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

July 20, 2026 updated by: Zhang Lifang, Universiti Sains Malaysia

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Henan
      • Xinxiang, Henan, China, 453100
        • Recruiting
        • The First Affiliated Hospital of Henan Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

The inclusion criteria include:

  1. Newly diagnosed breast cancer patients and patients with recurrent breast cancer confirmed by histopathological report, regardless of the stage of cancer.
  2. Those with HADS score of 8 or higher in both Depression and Anxiety sub-scales of the HADS.
  3. Patients who had been treated with surgery or were undergoing the standard regime of clinical anti-tumor treatment (chemotherapy, radiotherapy, immunotherapy, targeted therapy, etc.).
  4. Age 18 years old and above.
  5. Patients who were able to read and understand written Chinese.

The exclusion criteria are:

  1. 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.
  2. Those who have current and lifetime history of engaging in any psychotherapy
  3. Those who consumed alcohol and illicit drugs .
  4. 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
  5. 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.
  6. Patient who has suicidal tendency.
  7. those who are physically unfit to answer questionnaires. (those are bed-bound or too weak to answer the questionnaire).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: exergames-acceptance and commitment therapy (e-ACT)
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.
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.
Behavioral: Acceptance and commitment therapy (ACT)
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.
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.
pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.
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.
pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.
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.
pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.
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.
pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.
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.
pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
pre-intervention, immediately post-intervention (8 weeks)
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).
pre-intervention, immediately post-intervention (8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Sains Malaysia

Investigators

  • Principal Investigator: Lifang Zhang, Universiti Sains Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

July 15, 2026

First Submitted That Met QC Criteria

July 20, 2026

First Posted (Actual)

July 23, 2026

Study Record Updates

Last Update Posted (Actual)

July 23, 2026

Last Update Submitted That Met QC Criteria

July 20, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USM-eACT-BC-RCT-001
  • EC-025-213 (Other Identifier: Ethics Committee of The First Affiliated Hospital of Xinxiang Medical University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression Anxiety Disorder

Clinical Trials on exergames-acceptance and commitment therapy (e-ACT)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe