Clinical trial · Interventional
Mindfulness-based Stress Reduction Effects on Depression, Anxiety and Internalized Stigma Compared With Treatment-As-Usual Among Head and Neck Cancer Patients
Mindfulness-based Stress Reduction Effects on Depression, Anxiety and Internalized Stigma Compared With Treatment-As-Usual Among Head and Neck Cancer Patients: A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Head and neck cancer patients are vulnerable to various psychological complications due to the effects of both cancer itself and cancer treatment on patients' appearance and physical well-being. Nevertheless, few data have been obtained on effective psychosocial interventions that could protect this group of cancer patients' psychological well-being. Therefore, this two-armed, parallel-group, double-blind, randomized control trial (RCT) aims to evaluate and compare the effects of mindfulness-based stress reduction (MBSR) on psychosocial complications (depression, anxiety, and internalized stigma) among newly diagnosed head and neck cancer patients. This RCT will target newly diagnosed head and neck cancer patients who have been treated only with surgery or who have not yet received any treatment. In total, 106 patients who meet all of the study's inclusion criteria and none of its exclusion criteria will be randomly assigned into two groups-an MBSR group and a treatment-as-usual control group-at a 1:1' allocation ratio. Participants in the intervention group (MBSR group) will undergo an eight-week group intervention program. During this program, each intervention will comprise eight modules based on MBSR manual. Outcome assessments will be performed across a three-point timeline, including before the intervention (T0), immediately after the psychosocial intervention at eight weeks (T1), and 12 weeks after the intervention (T2). The primary outcome that will be assessed during this RCT is the severity of depression and anxiety. Meanwhile, the secondary outcome that will be evaluated in this study is such as internalized stigma.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of the Head and Neck | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Depression, Anxiety | — | UNRESOLVED | — |
| Psycho-Oncology | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MBSR | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Mindfulness-based stress reduction group
- description
- MBSR will be conducted as group sessions, with each session lasts for 2.5 hours, once a week for 8 weeks with another 45 minutes of home practice on daily basis.
- interventionNames
- Behavioral: MBSR
- type
- NO_INTERVENTION
- label
- Treatment-as-usual control group
- description
- The participants in the control group will receive treatment-as-usual in which routine oncology support such as appointment with oncologists or palliative care physicians, general practitioner for usual cancer care. The participants physical health and medications for their cancer treatment will be reviewed and treatment will be modified according to physical symptoms such as pain. Specific psychological interventions such as cognitive behavioral therapy, interpersonal therapy, mindfulness-based interventions, acceptance and commitment therapy, etc will be avoided.
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * those diagnosed with HNC confirmed by histopathological report and at any stage of cancer * those aged 18 years old and above * those who have completed surgery and started chemotherapy and/or radiotherapy * literate in the Malay language. Exclusion Criteria: * history of pre-existing psychiatric illnesses (such as psychotic disorder, bipolar disorder, anxiety disorder, depressive disorder, neurodevelopmental disorder, neurocognitive disorder) * history of pre-existing medical illnesses which may induce psychiatric symptoms (such as kidney and liver failure, ischemic heart disease, epilepsy, hyperthyroidism, hypothyroidism, Cushing's syndrome, Addison's disease, systemic lupus erythematosus, neurological disorder, rheumatoid arthritis) * history of illicit drug and alcohol use * pregnancy * suicidal tendency * those with history of engaged in other psychotherapy * those who are not physically and cognitively fit to participate in the study
References
Publications (1)
- DERIVEDZhang Z, Zhang Q, Lu P, Shari NI, Nik Jaafar NR, Mohamad Yunus MR, Qiu Q, Ismail F, Ab Muin NF, Leong Bin Abdullah MFI. Mindfulness-Based Stress Reduction Alleviates Depression, Anxiety, and Internalized Stigma Compared With Treatment-as-Usual Among Head and Neck Cancer Patients: Findings From a Randomized Controlled Trial. Depress Anxiety. 2025 Sep 11;2025:7499120. doi: 10.1155/da/7499120. eCollection 2025. PMID 40979247