or recent self-harm (PHQ-9 Item 9 score of 3 triggers further assessment; exclusion if active suicidal plan or recent self-harm present).
- Experiencing acute life stressors (e.g., domestic violence, ongoing treatment for serious physical illness).
- Currently receiving psychological counseling or psychotherapy.
- Other serious factors limiting participation (e.g., intellectual disability, significant cognitive impairment, severe vision or hearing impairment).
Key Trial Info
Start Date :
September 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07177365
Start Date
September 20 2025
End Date
June 30 2026
Last Update
September 22 2025
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