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eHealth Intervention to Manage Depression and Anxiety in Patients With Ischemic Heart Disease (eMYHeart)

Primary Purpose

Depression, Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
eHealth intervention
Usual Care
Sponsored by
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression, Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Aalborg University HospitalRecruiting
  • Helle Lynge KanstrupRecruiting
  • Herlev / Gentofte HospitalRecruiting
  • Regionshospital NordjyllandRecruiting
  • Holbæk HospitalRecruiting
  • Holbæk SygehusRecruiting
  • Sygehus Lillebælt KoldingRecruiting
  • Odense University Hospital (Odense)Recruiting
  • Randers MunicipalityRecruiting
  • Zealand University HospitalRecruiting
  • Odense University Hospital (Svendborg)Recruiting
  • Sygehus LillebæltRecruiting
  • Vordingborg MunicipalityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Treatment for depression and anxiety

Usual care

Arm Description

Treatment

Usual Care

Outcomes

Primary Outcome Measures

Symptoms of depression
Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)

Secondary Outcome Measures

Symptoms of anxiety
Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)
Symptoms of depression
Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)
Symptoms of anxiety
Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)
Symptoms of depression
Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)
Symptoms of anxiety
Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)
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)
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)
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)
Dropout
Number of patients dropped out in each arm
Cost-effectiveness
EUROQOL - 5 Questions with 5 levels with level 5 being the worst level
Cost-effectiveness
EUROQOL - 5 Questions with 5 levels with level 5 being the worst level
Cost-effectiveness
EUROQOL - 5 Questions with 5 levels with level 5 being the worst level
Perceived Stress
Measured with the Perceived Stress Scale (range 0-40 - high score = highest level of stress)
Perceived Stress
Measured with the Perceived Stress Scale (range 0-40 - high score = highest level of stress)
Perceived Stress
Measured with the Perceived Stress Scale (range 0-40 - high score = highest level of stress)
Health complaints
Measured with the Health Complaints Scale (range 0-95 - 95=worse health)
Health complaints
Measured with the Health Complaints Scale (range 0-95 - 95=worse health)
Health complaints
Measured with the Health Complaints Scale (range 0-95 - 95=worse health)

Full Information

First Posted
October 31, 2019
Last Updated
May 9, 2023
Sponsor
University of Southern Denmark
Collaborators
Odense Patient Data Explorative Network
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1. Study Identification

Unique Protocol Identification Number
NCT04172974
Brief Title
eHealth Intervention to Manage Depression and Anxiety in Patients With Ischemic Heart Disease
Acronym
eMYHeart
Official Title
Screening and Managing Depression and Anxiety With Therapist-assisted eHealth Intervention in Patients With Ischemic Heart Disease in the Cardiac Rehabilitation Setting
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern Denmark
Collaborators
Odense Patient Data Explorative Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Comparison of depression/anxiety treatment versus usual care
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
188 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment for depression and anxiety
Arm Type
Experimental
Arm Description
Treatment
Arm Title
Usual care
Arm Type
Other
Arm Description
Usual Care
Intervention Type
Other
Intervention Name(s)
eHealth intervention
Intervention Description
Modules developed for depression and anxiety based on cognitive behavioral therapy (CBT), acceptance and commitment therapy (ACT) and compassion-focused coping
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Treatment according to national clinical guideline (referral to GP)
Primary Outcome Measure Information:
Title
Symptoms of depression
Description
Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Symptoms of anxiety
Description
Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)
Time Frame
3 months
Title
Symptoms of depression
Description
Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)
Time Frame
6 months
Title
Symptoms of anxiety
Description
Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)
Time Frame
6 months
Title
Symptoms of depression
Description
Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)
Time Frame
12 months
Title
Symptoms of anxiety
Description
Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)
Time Frame
12 months
Title
Patient-reported quality of life
Description
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)
Time Frame
3 months
Title
Patient-reported quality of life
Description
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)
Time Frame
6 months
Title
Patient-reported Quality of life
Description
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)
Time Frame
12 months
Title
Dropout
Description
Number of patients dropped out in each arm
Time Frame
3 months
Title
Cost-effectiveness
Description
EUROQOL - 5 Questions with 5 levels with level 5 being the worst level
Time Frame
3 months
Title
Cost-effectiveness
Description
EUROQOL - 5 Questions with 5 levels with level 5 being the worst level
Time Frame
6 months
Title
Cost-effectiveness
Description
EUROQOL - 5 Questions with 5 levels with level 5 being the worst level
Time Frame
12 months
Title
Perceived Stress
Description
Measured with the Perceived Stress Scale (range 0-40 - high score = highest level of stress)
Time Frame
3 months
Title
Perceived Stress
Description
Measured with the Perceived Stress Scale (range 0-40 - high score = highest level of stress)
Time Frame
6 months
Title
Perceived Stress
Description
Measured with the Perceived Stress Scale (range 0-40 - high score = highest level of stress)
Time Frame
12 months
Title
Health complaints
Description
Measured with the Health Complaints Scale (range 0-95 - 95=worse health)
Time Frame
3 months
Title
Health complaints
Description
Measured with the Health Complaints Scale (range 0-95 - 95=worse health)
Time Frame
6 months
Title
Health complaints
Description
Measured with the Health Complaints Scale (range 0-95 - 95=worse health)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susanne S Pedersen, PhD
Phone
+4565507992
Email
sspedersen@health.sdu.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne S Pedersen, PhD
Organizational Affiliation
University of Southern Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leif Thuesen, MD
Email
leif.thuesen@rn.dk
Facility Name
Helle Lynge Kanstrup
City
Aarhus
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helle L Kanstrup, MD
Email
helle.kanstrup@rm.dk
Facility Name
Herlev / Gentofte Hospital
City
Herlev
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allan Z Iversen, MD
Email
allan.zeeberg.iversen@regionh.dk
Facility Name
Regionshospital Nordjylland
City
Hjørring
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gitte Nielsen, MD
Email
gn@rn.dk
Facility Name
Holbæk Hospital
City
Holbæk
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Soja
Email
amsj@regionsjaelland.dk
First Name & Middle Initial & Last Name & Degree
Marianne W Lindhardt
Facility Name
Holbæk Sygehus
City
Holbæk
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ian Raymond, MD
Email
iler@regionsjaelland.dk
First Name & Middle Initial & Last Name & Degree
Anne Merete Boas Soja
Email
amsj@regionsjaelland.dk
Facility Name
Sygehus Lillebælt Kolding
City
Kolding
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flemming Hald Steffensen, MD
Email
Flemming.Hald@rsyd.dk
First Name & Middle Initial & Last Name & Degree
Annette Nissen Sørensen, RN
Email
Anette.Nissen.Soerensen@rsyd.dk
Facility Name
Odense University Hospital (Odense)
City
Odense
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susanne S Pedersen, PhD
Email
sspedersen@health.sdu.dk
Facility Name
Randers Municipality
City
Randers
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanne M Palner
Email
sanne.palner@randers.dk
First Name & Middle Initial & Last Name & Degree
Jannie F Kristensen
Facility Name
Zealand University Hospital
City
Roskilde
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirsten C Helmark
Email
kche@regionsjaelland.dk
Facility Name
Odense University Hospital (Svendborg)
City
Svendborg
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claus Tveskov, MD
Email
claus.tveskov@rsyd.dk
Facility Name
Sygehus Lillebælt
City
Vejle
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ann Bovin
Email
ann.bovin@rsyd.dk
First Name & Middle Initial & Last Name & Degree
Flemming Hald
Facility Name
Vordingborg Municipality
City
Vordingborg
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulla B Henningsen
Email
ubhe@vordingborg.dk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33413109
Citation
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.
Results Reference
derived

Learn more about this trial

eHealth Intervention to Manage Depression and Anxiety in Patients With Ischemic Heart Disease

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