An interventional study of Internet-Based Cognitive Behavioral Therapy Program for Breast Cancer Survivors and Treatment as Usual (TAU) in Breast Cancer and Psychological Distress, sponsored by National Health Research Institutes, Taiwan. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by National Health Research Institutes, Taiwan · Not applicable, Interventional, and Supportive care
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.
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 100 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →National Health Research Institutes, Taiwan is the lead sponsor of 128 studies on the registry; 30 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: Internet-Based Cognitive Behavioral Therapy Program for Breast Cancer Survivors
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.
Other: Treatment as Usual (TAU)
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 known as: ICBT, Healthy Steps: Women's Mental Well-Being
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.
Also known as: TAU
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.
Time frame: Baseline to Week 9
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.
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
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.
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
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.
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
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.
Time frame: 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.
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
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.
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
Self-compassion will be assessed using the Self-Compassion Scale (SCS). Higher scores indicate greater self-compassion.
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
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.
Time frame: Baseline, Week 5, Week 9, and 3 months after the intervention period
No study locations are listed for this record.
Start is estimated for Oct 2026; primary completion for Aug 2027, 10 months later.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 10 months is below that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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