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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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 ses
• Поведенческое 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.

Первичные конечные точки

• Change in Depression Symptoms Measured by HADS-D Score [Срок оценки: pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.]
• Change in Anxiety Symptoms Measured by HADS-A Score [Срок оценки: pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.]

Вторичные конечные точки (5)

• Change in Quality of Life Measured by FACT-B Total Score [Срок оценки: pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.]
• Change in Posttraumatic Growth Measured by PTGI-SF Total Score [Срок оценки: pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.]
• Change in Cancer-Related Fatigue Measured by BFI Score [Срок оценки: pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.]
• Change in Psychological Flexibility Measured by AAQ-II Score [Срок оценки: pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.]
• Change in Valued Living Measured by VLQ Score [Срок оценки: pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.]

Критерии участия

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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Henan Medical University — Xinxiang

Публикации

• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07721753 · USM-eACT-BC-RCT-001 · EC-025-213

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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