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

NCT06891677 | Recruiting

• 1 other identifier: Dnr 2024-06453-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change from Baseline in Depression Symptoms Measured by Patient Health Questionnaire-9 (PHQ-9)

  Baseline (before intervention) and immediately after completing the intervention (8-10 weeks)

• Change in Anxiety Symptoms Measured by Generalized Anxiety Disorder-7 (GAD-7)

  Baseline and after completing the intervention (8-10 weeks)

• Change in COPD-Related Quality of Life measured by St. George's Respiratory Questionnaire (SGRQ)

  Baseline and immediately after completing the intervention (8-10 weeks)

• Change in Health-Related Quality of Life Measured by EuroQol-5 Dimensions (EQ5D)

  Baseline and after the intervention (8-10 weeks)

• Change in COPD Symptoms and Impact on Daily Life (COPD Assessment Test, CAT)

  Baseline and after intervention completion (8-10 weeks)

Other Outcomes (1)

• Participant Experiences of the Online Intervention (Qualitative Interviews)

  At completion of intervention (8-10 weeks)

Study Arms (1)

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.

Behavioral: Internet-Based Cognitive Behavioral Therapy (CBT) with ACT and COPD Education

Interventions

Internet-Based Cognitive Behavioral Therapy (CBT) with ACT and COPD Education BEHAVIORAL

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.

Also known as: Internet-based CBT, Online CBT, Internet CBT, Acceptance and Commitment Therapy, Educational intervention for COPD

Internet-Based CBT and Education for COPD

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jonas Agholme: lead

Study Sites (1)

Lung- och allergimottagningen, Vrinnevisjukhuset

Norrköping, Östergötland County, 603 79, Sweden

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Anxiety Disorders; Depression; Psychological Well-Being

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jonas Agholme, Medical Doctor

  Region Östergötland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Principal Investigator

CONTACT

+46101045202; jonas.agholme@regionostergotland.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Specialist in Internal Medicine, Department of Internal Medicine, Vrinnevi Hospital, Norrköping

Model Details: 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.

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 24, 2025
• Study Start: May 12, 2025
• Primary Completion: November 20, 2025
• Study Completion: December 15, 2025
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)