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

NCT ID: NCT04172974

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-22

Study Completion Date

2024-09-11

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.

Conditions

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Depression, Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Comparison of depression/anxiety treatment versus usual care
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Treatment for depression and anxiety

Treatment

Group Type EXPERIMENTAL

eHealth intervention

Intervention Type OTHER

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

Usual care

Usual Care

Group Type OTHER

Usual Care

Intervention Type OTHER

Treatment according to national clinical guideline (referral to GP)

Interventions

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eHealth intervention

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

Intervention Type OTHER

Usual Care

Treatment according to national clinical guideline (referral to GP)

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

UNKNOWN

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Susanne Schmidt Pedersen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susanne S Pedersen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern Denmark

Locations

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Aalborg University Hospital

Aalborg, , Denmark

Site Status

Helle Lynge Kanstrup

Aarhus, , Denmark

Site Status

Herlev / Gentofte Hospital

Herlev, , Denmark

Site Status

Regionshospital Nordjylland

Hjørring, , Denmark

Site Status

Holbæk Hospital

Holbæk, , Denmark

Site Status

Holbæk Sygehus

Holbæk, , Denmark

Site Status

Sygehus Lillebælt Kolding

Kolding, , Denmark

Site Status

Odense University Hospital (Odense)

Odense, , Denmark

Site Status

Randers Municipality

Randers, , Denmark

Site Status

Zealand University Hospital

Roskilde, , Denmark

Site Status

Odense University Hospital (Svendborg)

Svendborg, , Denmark

Site Status

Sygehus Lillebælt

Vejle, , Denmark

Site Status

Vordingborg Municipality

Vordingborg, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 33413109 (View on PubMed)

Other Identifiers

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18/39431

Identifier Type: -

Identifier Source: org_study_id