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

NCT07177365 | Not Yet Recruiting

• 2 other identifiers: 202506094RSPDC114B0B014500
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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) 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.

Conditions

Generalized Anxiety Disorder (GAD); Major Depressive Disorder (MDD)

Keywords

Internet-Based Cognitive Behavioral Therapy; ICBT; Digital Mental Health; Online Therapy; Randomized Controlled Trial; Cognitive Restructuring; Mindfulness; Self-Compassion; Taiwan; Treatment as Usual (TAU)

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline, Week 5 (mid-intervention), Week 9 (post-intervention), and 3-month follow-up.

• 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.

  Baseline, Week 5 (mid-intervention), Week 9 (post-intervention), and 3-month follow-up.

Other Outcomes (3)

• Course completion rate

  Week 9 (post-intervention)

• Platform usage metrics

  Week 9 (post-intervention)

• Changes in perception of online psychological interventions (POPII score)

  Baseline, Week 9 (post-intervention), and 3-month follow-up

Study Arms (2)

TAU + ICBT

EXPERIMENTAL

Participants will receive standard psychiatric care (Treatment as Usual, TAU) plus an 8-week Internet-based Cognitive Behavioral Therapy (ICBT) program delivered via the National Health Research Institutes platform.

Behavioral: Internet-Based Cognitive Behavioral Therapy (ICBT)

TAU Only

ACTIVE COMPARATOR

Participants will receive standard psychiatric care (TAU) without ICBT during the study period. After study completion, they may request access to the ICBT program.

Other: Treatment as Usual (TAU) Only

Interventions

Internet-Based Cognitive Behavioral Therapy (ICBT) BEHAVIORAL

An 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.

Also known as: Online CBT, Web-based CBT

TAU + ICBT

Treatment as Usual (TAU) Only OTHER

Routine 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.

Also known as: Standard Psychiatric Care

TAU Only

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead

MeSH Terms

Conditions

Generalized Anxiety Disorder; Depressive Disorder, Major

Interventions

Therapeutics; Single Person

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Depressive Disorder; Mood Disorders

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 17, 2025
• Study Start: September 20, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-08