Clinical trial NCT04172974: EHealth Intervention to Manage Depression and Anxiety in Patients with Ischemic Heart Disease
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
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Anxiety
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: OPEN - Odense Patient data Explorative Network, The University of Southern Denmark, Odense, Denmark
First posted: 2019-11-21
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison of depression/anxiety treatment versus usual care
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Symptoms of depression
timeFrame: 3 months
Secondary outcomes:
measure: Symptoms of anxiety
timeFrame: 3 months
measure: Symptoms of depression
timeFrame: 6 months
measure: Symptoms of anxiety
timeFrame: 6 months
measure: Symptoms of depression
timeFrame: 12 months
measure: Symptoms of anxiety
timeFrame: 12 months
measure: Patient-reported quality of life
timeFrame: 3 months
measure: Patient-reported quality of life
timeFrame: 6 months
measure: Patient-reported Quality of life
timeFrame: 12 months
measure: Dropout
timeFrame: 3 months
measure: Cost-effectiveness
timeFrame: 3 months
measure: Cost-effectiveness
timeFrame: 6 months
measure: Cost-effectiveness
timeFrame: 12 months
measure: Perceived Stress
timeFrame: 3 months
measure: Perceived Stress
timeFrame: 6 months
measure: Perceived Stress
timeFrame: 12 months
measure: Health complaints
timeFrame: 3 months
measure: Health complaints
timeFrame: 6 months
measure: Health complaints
timeFrame: 12 months
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Helle Lynge Kanstrup
city: Herlev
country: Denmark
facility: Herlev / Gentofte Hospital
city: Hjørring
country: Denmark
facility: Regionshospital Nordjylland
city: Holbæk
country: Denmark
facility: Holbæk Hospital
city: Holbæk
country: Denmark
facility: Holbæk Sygehus
city: Kolding
country: Denmark
facility: Sygehus Lillebælt Kolding
city: Odense
country: Denmark
facility: Odense University Hospital (Odense)
city: Randers
country: Denmark
facility: Randers Municipality
city: Roskilde
country: Denmark
facility: Zealand University Hospital
city: Svendborg
country: Denmark
facility: Odense University Hospital (Svendborg)
city: Vejle
country: Denmark
facility: Sygehus Lillebælt
city: Vordingborg
country: Denmark
facility: Vordingborg Municipality
Study officials:
affiliation: University of Southern Denmark
name: Susanne S Pedersen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.