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

NCT06991309 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-05-31

No results posted yet for this study

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

Interventions

BEHAVIORAL

MBSR

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.

Sponsors & Collaborators

  • Universiti Sains Malaysia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2023-06-30
Completion
2023-06-30

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06991309 on ClinicalTrials.gov