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

January 16, 2024 updated by: Wanling Li, Shanxi Bethune Hospital

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanxi Bethune Hospital

Investigators

  • Principal Investigator: Wanling Li, Shanxi Bethune Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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