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NCT07721753

Overview

NCT ID: NCT07721753
Lead Sponsor: Universiti Sains MalaysiaOTHER
Official Title: 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
Brief Summary: 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.

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 23, 2026Actual
Start Date: Mar 1, 2026Actual
Primary Completion Date: Sep 1, 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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).

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 120Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Contacts and Locations

Central Contacts: Lifang ZhangContact
Zhanglf_science@outlook.com+86 15836138029

Similar Studies

Participant Group/Arms

e-ACT Intervention GroupExperimental

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.

Behavioral: exergames-acceptance and commitment therapy (e-ACT)

ACT Intervention GroupActive Comparator

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.

Behavioral: Acceptance and commitment therapy (ACT)

Treatment-as-usual（TAU）No Intervention

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.