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DepressionU-CARE: HeartNCT01504191

Internet-based Cognitive Behavior Therapy After Myocardial Infarction

A study testing Internet-based CBT in people with Depression and Anxiety, run by Uppsala University at 25 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages Up to 75 years
Conditions the study is for
Depression, Anxiety, Myocardial Infarction
What is being tested?
Internet-based CBT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
239 participants
Where
25 sitesSweden
Study dates
Sep 2013to Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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)

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

Sweden25 sites

  • Ängelholms sjukhus

    Ängelholm

  • Enköpings lassarett

    Enköping

  • Falu Lasarett

    Falun, 79129

  • Gävle sjukhus

    Gävle, 80187

  • Sahlgrenska sjukhuset

    Gothenburg

  • Hässleholms sjukhus

    Hässleholm

  • Blekinge sjukhus

    Karlskrona

  • Karlstad sjukhus

    Karlstad

  • Kungälvs sjukhus

    Kungälv

  • Skaraborgs sjukhus

    Lidköping

  • Ljungby lasarett

    Ljungby

  • Skånes universitetssjukhus

    Malmö

  • Mora lassarett

    Mora

  • Nyköpings sjukhus

    Nyköping

  • Universitetssjukhuset Örebro

    Örebro, 70185

  • Oskarshamns sjukhus

    Oskarshamn

  • Piteå älvdals sjukhus

    Piteå

  • Danderyds sjukhus

    Stockholm

  • Karolinska sjukhuset i Huddinge

    Stockholm

  • Karolinska sjukhuset i Solna

    Stockholm

  • Södersjukhuset

    Stockholm

  • Länssjukhuset Sundsvall-Härnösand

    Sundsvall

  • Uppsala Akademiska sjukhus

    Uppsala, 75185

  • Varberg sjukhus

    Varberg

  • Växjö centrallasarett

    Vaxjo

Other trials in Sweden

About this study

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

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).

Read the 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.

Being tested
Internet-based CBT
Keywords
myocardial infarction, depression, anxiety, Internet-based CBT, genetic disposition
Medical subject headings
Depression, Anxiety Disorders, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Internet-based CBTBehavioural

    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.

Study groups in NCT01504191
Study groupRoleWhat they receive
Internet-based CBTExperimentalRandomized patients with symptoms of anxiety and/or depression after MI will participate in an Internet-based CBT-program.
Receives: Behavioral: Internet-based CBT
Treatment as usual (TAU)No interventionControl: 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: At baseline and 3 months later (after intervention)

  2. Change in Anxiety (difference between the intervention and the control group)

    Hospital Anxiety and Depression Scale (HADS) - anxiety ratings

    Measured: At baseline and 3 months later (after intervention)

Secondary outcomes (11)

  1. Change in Quality of Life (difference between the intervention and the control group)

    Ratings on EQ5d and Ladder of Life (LL)

    Measured: At baseline, during, after (3 months after baseline) and 7 months after treatment

  2. Change in Perceived Social Support (difference between the intervention and the control group)

    ENRICHED Social Support Inventory (ESSI)-ratings

    Measured: At baseline, after (3 months after baseline) and 7 months after treatment

  3. Change in Stress behaviors (difference between the intervention and the control group)

    Everyday Life Stress Scale (ELSS)-ratings

    Measured: At baseline, after (3 months after baseline) and 7 months after treatment

  4. Change in Fatigue (difference between the intervention and the control group)

    Maastricht Questionnaire (MQ)-ratings

    Measured: At baseline, after (3 months after baseline) and 7 months after treatment

  5. Change in Cardiac Anxiety (difference between the intervention and the control group)

    Cardiac Anxiety Questionnaire (CAQ)-ratings

    Measured: At baseline, after (3 months after baseline) and 7 months after treatment

  6. Change in Sleeping Problems (difference between the intervention and the control group)

    Insomnia Severity Index (ISI)-ratings

    Measured: At baseline, after (3 months after baseline) and 7 months after treatment

  7. Change in Posttraumatic Stress (difference between the intervention and the control group)

    Posttraumatic Stress Disorder Checklist- Civilian Version (PCL-C)-ratings

    Measured: At baseline, after (3 months after baseline) and 7 months after treatment

  8. Change in Posttraumatic Growth (difference between the intervention and the control group)

    The Posttraumatic Growth Inventory - Short Form (PTGI-SF)-ratings

    Measured: At baseline, after (3 months after baseline) and 7 months after treatment

  9. Quality of the Intervention

    Behavioral Activation for Depression Scale (BADS)-ratings

    Measured: At baseline, after (3 months after baseline) and 7 months after treatment

  10. Change to Follow-up in Anxiety (difference between the intervention and the control group)

    Hospital Anxiety and Depression Scale (HADS) - anxiety ratings

    Measured: At baseline, after (3 months after baseline) and 7 months after treatment

  11. 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)

    Measured: At baseline, after (3 months after baseline) and 7 months after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2012 (estimated)
  2. Study startSep 2013
  3. Primary completionDec 2017
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
239 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01504191
Sponsor's protocol ID
U-CARE: Heart
Acronym
U-CARE: Heart
Status last verified
Oct 2020
First submitted
19 Dec 2011
Last updated
29 Oct 2020
Results posted
No
Data monitoring committee
No

Publications

  • Leissner P, Held C, Rondung E, Olsson EMG. The factor structure of the cardiac anxiety questionnaire, and validation in a post-MI population. BMC Med Res Methodol. 2022 Dec 29;22(1):338. doi: 10.1186/s12874-022-01820-5.

    PubMed 36581833

  • 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.

    PubMed 34028358

  • 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.

    PubMed 30305255

  • 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.

    PubMed 29519777

  • 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.

    PubMed 25873137

Questions about this trial

What is this clinical trial studying?

A study testing Internet-based CBT in people with Depression and Anxiety, run by Uppsala University at 25 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Depression (difference between the intervention and the control group) (time frame: At baseline and 3 months later (after intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01504191, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2020.

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U-CARE: Heart Clinical Trial NCT01504191 | AzTrials