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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Louise-von Essen, Uppsala University
ClinicalTrials.gov Identifier:
NCT01504191
First received: December 19, 2011
Last updated: March 2, 2017
Last verified: March 2017
  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
Intervention Model: Parallel Assignment
Masking: 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) ]

    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) ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    Behavioral Activation for Depression Scale (BADS)-ratings

  • 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

  • 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)



Enrollment: 239
Study Start Date: September 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (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   (Child, Adult, Senior)
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)
  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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: March 2, 2017

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Anxiety Disorders
Infarction
Myocardial 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 May 25, 2017