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Completed

NCT Number: NCT04172974

EHealth Intervention to Manage Depression and Anxiety in Patients with Ischemic Heart Disease

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University Hospital, Aalborg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

eHealth intervention

Other

Modules developed for depression and anxiety based on cognitive behavioral therapy (CBT), acceptance and commitment therapy (ACT) and compassion-focused coping

Usual Care

Other

Treatment according to national clinical guideline (referral to GP)

Primary outcomes

  1. Symptoms of depression

    Time frame: 3 months

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

Secondary outcomes

  1. Symptoms of anxiety

    Time frame: 3 months

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

  2. Symptoms of depression

    Time frame: 6 months

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

  3. Symptoms of anxiety

    Time frame: 6 months

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

  4. Symptoms of depression

    Time frame: 12 months

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

  5. Symptoms of anxiety

    Time frame: 12 months

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

  6. Patient-reported quality of life

    Time frame: 3 months

    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)

  7. Patient-reported quality of life

    Time frame: 6 months

    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)

  8. Patient-reported Quality of life

    Time frame: 12 months

    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)

  9. Dropout

    Time frame: 3 months

    Number of patients dropped out in each arm

  10. Cost-effectiveness

    Time frame: 3 months

    EUROQOL - 5 Questions with 5 levels with level 5 being the worst level

  11. Cost-effectiveness

    Time frame: 6 months

    EUROQOL - 5 Questions with 5 levels with level 5 being the worst level

  12. Cost-effectiveness

    Time frame: 12 months

    EUROQOL - 5 Questions with 5 levels with level 5 being the worst level

  13. Perceived Stress

    Time frame: 3 months

    Measured with the Perceived Stress Scale (range 0-40 - high score = highest level of stress)

  14. Perceived Stress

    Time frame: 6 months

    Measured with the Perceived Stress Scale (range 0-40 - high score = highest level of stress)

  15. Perceived Stress

    Time frame: 12 months

    Measured with the Perceived Stress Scale (range 0-40 - high score = highest level of stress)

  16. Health complaints

    Time frame: 3 months

    Measured with the Health Complaints Scale (range 0-95 - 95=worse health)

  17. Health complaints

    Time frame: 6 months

    Measured with the Health Complaints Scale (range 0-95 - 95=worse health)

  18. Health complaints

    Time frame: 12 months

    Measured with the Health Complaints Scale (range 0-95 - 95=worse health)

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • OPEN - Odense Patient data Explorative Network, The University of Southern Denmark, Odense, Denmark

Registry information

Official study title

Screening and Managing Depression and Anxiety with Therapist-assisted EHealth Intervention in Patients with Ischemic Heart Disease in the Cardiac Rehabilitation Setting

Acronym: eMindYourHeart

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Nov 21, 2019
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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