ICBT and IEMDR-FT for Mental Health in Breast Cancer Patients (NCT06810830) | Clinical Trial Compass
CompletedNot Applicable
ICBT and IEMDR-FT for Mental Health in Breast Cancer Patients
Turkey (Türkiye)48 participantsStarted 2024-08-01
Plain-language summary
This study aims to compare the effectiveness of two internet-based therapy approaches in improving psychological well-being and reducing distress among patients diagnosed with breast cancer. Participants will be randomly assigned to one of two groups: a 7-week internet-based Cognitive Behavioral Therapy (iCBT) program or a 3-session internet-based Eye Movement Desensitization and Reprocessing Flash Technique (iEMDR-FT) within a week. Both interventions will be delivered online in a group format under the guidance of experienced therapists.
Participants' mental health status-including anxiety, depression, traumatic stress, fear of cancer recurrence, and overall quality of life-will be assessed before the intervention, immediately after completion, and again at a 3-month follow-up. The results of this study are expected to provide valuable insights into how digital psychotherapy methods can help breast cancer patients cope with emotional challenges during their treatment. The findings will also inform the development of future online psychosocial support models in oncology.
Who can participate
Age range
18 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Age: 18 to 65 years. Diagnosis: Diagnosed with breast cancer (any stage as determined by the treating oncologist, or specify Stage I-III, etc.).
Medical Status: Currently under medical follow-up for breast cancer or in remission (as appropriate for the study's design).
Language Proficiency: Able to read and write in Turkish (or the language used for the intervention materials).
Technical Requirements: Has stable internet access and is willing to participate in online group sessions.
Consent: Provides informed consent to participate in the study.
Exclusion Criteria:
Severe Psychiatric Disorders: Presence of a severe psychiatric disorder (e.g., active psychosis, bipolar disorder in a severe manic phase) that would impede participation in psychotherapy.
Neurological or Cognitive Impairment: Any significant neurological impairment or cognitive dysfunction that interferes with comprehension of online materials.
Confounding Study Participation: Concurrent enrollment in another clinical trial involving psychological or behavioral interventions that might confound study outcomes.
Attendance Issues: Inability or unwillingness to attend scheduled online group sessions.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in PTSD Symptom Severity (PCL-5)
Timeframe: Baseline (Pre-Intervention), Post-Intervention (iCBT: Week 7; iEMDR-FT: after 3 sessions in one week, measured one week after the final session), and 3 Months Post-Intervention.