The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness and Cost-effectiveness of an Integrated Psychological Internet Intervention (MindWellness) in Chinese COPD Patients: Study Protocol of a Randomized Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06026709
Recruitment Status : Not yet recruiting
First Posted : September 7, 2023
Last Update Posted : September 7, 2023
Sponsor:
Information provided by (Responsible Party):
Simiao Chen, Peking Union Medical College

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Background Mental health problems in chronic obstructive pulmonary disease (COPD) patients are prominent and neglected. Web-based self-help therapies may effectively reduce mental health problems, but their effectiveness has not been evaluated in Chinese COPD patients. We developed an integrated Internet-based psychological intervention (MindWellness). This study aims to evaluate the effectiveness and cost-effectiveness of MindWellness in enhancing the mental wellbeing of COPD patients.

Methods This study is a multicenter, two-arm, randomized controlled trial (RCT) with a parallel-group design to enroll at least 420 COPD patients over 35 years. Participants will be assigned to receive either usual care group or the usual care + MindWellness group. Assessments will take place at baseline (T0), 4 weeks (T1), 8 weeks (T2), and 16 weeks (T3) after baseline, and participants will be asked to complete questionnaires and take physical measurements. The primary outcome measure will assess mental well-being using the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS). Secondary outcome measures will assess mental health, physical health, COPD symptoms, health risk behaviors, socio-economic indicators, and healthcare utilization and expenditure. Analyses will utilize an intention-to-treat analysis.

Discussion This study is the first RCT to examine the value of MindWellness, the internet-based psychological intervention for COPD patients. If this low-cost intervention is effective, it could be rapidly scaled up for providing mental health care of COPD patients in China.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Depression Anxiety Behavioral: MindWellness Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effectiveness and Cost-effectiveness of an Integrated Psychological Internet Intervention (MindWellness) in Chinese COPD Patients: Study Protocol of a Randomized Controlled Trial
Estimated Study Start Date : September 15, 2023
Estimated Primary Completion Date : April 15, 2024
Estimated Study Completion Date : June 15, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: usual care + MindWellness group Behavioral: MindWellness
The online intervention "MindWellness" integrates two distinct trainings for anxiety and depression. Each training includes approximately twenty 10-minute sessions, and each are centered around different themes. These two trainings will be delivered through a WeChat Mini Program.
No Intervention: usual care


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) [ Time Frame: at baseline (T0), 4 weeks (T1), 8 weeks (T2), and 16 weeks (T3) after baseline ]
    Patients'mental wellbeing


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 35 years or older;
  2. Post-bronchodilator FEV1/FVC ≤70% or confirmed COPD patients;
  3. Literate and able to type;
  4. Have a smartphone;
  5. Be proficient in using the WeChat applet;
  6. Willingness to self-help iCBT sessions for 8 weeks, 10-20 minutes of practice per session, roughly 1 hour per week, time and place flexible;
  7. Receive three follow-up visits within four months (2 offline, 1 online) and complete a physical exam and online questionnaire; and
  8. Willingness to provide the hospital with their usual cell phone number.

Exclusion Criteria:

  1. Patients with a physician diagnosis of asthma or asthma-COPD overlap syndrome;
  2. Patients hospitalized for COPD within the previous one year;
  3. Having severe cognitive dysfunction and being unable to communicate;
  4. Severely ill with less than 12-month life expectancy.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Simiao Chen, professor, Peking Union Medical College
ClinicalTrials.gov Identifier: NCT06026709    
Other Study ID Numbers: CAMS&PUMC-IEC-2023-018
First Posted: September 7, 2023    Key Record Dates
Last Update Posted: September 7, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
 Chronic Disease
Disease Attributes
Pathologic Processes