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Completed

NCT Number: NCT01504191

Internet-based Cognitive Behavior Therapy After 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).

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Cardiovascular Diseases Heart Diseases Infarction Ischemia Mental Disorders Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

Up to 75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Enköpings lassarett, Enköping, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Internet-based CBT

Behavioral

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.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study 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

Acronym: U-CARE: Heart

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jan 5, 2012
Registry last updated
Oct 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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