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
Open accessAbstract
BACKGROUND: Major depression and depressive symptoms are common in patients with a recent myocardial infarction (MI), and depression is associated with adverse cardiovascular outcomes. Anxiety post-MI is less studied, but occurs commonly in patients with heart disease, and is also considered a risk factor for recurrence of cardiac events. Cognitive behavior therapy (CBT) is an established therapy for depression and anxiety disorders. To the best of our knowledge, there have not been any studies to determine if internet-based CBT (iCBT) can reduce the symptoms of depression and anxiety in patients with a recent MI. The main aim of the U-CARE Heart trial is to evaluate an iCBT intervention for patients with a recent MI. METHODS/DESIGN: This is a randomized, controlled, prospective study with a multicenter design. A total of 500 participants will be randomized at a 1:1 ratio, around two months after an acute MI, to either iCBT or to a control group. Both groups will receive an optimal standard of care according to guidelines. The intervention consists of a self-help program delivered via the internet with individual online support from a psychologist. Treatment duration is 14 weeks. The primary outcome is change in patients' self-rated anxiety and depression symptoms from baseline to end of treatment. An internal pilot study was conducted indicating sufficient levels of study acceptability and engagement in treatment. DISCUSSION: The present study is designed to evaluate an iCBT intervention targeting symptoms of depression and anxiety in a post-MI population. If effective, iCBT has several advantages, and will potentially be implemented as an easily accessible treatment option added to modern standard of care. TRIAL REGISTRATION: This trial was registered with Clinicaltrials.gov (identifier: NCT01504191 ) on 19 December 2011.
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Multiple sclerosis is a chronic and progressive disease of the central nervous system and is one of the most common neurological diseases that can severely affect different aspects of an individual as well as their family's life and cause disruption in the patient's quality of life.
“Multiple sclerosis is a chronic and progressive disease of the central nervous system and is one of the most common neurological diseases that can severely affect different aspects of an individual as well as their family's life and cause disruption in the patient's quality of life owing to different reasons.[12]”
From The effect of group cognitive behavioral therapy on stress, anxiety, and depression of women with multiple sclerosis (2017) · cites this paper as [12]
Split into 2 atoms — 0 confirmed, 0 partially supported, 0 disputed, 0 misattributed, 2 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measured
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
The citation lists haven’t been fetched yet
References 43 · Cited by 33
Research works printed but not linked: 21
- [3]Thombs BD de Jonge P Coyne JC Whooley MA Frasure-Smith N Mitchell AJ Depression screening and patient outcomes in cardiovascular care: a systematic review JAMA 2008 300 2161 71 10.1001/jama.2008.667 19001627 · DOI · Paper page
- [4]Glassman AH Helzer J Covey L Cottler L Stetner F Tipp J Smoking, smoking cessation, and major depression JAMA 1990 264 1546 10.1001/jama.1990.03450120058029 2395194 · DOI · Paper page
- [5]Carney RM Freedland KE Miller GE Jaffe AS Depression as a risk factor for cardiac mortality and morbidity: a review of potential mechanisms J Psychosom Res 2002 53 897 902 10.1016/S0022-3999(02)00311-2 12377300 · DOI · Paper page
- [6]Carney RM Freedland KE Veith RC Jaffe AS Can treating depression reduce mortality after an acute myocardial infarction? Psychosom Med 1999 61 666 75 10.1097/00006842-199909000-00009 10511015 · DOI
- [7]Mayou RA Gill D Thompson DR Day A Hicks N Volmink J Depression and anxiety as predictors of outcome after myocardial infarction Psychosom Med 2000 62 212 9 10.1097/00006842-200003000-00011 10772399 · DOI
- [9]Roest AM Martens EJ de Jonge P Denollet J Anxiety and risk of incident coronary heart disease: a meta-analysis J Am Coll Cardiol 2010 56 38 46 10.1016/j.jacc.2010.03.034 20620715 · DOI · Paper page
- [12]Dickens C Cherrington A Adeyemi I Roughley K Bower P Garrett C Characteristics of psychological interventions that improve depression in people with coronary heart disease: a systematic review and meta-regression Psychosom Med 2013 75 211 21 10.1097/PSY.0b013e31827ac009 23324874 · DOI · Paper page
- [13]Merswolken M Siebenhuener S Orth-Gomér K Zimmermann-Viehoff F Deter H-C Treating anxiety in patients with coronary heart disease: a randomized controlled trial Psychother Psychosom 2011 80 365 70 10.1159/000329177 21968457 · DOI
- [14]Friedman M Thoresen CE Gill JJ Ulmer D Powell LH Price V Alteration of type A behavior and its effect on cardiac recurrences in post myocardial infarction patients: summary results of the recurrent coronary prevention project Am Heart J 1986 112 653 65 10.1016/0002-8703(86)90458-8 3766365 · DOI
- [18]Berkman LF Blumenthal J Burg M Carney RM Catellier D Cowan MJ Effects of treating depression and low perceived social support on clinical events after myocardial infarction: the Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) Randomized Trial JAMA 2003 289 3106 16 10.1001/jama.289.23.3106 12813116 · DOI · Paper page
- [23]Sjöström J von Essen L Grönqvist H The origin and impact of ideals in eHealth research: experiences from the U-CARE research environment JMIR Res Protoc 2014 3 e28 10.2196/resprot.3202 24860071 PMC4051743 · DOI
- [24]Zigmond AS Snaith RP The hospital anxiety and depression scale Acta Psychiatr Scand 1983 67 361 70 10.1111/j.1600-0447.1983.tb09716.x 6880820 · DOI · Paper page
- [25]Svanborg P Asberg M A comparison between the Beck Depression Inventory (BDI) and the self-rating version of the Montgomery Asberg Depression Rating Scale (MADRS) J Affect Disord 2001 64 203 16 10.1016/S0165-0327(00)00242-1 11313087 · DOI · Paper page
- [27]Coyne JC van Sonderen E No further research needed: abandoning the Hospital and Anxiety Depression Scale (HADS) J Psychosom Res 2012 72 173 4 10.1016/j.jpsychores.2011.12.003 22325694 · DOI · Paper page
- [28]Tanaka-Matsumi J Kameoka VA Reliabilities and concurrent validities of popular self-report measures of depression, anxiety, and social desirability J Consult Clin Psychol 1986 54 328 33 10.1037/0022-006X.54.3.328 3722561 · DOI
- [32]Dyer MTD Goldsmith KA Sharples LS Buxton MJ A review of health utilities using the EQ-5D in studies of cardiovascular disease Health Qual Life Outcomes 2010 8 13 10.1186/1477-7525-8-13 20109189 PMC2824714 · DOI
- [33]Hilton BA Budgen C Molzahn AE Attridge CB Developing and testing instruments to measure client outcomes at the Comox Valley Nursing Center Public Health Nurs 2001 18 327 39 10.1046/j.1525-1446.2001.00327.x 11559416 · DOI
- [34]Claesson M Birgander LS Lindahl B Nasic S Aström M Asplund K Women’s hearts–stress management for women with ischemic heart disease: explanatory analyses of a randomized controlled trial J Cardiopulm Rehabil 2005 25 93 102 10.1097/00008483-200503000-00009 15818198 · DOI · Paper page
- [35]Appels A Höppener P Mulder P A questionnaire to assess premonitory symptoms of myocardial infarction Int J Cardiol 1987 17 15 24 10.1016/0167-5273(87)90029-5 3666994 · DOI
- [36]Bastien CH Vallières A Morin CM Validation of the Insomnia Severity Index as an outcome measure for insomnia research Sleep Med 2001 2 297 307 10.1016/S1389-9457(00)00065-4 11438246 · DOI · Paper page
- [39]Wittes J Brittain E The role of internal pilot studies in increasing the efficiency of clinical trials Stat Med 1990 9 65 71 10.1002/sim.4780090113 2345839 · DOI
- Authors
- Norlund, F., Olsson, E. M., Burell, G., Wallin, E., & Held, C.
- Affiliations
- Uppsala University (SE)
- Corresponding author
- Norlund, Fredrika
- Venue
- Trials
- Published
- 2015-04-11
- Volume
- 16
- Issue
- 1
- Pages
- 154-154
- ISSN
- 1745-6215 (ISSN-L)
- PMC
- PMC4404081
- OpenAlex
- W2158116770
- Cited by
- 33
- References
- 43
- Citations by year
- 2023: 2 · 2022: 2 · 2021: 4 · 2020: 1 · 2019: 2 · 2018: 8 · 2017: 8 · 2016: 5 · 2015: 1
- FWCI
- 11.89
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Trials (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Uppsala University Publications (Uppsala University) (submittedVersion, other-oa)
- Funders
- Vårdalstiftelsen (2014-0114)
- Riksförbundet HjärtLung
- Regionala Forskningsrådet Uppsala/Örebro
- Vetenskapsrådet (2009–1093, Dnr 2009-1093)
- Topics
- Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Health and Mental Health
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Keywords
- internet-based cognitive behavioral therapy, depression, anxiety, myocardial infarction, self-help intervention, online mental health services, cardiovascular outcomes, treatment engagement
- MeSH terms
- Aged, Anxiety, Clinical Protocols, Depression, Female, Humans, Male, Middle Aged, Myocardial Infarction, Prospective Studies, Research Design, Sweden, Therapy, Computer-Assisted, Time Factors, Cognitive Behavioral Therapy, Treatment Outcome, Telemedicine, Internet, Self Report
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
