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

NCT ID: NCT06891677

Last Updated: 2025-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-12

Study Completion Date

2025-12-15

Brief Summary

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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.

Detailed Description

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Conditions

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COPD (Chronic Obstructive Pulmonary Disease)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Internet-based CBT Online CBT Internet CBT Acceptance and Commitment Therapy Educational intervention for COPD

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jonas Agholme

OTHER

Sponsor Role lead

Responsible Party

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Jonas Agholme

Specialist in Internal Medicine, Department of Internal Medicine, Vrinnevi Hospital, Norrköping

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jonas Agholme, Medical Doctor

Role: PRINCIPAL_INVESTIGATOR

Region Östergötland

Locations

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Lung- och allergimottagningen, Vrinnevisjukhuset

Norrköping, Östergötland County, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Principal Investigator

Role: CONTACT

+46101045202

Facility Contacts

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Jonas Agholme

Role: primary

+46101045202

Other Identifiers

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Dnr 2024-06453-01

Identifier Type: -

Identifier Source: org_study_id

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