ICBT and IEMDR-FT for Mental Health in Breast Cancer Patients

NCT06810830 | Completed

• 2 other identifiers: 180/2024180/2024 Ethics Approval
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• 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).

  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)

  Baseline (Pre-Intervention), Post-Intervention (within one week), 3-Month Follow-Up.

Study Arms (2)

iCBT Group

EXPERIMENTAL

Participants receive a 7-week internet-based Cognitive Behavioral Therapy (iCBT) program.

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.

Behavioral: Internet-Based EMDR Flash Technique (iEMDR-FT)

Interventions

Internet-Based Cognitive Behavioral Therapy (iCBT) BEHAVIORAL

A structured 7-week program focusing on cognitive restructuring, stress management, and emotional regulation.

iCBT Group

Internet-Based EMDR Flash Technique (iEMDR-FT) BEHAVIORAL

A 3-session protocol adapted to minimize re-exposure to distressing cancer-related memories through rapid bilateral stimulation and positive imagery.

iEMDR-FT Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Okan University: lead

Study Sites (1)

Yeditepe University

Istanbul, Turkey (Türkiye)

Location

Related Links

• 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.

MeSH Terms

Conditions

Breast Neoplasms; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Psychologist PhD(c), Part time Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: January 4, 2025
• First Posted: February 6, 2025
• Study Start: August 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: October 30, 2024
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Start date: Immediately after publication of primary study results End date: Data will be available for 5 years following publication, after which archiving or removal from the repository may occur.
• Access Criteria: Qualified researchers should contact the Principal Investigator at psk.cigdem@gmail.com to request access. A data use agreement must be signed to ensure compliance with privacy regulations and ethical guidelines.

Locations

TU (1)