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

NCT07721753 | Recruiting

• 2 other identifiers: USM-eACT-BC-RCT-001EC-025-213
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer Survivors; Depression Anxiety Disorder

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (5)

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

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

• Change in Posttraumatic Growth Measured by PTGI-SF Total Score

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

• Change in Cancer-Related Fatigue Measured by BFI Score

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

• Change in Psychological Flexibility Measured by AAQ-II Score

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

• Change in Valued Living Measured by VLQ Score

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

Other Outcomes (2)

• serum IL-6

  pre-intervention, immediately post-intervention (8 weeks)

• serum BDNF

  pre-intervention, immediately post-intervention (8 weeks)

Study Arms (3)

e-ACT Intervention Group

EXPERIMENTAL

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)

ACT Intervention Group

ACTIVE COMPARATOR

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)

Treatment-as-usual（TAU）

NO INTERVENTION

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.

Interventions

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.

e-ACT Intervention Group

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.

ACT Intervention Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

The First Affiliated Hospital of Henan Medical University

Xinxiang, Henan, 453100, China

RECRUITING

Related Publications (5)

• Fawson S, Moon Z, Novogrudsky K, Moxham F, Forster K, Tribe I, Moss-Morris R, Johnson C, Hughes LD. Acceptance and commitment therapy processes and their association with distress in cancer: a systematic review and meta-analysis. Health Psychol Rev. 2024 Sep;18(3):456-477. doi: 10.1080/17437199.2023.2261518. Epub 2023 Oct 4.

  PMID: 37746724 BACKGROUND

• Tough D, Robinson J, Gowling S, Raby P, Dixon J, Harrison SL. The feasibility, acceptability and outcomes of exergaming among individuals with cancer: a systematic review. BMC Cancer. 2018 Nov 21;18(1):1151. doi: 10.1186/s12885-018-5068-0.

  PMID: 30463615 BACKGROUND

• Mosher CE, Secinti E, Li R, Hirsh AT, Bricker J, Miller KD, Schneider B, Storniolo AM, Mina L, Newton EV, Champion VL, Johns SA. Acceptance and commitment therapy for symptom interference in metastatic breast cancer patients: a pilot randomized trial. Support Care Cancer. 2018 Jun;26(6):1993-2004. doi: 10.1007/s00520-018-4045-0. Epub 2018 Jan 12.

  PMID: 29327085 BACKGROUND

• Hulbert-Williams NJ, Storey L, Wilson KG. Psychological interventions for patients with cancer: psychological flexibility and the potential utility of Acceptance and Commitment Therapy. Eur J Cancer Care (Engl). 2015;24(1):15-27. doi: 10.1111/ecc.12223. Epub 2014 Aug 6.

  PMID: 25100576 BACKGROUND

• Hayes SC, Luoma JB, Bond FW, Masuda A, Lillis J. Acceptance and commitment therapy: model, processes and outcomes. Behav Res Ther. 2006 Jan;44(1):1-25. doi: 10.1016/j.brat.2005.06.006.

  PMID: 16300724 BACKGROUND

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MeSH Terms

Interventions

Acceptance and Commitment Therapy

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Lifang Zhang

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lifang Zhang

CONTACT

+86 15836138029; Zhanglf_science@outlook.com

Mohammad Farris Iman Leong Bin Abdullah

CONTACT

018-6669950; farrisiman@unisza.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 23, 2026
• Study Start: March 1, 2026
• Primary Completion: September 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)