Depression, AnxietyeMindYourHeartNCT04172974
EHealth Intervention to Manage Depression and Anxiety in Patients with Ischemic Heart Disease
A study testing eHealth intervention in people with Depression, Anxiety, run by University of Southern Denmark at 13 sites in Denmark.
Trial summary
This study evaluates the effectiveness and cost-effectiveness of a therapy-assisted internet-based intervention in patients with ischemic heart disease and co-morbid depression and anxiety referred for cardiac rehabilitation. Half of the patients will receive the intervention and the other half usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- eHealth intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 13 sitesDenmark
- Study dates
- 22 May 2020to 11 Sep 2024
- 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
- Diagnosis of ischemic heart disease (diagnostic codes I20-I25)
- Referred for CR
- HADS score ≥ 8 on depression and or anxiety
- Access to a computer or smart phone
- Ability to use computer or smart phone
- Proficient in the Danish language
- Signing an informed consent form
Who cannot join
- Severe psychiatric disorder (i.e., borderline disorder, schizophrenia or bipolar disorder)
- Severe cognitive difficulties (e.g. severe brain damage, mental retardation, or dementia) that will prevent patients from participating
- Endorsement of suicidal ideation with daily suicidal thoughts (PHQ-9 item 9 >2)
- Participation in other intervention studies (unless they are clinical studies)
- Seeing a psychologist or mental health professional for the treatment of anxiety and depression
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Denmark13 sites
Aalborg University Hospital
Aalborg
Helle Lynge Kanstrup
Aarhus
Herlev / Gentofte Hospital
Herlev
Regionshospital Nordjylland
Hjørring
Holbæk Hospital
Holbæk
Holbæk Sygehus
Holbæk
Sygehus Lillebælt Kolding
Kolding
Odense University Hospital (Odense)
Odense
Randers Municipality
Randers
Zealand University Hospital
Roskilde
Odense University Hospital (Svendborg)
Svendborg
Sygehus Lillebælt
Vejle
Vordingborg Municipality
Vordingborg
About this study
Official title: Screening and Managing Depression and Anxiety with Therapist-assisted EHealth Intervention in Patients with Ischemic Heart Disease in the Cardiac Rehabilitation Setting
This study evaluates the effectiveness and cost-effectiveness of a therapy-assisted internet-based intervention in patients with ischemic heart disease and co-morbid depression and anxiety referred for cardiac rehabilitation. Half of the patients will receive the intervention and the other half usual care. We hypothesize that the intervention will lead to a reduction in patients' symptoms of depression and anxiety and be cost-effective.
Read the detailed description
The 12-week intervention will consist of 9 modules and 2 optional modules that will be delivered to patients in the active intervention via a platform or app. Psychologists will provide asynchronous guidance via the platform. Motivational interviewing will be used during the intervention to prevent dropout. The psychologist may contact patients via telephone during the intervention if needed. All patients will have access to the intervention up to 6 months' post intervention so that they can revisit the material and reuse it on a need-to-basis. Patients will be recommended to use this option and to note specific time points in their agenda where they will access the intervention. A brief purpose-designed interview protocol that includes elements from the SCAN interview will be carried out by psychologists trained in conducting the interview.
- Conditions
- Depression, Anxiety
- Being tested
- eHealth intervention, Usual Care
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eHealth interventionOther
Modules developed for depression and anxiety based on cognitive behavioral therapy (CBT), acceptance and commitment therapy (ACT) and compassion-focused coping
Usual CareOther
Treatment according to national clinical guideline (referral to GP)
| Study group | Role | What they receive |
|---|---|---|
| Treatment for depression and anxiety | Experimental | Treatment Receives: Other: eHealth intervention |
| Usual care | Other | Usual Care Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of depression
Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)
Measured: 3 months
Secondary outcomes (18)
Symptoms of anxiety
Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)
Measured: 3 months
Symptoms of depression
Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)
Measured: 6 months
Symptoms of anxiety
Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)
Measured: 6 months
Symptoms of depression
Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)
Measured: 12 months
Symptoms of anxiety
Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)
Measured: 12 months
Patient-reported quality of life
Measured by the Health-related quality of life questionnaire (HeartQoL) - The measure consists of a global, physical and emotional sub scale. Score range is from 0-3 (high score = better QoL)
Measured: 3 months
Patient-reported quality of life
Measured by the Health-related quality of life questionnaire (HeartQoL) - The measure consists of a global, physical and emotional sub scale. Score range is from 0-3 (high score = better QoL)
Measured: 6 months
Patient-reported Quality of life
Measured by the Health-related quality of life questionnaire (HeartQoL) - The measure consists of a global, physical and emotional sub scale. Score range is from 0-3 (high score = better QoL)
Measured: 12 months
Dropout
Number of patients dropped out in each arm
Measured: 3 months
Cost-effectiveness
EUROQOL - 5 Questions with 5 levels with level 5 being the worst level
Measured: 3 months
Cost-effectiveness
EUROQOL - 5 Questions with 5 levels with level 5 being the worst level
Measured: 6 months
Cost-effectiveness
EUROQOL - 5 Questions with 5 levels with level 5 being the worst level
Measured: 12 months
Perceived Stress
Measured with the Perceived Stress Scale (range 0-40 - high score = highest level of stress)
Measured: 3 months
Perceived Stress
Measured with the Perceived Stress Scale (range 0-40 - high score = highest level of stress)
Measured: 6 months
Perceived Stress
Measured with the Perceived Stress Scale (range 0-40 - high score = highest level of stress)
Measured: 12 months
Health complaints
Measured with the Health Complaints Scale (range 0-95 - 95=worse health)
Measured: 3 months
Health complaints
Measured with the Health Complaints Scale (range 0-95 - 95=worse health)
Measured: 6 months
Health complaints
Measured with the Health Complaints Scale (range 0-95 - 95=worse health)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start22 May 2020
- Primary completion9 Dec 2023
- Study completion11 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- Comparison of depression/anxiety treatment versus usual care
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense Patient Data Explorative Network
- Responsible party
- Principal investigator, Susanne Schmidt Pedersen, University of Southern Denmark
- Investigators
- Susanne S Pedersen, PhD, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172974
- Sponsor's protocol ID
- 18/39431
- Acronym
- eMindYourHeart
- Status last verified
- Dec 2024
- First submitted
- 31 Oct 2019
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pedersen SS, Andersen CM, Ahm R, Skovbakke SJ, Kok R, Helmark C, Wiil UK, Schmidt T, Olsen KR, Hjelmborg J, Zwisler AD, Frostholm L. Efficacy and cost-effectiveness of a therapist-assisted web-based intervention for depression and anxiety in patients with ischemic heart disease attending cardiac rehabilitation [eMindYourHeart trial]: a randomised controlled trial protocol. BMC Cardiovasc Disord. 2021 Jan 7;21(1):20. doi: 10.1186/s12872-020-01801-w.
PubMed 33413109
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Managing Depression and Anxiety with Therapist-assisted EHealth Intervention in Patients with Ischemic Heart Disease in the Cardiac Rehabilitation Setting
- ClinicalTrials.gov ID
- NCT04172974
- Acronym / sponsor ID
- eMindYourHeart / 18/39431
- Conditions
- Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense Patient Data Explorative Network
- Study start
- 22 May 2020 (actual)
- Primary completion
- 9 Dec 2023 (actual)
- Study completion
- 11 Sep 2024 (actual)
- First posted
- 21 Nov 2019 (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.
This study evaluates the effectiveness and cost-effectiveness of a therapy-assisted internet-based intervention in patients with ischemic heart disease and co-morbid depression and anxiety referred for cardiac rehabilitation. Half of the patients will receive the intervention and the other half usual care. We hypothesize that the intervention will lead to a reduction in patients' symptoms of depression and anxiety and be cost-effective.
Detailed description
The 12-week intervention will consist of 9 modules and 2 optional modules that will be delivered to patients in the active intervention via a platform or app. Psychologists will provide asynchronous guidance via the platform. Motivational interviewing will be used during the intervention to prevent dropout. The psychologist may contact patients via telephone during the intervention if needed. All patients will have access to the intervention up to 6 months' post intervention so that they can revisit the material and reuse it on a need-to-basis. Patients will be recommended to use this option and to note specific time points in their agenda where they will access the intervention. A brief purpose-designed interview protocol that includes elements from the SCAN interview will be carried out by psychologists trained in conducting the interview.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- Comparison of depression/anxiety treatment versus usual care
| Arm | Type | Receives |
|---|---|---|
| Treatment for depression and anxiety | Experimental | Other: eHealth interventionTreatment |
| Usual care | Other | Other: Usual CareUsual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- Diagnosis of ischemic heart disease (diagnostic codes I20-I25)
- Referred for CR
- HADS score ≥ 8 on depression and or anxiety
- Access to a computer or smart phone
Key exclusion criteria (5 listed)
- Severe psychiatric disorder (i.e., borderline disorder, schizophrenia or bipolar disorder)
- Severe cognitive difficulties (e.g. severe brain damage, mental retardation, or dementia) that will prevent patients from participating
- Endorsement of suicidal ideation with daily suicidal thoughts (PHQ-9 item 9 >2)
- Participation in other intervention studies (unless they are clinical studies)
- Seeing a psychologist or mental health professional for the treatment of anxiety and depression
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 |
|---|---|---|
| eHealth interventionModules developed for depression and anxiety based on cognitive behavioral therapy (CBT), acceptance and commitment therapy (ACT) and compassion-focused coping | Other | Treatment for depression and anxiety |
| Usual CareTreatment according to national clinical guideline (referral to GP) | Other | Usual care |
Primary outcome
Symptoms of depression
Time frame: 3 months
Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)
18 secondary outcomes
Symptoms of anxiety
Time frame: 3 months
Symptoms of depression
Time frame: 6 months
Symptoms of anxiety
Time frame: 6 months
Symptoms of depression
Time frame: 12 months
Symptoms of anxiety
Time frame: 12 months
Patient-reported quality of life
Time frame: 3 months
Patient-reported quality of life
Time frame: 6 months
Patient-reported Quality of life
Time frame: 12 months
Dropout
Time frame: 3 months
Cost-effectiveness
Time frame: 3 months
Cost-effectiveness
Time frame: 6 months
Cost-effectiveness
Time frame: 12 months
Perceived Stress
Time frame: 3 months
Perceived Stress
Time frame: 6 months
Perceived Stress
Time frame: 12 months
Health complaints
Time frame: 3 months
Health complaints
Time frame: 6 months
Health complaints
Time frame: 12 months
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 6 Dec 2024.
- Derived from this study: PubMed 33413109Pedersen SS, Andersen CM, Ahm R, Skovbakke SJ, Kok R, Helmark C, Wiil UK, Schmidt T, Olsen KR, Hjelmborg J, Zwisler AD, Frostholm L. Efficacy and cost-effectiveness of a therapist-assisted web-based intervention for depression and anxiety in patients with ischemic heart disease attending cardiac rehabilitation [eMindYourHeart trial]: a randomised controlled trial protocol. BMC Cardiovasc Disord. 2021 Jan 7;21(1):20. doi: 10.1186/s12872-020-01801-w.
- Individual participant dataSharing planned: No
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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.
Susanne S Pedersen, PhD principal investigator
University of Southern Denmark
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eHealth intervention in people with Depression, Anxiety, run by University of Southern Denmark at 13 sites in Denmark.
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 8 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 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Denmark. 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?
Symptoms of depression (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04172974, which also lists 1 linked publication.
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 6 Dec 2024.