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

Primary Purpose

Depression, Anxiety, Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-based CBT
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring myocardial infarction, depression, anxiety, Internet-based CBT, genetic disposition

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Enköpings lassarett
  • Falu Lasarett
  • Gävle sjukhus
  • Sahlgrenska sjukhuset
  • Hässleholms sjukhus
  • Blekinge sjukhus
  • Karlstad sjukhus
  • Kungälvs sjukhus
  • Skaraborgs sjukhus
  • Ljungby lasarett
  • Skånes universitetssjukhus
  • Mora lassarett
  • Nyköpings sjukhus
  • Oskarshamns sjukhus
  • Piteå älvdals sjukhus
  • Danderyds sjukhus
  • Karolinska sjukhuset i Huddinge
  • Karolinska sjukhuset i Solna
  • Södersjukhuset
  • Länssjukhuset Sundsvall-Härnösand
  • Uppsala Akademiska sjukhus
  • Varberg sjukhus
  • Växjö centrallasarett
  • Ängelholms sjukhus
  • Universitetssjukhuset Örebro

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Internet-based CBT

Treatment as usual (TAU)

Arm Description

Randomized patients with symptoms of anxiety and/or depression after MI will participate in an Internet-based CBT-program.

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).

Outcomes

Primary Outcome Measures

Change in Depression (difference between the intervention and the control group)
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)
Hospital Anxiety and Depression Scale (HADS) - anxiety ratings

Secondary Outcome Measures

Change in Quality of Life (difference between the intervention and the control group)
Ratings on EQ5d and Ladder of Life (LL)
Change in Perceived Social Support (difference between the intervention and the control group)
ENRICHED Social Support Inventory (ESSI)-ratings
Change in Stress behaviors (difference between the intervention and the control group)
Everyday Life Stress Scale (ELSS)-ratings
Change in Fatigue (difference between the intervention and the control group)
Maastricht Questionnaire (MQ)-ratings
Change in Cardiac Anxiety (difference between the intervention and the control group)
Cardiac Anxiety Questionnaire (CAQ)-ratings
Change in Sleeping Problems (difference between the intervention and the control group)
Insomnia Severity Index (ISI)-ratings
Change in Posttraumatic Stress (difference between the intervention and the control group)
Posttraumatic Stress Disorder Checklist- Civilian Version (PCL-C)-ratings
Change in Posttraumatic Growth (difference between the intervention and the control group)
The Posttraumatic Growth Inventory - Short Form (PTGI-SF)-ratings
Quality of the Intervention
Behavioral Activation for Depression Scale (BADS)-ratings
Change to Follow-up in Anxiety (difference between the intervention and the control group)
Hospital Anxiety and Depression Scale (HADS) - anxiety ratings
Change to Follow-up in Depression (difference between the intervention and the control group)
Hospital Anxiety and Depression Scale (HADS) - depression ratings; Montgomery Åsberg Depression Rating Scale (MADRS)

Full Information

First Posted
December 19, 2011
Last Updated
October 27, 2020
Sponsor
Uppsala University
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1. Study Identification

Unique Protocol Identification Number
NCT01504191
Brief Title
Internet-based Cognitive Behavior Therapy After Myocardial Infarction
Acronym
U-CARE: Heart
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 Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Myocardial Infarction
Keywords
myocardial infarction, depression, anxiety, Internet-based CBT, genetic disposition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
239 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internet-based CBT
Arm Type
Experimental
Arm Description
Randomized patients with symptoms of anxiety and/or depression after MI will participate in an Internet-based CBT-program.
Arm Title
Treatment as usual (TAU)
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Internet-based CBT
Intervention Description
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 Outcome Measure Information:
Title
Change in Depression (difference between the intervention and the control group)
Description
Hospital Anxiety and Depression Scale (HADS) - depression ratings; Montgomery Åsberg Depression Rating Scale (MADRS)
Time Frame
At baseline and 3 months later (after intervention)
Title
Change in Anxiety (difference between the intervention and the control group)
Description
Hospital Anxiety and Depression Scale (HADS) - anxiety ratings
Time Frame
At baseline and 3 months later (after intervention)
Secondary Outcome Measure Information:
Title
Change in Quality of Life (difference between the intervention and the control group)
Description
Ratings on EQ5d and Ladder of Life (LL)
Time Frame
At baseline, during, after (3 months after baseline) and 7 months after treatment
Title
Change in Perceived Social Support (difference between the intervention and the control group)
Description
ENRICHED Social Support Inventory (ESSI)-ratings
Time Frame
At baseline, after (3 months after baseline) and 7 months after treatment
Title
Change in Stress behaviors (difference between the intervention and the control group)
Description
Everyday Life Stress Scale (ELSS)-ratings
Time Frame
At baseline, after (3 months after baseline) and 7 months after treatment
Title
Change in Fatigue (difference between the intervention and the control group)
Description
Maastricht Questionnaire (MQ)-ratings
Time Frame
At baseline, after (3 months after baseline) and 7 months after treatment
Title
Change in Cardiac Anxiety (difference between the intervention and the control group)
Description
Cardiac Anxiety Questionnaire (CAQ)-ratings
Time Frame
At baseline, after (3 months after baseline) and 7 months after treatment
Title
Change in Sleeping Problems (difference between the intervention and the control group)
Description
Insomnia Severity Index (ISI)-ratings
Time Frame
At baseline, after (3 months after baseline) and 7 months after treatment
Title
Change in Posttraumatic Stress (difference between the intervention and the control group)
Description
Posttraumatic Stress Disorder Checklist- Civilian Version (PCL-C)-ratings
Time Frame
At baseline, after (3 months after baseline) and 7 months after treatment
Title
Change in Posttraumatic Growth (difference between the intervention and the control group)
Description
The Posttraumatic Growth Inventory - Short Form (PTGI-SF)-ratings
Time Frame
At baseline, after (3 months after baseline) and 7 months after treatment
Title
Quality of the Intervention
Description
Behavioral Activation for Depression Scale (BADS)-ratings
Time Frame
At baseline, after (3 months after baseline) and 7 months after treatment
Title
Change to Follow-up in Anxiety (difference between the intervention and the control group)
Description
Hospital Anxiety and Depression Scale (HADS) - anxiety ratings
Time Frame
At baseline, after (3 months after baseline) and 7 months after treatment
Title
Change to Follow-up in Depression (difference between the intervention and the control group)
Description
Hospital Anxiety and Depression Scale (HADS) - depression ratings; Montgomery Åsberg Depression Rating Scale (MADRS)
Time Frame
At baseline, after (3 months after baseline) and 7 months after treatment

10. Eligibility

Sex
All
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louise von Essen, PhD
Organizational Affiliation
Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Enköpings lassarett
City
Enköping
Country
Sweden
Facility Name
Falu Lasarett
City
Falun
ZIP/Postal Code
79129
Country
Sweden
Facility Name
Gävle sjukhus
City
Gävle
ZIP/Postal Code
80187
Country
Sweden
Facility Name
Sahlgrenska sjukhuset
City
Göteborg
Country
Sweden
Facility Name
Hässleholms sjukhus
City
Hässleholm
Country
Sweden
Facility Name
Blekinge sjukhus
City
Karlskrona
Country
Sweden
Facility Name
Karlstad sjukhus
City
Karlstad
Country
Sweden
Facility Name
Kungälvs sjukhus
City
Kungälv
Country
Sweden
Facility Name
Skaraborgs sjukhus
City
Lidköping
Country
Sweden
Facility Name
Ljungby lasarett
City
Ljungby
Country
Sweden
Facility Name
Skånes universitetssjukhus
City
Malmö
Country
Sweden
Facility Name
Mora lassarett
City
Mora
Country
Sweden
Facility Name
Nyköpings sjukhus
City
Nyköping
Country
Sweden
Facility Name
Oskarshamns sjukhus
City
Oskarshamn
Country
Sweden
Facility Name
Piteå älvdals sjukhus
City
Piteå
Country
Sweden
Facility Name
Danderyds sjukhus
City
Stockholm
Country
Sweden
Facility Name
Karolinska sjukhuset i Huddinge
City
Stockholm
Country
Sweden
Facility Name
Karolinska sjukhuset i Solna
City
Stockholm
Country
Sweden
Facility Name
Södersjukhuset
City
Stockholm
Country
Sweden
Facility Name
Länssjukhuset Sundsvall-Härnösand
City
Sundsvall
Country
Sweden
Facility Name
Uppsala Akademiska sjukhus
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
Varberg sjukhus
City
Varberg
Country
Sweden
Facility Name
Växjö centrallasarett
City
Växjö
Country
Sweden
Facility Name
Ängelholms sjukhus
City
Ängelholm
Country
Sweden
Facility Name
Universitetssjukhuset Örebro
City
Örebro
ZIP/Postal Code
70185
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
34028358
Citation
Humphries SM, Wallert J, Norlund F, Wallin E, Burell G, von Essen L, Held C, Olsson EMG. Internet-Based Cognitive Behavioral Therapy for Patients Reporting Symptoms of Anxiety and Depression After Myocardial Infarction: U-CARE Heart Randomized Controlled Trial Twelve-Month Follow-up. J Med Internet Res. 2021 May 24;23(5):e25465. doi: 10.2196/25465.
Results Reference
derived
PubMed Identifier
30305255
Citation
Wallert J, Gustafson E, Held C, Madison G, Norlund F, von Essen L, Olsson EMG. Predicting Adherence to Internet-Delivered Psychotherapy for Symptoms of Depression and Anxiety After Myocardial Infarction: Machine Learning Insights From the U-CARE Heart Randomized Controlled Trial. J Med Internet Res. 2018 Oct 10;20(10):e10754. doi: 10.2196/10754.
Results Reference
derived
PubMed Identifier
29519777
Citation
Norlund F, Wallin E, Olsson EMG, Wallert J, Burell G, von Essen L, Held C. Internet-Based Cognitive Behavioral Therapy for Symptoms of Depression and Anxiety Among Patients With a Recent Myocardial Infarction: The U-CARE Heart Randomized Controlled Trial. J Med Internet Res. 2018 Mar 8;20(3):e88. doi: 10.2196/jmir.9710.
Results Reference
derived
PubMed Identifier
25873137
Citation
Norlund F, Olsson EM, Burell G, Wallin E, Held C. Treatment of depression and anxiety with internet-based cognitive behavior therapy in patients with a recent myocardial infarction (U-CARE Heart): study protocol for a randomized controlled trial. Trials. 2015 Apr 11;16:154. doi: 10.1186/s13063-015-0689-y.
Results Reference
derived
Links:
URL
http://www.u-care.uu.se/?languageId=1
Description
U-CARE

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Internet-based Cognitive Behavior Therapy After Myocardial Infarction

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