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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Uppsala University
Sponsor:
Information provided by (Responsible Party):
Louise-von Essen, Uppsala University
ClinicalTrials.gov Identifier:
NCT01504191
First received: December 19, 2011
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Depression
Anxiety
Myocardial Infarction
Behavioral: Internet‐based CBT
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • Change in Depression (difference between the intervention and the control group) [ Time Frame: At baseline and 3 months later (after intervention) ] [ Designated as safety issue: No ]

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

    Montgomery Åsberg Depression Rating Scale (MADRS)


  • Change in Anxiety (difference between the intervention and the control group) [ Time Frame: At baseline and 3 months later (after intervention) ] [ Designated as safety issue: No ]
    Hospital Anxiety and Depression Scale (HADS) - anxiety ratings


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Ratings on EQ5d and Ladder of Life (LL)

  • 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 ] [ Designated as safety issue: No ]
    ENRICHED Social Support Inventory (ESSI)-ratings

  • 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 ] [ Designated as safety issue: No ]
    Everyday Life Stress Scale (ELSS)-ratings

  • 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 ] [ Designated as safety issue: No ]
    Maastricht Questionnaire (MQ)-ratings

  • 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 ] [ Designated as safety issue: No ]
    Cardiac Anxiety Questionnaire (CAQ)-ratings

  • 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 ] [ Designated as safety issue: No ]
    Insomnia Severity Index (ISI)-ratings

  • 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 ] [ Designated as safety issue: No ]
    Posttraumatic Stress Disorder Checklist‐ Civilian Version (PCL-C)-ratings

  • 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 ] [ Designated as safety issue: No ]
    The Posttraumatic Growth Inventory ‐ Short Form (PTGI-SF)-ratings

  • Quality of the Intervention [ Time Frame: At baseline, after (3 months after baseline) and 7 months after treatment ] [ Designated as safety issue: No ]
    Behavioral Activation for Depression Scale (BADS)-ratings

  • Change in Myocardial Necrosis and Function (difference between the intervention and the control group) [ Time Frame: At baseline and 3 months later (after treatment) ] [ Designated as safety issue: No ]
    Troponin I, S‐NT‐proBNP, GDF‐15, options for others

  • Change in Inflammation (difference between the intervention and the control group) [ Time Frame: At baseline and 3 months later (after treatment) ] [ Designated as safety issue: No ]
    CRP, IL‐6, IL‐10, IL‐18, matrix metalloproteinases 9 (MMP‐9), ICAM, VCAM, V Willebrand, options for others

  • Change in Renal Function (difference between the intervention and the control group) [ Time Frame: At baseline and 3 months later (after treatment) ] [ Designated as safety issue: No ]
    creatinine, cystatine C

  • Change in Coagulation and Platelets (difference between the intervention and the control group) [ Time Frame: At baseline and 3 months later (after treatment) ] [ Designated as safety issue: No ]
    D‐dimer, P‐Selectin, options for others

  • Change in Metabolism and Lipoproteins (difference between the intervention and the control group) [ Time Frame: At baseline and 3 months later (after treatment) ] [ Designated as safety issue: No ]
    HbA1C, s‐glucose, LDL‐cholesterol, HDL‐cholesterol, apoA1, ApoB, options for others

  • 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 ] [ Designated as safety issue: No ]
    Hospital Anxiety and Depression Scale (HADS) - anxiety ratings

  • 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 ] [ Designated as safety issue: No ]

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

    Montgomery Åsberg Depression Rating Scale (MADRS)



Estimated Enrollment: 750
Study Start Date: September 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).


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.

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
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 > 10 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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01504191

Contacts
Contact: Erik MG Olsson, PhD 018-4716663 erik.olsson@pubcare.uu.se

Locations
Sweden
Falu Lasarett Not yet recruiting
Falun, Sweden, 79129
Contact: Pär Lennart Ågren    023-49 25 00      
Gävle sjukhus Not yet recruiting
Gävle, Sweden, 80187
Contact: Oscar Persson         
Uppsala Akademiska sjukhus Recruiting
Uppsala, Sweden, 75185
Contact: Gunnar Frostfeldt    018-611 02 31      
Universitetssjukhuset Örebro Not yet recruiting
Örebro, Sweden, 70185
Contact: Stella Cizinsky    019-602 54 00      
Sponsors and Collaborators
Uppsala University
Investigators
Principal Investigator: Louise von Essen, PhD Uppsala University
  More Information

Additional Information:
U-CARE  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Louise-von Essen, Programme Director for U-CARE, Uppsala University
ClinicalTrials.gov Identifier: NCT01504191     History of Changes
Other Study ID Numbers: U-CARE Heart
Study First Received: December 19, 2011
Last Updated: November 20, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Uppsala University:
myocardial infarction
depression
anxiety
Internet‐based CBT
genetic disposition

Additional relevant MeSH terms:
Myocardial Infarction
Depression
Depressive Disorder
Anxiety Disorders
Infarction
Behavioral Symptoms
Mood Disorders
Mental Disorders
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014