Breast CancerICBT-TW-2NCT07835698
The Validation of ICBT Clinical Trial: Disease Stress Adjustment in Breast Cancer Patients
A study testing Internet-Based Cognitive Behavioral Therapy Program for Breast Cancer Survivors and Treatment as Usual (TAU) in people with Breast Cancer and Psychological Distress, run by National Health Research Institutes, Taiwan.
Trial summary
Breast cancer and its treatment can cause ongoing emotional distress, including anxiety, depressive symptoms, stress-related reactions, and difficulties adjusting to life after treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Breast Cancer, Psychological Distress
- What is being tested?
- Internet-Based Cognitive Behavioral Therapy Program for Breast Cancer Survivors and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 21 Aug 2027
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 years.
- Diagnosis of stage I-III breast cancer.
- Completion of primary breast cancer treatment, including surgery, chemotherapy, radiation therapy, and/or targeted therapy. Participants currently receiving endocrine therapy are eligible.
- Ability to read and write Chinese and to use a mobile application and the Internet.
- Access to an Internet-enabled device and ability to independently participate in the online intervention.
- Willingness to complete the online intervention modules and study assessment questionnaires.
Who cannot join
- Diagnosis of stage IV breast cancer.
- Concurrent diagnosis of another type of cancer.
- Currently receiving surgery, chemotherapy, radiation therapy, or targeted therapy for breast cancer.
- Diagnosis of a psychiatric disorder within the past 6 months, including major depressive disorder, generalized anxiety disorder, or schizophrenia.
- No current psychiatric diagnosis but a Patient Health Questionnaire-9 (PHQ-9) score greater than 20 at screening.
- Current suicidal intent or a history of actual self-harm behavior.
- Currently receiving another form of psychotherapy or having recently received cognitive behavioral therapy.
- Inability to independently use the online intervention application because of insufficient Chinese literacy, Internet proficiency, or access to an Internet-enabled device.
About this study
Breast cancer and its treatment can cause ongoing emotional distress, including anxiety, depressive symptoms, stress-related reactions, and difficulties adjusting to life after treatment. This study evaluates an 8-week Internet-based cognitive behavioral therapy (ICBT) program designed to support psychological adjustment and improve quality of life among adults with stage I-III breast cancer who have completed primary cancer treatment.
Approximately 100 participants will be randomly assigned to either an ICBT group or a control group. Participants in the ICBT group will receive treatment as usual together with the 8-week online program, while participants in the control group will receive treatment as usual alone during the main study period. The study will compare changes in anxiety, depressive symptoms, post-traumatic stress symptoms, and quality of life between the two groups.
Read the detailed description
Breast cancer survivors may continue to experience psychological distress after completing primary cancer treatment. Barriers such as limited access to psychological services, time constraints, and concerns about stigma may prevent patients from receiving timely mental health support. Internet-based cognitive behavioral therapy may provide a flexible and accessible approach to supporting psychological adjustment among this population.
This randomized, parallel-group study aims to evaluate the effectiveness of an 8-week culturally adapted Internet-based cognitive behavioral therapy program for adults with stage I-III breast cancer who have completed primary treatment. The program, titled "Healthy Steps: Women's Mental Well-Being," integrates cognitive behavioral therapy principles, psycho-oncology experience, and digital intervention technology.
Approximately 100 participants will be randomly assigned to one of two groups. Participants in the intervention group will continue to receive treatment as usual and will additionally complete the 8-week ICBT program through a mobile application developed by the National Health Research Institutes. The program includes content and exercises related to self-compassion, cognitive restructuring, emotional regulation, and stress management. The study system will be used to record learning progress, questionnaire completion, and program use.
Participants in the control group will receive treatment as usual without additional ICBT during the main comparative study period. After completing the study assessments, control-group participants may request access to the ICBT program.
Assessments will be conducted at baseline, week 5, week 9, and 3 months after completion of the intervention period. The primary analyses will compare changes in anxiety symptoms, depressive symptoms, post-traumatic stress symptoms, and quality of life between the intervention and control groups. Exploratory analyses will examine the relationships between attachment orientation and changes in psychological outcomes.
- Conditions
- Breast Cancer, Psychological Distress
- Being tested
- Internet-Based Cognitive Behavioral Therapy Program for Breast Cancer Survivors, Treatment as Usual (TAU)
- Keywords
- Breast Cancer Survivors, Internet-Based Cognitive Behavioral Therapy, Digital Mental Health Intervention, Psycho-Oncology, Psychological Adjustment, Quality of Life, ICBT
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-Based Cognitive Behavioral Therapy Program for Breast Cancer SurvivorsBehavioural
Also called ICBT, Healthy Steps: Women's Mental Well-Being
An 8-week Internet-based cognitive behavioral therapy program delivered through a mobile application. The program includes psychoeducational content and exercises related to self-compassion, cognitive restructuring, emotional regulation, stress management, relaxation, mindfulness, and coping with cancer-related concerns.
Also called TAU
Participants will continue to receive routine clinical care provided by their treating health care professionals. No additional Internet-based cognitive behavioral therapy will be provided during the main comparative study period.
| Study group | Role | What they receive |
|---|---|---|
| ICBT Plus Treatment as Usual | Experimental | Participants will continue to receive treatment as usual and will additionally complete the 8-week "Healthy Steps: Women's Mental Well-Being" Internet-based cognitive behavioral therapy program through a mobile application. The program includes psychoeducational content and exercises related to self-compassion, cognitive restructuring, emotional regulation, and stress management. Participants' learning progress, questionnaire completion, and application use will be recorded through the study system. Receives: Behavioral: Internet-Based Cognitive Behavioral Therapy Program for Breast Cancer Survivors |
| Treatment as Usual Control | Active comparator | Participants assigned to this arm will receive treatment as usual (TAU), consisting of routine clinical care provided by their treating health care professionals. They will not receive the Internet-based cognitive behavioral therapy program during the main comparative study period and will complete assessments according to the same schedule as the intervention group. After completing all study assessments, participants may request access to the ICBT program. Receives: Other: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Psychological Distress as Assessed by the Depression, Anxiety and Stress Scale-21
Psychological distress will be assessed using the 21-item Depression, Anxiety and Stress Scale (DASS-21), which includes depression, anxiety, and stress subscales. Each item is rated on a 4-point scale from 0 to 3. Higher scores indicate greater levels of psychological distress. Changes in scores will be compared between the ICBT and TAU groups.
Measured: Baseline to Week 9
Secondary outcomes (8)
Change in Depressive Symptoms as Assessed by the Patient Health Questionnaire-9
Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire (PHQ-9). The total score ranges from 0 to 27, with higher scores indicating greater severity of depressive symptoms. Changes in scores will be compared between the ICBT and TAU groups.
Measured: Baseline, Week 5, Week 9, and 3 months after the intervention period
Change in Post-Traumatic Stress Symptoms as Assessed by the Posttraumatic Diagnostic Scale for DSM-5
Post-traumatic stress symptoms will be assessed using the Posttraumatic Diagnostic Scale for DSM-5 (PDS-5). The scale assesses the severity of post-traumatic stress symptoms and associated distress and functional impairment. Higher scores indicate greater severity of post-traumatic stress symptoms.
Measured: Baseline, Week 5, Week 9, and 3 months after the intervention period
Change in Life Satisfaction as Assessed by the Satisfaction With Life Scale
Life satisfaction will be assessed using the 5-item Satisfaction With Life Scale (SWLS). The total score ranges from 5 to 35, with higher scores indicating greater satisfaction with life.
Measured: Baseline, Week 5, Week 9, and 3 months after the intervention period
Change in Insomnia Severity as Assessed by the Insomnia Severity Index
Insomnia severity will be assessed using the 7-item Insomnia Severity Index (ISI). The total score ranges from 0 to 28, with higher scores indicating greater insomnia severity.
Measured: Baseline, Week 5, Week 9, and 3 months after the intervention period
Change in Fatigue as Assessed by the Brief Fatigue Inventory
Fatigue will be assessed using the 9-item Brief Fatigue Inventory (BFI), which evaluates fatigue severity and its interference with daily functioning during the previous 24 hours. Items are rated from 0 to 10, with higher scores indicating greater fatigue severity or interference.
Measured: Baseline, Week 5, Week 9, and 3 months after the intervention period
Change in Fear of Cancer Recurrence as Assessed by the 7-Item Fear of Cancer Recurrence Scale
Fear of cancer recurrence will be assessed using the 7-item Fear of Cancer Recurrence Scale (FCR7). Each item is rated from 0 to 4, and the total score ranges from 0 to 28. Higher scores indicate greater fear of cancer recurrence.
Measured: Baseline, Week 5, Week 9, and 3 months after the intervention period
Change in Self-Compassion as Assessed by the Self-Compassion Scale
Self-compassion will be assessed using the Self-Compassion Scale (SCS). Higher scores indicate greater self-compassion.
Measured: Baseline, Week 5, Week 9, and 3 months after the intervention period
Change in Post-Traumatic Growth as Assessed by the Posttraumatic Growth Inventory-X
Post-traumatic growth will be assessed using the 25-item Posttraumatic Growth Inventory-X (PTGI-X). Items are rated from 0 to 5, resulting in a total score ranging from 0 to 125. Higher scores indicate greater perceived positive change following a traumatic experience.
Measured: Baseline, Week 5, Week 9, and 3 months after the intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion21 Aug 2027 (estimated)
- Study completion21 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 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
- NCT07835698
- Sponsor's protocol ID
- CS2-26054
- Other IDs
- C115B0C014900
- Acronym
- ICBT-TW-2
- Status last verified
- Aug 2026
- First submitted
- 17 Sep 2026
- Last updated
- 23 Sep 2026
- 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 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validation of ICBT Clinical Trial: Disease Stress Adjustment in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT07835698
- Acronym / sponsor ID
- ICBT-TW-2 / CS2-26054
- Conditions
- Breast Cancer, Psychological Distress
- Keywords
- Breast Cancer Survivors, Internet-Based Cognitive Behavioral Therapy, Digital Mental Health Intervention, Psycho-Oncology, Psychological Adjustment, Quality of Life, ICBT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 21 Aug 2027 (estimated)
- Study completion
- 21 Aug 2027 (estimated)
- First posted
- 23 Sep 2026 (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.
Breast cancer and its treatment can cause ongoing emotional distress, including anxiety, depressive symptoms, stress-related reactions, and difficulties adjusting to life after treatment. This study evaluates an 8-week Internet-based cognitive behavioral therapy (ICBT) program designed to support psychological adjustment and improve quality of life among adults with stage I-III breast cancer who have completed primary cancer treatment.
Approximately 100 participants will be randomly assigned to either an ICBT group or a control group. Participants in the ICBT group will receive treatment as usual together with the 8-week online program, while participants in the control group will receive treatment as usual alone during the main study period. The study will compare changes in anxiety, depressive symptoms, post-traumatic stress symptoms, and quality of life between the two groups.
Detailed description
Breast cancer survivors may continue to experience psychological distress after completing primary cancer treatment. Barriers such as limited access to psychological services, time constraints, and concerns about stigma may prevent patients from receiving timely mental health support. Internet-based cognitive behavioral therapy may provide a flexible and accessible approach to supporting psychological adjustment among this population.
This randomized, parallel-group study aims to evaluate the effectiveness of an 8-week culturally adapted Internet-based cognitive behavioral therapy program for adults with stage I-III breast cancer who have completed primary treatment. The program, titled "Healthy Steps: Women's Mental Well-Being," integrates cognitive behavioral therapy principles, psycho-oncology experience, and digital intervention technology.
Approximately 100 participants will be randomly assigned to one of two groups. Participants in the intervention group will continue to receive treatment as usual and will additionally complete the 8-week ICBT program through a mobile application developed by the National Health Research Institutes. The program includes content and exercises related to self-compassion, cognitive restructuring, emotional regulation, and stress management. The study system will be used to record learning progress, questionnaire completion, and program use.
Participants in the control group will receive treatment as usual without additional ICBT during the main comparative study period. After completing the study assessments, control-group participants may request access to the ICBT program.
Assessments will be conducted at baseline, week 5, week 9, and 3 months after completion of the intervention period. The primary analyses will compare changes in anxiety symptoms, depressive symptoms, post-traumatic stress symptoms, and quality of life between the intervention and control groups. Exploratory analyses will examine the relationships between attachment orientation and changes in psychological outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICBT Plus Treatment as Usual | Experimental | Behavioral: Internet-Based Cognitive Behavioral Therapy Program for Breast Cancer SurvivorsParticipants will continue to receive treatment as usual and will additionally complete the 8-week "Healthy Steps: Women's Mental Well-Being" Internet-based cognitive behavioral therapy program through a mobile application. The program includes psychoeducational content and exercises related to self-compassion, cognitive restructuring, emotional regulation, and stress management. Participants' learning progress, questionnaire completion, and application use will be recorded through the study system. |
| Treatment as Usual Control | Active comparator | Other: Treatment as Usual (TAU)Participants assigned to this arm will receive treatment as usual (TAU), consisting of routine clinical care provided by their treating health care professionals. They will not receive the Internet-based cognitive behavioral therapy program during the main comparative study period and will complete assessments according to the same schedule as the intervention group. After completing all study assessments, participants may request access to the ICBT program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18-65 years.
- Diagnosis of stage I-III breast cancer.
- Completion of primary breast cancer treatment, including surgery, chemotherapy, radiation therapy, and/or targeted therapy. Participants currently receiving endocrine therapy are eligible.
- Ability to read and write Chinese and to use a mobile application and the Internet.
- Access to an Internet-enabled device and ability to independently participate in the online intervention.
Key exclusion criteria (8 listed)
- Diagnosis of stage IV breast cancer.
- Concurrent diagnosis of another type of cancer.
- Currently receiving surgery, chemotherapy, radiation therapy, or targeted therapy for breast cancer.
- Diagnosis of a psychiatric disorder within the past 6 months, including major depressive disorder, generalized anxiety disorder, or schizophrenia.
- No current psychiatric diagnosis but a Patient Health Questionnaire-9 (PHQ-9) score greater than 20 at screening.
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 Program for Breast Cancer SurvivorsAlso: ICBT, Healthy Steps: Women's Mental Well-BeingAn 8-week Internet-based cognitive behavioral therapy program delivered through a mobile application. The program includes psychoeducational content and exercises related to self-compassion, cognitive restructuring, emotional regulation, stress management, relaxation, mindfulness, and coping with cancer-related concerns. | Behavioural | ICBT Plus Treatment as Usual |
| Treatment as Usual (TAU)Also: TAUParticipants will continue to receive routine clinical care provided by their treating health care professionals. No additional Internet-based cognitive behavioral therapy will be provided during the main comparative study period. | Other | Treatment as Usual Control |
Primary outcome
Change in Psychological Distress as Assessed by the Depression, Anxiety and Stress Scale-21
Time frame: Baseline to Week 9
Psychological distress will be assessed using the 21-item Depression, Anxiety and Stress Scale (DASS-21), which includes depression, anxiety, and stress subscales. Each item is rated on a 4-point scale from 0 to 3. Higher scores indicate greater levels of psychological distress. Changes in scores will be compared between the ICBT and TAU groups.
8 secondary outcomes
Change in Depressive Symptoms as Assessed by the Patient Health Questionnaire-9
Time frame: Baseline, Week 5, Week 9, and 3 months after the intervention period
Change in Post-Traumatic Stress Symptoms as Assessed by the Posttraumatic Diagnostic Scale for DSM-5
Time frame: Baseline, Week 5, Week 9, and 3 months after the intervention period
Change in Life Satisfaction as Assessed by the Satisfaction With Life Scale
Time frame: Baseline, Week 5, Week 9, and 3 months after the intervention period
Change in Insomnia Severity as Assessed by the Insomnia Severity Index
Time frame: Baseline, Week 5, Week 9, and 3 months after the intervention period
Change in Fatigue as Assessed by the Brief Fatigue Inventory
Time frame: Baseline, Week 5, Week 9, and 3 months after the intervention period
Change in Fear of Cancer Recurrence as Assessed by the 7-Item Fear of Cancer Recurrence Scale
Time frame: Baseline, Week 5, Week 9, and 3 months after the intervention period
Change in Self-Compassion as Assessed by the Self-Compassion Scale
Time frame: Baseline, Week 5, Week 9, and 3 months after the intervention period
Change in Post-Traumatic Growth as Assessed by the Posttraumatic Growth Inventory-X
Time frame: Baseline, Week 5, Week 9, and 3 months after the intervention period
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 23 Sep 2026.
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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 Program for Breast Cancer Survivors and Treatment as Usual (TAU) in people with Breast Cancer and Psychological Distress, 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 6 inclusion and 8 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 23 Sep 2026. 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 Psychological Distress as Assessed by the Depression, Anxiety and Stress Scale-21 (time frame: Baseline to Week 9). 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 23 Sep 2026.