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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Depression Symptoms Measured by HADS-D Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: exergames-acceptance and commitment therapy (e-ACT) (Behavioral)
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.
干预措施: Acceptance and commitment therapy (ACT) (Behavioral)
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.
结局指标
主要结局
Change in Depression Symptoms Measured by HADS-D Score
时间窗: 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.
Change in Anxiety Symptoms Measured by HADS-A Score
时间窗: 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.
次要结局
- 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.)
研究者
Zhang Lifang
PhD Candidate
Universiti Sains Malaysia