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NCT Number: NCT06224504

Clinical Effectiveness of Combining Mindfulness-Based Stress Reduction With Exercise Interventione

This study is to assess the clinical effectiveness of combining Mindfulness-Based Stress Reduction (MBSR) with exercise intervention in improving anxiety, depression, sleep quality, and mood regulation in Chinese patients with non-small cell lung cancer (NSCLC).The control group received conventional psychological nursing care, while the intervention group received a combination of MBSR and exercise therapy. Pre- and post-treatment scores of anxiety, depression, sleep quality, and the BSRS-5 were compared.

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Key information

Conditions

Non-small Cell Lung Cancer Anxiety Disorders Behavior Behavioral Symptoms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Depression Lung Diseases Lung Neoplasms Mental Disorders Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

44 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Combined Mindfulness-Based Stress Reduction and Exercise Intervention for Improving Psychological Well-being in Chinese Patients with Non-Small Cell Lung Cancer

Taiyuan, Shanxi, 030032, China

About this study

To assess the clinical effectiveness of combining Mindfulness-Based Stress Reduction (MBSR) with exercise intervention in improving anxiety, depression, sleep quality, and mood regulation in Chinese patients with non-small cell lung cancer (NSCLC). A total of 60 lung cancer patients from a hospital in Shanxi Province were selected using convenience sampling and divided into an intervention group and a control group, with 30 patients in each group. The control group received conventional psychological nursing care, while the intervention group received a combination of MBSR and exercise therapy. The two group were evaluated by the questionnaire three times. One day before the intervention, the first questionnaire was conducted, and the basic data of the two groups of patients were collected. The second questionnaire evaluation of anxiety, depression, sleep quality, and the Brief Symptom Rating Scale (BSRS-5) was conducted 6 weeks after the end of the intervention, and the third questionnaire evaluation was conducted 8 weeks after the end of the intervention to evaluate the intervention effect of the two groups. Pre- and post-treatment scores of anxiety, depression, sleep quality, and the BSRS-5 were compared.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients diagnosed with non-small cell lung cancer
  • patients aged between 20 and 74 years, without gender limitation
  • a score of 4-14 on the Short Symptom Rating Scale (BSRS-5)
  • a clinical prognosis of at least 6 months
  • clear consciousness, good functional ability, and unrestricted language communication
  • written informed consent provided by the patient

Exclusion criteria

  • patients with severe physical illnesses or symptoms that impede learning and are considered life-threatening
  • patients with a BSRS-5 assessment score > 15 and suicidal ideation > 2
  • patients unable to accurately describe their symptoms
  • patients with limited cooperation ability
  • patients who have previously undergone MBSR or other positive-thinking-focused psychotherapy methods

Treatment and study plan

routine health education

Behavioral

guided the diet of patients, and introduced the knowledge of the disease in detail

psychological nursing

Behavioral

hen the patient has negative emotions, patiently listen to the patient's expression, and timely provide language comfort and guidance to the negative psychological emotions

MBSR therapy

Behavioral

Conducted in small groups once a week for 8 weeks, with each session lasting approximately 1-1.5 hours, encompassed mindfulness-based breathing exercises, dietary interventions, and body scans

Exercise Therapy

Behavioral

Participants were assigned daily tasks for each session, requiring approximately 35-45 minutes per day

Primary outcomes

  1. SAS score

    Time frame: one day before the intervention

    Self-Rating Anxiety Scale (SAS)

  2. SAS score

    Time frame: at 6 weeks after the intervention

    Self-Rating Anxiety Scale (SAS)

  3. SAS score

    Time frame: at 8 weeks after the intervention

    Self-Rating Anxiety Scale (SAS)

  4. SDS score

    Time frame: one day before the intervention

    Self-Rating Depression Scale (SDS)

  5. SDS score

    Time frame: at 6 weeks after the intervention

    Self-Rating Depression Scale (SDS)

  6. SDS score

    Time frame: at 8 weeks after the intervention

    Self-Rating Depression Scale (SDS)

  7. BSRS-5 score

    Time frame: one day before the intervention

    the five-item Brief Symptom Rating Scale (BSRS-5)

  8. BSRS-5 score

    Time frame: at 6 weeks after the intervention

    the five-item Brief Symptom Rating Scale (BSRS-5)

  9. BSRS-5 score

    Time frame: at 8 weeks after the intervention

    the five-item Brief Symptom Rating Scale (BSRS-5)

  10. PSQI score

    Time frame: one day before the intervention

    Pittsburgh Sleep Quality Index (PSQI)

  11. PSQI score

    Time frame: at 6 weeks after the intervention

    Pittsburgh Sleep Quality Index (PSQI)

  12. PSQI score

    Time frame: at 8 weeks after the intervention

    Pittsburgh Sleep Quality Index (PSQI)

Sponsors and collaborators

Lead sponsor

Shanxi Bethune Hospital

Other

Registry information

Official study title

Combined Mindfulness-Based Stress Reduction and Exercise Intervention for Improving Psychological Well-being in Chinese Patients With Non-Small Cell Lung Cancer

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
Jan 25, 2024
Registry last updated
Jan 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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