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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

December 19, 2011
November 20, 2013
September 2013
April 2015   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01504191 on ClinicalTrials.gov Archive Site
  • 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)

Same as current
Not Provided
Not Provided
 
Internet-based Cognitive Behavior Therapy After Myocardial Infarction
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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Depression
  • Anxiety
  • Myocardial Infarction
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.

  • Experimental: Internet‐based CBT
    Randomized patients with symptoms of anxiety and/or depression after MI will participate in an Internet‐based CBT‐program.
    Intervention: Behavioral: Internet‐based CBT
  • 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).

Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
750
December 2015
April 2015   (final data collection date for primary outcome measure)

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)
Both
up to 75 Years
No
Contact: Erik MG Olsson, PhD 018-4716663 erik.olsson@pubcare.uu.se
Sweden
 
NCT01504191
U-CARE Heart
Not Provided
Louise-von Essen, Uppsala University
Uppsala University
Not Provided
Principal Investigator: Louise von Essen, PhD Uppsala University
Uppsala University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP