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.
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.
Pregnant women，considered for the following reasons: Pregnancy involves significant hormonal and physical changes that could affect the participant's response to the e-ACT; the safety of e-ACT to the unborn child was of concern.
Those who have current and lifetime history of engaging in any psychotherapy
Those who consumed alcohol and illicit drugs .
Those who has current and lifetime history of other psychiatric illnesses, such as psychotic disorders (schizophrenia, schizophreniform disorder, schizoaffective disorders, brief psychotic disorder, and delusional disorder), bipolar mood disorder, obsessive compulsive disorder, posttraumatic stress disorder, and attention deficit hyperactive disorder, and autism spectrum disorder
Parallel
exergames-acceptance and commitment therapy (e-ACT)
BehavioralThe exergame-based Acceptance and Commitment Therapy (e-ACT) is an 8-week behavioral intervention that integrates Acceptance and Commitment Therapy (ACT) with exergame-based physical activity using Nintendo Ring Fit Adventure. The intervention combines psychological skills training based on ACT principles, including acceptance, cognitive defusion, mindfulness, values clarification, and committed action, with structured game-based physical activity. Participants will receive weekly supervised sessions designed to promote psychological well-being, physical activity engagement among cancer patients.
Acceptance and commitment therapy (ACT)
BehavioralAcceptance and Commitment Therapy (ACT) is an 8-week structured psychological intervention based on psychological flexibility theory. The program focuses on acceptance, cognitive defusion, mindfulness, self-as-context, values clarification, and committed action to help participants develop adaptive responses to cancer-related psychological distress.
Change in Depression Symptoms Measured by HADS-D Score
The Chinese version of the Hospital Anxiety and Depression Scale-Depression subscale (HADS-D) will be used to assess depressive symptoms. The HADS-D consists of 7 items, with each item scored from 0 to 3, resulting in a total score ranging from 0 to 21. Higher scores indicate greater severity of depressive symptoms.
Change in Anxiety Symptoms Measured by HADS-A Score
The Chinese version of the Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A) will be used to assess depressive symptoms. The HADS-A consists of 7 items, with each item scored from 0 to 3, resulting in a total score ranging from 0 to 21. Higher scores indicate greater severity of depressive symptoms.
Change in Quality of Life Measured by FACT-B Total Score
The Chinese version of the Functional Assessment of Cancer Therapy-Breast (FACT-B) will be used to assess health-related quality of life in breast cancer patients. The FACT-B consists of 39 items across five subscales. Each item is rated on a 5-point Likert scale ranging from 0 to 4. Higher scores indicate better quality of life.
Change in Posttraumatic Growth Measured by PTGI-SF Total Score
The Chinese version of the Posttraumatic Growth Inventory-Short Form (PTGI-SF) will be used to assess positive psychological changes following cancer experience. The PTGI-SF consists of 10 items across five domains. Higher scores indicate greater posttraumatic growth.
Change in Cancer-Related Fatigue Measured by BFI Score
The Chinese version of the Brief Fatigue Inventory (BFI) will be used to assess cancer-related fatigue severity and its interference with daily functioning. This one-page questionnaire uses an 11-point scale (0-10) to assess fatigue severity and fatigue-related interference. Three items assess fatigue severity at its "worst," "usual," and "now" during the past 24 hours, with 0 indicating "no fatigue" and 10 indicating "fatigue as bad as you can imagine." Six additional items assess how much fatigue has interfered with different aspects of the patient's life during the past 24 hours. Higher scores indicate greater fatigue severity and interference.
Change in Psychological Flexibility Measured by AAQ-II Score
The Chinese version of the Acceptance and Action Questionnaire-II (AAQ-II) will be used to assess experiential avoidance and psychological inflexibility. The AAQ-II contains seven items, and each item is rated on a 7-point Likert scale ranging from 1 (never true) to 7 (always true). Higher scores indicate greater experiential avoidance and psychological inflexibility.
serum IL-6
Serum interleukin-6 (IL-6) concentration Serum samples will be analyzed for the concentration of interleukin-6 (IL-6) using a commercial enzyme-linked immunosorbent assay (ELISA) kit following the manufacturer's instructions. IL-6 concentration will be reported in picograms per milliliter (pg/mL).
serum BDNF
Serum samples will be analyzed for the concentration of brain-derived neurotrophic factor (BDNF) using a commercial enzyme-linked immunosorbent assay (ELISA) kit following the manufacturer's instructions. BDNF concentration will be reported in picograms per milliliter (pg/mL).
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