Internet-Based Cognitive Behavioral Therapy and Educational Program for People Living With Chronic Obstructive Pulmonary Disease (COPD) (COPD BALANCE)

COPD BALANCE: A Feasibility Study of Internet-Based Cognitive Behavioral Therapy and Educational Intervention to Improve Mental Health, Disease Knowledge, and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease

The goal of this clinical trial is to learn if an internet-based cognitive behavioral therapy (CBT) and education program can help improve mental health, disease knowledge, and quality of life in adults with chronic obstructive pulmonary disease (COPD). This is a feasibility study, meaning researchers want to find out if this online treatment program is practical, acceptable, and effective enough to use in a larger future study.

The main questions it aims to answer are:

Can internet-based CBT and disease education help participants feel less anxious, depressed, or stressed? Can this online program help participants better manage COPD symptoms and improve their quality of life? How easy and acceptable do participants find the online CBT and educational program?

Researchers will measure the following outcomes to see how well the program works:

Quantitative outcomes (using questionnaires and tests):

Depression symptoms (using Patient Health Questionnaire-9, PHQ-9) Anxiety symptoms (using Generalized Anxiety Disorder-7, GAD-7) Stress levels (using Perceived Stress Scale, PSS) Quality of life related to COPD (using St. George's Respiratory Questionnaire, SGRQ, and EuroQol-5 Dimensions, EQ5D) COPD-specific symptoms and impact on daily life (using COPD Assessment Test, CAT) Breathlessness severity during daily activities (using Modified Medical Research Council Dyspnea Scale, MRC) Physical capacity (using a 6-minute walk test) Lung function (using spirometry, a breathing test)

Qualitative outcomes (using interviews):

Participants' experiences and satisfaction with the internet-based therapy and education What participants think helps or hinders them from engaging with the online program How the program affects participants' daily lives and how they cope with COPD

Participants in the study will:

Take part in an internet-based CBT and education program designed specifically for COPD lasting 8-10 weeks. They can complete the program from home.

Answer questionnaires about mental health, stress, quality of life, COPD symptoms, and breathlessness before and after completing the program.

Visit the clinic two times (before and after the program) for breathing tests (spirometry) and physical capacity tests (6-minute walking test).

Some participants (10-15) will also participate in an interview to discuss their experiences and how they feel about the online treatment program.

The results of this study will help researchers understand whether internet-based CBT and COPD education is helpful and practical enough to study in a larger clinical trial in the future.

Study Overview

• Status: Recruiting
• Conditions: COPD (Chronic Obstructive Pulmonary Disease)
• Intervention / Treatment: Behavioral: Internet-Based Cognitive Behavioral Therapy (CBT) with ACT and COPD Education

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Principal Investigator; Phone Number: +46101045202; Email: jonas.agholme@regionostergotland.se

Study Locations

• Sweden
  • Östergötland
    • Norrköping, Östergötland, Sweden, 603 79
      • Recruiting
      • Lung- och allergimottagningen, Vrinnevisjukhuset
      • Contact: Jonas Agholme; Phone Number: +46101045202; Email: jonas.agholme@regionostergotland.se

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Diagnosis of Chronic Obstructive Pulmonary Disease (COPD).
• Access to a computer and stable internet connection.

Exclusion Criteria:

• Significant psychiatric illness requiring specialist psychiatric treatment by healthcare services within the last five years.
• Life expectancy less than six months.
• Dementia or cognitive impairment affecting the ability to participate.
• Limited proficiency in the Swedish language.
• Disabilities preventing computer use.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Internet-Based CBT and Education for COPD; Participants will receive an internet-based cognitive behavioral therapy (CBT) and educational program specifically designed for people with COPD. The intervention combines disease-specific education with CBT techniques, including elements of Acceptance and Commitment Therapy (ACT). The goal is to help participants manage COPD symptoms, reduce stress and anxiety, and improve their quality of life. Participants complete this 8-10-week online program at home.

Behavioral: Internet-Based Cognitive Behavioral Therapy (CBT) with ACT and COPD Education; Participants receive an internet-based cognitive behavioral therapy (CBT) intervention combined with education specifically developed for COPD. The CBT program includes Acceptance and Commitment Therapy (ACT) components. The intervention lasts 8-10 weeks and consists of several online modules. Modules cover topics such as coping strategies, mindfulness techniques, disease knowledge, and symptom management. Participants complete the modules at home via a secure online platform, with regular support and feedback from trained healthcare professionals. The program aims to improve mental health, reduce anxiety and depression, enhance COPD knowledge, and help participants manage symptoms and daily life more effectively.; Other Names: Acceptance and Commitment Therapy; Internet-based CBT; Internet CBT; Online CBT; Educational intervention for COPD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Internet-Based CBT and Educational Intervention for COPD	Feasibility is measured by participant adherence (how many complete at least 75% of the online program), acceptability (participant satisfaction through questionnaires and interviews), and recruitment rate (how quickly participants join the study). High feasibility means that participants find the intervention practical, acceptable, and manageable, indicating it could be used in a larger clinical trial.	At completion of the intervention (8-10 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Depression Symptoms Measured by Patient Health Questionnaire-9 (PHQ-9)	Participants' symptoms of depression will be measured using the Patient Health Questionnaire-9 (PHQ-9). This is a 9-item questionnaire that measures depression severity, with scores ranging from 0 (no depression) to 27 (severe depression). Researchers will assess if depression symptoms decrease after participants complete the internet-based CBT and educational intervention.	Baseline (before intervention) and immediately after completing the intervention (8-10 weeks)
Change in Anxiety Symptoms Measured by Generalized Anxiety Disorder-7 (GAD-7)	Anxiety is measured with the Generalized Anxiety Disorder-7 questionnaire, scoring from 0 (no anxiety) to 21 (severe anxiety). Lower scores after intervention indicate improvement.	Baseline and after completing the intervention (8-10 weeks)
Change in COPD-Related Quality of Life measured by St. George's Respiratory Questionnaire (SGRQ)	COPD-specific quality of life is measured using the St. George's Respiratory Questionnaire (SGRQ). Scores range from 0 to 100, with lower scores meaning better quality of life and fewer COPD symptoms.	Baseline and immediately after completing the intervention (8-10 weeks)
Change in Health-Related Quality of Life Measured by EuroQol-5 Dimensions (EQ5D)	General quality of life is measured with EuroQol-5 Dimensions (EQ5D). The EQ5D evaluates general health status across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Higher scores indicate better quality of life.	Baseline and after the intervention (8-10 weeks)
Change in COPD Symptoms and Impact on Daily Life (COPD Assessment Test, CAT)	COPD symptoms and their impact on daily activities are measured using the COPD Assessment Test (CAT). Scores range from 0 to 40, where lower scores mean fewer COPD-related symptoms and problems.	Baseline and after intervention completion (8-10 weeks)
Change in Breathlessness Severity (Modified Medical Research Council Dyspnea Scale, MRC)	Breathlessness during everyday activities is measured with the Modified Medical Research Council Dyspnea Scale (MRC). Scores range from 0 (breathless only during heavy exertion) to 4 (too breathless to leave the house). Lower scores after the intervention indicate improvement.	Baseline and immediately after completing the intervention (8-10 weeks)
Change in Perceived Stress (Perceived Stress Scale, PSS-10)	Stress levels are measured using the Perceived Stress Scale (PSS-10), with scores ranging from 0 (no stress) to 40 (high stress). The goal is to see if the intervention reduces participants' perceived stress.	Baseline and after completing the intervention (8-10 weeks)
Change in Physical Capacity (6-Minute Walk Test)	Physical capacity is measured with a 6-minute walk test (6MWT). Researchers measure how far participants can walk in six minutes, in meters, before and after the intervention to see if participants' physical ability improves.	Baseline and after intervention (8-10 weeks)
Change in Lung Function (Spirometry, FEV1 and FVC)	Lung function is measured using spirometry, testing forced expiratory volume in one second (FEV1) and forced vital capacity (FVC).	Baseline and immediately after completing the intervention (8-10 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Experiences of the Online Intervention (Qualitative Interviews)	Participants' experiences, satisfaction, and perceived impact of the online intervention are assessed through qualitative interviews. Researchers aim to understand participant views about barriers, benefits, and the intervention's impact on daily life.	At completion of intervention (8-10 weeks)

Collaborators and Investigators

• Sponsor: Jonas Agholme
• Investigators: Principal Investigator: Jonas Agholme, Medical Doctor, Region Östergötland

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2025
• Primary Completion (Estimated): November 20, 2025
• Study Completion (Estimated): December 15, 2025

Study Registration Dates

• First Submitted: March 17, 2025
• First Submitted That Met QC Criteria: March 17, 2025
• First Posted (Actual): March 24, 2025

Study Record Updates

• Last Update Posted (Actual): May 25, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Depression; Acceptance and Commitment Therapy; Anxiety; COPD; Quality of life; Telehealth; Pulmonary rehabilitation; Mental health; Chronic Obstructive Pulmonary Disease; Disease management; ACT; Feasibility study; Educational intervention; Digital health; Online CBT; Internet-based Cognitive Behavioral Therapy; Self-management education; Respiratory medicine
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: Dnr 2024-06453-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared publicly due to privacy considerations and ethical restrictions. Sharing individual participant data could risk compromising participant confidentiality and privacy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No