Internet-based Cognitive Behavior Therapy After Myocardial Infarction
NCT ID: NCT01504191
Last Updated: 2020-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
239 participants
INTERVENTIONAL
2013-09-30
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Internet-based CBT
Randomized patients with symptoms of anxiety and/or depression after MI will participate in an Internet-based CBT-program.
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.
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).
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
75 Years
ALL
No
Sponsors
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Uppsala University
OTHER
Responsible Party
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Louise-von Essen
Programme Director for U-CARE
Principal Investigators
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Louise von Essen, PhD
Role: PRINCIPAL_INVESTIGATOR
Uppsala University
Locations
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Ängelholms sjukhus
Ängelholm, , Sweden
Enköpings lassarett
Enköping, , Sweden
Falu Lasarett
Falun, , Sweden
Gävle sjukhus
Gävle, , Sweden
Sahlgrenska sjukhuset
Gothenburg, , 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
Malmo, , Sweden
Mora lassarett
Mora, , Sweden
Nyköpings sjukhus
Nyköping, , Sweden
Oskarshamns sjukhus
Oskarshamn, , Sweden
Universitetssjukhuset Örebro
Örebro, , 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
Varberg sjukhus
Varberg, , Sweden
Växjö centrallasarett
Vaxjo, , Sweden
Countries
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References
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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.
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.
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.
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.
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.
Related Links
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Other Identifiers
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U-CARE: Heart
Identifier Type: -
Identifier Source: org_study_id