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NCT Number: NCT07721753

Exergames-acceptance and Commitment Therapy(e-ACT) for Breast Cancer Depression and Anxiety: A Randomized Controlled Trial

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.

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Key information

Conditions

Breast Cancer Survivors Depression Anxiety Disorder

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Henan Medical University

Xinxiang, Henan, 453100, China

Location status: Recruiting

Location contact

Lifang zhang

CONTACT

[email protected]

+86 15836138029

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

The inclusion criteria include:

  • 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.

The exclusion criteria are:

  • 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
  • Those who are on medications that can induce psychiatric symptoms, such as cardiovascular agents (clonidine, guanethidine, methyldopa, reserpine, beta blockers), dermatologic agents (isotretinoin), anticonvulsants (levetiracetam), antimigraine medications (triptans), hormonal agents (corticosteroids, oral contraceptives, gonadotropin-releasing hormone agonists, tamoxifen), varenicline, immunological agents (interferons), and levodopa.Or those who ccurrently using any psychotropic medication.
  • Patient who has suicidal tendency.
  • those who are physically unfit to answer questionnaires. (those are bed-bound or too weak to answer the questionnaire).

Treatment and study plan

exergames-acceptance and commitment therapy (e-ACT)

Behavioral

The 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)

Behavioral

Acceptance 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.

Primary outcomes

  1. Change in Depression Symptoms Measured by HADS-D Score

    Time frame: pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.

    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.

  2. Change in Anxiety Symptoms Measured by HADS-A Score

    Time frame: pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.

    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.

Secondary outcomes

  1. Change in Quality of Life Measured by FACT-B Total Score

    Time frame: pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.

    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.

  2. Change in Posttraumatic Growth Measured by PTGI-SF Total Score

    Time frame: pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.

    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.

  3. Change in Cancer-Related Fatigue Measured by BFI Score

    Time frame: pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.

    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.

  4. Change in Psychological Flexibility Measured by AAQ-II Score

    Time frame: pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.

    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.

  5. Change in Valued Living Measured by VLQ Score

    Time frame: pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.

    The Chinese version of the Valued Living Questionnaire (VLQ) will be used to assess consistency between personal values and daily actions. The VLQ assesses 10 valued domains, with each domain rated on two dimensions: the importance of the value and the consistency of actions with that value. Each dimension is rated on a 10-point Likert scale ranging from 1 (not at all important/not at all consistent) to 10 (extremely important/perfectly consistent). Higher scores indicate greater valued living.

Other outcomes

  1. serum IL-6

    Time frame: pre-intervention, immediately post-intervention (8 weeks)

    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).

  2. serum BDNF

    Time frame: pre-intervention, immediately post-intervention (8 weeks)

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Lifang Zhang

CONTACT

[email protected]

+86 15836138029

Mohammad Farris Iman Leong Bin Abdullah

CONTACT

[email protected]

018-6669950

Sponsors and collaborators

Lead sponsor

Universiti Sains Malaysia

Other

Registry information

Official study title

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

Acronym: e-ACT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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