The Validation of ICBT Clinical Trial: Disease Stress Adjustment in Breast Cancer Patients

NCT07835698 | Not Yet Recruiting

• 2 other identifiers: CS2-26054C115B0C014900
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to Week 9

Secondary Outcomes (8)

• Change in Depressive Symptoms as Assessed by the Patient Health Questionnaire-9

  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

  Baseline, Week 5, Week 9, and 3 months after the intervention period

• Change in Life Satisfaction as Assessed by the Satisfaction With Life Scale

  Baseline, Week 5, Week 9, and 3 months after the intervention period

• Change in Insomnia Severity as Assessed by the Insomnia Severity Index

  Baseline, Week 5, Week 9, and 3 months after the intervention period

• Change in Fatigue as Assessed by the Brief Fatigue Inventory

  Baseline, Week 5, Week 9, and 3 months after the intervention period

Study Arms (2)

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.

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.

Other: Treatment as Usual (TAU)

Interventions

Treatment as Usual (TAU) OTHER

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

Treatment as Usual Control

Internet-Based Cognitive Behavioral Therapy Program for Breast Cancer Survivors BEHAVIORAL

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

ICBT Plus Treatment as Usual

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

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

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 23, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): August 21, 2027
• Study Completion (Estimated): August 21, 2027
• Last Updated: September 23, 2026

Record last verified: 2026-08