Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01504191
Recruitment Status : Completed
First Posted : January 5, 2012
Last Update Posted : October 29, 2020
Sponsor:
Information provided by (Responsible Party):
Louise-von Essen, Uppsala University

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Depression Anxiety Myocardial Infarction Behavioral: Internet-based CBT Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 239 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study of the Effects of Internet-based Cognitive Behavior Therapy on Depression and Anxiety in Patients With a Previous Myocardial Infarction
Study Start Date : September 2013
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. 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)


  2. 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


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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)




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01504191


Locations
Show Show 25 study locations
Sponsors and Collaborators
Uppsala University
Investigators
Layout table for investigator information
Principal Investigator: Louise von Essen, PhD Uppsala University
Additional Information:
U-CARE  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Louise-von Essen, Programme Director for U-CARE, Uppsala University
ClinicalTrials.gov Identifier: NCT01504191    
Other Study ID Numbers: U-CARE: Heart
First Posted: January 5, 2012    Key Record Dates
Last Update Posted: October 29, 2020
Last Verified: October 2020
Keywords provided by Louise-von Essen, Uppsala University:
myocardial infarction
depression
anxiety
Internet-based CBT
genetic disposition
Additional relevant MeSH terms:
Layout table for MeSH terms
Myocardial Infarction
Infarction
Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases