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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Screening and Managing Depression and Anxiety With Therapist-assisted eHealth Intervention in Patients With Ischemic Heart Disease in the Cardiac Rehabilitation Setting

Conditions
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Depression, Anxiety

Intervention / Treatment
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* Other: eHealth intervention
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comparison of depression/anxiety treatment versus usual care
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment for depression and anxiety<br>Treatment | Other: eHealth intervention<br>* Modules developed for depression and anxiety based on cognitive behavioral therapy (CBT), acceptance and commitment therapy (ACT) and compassion-focused coping<br>|
| Other: Usual care<br>Usual Care | Other: Usual Care<br>* Treatment according to national clinical guideline (referral to GP)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms of depression | Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms of anxiety | Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms) | 3 months | 
| Symptoms of depression | Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms) | 6 months | 
| Symptoms of anxiety | Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms) | 6 months | 
| Symptoms of depression | Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms) | 12 months | 
| Symptoms of anxiety | Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms) | 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) | 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) | 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) | 12 months | 
| Dropout | Number of patients dropped out in each arm | 3 months | 
| Cost-effectiveness | EUROQOL - 5 Questions with 5 levels with level 5 being the worst level | 3 months | 
| Cost-effectiveness | EUROQOL - 5 Questions with 5 levels with level 5 being the worst level | 6 months | 
| Cost-effectiveness | EUROQOL - 5 Questions with 5 levels with level 5 being the worst level | 12 months | 
| Perceived Stress | Measured with the Perceived Stress Scale (range 0-40 - high score = highest level of stress) | 3 months | 
| Perceived Stress | Measured with the Perceived Stress Scale (range 0-40 - high score = highest level of stress) | 6 months | 
| Perceived Stress | Measured with the Perceived Stress Scale (range 0-40 - high score = highest level of stress) | 12 months | 
| Health complaints | Measured with the Health Complaints Scale (range 0-95 - 95=worse health) | 3 months | 
| Health complaints | Measured with the Health Complaints Scale (range 0-95 - 95=worse health) | 6 months | 
| Health complaints | Measured with the Health Complaints Scale (range 0-95 - 95=worse health) | 12 months |