- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01504191
Internet-based Cognitive Behavior Therapy After Myocardial Infarction (U-CARE: Heart)
A Randomized Controlled Study of the Effects of Internet-based Cognitive Behavior Therapy on Depression and Anxiety in Patients With a Previous Myocardial Infarction
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Enköping, Sverige
- Enköpings lassarett
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Falun, Sverige, 79129
- Falu Lasarett
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Gävle, Sverige, 80187
- Gavle Sjukhus
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Göteborg, Sverige
- Sahlgrenska sjukhuset
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Hässleholm, Sverige
- Hässleholms Sjukhus
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Karlskrona, Sverige
- Blekinge sjukhus
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Karlstad, Sverige
- Karlstad sjukhus
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Kungälv, Sverige
- Kungälvs sjukhus
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Lidköping, Sverige
- Skaraborgs sjukhus
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Ljungby, Sverige
- Ljungby lasarett
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Malmö, Sverige
- Skånes universitetssjukhus
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Mora, Sverige
- Mora lassarett
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Nyköping, Sverige
- Nyköpings sjukhus
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Oskarshamn, Sverige
- Oskarshamns sjukhus
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Piteå, Sverige
- Piteå älvdals sjukhus
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Stockholm, Sverige
- Danderyds sjukhus
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Stockholm, Sverige
- Karolinska sjukhuset i Huddinge
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Stockholm, Sverige
- Karolinska sjukhuset i Solna
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Stockholm, Sverige
- Södersjukhuset
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Sundsvall, Sverige
- Länssjukhuset Sundsvall-Härnösand
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Uppsala, Sverige, 75185
- Uppsala Akademiska Sjukhus
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Varberg, Sverige
- Varberg sjukhus
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Växjö, Sverige
- Växjö centrallasarett
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Ängelholm, Sverige
- Ängelholms sjukhus
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Örebro, Sverige, 70185
- Universitetssjukhuset Örebro
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Internet-based CBT
Randomized patients with symptoms of anxiety and/or depression after MI will participate in an Internet-based CBT-program.
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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. |
Ingen indgriben: 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). |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change in Depression (difference between the intervention and the control group)
Tidsramme: At baseline and 3 months later (after intervention)
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Hospital Anxiety and Depression Scale (HADS) - depression ratings; Montgomery Åsberg Depression Rating Scale (MADRS) |
At baseline and 3 months later (after intervention)
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Change in Anxiety (difference between the intervention and the control group)
Tidsramme: At baseline and 3 months later (after intervention)
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Hospital Anxiety and Depression Scale (HADS) - anxiety ratings
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At baseline and 3 months later (after intervention)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in Quality of Life (difference between the intervention and the control group)
Tidsramme: At baseline, during, after (3 months after baseline) and 7 months after treatment
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Ratings on EQ5d and Ladder of Life (LL)
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At baseline, during, after (3 months after baseline) and 7 months after treatment
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Change in Perceived Social Support (difference between the intervention and the control group)
Tidsramme: At baseline, after (3 months after baseline) and 7 months after treatment
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ENRICHED Social Support Inventory (ESSI)-ratings
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At baseline, after (3 months after baseline) and 7 months after treatment
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Change in Stress behaviors (difference between the intervention and the control group)
Tidsramme: At baseline, after (3 months after baseline) and 7 months after treatment
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Everyday Life Stress Scale (ELSS)-ratings
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At baseline, after (3 months after baseline) and 7 months after treatment
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Change in Fatigue (difference between the intervention and the control group)
Tidsramme: At baseline, after (3 months after baseline) and 7 months after treatment
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Maastricht Questionnaire (MQ)-ratings
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At baseline, after (3 months after baseline) and 7 months after treatment
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Change in Cardiac Anxiety (difference between the intervention and the control group)
Tidsramme: At baseline, after (3 months after baseline) and 7 months after treatment
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Cardiac Anxiety Questionnaire (CAQ)-ratings
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At baseline, after (3 months after baseline) and 7 months after treatment
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Change in Sleeping Problems (difference between the intervention and the control group)
Tidsramme: At baseline, after (3 months after baseline) and 7 months after treatment
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Insomnia Severity Index (ISI)-ratings
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At baseline, after (3 months after baseline) and 7 months after treatment
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Change in Posttraumatic Stress (difference between the intervention and the control group)
Tidsramme: At baseline, after (3 months after baseline) and 7 months after treatment
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Posttraumatic Stress Disorder Checklist- Civilian Version (PCL-C)-ratings
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At baseline, after (3 months after baseline) and 7 months after treatment
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Change in Posttraumatic Growth (difference between the intervention and the control group)
Tidsramme: At baseline, after (3 months after baseline) and 7 months after treatment
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The Posttraumatic Growth Inventory - Short Form (PTGI-SF)-ratings
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At baseline, after (3 months after baseline) and 7 months after treatment
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Quality of the Intervention
Tidsramme: At baseline, after (3 months after baseline) and 7 months after treatment
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Behavioral Activation for Depression Scale (BADS)-ratings
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At baseline, after (3 months after baseline) and 7 months after treatment
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Change to Follow-up in Anxiety (difference between the intervention and the control group)
Tidsramme: At baseline, after (3 months after baseline) and 7 months after treatment
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Hospital Anxiety and Depression Scale (HADS) - anxiety ratings
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At baseline, after (3 months after baseline) and 7 months after treatment
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Change to Follow-up in Depression (difference between the intervention and the control group)
Tidsramme: At baseline, after (3 months after baseline) and 7 months after treatment
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Hospital Anxiety and Depression Scale (HADS) - depression ratings; Montgomery Åsberg Depression Rating Scale (MADRS) |
At baseline, after (3 months after baseline) and 7 months after treatment
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Louise von Essen, PhD, Uppsala University
Publikationer og nyttige links
Generelle publikationer
- 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.
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- U-CARE: Heart
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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