eHealth intervention
OtherModules developed for depression and anxiety based on cognitive behavioral therapy (CBT), acceptance and commitment therapy (ACT) and compassion-focused coping
NCT Number: NCT04172974
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Aalborg University Hospital, Aalborg, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Modules developed for depression and anxiety based on cognitive behavioral therapy (CBT), acceptance and commitment therapy (ACT) and compassion-focused coping
Treatment according to national clinical guideline (referral to GP)
Time frame: 3 months
Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)
Time frame: 3 months
Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)
Time frame: 6 months
Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)
Time frame: 6 months
Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)
Time frame: 12 months
Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)
Time frame: 12 months
Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)
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)
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)
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)
Time frame: 3 months
Number of patients dropped out in each arm
Time frame: 3 months
EUROQOL - 5 Questions with 5 levels with level 5 being the worst level
Time frame: 6 months
EUROQOL - 5 Questions with 5 levels with level 5 being the worst level
Time frame: 12 months
EUROQOL - 5 Questions with 5 levels with level 5 being the worst level
Time frame: 3 months
Measured with the Perceived Stress Scale (range 0-40 - high score = highest level of stress)
Time frame: 6 months
Measured with the Perceived Stress Scale (range 0-40 - high score = highest level of stress)
Time frame: 12 months
Measured with the Perceived Stress Scale (range 0-40 - high score = highest level of stress)
Time frame: 3 months
Measured with the Health Complaints Scale (range 0-95 - 95=worse health)
Time frame: 6 months
Measured with the Health Complaints Scale (range 0-95 - 95=worse health)
Time frame: 12 months
Measured with the Health Complaints Scale (range 0-95 - 95=worse health)
University of Southern Denmark
Other
Screening and Managing Depression and Anxiety with Therapist-assisted EHealth Intervention in Patients with Ischemic Heart Disease in the Cardiac Rehabilitation Setting
Acronym: eMindYourHeart
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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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