Cardiovascular DiseaseNCT04726722
Evaluation of a Personcentered Internet-based CBT Program for Stress, Anxiety and Depressive Symptoms in Patients With Cardiovascular Disease
A study testing internet-based cognitive behavioral theraphy in people with Cardiovascular Disease and Psychological Distress, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
To evaluate a nine-week adaptable and person-centred I-CBT program that can be directed towards stress, anxiety and depressive symptoms in persons with CVD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease, Psychological Distress
- What is being tested?
- internet-based cognitive behavioral theraphy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 1 siteSweden
- Study dates
- 13 Mar 2023to 30 Jun 2025
- 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
- age 18 years and above
- treatment for cardiovascular disease (CVD) according to European Society of Cardiology guidelines
- stable CVD (New York Heart Association class I-III) and not having been hospitalised for CVD in in the last four weeks.
- stress (Perceived Stress Scale (PSS)-10>13 points) and/or
- anxiety (i.e. General Anxiety Disorder Scale (GAD) ≥5 points) and/or
- depressive symptoms (Patient Health Questionnaire-9 28 (PHQ-9) > 5 points)
Who cannot join
- severe CVD (New York Heart Association classification IV) or another severe chronic life-threatening disease
- severe stress, anxiety or depression assessed as requiring acute treatment
- not being able to dedicate 3-4 hours per week to participate in the program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of an Adaptable and Personcentered Internet-based CBT Program Aimed to Treat Stress, Anxiety and Depressive Symptoms in Patients With Cardiovascular Disease
To evaluate a nine-week adaptable and person-centred I-CBT program that can be directed towards stress, anxiety and depressive symptoms in persons with CVD.
Read the detailed description
All patients diagnosed as CVD (i.e. diagnosis Ischemia (ICD-code I20., I25.), Heart Failure (ICD-code I50., I42.) or Arrhythmia (ICD-code I48, I49, DF016) and who received care in the last 12 months at hospitals in the south-east of Sweden will be contacted by letter with information about the study.
Participants who are interested are invited to visit our website for more information, registration and provision of informed consent. After registration, participants will respond to questions about demographics, medical history, stress, anxiety and depressive symptoms on the website. Inclusion or exclusion will be assessed by a group consisting of a psychologist, cardiology specialist nurse and a psychiatry specialist nurse.
Before final inclusion and randomization eligible participants will be contacted for a telephone interview held by the study nurses.
Included (n=400) participants will, on our website (www.xxxxxx), complete the baseline study questionnaires and then be randomized according to a 2 x2 factorial design.
- Conditions
- Cardiovascular Disease, Psychological Distress
- Being tested
- internet-based cognitive behavioral theraphy
- Keywords
- Cardiovascular disease, Psychological distress, Internet-based cognitive behavioural therapy
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
internet-based cognitive behavioral theraphyBehavioural
When determining the content of the I-CBT program, the participants and therapist will be allowed to choose from a library of treatment modules.
Therapist controlled support and feedback are given weekly and in a structured manner. Participants will be able to contact the therapist when support and feedback is desired
| Study group | Role | What they receive |
|---|---|---|
| Design of the CBT treatment content | Experimental | Patient determined CBT content (i.e. person-centered) vs. therapist determined I-CBT content Receives: Behavioral: internet-based cognitive behavioral theraphy |
| Control of support and feedback | Experimental | Patient-controlled support and feedback (person-centred) vs. therapist -controlled. Receives: Behavioral: internet-based cognitive behavioral theraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in stress from baseline to 9 weeks on the 10 item Perceived Stress Scale
The 10-item Perceived Stress Scale is a valideted self-report of Stress. The instreument measures the degree to which individuals perceives their life situations as stressful. The 10 items are rated on a 5 point scale and higher scores means more stress
Measured: From baseline to 9 weeks at the end of the intervention.
Change in anxiety from baseline to 9 weeks on the 7-item Generalized Anxiety Disorder Scale.
General Anxiety Disorder scale is validagted self-resport that measure symptoms of general anxiety during the last two weeks. The 7-items range from 0 (not bothered at all) to 3 (nearly every day). A higher score indicate more anxiety and the cut-off 5 suggests at least mild anxiety.
Measured: From baseline to 9 weeks at the end of the intervention.
Change in depressive symptoms from baseline to 9 weeks on the 9 item Patient Health Questionnaire.
The 9-item Patient Health Questionnaire is a validated self-report that measure depressive symtpoms during the last two weeks. Each item is answered on a four graded scale where 0 means that the person not is affected and 3 where the person is affected several Days to almost every day. Higher numbers represents higher levels of depressive symptoms. A cut-off >5 represents at least mild depression.
Measured: From baseline to 9 weeks at the end of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start13 Mar 2023
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies 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
- Randomised
- Intervention model
- Factorial
- Model description
- 2 x 2
- Masking
- None (open label)
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Johansson, Linkoeping University
- Investigators
- Peter Johansson, Ph.D, Principal investigator, Department of Health, Medicine and Caring Sciences, Linkoping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726722
- Sponsor's protocol ID
- 2020-00935
- Status last verified
- Nov 2025
- First submitted
- 22 Jan 2021
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Our university works with the question of we can share IPD without violoating GPDR
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Adaptable and Personcentered Internet-based CBT Program Aimed to Treat Stress, Anxiety and Depressive Symptoms in Patients With Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT04726722
- Acronym / sponsor ID
- 2020-00935
- Conditions
- Cardiovascular Disease, Psychological Distress
- Keywords
- Cardiovascular disease, Psychological distress, Internet-based cognitive behavioural therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 27 Jan 2021 (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.
To evaluate a nine-week adaptable and person-centred I-CBT program that can be directed towards stress, anxiety and depressive symptoms in persons with CVD.
Detailed description
All patients diagnosed as CVD (i.e. diagnosis Ischemia (ICD-code I20., I25.), Heart Failure (ICD-code I50., I42.) or Arrhythmia (ICD-code I48, I49, DF016) and who received care in the last 12 months at hospitals in the south-east of Sweden will be contacted by letter with information about the study.
Participants who are interested are invited to visit our website for more information, registration and provision of informed consent. After registration, participants will respond to questions about demographics, medical history, stress, anxiety and depressive symptoms on the website. Inclusion or exclusion will be assessed by a group consisting of a psychologist, cardiology specialist nurse and a psychiatry specialist nurse.
Before final inclusion and randomization eligible participants will be contacted for a telephone interview held by the study nurses.
Included (n=400) participants will, on our website (www.xxxxxx), complete the baseline study questionnaires and then be randomized according to a 2 x2 factorial design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 x 2
| Arm | Type | Receives |
|---|---|---|
| Design of the CBT treatment content | Experimental | Behavioral: internet-based cognitive behavioral theraphyPatient determined CBT content (i.e. person-centered) vs. therapist determined I-CBT content |
| Control of support and feedback | Experimental | Behavioral: internet-based cognitive behavioral theraphyPatient-controlled support and feedback (person-centred) vs. therapist -controlled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age 18 years and above
- treatment for cardiovascular disease (CVD) according to European Society of Cardiology guidelines
- stable CVD (New York Heart Association class I-III) and not having been hospitalised for CVD in in the last four weeks.
- stress (Perceived Stress Scale (PSS)-10>13 points) and/or
- anxiety (i.e. General Anxiety Disorder Scale (GAD) ≥5 points) and/or
Key exclusion criteria (3 listed)
- severe CVD (New York Heart Association classification IV) or another severe chronic life-threatening disease
- severe stress, anxiety or depression assessed as requiring acute treatment
- not being able to dedicate 3-4 hours per week to participate in the program
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 theraphyWhen determining the content of the I-CBT program, the participants and therapist will be allowed to choose from a library of treatment modules. Therapist controlled support and feedback are given weekly and in a structured manner. Participants will be able to contact the therapist when support and feedback is desired | Behavioural | Control of support and feedback, Design of the CBT treatment content |
Primary outcome
Change in stress from baseline to 9 weeks on the 10 item Perceived Stress Scale
Time frame: From baseline to 9 weeks at the end of the intervention.
The 10-item Perceived Stress Scale is a valideted self-report of Stress. The instreument measures the degree to which individuals perceives their life situations as stressful. The 10 items are rated on a 5 point scale and higher scores means more stress
Change in anxiety from baseline to 9 weeks on the 7-item Generalized Anxiety Disorder Scale.
Time frame: From baseline to 9 weeks at the end of the intervention.
General Anxiety Disorder scale is validagted self-resport that measure symptoms of general anxiety during the last two weeks. The 7-items range from 0 (not bothered at all) to 3 (nearly every day). A higher score indicate more anxiety and the cut-off 5 suggests at least mild anxiety.
Change in depressive symptoms from baseline to 9 weeks on the 9 item Patient Health Questionnaire.
Time frame: From baseline to 9 weeks at the end of the intervention.
The 9-item Patient Health Questionnaire is a validated self-report that measure depressive symtpoms during the last two weeks. Each item is answered on a four graded scale where 0 means that the person not is affected and 3 where the person is affected several Days to almost every day. Higher numbers represents higher levels of depressive symptoms. A cut-off >5 represents at least mild depression.
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 24 Nov 2025.
- Individual participant dataSharing planned: Undecided. Our university works with the question of we can share IPD without violoating GPDR
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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.
Peter Johansson, Ph.D principal investigator
Department of Health, Medicine and Caring Sciences, Linkoping University
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 theraphy in people with Cardiovascular Disease and Psychological Distress, run by University Hospital, Linkoeping 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 6 inclusion and 3 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 24 Nov 2025. 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?
Change in stress from baseline to 9 weeks on the 10 item Perceived Stress Scale (time frame: From baseline to 9 weeks at the end of the intervention.). The study lists 3 primary outcomes in all. 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 24 Nov 2025.