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NCT07177365Not yet recruiting

Internet-Based Cognitive Behavioral Therapy With Treatment as Usual for Generalized Anxiety Disorder and Major Depressive Disorder in Taiwan (ICBT-TW)

ICBT Clinical Validation - A Clinical Study on Internet-based Cognitive Behavioral Intervention for Generalized Anxiety Disorder and Major Depressive Disorder

Source: ClinicalTrials.gov · Last updated 22 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
120 (estimated)
First submitted
15 Sept 2025
Start date
20 Sept 2025
Primary completion date
30 Jun 2026
Lead sponsor
National Health Research Institutes, Taiwan
Diseases
Depression
NCT number
NCT07177365

What you commit to

  • Study type: Interventional
  • Planned participants: 120
  • From 20 Sept 2025 to the primary completion date, 30 Jun 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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).

Who the study is looking for

  • 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).

Age in the registry: 20 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.