Exergames-acceptance and Commitment Therapy for Breast Cancer Depression and Anxiety

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, three-arm study compares an exergame-acceptance and commitment therapy (e-ACT) program to ACT alone and to treatment as usual in adults with breast cancer experiencing depression or anxiety. Participants are assessed at baseline, 8 weeks, and 12 weeks to measure outcomes including depressive and anxiety symptoms, fatigue, experiential avoidance, inflammatory markers, and quality of life. The study aims to determine if the e-ACT approach yields greater improvements in psychological distress and wellbeing. Exclusion criteria include pregnancy, active psychotherapy, and substance use. The trial is led by Universiti Sains Malaysia with collaboration from The First Affiliated Hospital of Henan Medical University in Xinxiang, Henan.

Why it matters

Who can join: the full rules

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).

Where it's running

• The First Affiliated Hospital of Henan Medical University
  Xinxiang, Henan, China Recruiting

Study contacts

• Principal investigator: Lifang Zhang — Universiti Sains Malaysia
• Study coordinator: Lifang Zhang
• Email: Zhanglf_science@outlook.com
• Phone: +86 15836138029

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.