Clinical trial NCT01504191: Internet-based Cognitive Behavior Therapy After Myocardial Infarction
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
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Myocardial Infarction
Keywords: myocardial infarction
depression
anxiety
Internet-based CBT
genetic disposition
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2012-01-05
Enrollment: 239
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in Depression (difference between the intervention and the control group)
timeFrame: At baseline and 3 months later (after intervention)
measure: Change in Anxiety (difference between the intervention and the control group)
timeFrame: At baseline and 3 months later (after intervention)
Secondary outcomes:
measure: Change in Quality of Life (difference between the intervention and the control group)
timeFrame: At baseline, during, after (3 months after baseline) and 7 months after treatment
measure: Change in Perceived Social Support (difference between the intervention and the control group)
timeFrame: At baseline, after (3 months after baseline) and 7 months after treatment
measure: Change in Stress behaviors (difference between the intervention and the control group)
timeFrame: At baseline, after (3 months after baseline) and 7 months after treatment
measure: Change in Fatigue (difference between the intervention and the control group)
timeFrame: At baseline, after (3 months after baseline) and 7 months after treatment
measure: Change in Cardiac Anxiety (difference between the intervention and the control group)
timeFrame: At baseline, after (3 months after baseline) and 7 months after treatment
measure: Change in Sleeping Problems (difference between the intervention and the control group)
timeFrame: At baseline, after (3 months after baseline) and 7 months after treatment
measure: Change in Posttraumatic Stress (difference between the intervention and the control group)
timeFrame: At baseline, after (3 months after baseline) and 7 months after treatment
measure: Change in Posttraumatic Growth (difference between the intervention and the control group)
timeFrame: At baseline, after (3 months after baseline) and 7 months after treatment
measure: Quality of the Intervention
timeFrame: At baseline, after (3 months after baseline) and 7 months after treatment
measure: Change to Follow-up in Anxiety (difference between the intervention and the control group)
timeFrame: At baseline, after (3 months after baseline) and 7 months after treatment
measure: Change to Follow-up in Depression (difference between the intervention and the control group)
timeFrame: At baseline, after (3 months after baseline) and 7 months after treatment
Other outcomes:
Locations:
city: Enköping
country: Sweden
facility: Enköpings lassarett
city: Falun
country: Sweden
facility: Falu Lasarett
city: Gävle
country: Sweden
facility: Gävle sjukhus
city: Göteborg
country: Sweden
facility: Sahlgrenska sjukhuset
city: Hässleholm
country: Sweden
facility: Hässleholms sjukhus
city: Karlskrona
country: Sweden
facility: Blekinge sjukhus
city: Karlstad
country: Sweden
facility: Karlstad sjukhus
city: Kungälv
country: Sweden
facility: Kungälvs sjukhus
city: Lidköping
country: Sweden
facility: Skaraborgs sjukhus
city: Ljungby
country: Sweden
facility: Ljungby lasarett
city: Malmö
country: Sweden
facility: Skånes universitetssjukhus
city: Mora
country: Sweden
facility: Mora lassarett
city: Nyköping
country: Sweden
facility: Nyköpings sjukhus
city: Oskarshamn
country: Sweden
facility: Oskarshamns sjukhus
city: Piteå
country: Sweden
facility: Piteå älvdals sjukhus
city: Stockholm
country: Sweden
facility: Danderyds sjukhus
city: Stockholm
country: Sweden
facility: Karolinska sjukhuset i Huddinge
city: Stockholm
country: Sweden
facility: Karolinska sjukhuset i Solna
city: Stockholm
country: Sweden
facility: Södersjukhuset
city: Sundsvall
country: Sweden
facility: Länssjukhuset Sundsvall-Härnösand
city: Uppsala
country: Sweden
facility: Uppsala Akademiska sjukhus
city: Varberg
country: Sweden
facility: Varberg sjukhus
city: Växjö
country: Sweden
facility: Växjö centrallasarett
city: Ängelholm
country: Sweden
facility: Ängelholms sjukhus
city: Örebro
country: Sweden
facility: Universitetssjukhuset Örebro
Study officials:
affiliation: Uppsala University
name: Louise von Essen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.