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

NCT06224504 | Completed

• 1 other identifier: SBH-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

Lung cancer; Mindfulness-Based Stress Reduction; Exercise intervention; Anxiety; Depression

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (2)

the intervention group

EXPERIMENTAL

routine health education ， psychological nursing， MBSR therapy ， exercise therapy

Behavioral: routine health education; Behavioral: psychological nursing; Behavioral: MBSR therapy; Behavioral: exercise therapy

the control group

ACTIVE COMPARATOR

routine health education ， psychological nursing

Behavioral: routine health education; Behavioral: psychological nursing

Interventions

routine health education BEHAVIORAL

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

the control group; the intervention group

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

the control group; the intervention group

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

the intervention group

exercise therapy BEHAVIORAL

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

the intervention group

Eligibility Criteria

• Age: 44 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanxi Bethune Hospital: lead

Study Sites (1)

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

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Anxiety Disorders; Depression

Interventions

Mindfulness-Based Stress Reduction; Exercise Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Wanling Li

  Shanxi Bethune Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 25, 2024
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2024
• Last Updated: January 25, 2024

Record last verified: 2024-01

Locations

CN (1)