Mindfulness-based Stress Reduction Effects on Depression, Anxiety and Internalized Stigma Compared With Treatment-As-Usual Among Head and Neck Cancer Patients

NCT06991309 | Completed DMC

• 1 other identifier: LHGJ20230512
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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

Depression, Anxiety; Cancer of the Head and Neck; Psycho-Oncology

Keywords

Depression; Anxiety; Internalized stigma; head and neck cancer; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Hospital Anxiety and Depression Scale

  The Malay version of the "Hospital Anxiety and Depression Scale" (HADS) will be used to assess the severity of depression and anxiety symptoms among participants. The HADS is a 14-item, self-rated questionnaire with seven items in each of its subscales. Each item is scored from 0 to 3, and the total score for both the depression and anxiety subscales ranges from 0 to 21 per subscale. The cut-off for depression cases is 8/21, and the cut-off for anxiety cases is also 8/21. The Malay version of the HADS has been validated among Malaysian breast cancer patients, and it exhibited acceptable to good internal consistency for its total score and subscales with Cronbach's alphas ranging from 0.73 to 0.87

  Change of the mean HADS Depression and Anxiety Subscale scores between baseline and 8 weeks of commence of intervention and between 8 weeks of commence of intervention to 12 weeks after completion of intervention

Secondary Outcomes (1)

• Shame and Stigma Scale

  Change of the mean total SSS scores between baseline and 8 weeks of commence of intervention and between 8 weeks of commence of intervention to 12 weeks after completion of intervention

Study Arms (2)

Mindfulness-based stress reduction group

EXPERIMENTAL

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.

Behavioral: MBSR

Treatment-as-usual control group

NO INTERVENTION

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.

Interventions

MBSR BEHAVIORAL

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. The MBSR sessions will be based on therapy format developed by Kabat-Zinn. All the sessions focus on mindfulness practices, sharing of experiences with others, and didactic teaching on stress. Mindfulness practices which will be discussed include body scan exercise, and mindful breathing meditation techniques, three-minute breathing exercises, five-minute seeing or hearing exercises, bodily mindfulness in movement and mindful stretching, yoga and sitting meditation. The therapists will review feedbacks for each session, acknowledge the thoughts, feelings, and senses, examine how participants practice mindfulness, and give assignments to encourage participants to continually practice mindfulness at home. Each participant will receive a CD detailing on meditation practices and a workbook on the mindfulness practices.

Mindfulness-based stress reduction group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Pusat Perubatan Universiti Sains Malaysia Bertam

Kepala Batas, Pulau Pinang, 13200, Malaysia

Location

Related Publications (1)

• Zhang 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 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 27, 2025
• Study Start: January 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)