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

20 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

120

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Cina
    • Henan
      • Xinxiang, Henan, Cina, 453100
        • Reclutamento
        • The First Affiliated Hospital of Henan Medical University
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Comparatore attivo: 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.
Comportamentale: 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.
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Depression Symptoms Measured by HADS-D Score
Lasso di tempo: 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
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Quality of Life Measured by FACT-B Total Score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
serum IL-6
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Universiti Sains Malaysia

Investigatori

  • Investigatore principale: Lifang Zhang, Universiti Sains Malaysia

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 marzo 2026

Completamento primario (Stimato)

1 settembre 2026

Completamento dello studio (Stimato)

31 dicembre 2026

Date di iscrizione allo studio

Primo inviato

15 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

20 luglio 2026

Primo Inserito (Effettivo)

23 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

23 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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