Internet-based Cognitive Behavior Therapy After Myocardial Infarction (U-CARE: Heart)

October 27, 2020 updated by: Louise-von Essen, Uppsala University

A Randomized Controlled Study of the Effects of Internet-based Cognitive Behavior Therapy on Depression and Anxiety in Patients With a Previous Myocardial Infarction

The overall aim and primary objective is to evaluate the effects on level of depression and anxiety of an Internet-based CBT-program in depressed and/or anxious patients after a myocardial infarction (MI).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Major or minor depressive disorders and anxiety disorders are present in many patients with cardiovascular disease (CVD) and are associated with adverse cardiovascular outcomes, even after controlling for other risk factors. 500 patients with symptoms of anxiety and/or depression after MI will be randomized either to a 14 week Internet-based CBT-program or to treatment as usual (TAU) which is the control condition. A reference group of 250 participants without depressive or anxiety symptoms will also be studied during TAU. Data will be collected before, after and 7 months after treatment. Anxiety and depression according to ratings on the Hospital Anxiety and Depression Scale (HADS) are the primary outcome measures.

Study Type

Interventional

Enrollment (Actual)

239

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Enköping, Sweden
        • Enköpings lassarett
      • Falun, Sweden, 79129
        • Falu Lasarett
      • Gävle, Sweden, 80187
        • Gävle sjukhus
      • Göteborg, Sweden
        • Sahlgrenska Sjukhuset
      • Hässleholm, Sweden
        • Hässleholms Sjukhus
      • Karlskrona, Sweden
        • Blekinge sjukhus
      • Karlstad, Sweden
        • Karlstad sjukhus
      • Kungälv, Sweden
        • Kungälvs sjukhus
      • Lidköping, Sweden
        • Skaraborgs Sjukhus
      • Ljungby, Sweden
        • Ljungby Lasarett
      • Malmö, Sweden
        • Skånes Universitetssjukhus
      • Mora, Sweden
        • Mora lassarett
      • Nyköping, Sweden
        • Nyköpings sjukhus
      • Oskarshamn, Sweden
        • Oskarshamns sjukhus
      • Piteå, Sweden
        • Piteå älvdals sjukhus
      • Stockholm, Sweden
        • Danderyds Sjukhus
      • Stockholm, Sweden
        • Karolinska sjukhuset i Huddinge
      • Stockholm, Sweden
        • Karolinska sjukhuset i Solna
      • Stockholm, Sweden
        • Södersjukhuset
      • Sundsvall, Sweden
        • Länssjukhuset Sundsvall-Härnösand
      • Uppsala, Sweden, 75185
        • Uppsala Akademiska Sjukhus
      • Varberg, Sweden
        • Varberg sjukhus
      • Växjö, Sweden
        • Växjö centrallasarett
      • Ängelholm, Sweden
        • Ängelholms sjukhus
      • Örebro, Sweden, 70185
        • Universitetssjukhuset Örebro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients younger than 75 years with a recent acute MI (< 3 months)
  • Depression and/or anxiety score of > 7 on one or both of the HADS subscales (concerns only the intervention, not the reference group)

Exclusion Criteria:

  • Patients that are scheduled for a coronary artery bypass surgery (CABG)
  • Unable or unwilling to use computer or Internet
  • Difficulties in reading or understanding Swedish
  • A life expectancy of less than a year
  • Anticipated poor compliance (multi-disease, substance abuse etc.)
  • Highly depressed or suicidal (MADRS-score > 29 or MADRS item 9 > 3)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Internet-based CBT
Randomized patients with symptoms of anxiety and/or depression after MI will participate in an Internet-based CBT-program.
Behavioral: Internet-based CBT

The participants read texts and do weekly homework assignments instructed from an Internet page. Additional resources like discussion forum, pictures, animations, videos and sounds will be a part of the treatment program.

A psychologist will communicate with the participants through internal text-messages. The therapist will devote about 10 minutes to each participant each week via the Internet. The content of the intervention will be standard components from CBT, for example relaxation training, behavioral activation, exposure for fear related stimuli, cognitive restructuring, behavioral sleep treatment etc.
No Intervention: Treatment as usual (TAU)

Control: After randomization patients with symptoms of anxiety and/or depression after MI will participate in the treatment as usual (TAU).

Reference: A reference group without depressive or anxiety symptoms will participate in the treatment as usual (TAU).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Depression (difference between the intervention and the control group)
Time Frame: At baseline and 3 months later (after intervention)

Hospital Anxiety and Depression Scale (HADS) - depression ratings;

Montgomery Åsberg Depression Rating Scale (MADRS)
At baseline and 3 months later (after intervention)
Change in Anxiety (difference between the intervention and the control group)
Time Frame: At baseline and 3 months later (after intervention)
Hospital Anxiety and Depression Scale (HADS) - anxiety ratings
At baseline and 3 months later (after intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality of Life (difference between the intervention and the control group)
Time Frame: At baseline, during, after (3 months after baseline) and 7 months after treatment
Ratings on EQ5d and Ladder of Life (LL)
At baseline, during, after (3 months after baseline) and 7 months after treatment
Change in Perceived Social Support (difference between the intervention and the control group)
Time Frame: At baseline, after (3 months after baseline) and 7 months after treatment
ENRICHED Social Support Inventory (ESSI)-ratings
At baseline, after (3 months after baseline) and 7 months after treatment
Change in Stress behaviors (difference between the intervention and the control group)
Time Frame: At baseline, after (3 months after baseline) and 7 months after treatment
Everyday Life Stress Scale (ELSS)-ratings
At baseline, after (3 months after baseline) and 7 months after treatment
Change in Fatigue (difference between the intervention and the control group)
Time Frame: At baseline, after (3 months after baseline) and 7 months after treatment
Maastricht Questionnaire (MQ)-ratings
At baseline, after (3 months after baseline) and 7 months after treatment
Change in Cardiac Anxiety (difference between the intervention and the control group)
Time Frame: At baseline, after (3 months after baseline) and 7 months after treatment
Cardiac Anxiety Questionnaire (CAQ)-ratings
At baseline, after (3 months after baseline) and 7 months after treatment
Change in Sleeping Problems (difference between the intervention and the control group)
Time Frame: At baseline, after (3 months after baseline) and 7 months after treatment
Insomnia Severity Index (ISI)-ratings
At baseline, after (3 months after baseline) and 7 months after treatment
Change in Posttraumatic Stress (difference between the intervention and the control group)
Time Frame: At baseline, after (3 months after baseline) and 7 months after treatment
Posttraumatic Stress Disorder Checklist- Civilian Version (PCL-C)-ratings
At baseline, after (3 months after baseline) and 7 months after treatment
Change in Posttraumatic Growth (difference between the intervention and the control group)
Time Frame: At baseline, after (3 months after baseline) and 7 months after treatment
The Posttraumatic Growth Inventory - Short Form (PTGI-SF)-ratings
At baseline, after (3 months after baseline) and 7 months after treatment
Quality of the Intervention
Time Frame: At baseline, after (3 months after baseline) and 7 months after treatment
Behavioral Activation for Depression Scale (BADS)-ratings
At baseline, after (3 months after baseline) and 7 months after treatment
Change to Follow-up in Anxiety (difference between the intervention and the control group)
Time Frame: At baseline, after (3 months after baseline) and 7 months after treatment
Hospital Anxiety and Depression Scale (HADS) - anxiety ratings
At baseline, after (3 months after baseline) and 7 months after treatment
Change to Follow-up in Depression (difference between the intervention and the control group)
Time Frame: At baseline, after (3 months after baseline) and 7 months after treatment

Hospital Anxiety and Depression Scale (HADS) - depression ratings;

Montgomery Åsberg Depression Rating Scale (MADRS)
At baseline, after (3 months after baseline) and 7 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Investigators

  • Principal Investigator: Louise von Essen, PhD, Uppsala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

December 19, 2011

First Submitted That Met QC Criteria

January 4, 2012

First Posted (Estimate)

January 5, 2012

Study Record Updates

Last Update Posted (Actual)

October 29, 2020

Last Update Submitted That Met QC Criteria

October 27, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U-CARE: Heart

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on Internet-based CBT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe