Generalized Anxiety Disorder (GAD)ICBT-TWNCT07177365
Internet-Based Cognitive Behavioral Therapy With Treatment as Usual for Generalized Anxiety Disorder and Major Depressive Disorder in Taiwan (ICBT-TW)
A study testing Internet-Based Cognitive Behavioral Therapy (ICBT) and Treatment as Usual (TAU) Only in people with Generalized Anxiety Disorder (GAD) and Major Depressive Disorder (MDD), run by National Health Research Institutes, Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorder (GAD), Major Depressive Disorder (MDD)
- What is being tested?
- Internet-Based Cognitive Behavioral Therapy (ICBT) and Treatment as Usual (TAU) Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 13Show fewer
- 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).
About this study
Official title: ICBT Clinical Validation - A Clinical Study on Internet-based Cognitive Behavioral Intervention for Generalized Anxiety Disorder and Major Depressive Disorder
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.
Read more
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.
Read the 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 (GAD) or major depressive disorder (MDD) in Taiwan. The trial will be conducted at the Department of Psychiatry, National Taiwan University Hospital Hsin-Chu Branch, in collaboration with the National Health Research Institutes (NHRI).
A total of 160 eligible participants (aged 20-65 years) diagnosed with GAD or MDD will be recruited and randomly assigned to either the experimental group (TAU + ICBT) or the control group (TAU only), with 80 participants in each diagnostic category. The ICBT program lasts for 8 weeks and consists of 12 online modules, each released every 5 days, incorporating techniques such as cognitive restructuring, mindfulness, self-compassion, and behavioral activation. The control group will receive TAU and will be offered access to the ICBT program after study completion.
Assessments will be conducted at baseline, mid-intervention (week 5), post-intervention (week 9), and 3-month follow-up, using standardized self-report measures including GAD-7, PHQ-9, DASS-21, ISI, and other psychological well-being and user experience scales.
Primary outcomes are symptom reduction in anxiety (GAD-7) and depression (PHQ-9). Secondary outcomes include changes in psychological distress, insomnia severity, self-compassion, intolerance of uncertainty, and user satisfaction. Data will be analyzed using between-group comparisons and hierarchical linear modeling to evaluate both immediate and sustained intervention effects.
The study is expected to provide empirical evidence for the integration of digital mental health interventions into clinical practice, improve treatment accessibility, and support policy and service innovation in Taiwan.
- Being tested
- Internet-Based Cognitive Behavioral Therapy (ICBT), Treatment as Usual (TAU) Only
- 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)
- Medical subject headings
- Generalized Anxiety Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-Based Cognitive Behavioral Therapy (ICBT)Behavioural
Also called Online CBT, Web-based CBT
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.
Treatment as Usual (TAU) OnlyOther
Also called Standard Psychiatric Care
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Treatment as Usual (TAU) Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, Week 5 (mid-intervention), Week 9 (post-intervention), and 3-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start20 Sep 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety Disorder (GAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07177365
- Sponsor's protocol ID
- 202506094RSPD
- Other IDs
- C114B0B014500
- Acronym
- ICBT-TW
- Status last verified
- Aug 2025
- First submitted
- 15 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICBT Clinical Validation - A Clinical Study on Internet-based Cognitive Behavioral Intervention for Generalized Anxiety Disorder and Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT07177365
- Acronym / sponsor ID
- ICBT-TW / 202506094RSPD
- Keywords
- Internet-Based Cognitive Behavioral Therapy, ICBT, Digital Mental Health, Online Therapy, Randomized Controlled Trial, Cognitive Restructuring, Mindfulness, Self-Compassion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Study start
- 20 Sep 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 17 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (GAD) or major depressive disorder (MDD) in Taiwan. The trial will be conducted at the Department of Psychiatry, National Taiwan University Hospital Hsin-Chu Branch, in collaboration with the National Health Research Institutes (NHRI).
A total of 160 eligible participants (aged 20-65 years) diagnosed with GAD or MDD will be recruited and randomly assigned to either the experimental group (TAU + ICBT) or the control group (TAU only), with 80 participants in each diagnostic category. The ICBT program lasts for 8 weeks and consists of 12 online modules, each released every 5 days, incorporating techniques such as cognitive restructuring, mindfulness, self-compassion, and behavioral activation. The control group will receive TAU and will be offered access to the ICBT program after study completion.
Assessments will be conducted at baseline, mid-intervention (week 5), post-intervention (week 9), and 3-month follow-up, using standardized self-report measures including GAD-7, PHQ-9, DASS-21, ISI, and other psychological well-being and user experience scales.
Primary outcomes are symptom reduction in anxiety (GAD-7) and depression (PHQ-9). Secondary outcomes include changes in psychological distress, insomnia severity, self-compassion, intolerance of uncertainty, and user satisfaction. Data will be analyzed using between-group comparisons and hierarchical linear modeling to evaluate both immediate and sustained intervention effects.
The study is expected to provide empirical evidence for the integration of digital mental health interventions into clinical practice, improve treatment accessibility, and support policy and service innovation in Taiwan.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAU + ICBT | Experimental | Behavioral: Internet-Based Cognitive Behavioral Therapy (ICBT)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. |
| TAU Only | Active comparator | Other: Treatment as Usual (TAU) OnlyParticipants will receive standard psychiatric care (TAU) without ICBT during the study period. After study completion, they may request access to the ICBT program. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (13 listed)
- For GAD ICBT participants
- For MDD ICBT participants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-Based Cognitive Behavioral Therapy (ICBT)Also: Online CBT, Web-based CBTAn 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. | Behavioural | TAU + ICBT |
| Treatment as Usual (TAU) OnlyAlso: Standard Psychiatric CareRoutine 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. | Other | TAU Only |
Primary outcome
Change in Generalized Anxiety Disorder symptoms (GAD-7 score) between intervention and control groups
Time frame: Baseline, Week 5 (mid-intervention), Week 9 (post-intervention), and 3-month follow-up.
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
Time frame: Baseline, Week 5 (mid-intervention), Week 9 (post-intervention), and 3-month follow-up.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
Related trials for Generalized Anxiety Disorder (GAD)
Not yet recruiting
Effectiveness of Internet-based Unified Protocol (iUP) for Emotional Problems: A Randomized Controlled Trial
Depression - Major Depressive Disorder, Generalised Anxiety Disorder
Not yet recruiting
Temporal Interference Transcranial Alternating Current Stimulation Targeting the BNST or Amygdala for Generalized Anxiety Disorder
Generalized Anxiety Disorder (GAD)
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
Not yet recruitingPhase 1
Microbiota Modulation for Psychiatry Patients
Depression - Major Depressive Disorder, Generalized Anxiety Disorder (GAD)
Not yet recruiting
Miles for Mental Health
Generalized Anxiety Disorder (GAD), Depressive and Anxiety Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-Based Cognitive Behavioral Therapy (ICBT) and Treatment as Usual (TAU) Only in people with Generalized Anxiety Disorder (GAD) and Major Depressive Disorder (MDD), run by National Health Research Institutes, Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Generalized Anxiety Disorder symptoms (GAD-7 score) between intervention and control groups (time frame: Baseline, Week 5 (mid-intervention), Week 9 (post-intervention), and 3-month follow-up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025; AzTrials last refreshed its copy on 3 Nov 2026.