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

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

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.

Study Overview

• Status: Completed
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Behavioral: routine health education; Behavioral: psychological nursing; Behavioral: MBSR therapy; Behavioral: exercise therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanxi
    • Taiyuan, Shanxi, China, 030032
      • Combined Mindfulness-Based Stress Reduction and Exercise Intervention for Improving Psychological Well-being in Chinese Patients with Non-Small Cell Lung Cancer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the intervention group; routine health education ， psychological nursing， MBSR therapy ， exercise therapy	Behavioral: routine health education; guided the diet of patients, and introduced the knowledge of the disease in detail; Behavioral: psychological nursing; 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; Behavioral: MBSR therapy; 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; Behavioral: exercise therapy; Participants were assigned daily tasks for each session, requiring approximately 35-45 minutes per day
Active Comparator: the control group; routine health education ， psychological nursing	Behavioral: routine health education; guided the diet of patients, and introduced the knowledge of the disease in detail; Behavioral: psychological nursing; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SAS score	Self-Rating Anxiety Scale (SAS)	one day before the intervention
SAS score	Self-Rating Anxiety Scale (SAS)	at 6 weeks after the intervention
SAS score	Self-Rating Anxiety Scale (SAS)	at 8 weeks after the intervention
SDS score	Self-Rating Depression Scale (SDS)	one day before the intervention
SDS score	Self-Rating Depression Scale (SDS)	at 6 weeks after the intervention
SDS score	Self-Rating Depression Scale (SDS)	at 8 weeks after the intervention
BSRS-5 score	the five-item Brief Symptom Rating Scale (BSRS-5)	one day before the intervention
BSRS-5 score	the five-item Brief Symptom Rating Scale (BSRS-5)	at 6 weeks after the intervention
BSRS-5 score	the five-item Brief Symptom Rating Scale (BSRS-5)	at 8 weeks after the intervention
PSQI score	Pittsburgh Sleep Quality Index (PSQI)	one day before the intervention
PSQI score	Pittsburgh Sleep Quality Index (PSQI)	at 6 weeks after the intervention
PSQI score	Pittsburgh Sleep Quality Index (PSQI)	at 8 weeks after the intervention

Collaborators and Investigators

• Sponsor: Shanxi Bethune Hospital
• Investigators: Principal Investigator: Wanling Li, Shanxi Bethune Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: January 16, 2024
• First Submitted That Met QC Criteria: January 16, 2024
• First Posted (Estimated): January 25, 2024

Study Record Updates

• Last Update Posted (Estimated): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Lung cancer; Mindfulness-Based Stress Reduction; Exercise intervention
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: SBH-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No