COPD (Chronic Obstructive Pulmonary Disease)COPD BALANCENCT06891677
Internet-Based Cognitive Behavioral Therapy and Educational Program for People Living With Chronic Obstructive Pulmonary Disease (COPD)
A study testing Internet-Based Cognitive Behavioral Therapy (CBT) with ACT and COPD Education in people with COPD (Chronic Obstructive Pulmonary Disease), run by Jonas Agholme at 1 site in Sweden.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- Internet-Based Cognitive Behavioral Therapy (CBT) with ACT and COPD Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSweden
- Study dates
- 12 May 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD).
- Access to a computer and stable internet connection.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Lung- och allergimottagningen, Vrinnevisjukhuset
Norrköping, Östergötland County, 603 79
About this study
Official title: 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:
Read more
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.
- Being tested
- Internet-Based Cognitive Behavioral Therapy (CBT) with ACT and COPD Education
- Keywords
- COPD, Chronic Obstructive Pulmonary Disease, Internet-based Cognitive Behavioral Therapy, Online CBT, Acceptance and Commitment Therapy, ACT, Educational intervention, Anxiety, Depression, Mental health, Quality of life, Feasibility study, Disease management, Pulmonary rehabilitation, Self-management education, Telehealth, Digital health, Respiratory medicine
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Anxiety Disorders, Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-Based Cognitive Behavioral Therapy (CBT) with ACT and COPD EducationBehavioural
Also called Internet-based CBT, Online CBT, Internet CBT, Acceptance and Commitment Therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Internet-Based CBT and Education for COPD | Experimental | 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. Receives: Behavioral: Internet-Based Cognitive Behavioral Therapy (CBT) with ACT and COPD Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At completion of the intervention (8-10 weeks)
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline and immediately after completing the intervention (8-10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start12 May 2025
- Primary completion20 May 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-group feasibility study in which all participants receive the same internet-based cognitive behavioral therapy (CBT) and educational intervention specifically designed for people with COPD. Outcomes will be assessed by comparing measures before and after the intervention on an individual level. Additionally, feasibility aspects such as recruitment rate, acceptability, adherence, and practicality of the intervention will be evaluated. No separate control group is included.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonas Agholme
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jonas Agholme, Region Östergötland
- Investigators
- Jonas Agholme, Medical Doctor, Principal investigator, Region Östergötland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06891677
- Sponsor's protocol ID
- Dnr 2024-06453-01
- Acronym
- COPD BALANCE
- Status last verified
- Aug 2026
- First submitted
- 17 Mar 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06891677
- Acronym / sponsor ID
- COPD BALANCE / Dnr 2024-06453-01
- Keywords
- COPD, Chronic Obstructive Pulmonary Disease, Internet-based Cognitive Behavioral Therapy, Online CBT, Acceptance and Commitment Therapy, ACT, Educational intervention, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Jonas AgholmeUniversity, hospital or other
- Study start
- 12 May 2025 (actual)
- Primary completion
- 20 May 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-group feasibility study in which all participants receive the same internet-based cognitive behavioral therapy (CBT) and educational intervention specifically designed for people with COPD. Outcomes will be assessed by comparing measures before and after the intervention on an individual level. Additionally, feasibility aspects such as recruitment rate, acceptability, adherence, and practicality of the intervention will be evaluated. No separate control group is included.
| Arm | Type | Receives |
|---|---|---|
| Internet-Based CBT and Education for COPD | Experimental | Behavioral: Internet-Based Cognitive Behavioral Therapy (CBT) with ACT and COPD EducationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD).
- Access to a computer and stable internet connection.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-Based Cognitive Behavioral Therapy (CBT) with ACT and COPD EducationAlso: Internet-based CBT, Online CBT, Internet CBT, Acceptance and Commitment TherapyParticipants 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. | Behavioural | Internet-Based CBT and Education for COPD |
Primary outcome
Feasibility of Internet-Based CBT and Educational Intervention for COPD
Time frame: At completion of the intervention (8-10 weeks)
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.
9 secondary outcomes
Change from Baseline in Depression Symptoms Measured by Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline (before intervention) and immediately after completing the intervention (8-10 weeks)
Change in Anxiety Symptoms Measured by Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Baseline and after completing the intervention (8-10 weeks)
Change in COPD-Related Quality of Life measured by St. George's Respiratory Questionnaire (SGRQ)
Time frame: Baseline and immediately after completing the intervention (8-10 weeks)
Change in Health-Related Quality of Life Measured by EuroQol-5 Dimensions (EQ5D)
Time frame: Baseline and after the intervention (8-10 weeks)
Change in COPD Symptoms and Impact on Daily Life (COPD Assessment Test, CAT)
Time frame: Baseline and after intervention completion (8-10 weeks)
Change in Breathlessness Severity (Modified Medical Research Council Dyspnea Scale, MRC)
Time frame: Baseline and immediately after completing the intervention (8-10 weeks)
Change in Perceived Stress (Perceived Stress Scale, PSS-10)
Time frame: Baseline and after completing the intervention (8-10 weeks)
Change in Physical Capacity (6-Minute Walk Test)
Time frame: Baseline and after intervention (8-10 weeks)
Change in Lung Function (Spirometry, FEV1 and FVC)
Time frame: Baseline and immediately after completing the intervention (8-10 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonas Agholme, Medical Doctor principal investigator
Region Östergötland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-Based Cognitive Behavioral Therapy (CBT) with ACT and COPD Education in people with COPD (Chronic Obstructive Pulmonary Disease), run by Jonas Agholme at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Internet-Based CBT and Educational Intervention for COPD (time frame: At completion of the intervention (8-10 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.