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The Efficacy of Exergames-acceptance and Commitment Therapy Program for Treatment of Depression and Other Psychological Complications in Breast Cancer: Comparison With Acceptance and Commitment Therapy Alone and Treatment-as-usual in a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this three arm, double-blind, randomized controlled trial is to learn if an exergame-acceptance and commitment therapy (e-ACT) program can treat depression and anxiety in breast cancer patients, compared to acceptance and commitment therapy (ACT) alone and treatment-as-usual. The main question it aims to answer is: Is there a difference in the effectiveness of the e-ACT program in reducing depressive and anxiety symptoms, cancer-related fatigue, experiential avoidance, and serum IL-6 levels, while increasing BDNF and improving posttraumatic growth and quality of life among breast cancer patients, compared to ACT alone and treatment-as-usual, measured at baseline, 8 weeks (post-intervention), and 12 weeks after the intervention (follow-up)? Researchers will compare the e-ACT group, the ACT-alone group, and the treatment-as-usual group to see if the e-ACT program yields superior outcomes in reducing psychological distress and improving well-being. Participants will: Be randomly assigned to one of three groups: (1) e-ACT (exergame + ACT), (2) ACT alone, or (3) treatment-as-usual (general patient education). Attend an 8-week program (one session per week) if in the e-ACT or ACT group; the control group continues their usual care. Complete questionnaires at three time points (baseline, 8 weeks, and 20 weeks) to assess depression, anxiety, quality of life, posttraumatic growth, valued living, experiential avoidance, and cancer-related fatigue. Provide blood samples at pre-intervention and post-intervention (week 8) for analysis of interleukin-6 (IL-6) and brain-derived neurotrophic factor (BDNF) biomarkers.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Newly diagnosed breast cancer patients and patients with recurrent breast cancer confirmed by histopathological report, regardless of the stage of cancer.

• Those with HADS score of 8 or higher in both Depression and Anxiety sub-scales of the HADS.

• Patients who had been treated with surgery or were undergoing the standard regime of clinical anti-tumor treatment (chemotherapy, radiotherapy, immunotherapy, targeted therapy, etc.).

• Age 18 years old and above.

• Patients who were able to read and understand written Chinese.

Locations
Other Locations
China
The First Affiliated Hospital of Henan Medical University
RECRUITING
Xinxiang
Contact Information
Primary
Lifang Zhang
Zhanglf_science@outlook.com
+86 15836138029
Backup
Mohammad Farris Iman Leong Bin Abdullah
farrisiman@unisza.edu.my
018-6669950
Time Frame
Start Date: 2026-03-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 120
Treatments
Experimental: e-ACT Intervention Group
Participants in the e-ACT group receive an 8-week combined intervention consisting of weekly ACT sessions and three weekly exergame sessions. The program is delivered at the psychology labs of XXMU, with each weekly session held at a fixed time and venue to ensure standardization.
Active_comparator: ACT Intervention Group
Participants in the ACT group receive an 8-week standard ACT program, with one 50-minute session per week delivered at a fixed time and venue.
No_intervention: Treatment-as-usual(TAU)
Participants in the control group receive treatment-as-usual (TAU), consisting of 8 weekly sessions providing general psychological support (e.g., reassurance, problem identification, and deep breathing exercises), with equal therapist time and attention as the intervention groups, delivered at a fixed time and venue.
Related Therapeutic Areas
Sponsors
Leads: Universiti Sains Malaysia

This content was sourced from clinicaltrials.gov