Breast CancerNCT06810830
ICBT and IEMDR-FT for Mental Health in Breast Cancer Patients
A study testing Internet-Based Cognitive Behavioral Therapy (iCBT) and Internet-Based EMDR Flash Technique (iEMDR-FT) in people with Breast Cancer and Traumatic Stress, run by Okan University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer, Traumatic Stress, Anxiety
- What is being tested?
- Internet-Based Cognitive Behavioral Therapy (iCBT) and Internet-Based EMDR Flash Technique (iEMDR-FT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 30 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial on Internet-Based Cognitive Behavioral Therapy (iCBT) and Internet-Based Eye Movement Desensitization and Reprocessing Flash Technique (iEMDR-FT) for Improving Mental Health in Breast Cancer Patients
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.
Read the detailed description
Breast cancer is widely considered a complex condition that entails profound psychological repercussions alongside physical challenges. In addition to the stress of undergoing medical treatments, many patients develop an intense fear of cancer recurrence (FCR), depressive and anxious states, and symptoms that may meet the criteria for posttraumatic stress disorder (PTSD). Given these extensive emotional burdens, structured psychological interventions have emerged as vital components of comprehensive oncological care. While Cognitive Behavioral Therapy (CBT) is established as the gold standard for reducing anxiety and depression, emerging trauma-focused therapies-such as Eye Movement Desensitization and Reprocessing (EMDR)-are increasingly recognized for their efficacy in addressing cancer-related traumatic stress.
Among EMDR-based interventions, the Flash Technique (FT) represents an innovative adaptation designed to minimize the discomfort of processing traumatic memories. Unlike traditional EMDR protocols, which may require individuals to recall and discuss disturbing events in detail, the Flash Technique uses brief exposures to distressing imagery, followed by rapid bilateral stimulation and positive recall. These "flashes" can quickly desensitize the emotional intensity of cancer-related memories while reducing the risk of re-traumatization. Early studies on the Flash Technique have shown promise in alleviating traumatic symptoms in non-cancer populations, highlighting the method's potential to offer quick, effective relief from emotionally charged recollections. However, there is a notable lack of research exploring its efficacy specifically in patients with breast cancer.
This randomized controlled trial (RCT) is the first known study to directly compare the Flash Technique, adapted for online delivery (iEMDR-FT), with an internet-based CBT program (iCBT) in breast cancer patients. Participants are randomly assigned to one of two groups: a 7-week iCBT program or a 3-session iEMDR-FT protocol. The iCBT program focuses on cognitive restructuring, stress management, and emotional regulation skills tailored to address the unique challenges of cancer-related thought patterns (e.g., catastrophic thinking, fear of recurrence). In contrast, the iEMDR-FT group engages in low-intensity trauma processing, wherein participants briefly recall cancer-related distressing scenes, then undergo sets of rapid bilateral stimulation combined with positive imagery ("flash" sets). This approach aims to swiftly reduce traumatic arousal without requiring the prolonged confrontation of painful memories often associated with traditional trauma therapies.
Both interventions are delivered online in a group format, guided by experienced therapists. Assessments include measures of posttraumatic stress (PCL-5), fear of cancer recurrence, depression-anxiety-stress (DASS-21), and quality of life (WHOQOL-BREF). Data are collected at baseline, immediately post-intervention, and three months post-intervention to evaluate both immediate and sustained changes in participants' mental health status. By comparing these two distinct therapeutic modalities, the study seeks to determine whether the rapid, minimal-exposure Flash Technique offers advantages over-or is equivalent to-the more extended, structured cognitive framework of CBT.
The outcomes of this investigation may fill a critical gap in the current literature by clarifying the practical utility, safety, and acceptability of online EMDR Flash Technique in an oncology setting. If iEMDR-FT proves to be equally effective or superior to iCBT in reducing traumatic stress, fear of cancer recurrence, and emotional distress, it could represent a valuable, time-efficient option for treating psychological sequelae in breast cancer. Conversely, if iCBT demonstrates better long-term gains in certain domains-such as cognitive restructuring of illness-related beliefs-this will inform clinicians about the relative strengths of each intervention. Ultimately, this study is poised to provide evidence-based guidance for mental health professionals and oncology teams in selecting or integrating internet-based interventions, thereby contributing to more flexible and patient-centered psychosocial care for individuals coping with breast cancer.
- Conditions
- Breast Cancer, Traumatic Stress, Anxiety, Quality of Lifte, Depression
- Being tested
- Internet-Based Cognitive Behavioral Therapy (iCBT), Internet-Based EMDR Flash Technique (iEMDR-FT)
- Keywords
- Breast cancer, internet-based cognitive behavioral therapy, EMDR, Flash Technique, psychological distress, quality of life
- Medical subject headings
- Breast Neoplasms, Anxiety Disorders, Depression
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
A structured 7-week program focusing on cognitive restructuring, stress management, and emotional regulation.
Internet-Based EMDR Flash Technique (iEMDR-FT)Behavioural
A 3-session protocol adapted to minimize re-exposure to distressing cancer-related memories through rapid bilateral stimulation and positive imagery.
| Study group | Role | What they receive |
|---|---|---|
| iCBT Group | Experimental | Participants receive a 7-week internet-based Cognitive Behavioral Therapy (iCBT) program. Receives: Behavioral: Internet-Based Cognitive Behavioral Therapy (iCBT) |
| iEMDR-FT Group | Experimental | Participants receive a 3-session internet-based EMDR Flash Technique (iEMDR-FT) within a one week. Receives: Behavioral: Internet-Based EMDR Flash Technique (iEMDR-FT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD Symptom Severity (PCL-5)
PTSD symptom severity was assessed using the Posttraumatic Stress Disorder Checklist-5 (PCL-5), developed based on DSM-5 diagnostic criteria. The PCL-5 total score ranges from 0 to 80; a higher score reflects more severe posttraumatic stress symptoms. The change in score between pre-intervention, post-intervention, and the 3-month follow-up measurements indicates improvement in posttraumatic stress symptoms among participants in the two different internet-based therapy groups (iCBT and iEMDR-FT).
Measured: 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.
Secondary outcomes (1)
Change in Depression, Anxiety, and Stress Levels (DASS-21)
Description: The Depression Anxiety Stress Scales-21 (DASS-21) is a 21-item self-report tool that measures levels of depression, anxiety, and stress. Each subscale contains seven items scored on a 4-point Likert scale (0-3). Higher scores indicate greater symptom severity. Assessments will be conducted at Baseline (Pre-Intervention), Post-Intervention (within one week), and 3 Months Post-Intervention.
Measured: Baseline (Pre-Intervention), Post-Intervention (within one week), 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 posted6 Feb 2025
- Study start1 Aug 2024
- Primary completion1 Sep 2024
- Study completion30 Oct 2024
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a parallel assignment model. Participants are randomly assigned to one of two interventions-an internet-based Cognitive Behavioral Therapy (iCBT) program or an internet-based EMDR Flash Technique (iEMDR-FT)-and both groups receive their respective treatments over the designated study period. Outcomes are assessed at baseline, post-intervention, and at a three-month follow-up. The trial is open-label (no masking), as both participants and researchers are aware of the assigned intervention. It is designed to compare the two arms directly to evaluate their differential effectiveness in reducing psychological distress among breast cancer patients.
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çiğdem Kınık, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810830
- Sponsor's protocol ID
- 180/2024
- Other IDs
- 180/2024 Ethics Approval
- Status last verified
- Feb 2025
- First submitted
- 4 Jan 2025
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the publication of the primary results, de-identified individual participant data will be made available upon request to qualified researchers via an institutional data-sharing agreement. Data will be accessible for analyses related to the aims of this study and subject to ethical approval. Requests can be submitted to the Principal Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on Internet-Based Cognitive Behavioral Therapy (iCBT) and Internet-Based Eye Movement Desensitization and Reprocessing Flash Technique (iEMDR-FT) for Improving Mental Health in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06810830
- Acronym / sponsor ID
- 180/2024
- Conditions
- Breast Cancer, Traumatic Stress, Anxiety, Quality of Lifte, Depression
- Keywords
- Breast cancer, internet-based cognitive behavioral therapy, EMDR, Flash Technique, psychological distress, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 6 Feb 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 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.
Detailed description
Breast cancer is widely considered a complex condition that entails profound psychological repercussions alongside physical challenges. In addition to the stress of undergoing medical treatments, many patients develop an intense fear of cancer recurrence (FCR), depressive and anxious states, and symptoms that may meet the criteria for posttraumatic stress disorder (PTSD). Given these extensive emotional burdens, structured psychological interventions have emerged as vital components of comprehensive oncological care. While Cognitive Behavioral Therapy (CBT) is established as the gold standard for reducing anxiety and depression, emerging trauma-focused therapies-such as Eye Movement Desensitization and Reprocessing (EMDR)-are increasingly recognized for their efficacy in addressing cancer-related traumatic stress.
Among EMDR-based interventions, the Flash Technique (FT) represents an innovative adaptation designed to minimize the discomfort of processing traumatic memories. Unlike traditional EMDR protocols, which may require individuals to recall and discuss disturbing events in detail, the Flash Technique uses brief exposures to distressing imagery, followed by rapid bilateral stimulation and positive recall. These "flashes" can quickly desensitize the emotional intensity of cancer-related memories while reducing the risk of re-traumatization. Early studies on the Flash Technique have shown promise in alleviating traumatic symptoms in non-cancer populations, highlighting the method's potential to offer quick, effective relief from emotionally charged recollections. However, there is a notable lack of research exploring its efficacy specifically in patients with breast cancer.
This randomized controlled trial (RCT) is the first known study to directly compare the Flash Technique, adapted for online delivery (iEMDR-FT), with an internet-based CBT program (iCBT) in breast cancer patients. Participants are randomly assigned to one of two groups: a 7-week iCBT program or a 3-session iEMDR-FT protocol. The iCBT program focuses on cognitive restructuring, stress management, and emotional regulation skills tailored to address the unique challenges of cancer-related thought patterns (e.g., catastrophic thinking, fear of recurrence). In contrast, the iEMDR-FT group engages in low-intensity trauma processing, wherein participants briefly recall cancer-related distressing scenes, then undergo sets of rapid bilateral stimulation combined with positive imagery ("flash" sets). This approach aims to swiftly reduce traumatic arousal without requiring the prolonged confrontation of painful memories often associated with traditional trauma therapies.
Both interventions are delivered online in a group format, guided by experienced therapists. Assessments include measures of posttraumatic stress (PCL-5), fear of cancer recurrence, depression-anxiety-stress (DASS-21), and quality of life (WHOQOL-BREF). Data are collected at baseline, immediately post-intervention, and three months post-intervention to evaluate both immediate and sustained changes in participants' mental health status. By comparing these two distinct therapeutic modalities, the study seeks to determine whether the rapid, minimal-exposure Flash Technique offers advantages over-or is equivalent to-the more extended, structured cognitive framework of CBT.
The outcomes of this investigation may fill a critical gap in the current literature by clarifying the practical utility, safety, and acceptability of online EMDR Flash Technique in an oncology setting. If iEMDR-FT proves to be equally effective or superior to iCBT in reducing traumatic stress, fear of cancer recurrence, and emotional distress, it could represent a valuable, time-efficient option for treating psychological sequelae in breast cancer. Conversely, if iCBT demonstrates better long-term gains in certain domains-such as cognitive restructuring of illness-related beliefs-this will inform clinicians about the relative strengths of each intervention. Ultimately, this study is poised to provide evidence-based guidance for mental health professionals and oncology teams in selecting or integrating internet-based interventions, thereby contributing to more flexible and patient-centered psychosocial care for individuals coping with breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a parallel assignment model. Participants are randomly assigned to one of two interventions-an internet-based Cognitive Behavioral Therapy (iCBT) program or an internet-based EMDR Flash Technique (iEMDR-FT)-and both groups receive their respective treatments over the designated study period. Outcomes are assessed at baseline, post-intervention, and at a three-month follow-up. The trial is open-label (no masking), as both participants and researchers are aware of the assigned intervention. It is designed to compare the two arms directly to evaluate their differential effectiveness in reducing psychological distress among breast cancer patients.
| Arm | Type | Receives |
|---|---|---|
| iCBT Group | Experimental | Behavioral: Internet-Based Cognitive Behavioral Therapy (iCBT)Participants receive a 7-week internet-based Cognitive Behavioral Therapy (iCBT) program. |
| iEMDR-FT Group | Experimental | Behavioral: Internet-Based EMDR Flash Technique (iEMDR-FT)Participants receive a 3-session internet-based EMDR Flash Technique (iEMDR-FT) within a one week. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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)A structured 7-week program focusing on cognitive restructuring, stress management, and emotional regulation. | Behavioural | iCBT Group |
| Internet-Based EMDR Flash Technique (iEMDR-FT)A 3-session protocol adapted to minimize re-exposure to distressing cancer-related memories through rapid bilateral stimulation and positive imagery. | Behavioural | iEMDR-FT Group |
Primary outcome
Change in PTSD Symptom Severity (PCL-5)
Time frame: 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.
PTSD symptom severity was assessed using the Posttraumatic Stress Disorder Checklist-5 (PCL-5), developed based on DSM-5 diagnostic criteria. The PCL-5 total score ranges from 0 to 80; a higher score reflects more severe posttraumatic stress symptoms. The change in score between pre-intervention, post-intervention, and the 3-month follow-up measurements indicates improvement in posttraumatic stress symptoms among participants in the two different internet-based therapy groups (iCBT and iEMDR-FT).
1 secondary outcome
Change in Depression, Anxiety, and Stress Levels (DASS-21)
Time frame: Baseline (Pre-Intervention), Post-Intervention (within one week), 3-Month Follow-Up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- An RCT found iEMDR-FT effectively reducing traffic-accident trauma, depression, anxiety, stress, and boosting quality of life with brief "flash" exposures and minimal emotional confrontation.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. After the publication of the primary results, de-identified individual participant data will be made available upon request to qualified researchers via an institutional data-sharing agreement. Data will be accessible for analyses related to the aims of this study and subject to ethical approval. Requests can be submitted to the Principal Investigator.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-Based Cognitive Behavioral Therapy (iCBT) and Internet-Based EMDR Flash Technique (iEMDR-FT) in people with Breast Cancer and Traumatic Stress, run by Okan University at 1 site in Turkey (Türkiye).
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 PTSD Symptom Severity (PCL-5) (time frame: 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.). 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 10 Feb 2025.