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

NCT04172974 | Completed

• 1 other identifier: 18/39431
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 13

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.

Conditions

Depression, Anxiety

Outcome Measures

Primary Outcomes (1)

• Symptoms of depression

  Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)

  3 months

Secondary Outcomes (18)

• Symptoms of anxiety

  3 months

• Symptoms of depression

  6 months

• Symptoms of anxiety

  6 months

• Symptoms of depression

  12 months

• Symptoms of anxiety

  12 months

Study Arms (2)

Treatment for depression and anxiety

EXPERIMENTAL

Treatment

Other: eHealth intervention

Usual care

OTHER

Usual Care

Other: Usual Care

Interventions

eHealth intervention OTHER

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

Treatment for depression and anxiety

Usual Care OTHER

Treatment according to national clinical guideline (referral to GP)

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern Denmark: lead
• OPEN - Odense Patient data Explorative Network, The University of Southern Denmark, Odense, Denmark: collaborator

Study Sites (13)

Aalborg University Hospital

Aalborg, Denmark

Location

Helle Lynge Kanstrup

Aarhus, Denmark

Location

Herlev / Gentofte Hospital

Herlev, Denmark

Location

Regionshospital Nordjylland

Hjørring, Denmark

Location

Holbæk Hospital

Holbæk, Denmark

Location

Holbæk Sygehus

Holbæk, Denmark

Location

Sygehus Lillebælt Kolding

Kolding, Denmark

Location

Odense University Hospital (Odense)

Odense, Denmark

Location

Randers Municipality

Randers, Denmark

Location

Zealand University Hospital

Roskilde, Denmark

Location

Odense University Hospital (Svendborg)

Svendborg, Denmark

Location

Sygehus Lillebælt

Vejle, Denmark

Location

Vordingborg Municipality

Vordingborg, Denmark

Location

Related Publications (1)

• 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.

  PMID: 33413109 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Susanne S Pedersen, PhD

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Comparison of depression/anxiety treatment versus usual care

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 21, 2019
• Study Start: May 22, 2020
• Primary Completion: December 9, 2023
• Study Completion: September 11, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (13)