Exergames-acceptance and Commitment Therapy(e-ACT) for Breast Cancer Depression and Anxiety: A Randomized Controlled Trial (e-ACT)
20. července 2026 aktualizováno: 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.
Přehled studie
Postavení
Nábor
Typ studie
Intervenční
Zápis (Odhadovaný)
120
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Lifang zhang
- Telefonní číslo: +86 15836138029
- E-mail: Zhanglf_science@outlook.com
Studijní záloha kontaktů
- Jméno: Mohammad Farris Iman Leong Bin Abdullah
- Telefonní číslo: 018-6669950
- E-mail: farrisiman@unisza.edu.my
Studijní místa
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Henan
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Xinxiang, Henan, Čína, 453100
- Nábor
- The First Affiliated Hospital of Henan Medical University
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Kontakt:
- Lifang zhang
- Telefonní číslo: +86 15836138029
- E-mail: Zhanglf_science@outlook.com
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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).
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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.
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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.
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Aktivní komparátor: 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.
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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.
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Žádný zásah: 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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change in Depression Symptoms Measured by HADS-D Score
Časové okno: pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.
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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.
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pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.
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Change in Anxiety Symptoms Measured by HADS-A Score
Časové okno: pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.
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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.
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pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Quality of Life Measured by FACT-B Total Score
Časové okno: pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.
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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.
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pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.
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Change in Posttraumatic Growth Measured by PTGI-SF Total Score
Časové okno: pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.
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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.
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pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.
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Change in Cancer-Related Fatigue Measured by BFI Score
Časové okno: pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.
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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.
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pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.
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Change in Psychological Flexibility Measured by AAQ-II Score
Časové okno: pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.
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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.
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pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.
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Change in Valued Living Measured by VLQ Score
Časové okno: pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.
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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.
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pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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serum IL-6
Časové okno: pre-intervention, immediately post-intervention (8 weeks)
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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).
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pre-intervention, immediately post-intervention (8 weeks)
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serum BDNF
Časové okno: pre-intervention, immediately post-intervention (8 weeks)
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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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pre-intervention, immediately post-intervention (8 weeks)
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Lifang Zhang, Universiti Sains Malaysia
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
- 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.
- 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.
- 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.
- 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.
Užitečné odkazy
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. března 2026
Primární dokončení (Odhadovaný)
1. září 2026
Dokončení studie (Odhadovaný)
31. prosince 2026
Termíny zápisu do studia
První předloženo
15. července 2026
První předloženo, které splnilo kritéria kontroly kvality
20. července 2026
První zveřejněno (Aktuální)
23. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
23. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
20. července 2026
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- USM-eACT-BC-RCT-001
- EC-025-213 (Jiný identifikátor: Ethics Committee of The First Affiliated Hospital of Xinxiang Medical University)
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Klinické studie na exergames-acceptance and commitment therapy (e-ACT)
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