Depression, Anxiety
Conditions
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.
Interventions
OTHEReHealth intervention
Modules developed for depression and anxiety based on cognitive behavioral therapy (CBT), acceptance and commitment therapy (ACT) and compassion-focused coping
OTHERUsual Care
Treatment according to national clinical guideline (referral to GP)
Sponsors
OPEN - Odense Patient data Explorative Network, The University of Southern Denmark, Odense, Denmark
University of Southern Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Intervention model description
Comparison of depression/anxiety treatment versus usual care
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms of depression | 3 months | Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms of depression | 6 months | Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms) |
| Patient-reported quality of life | 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) |
| Patient-reported Quality of life | 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) |
| Symptoms of anxiety | 3 months | Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms) |
| Cost-effectiveness | 3 months | EUROQOL - 5 Questions with 5 levels with level 5 being the worst level |
| Perceived Stress | 3 months | Measured with the Perceived Stress Scale (range 0-40 - high score = highest level of stress) |
| Health complaints | 3 months | Measured with the Health Complaints Scale (range 0-95 - 95=worse health) |
| Dropout | 3 months | Number of patients dropped out in each arm |
Countries
Denmark
Outcome results
None listed