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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

239

participants targeted

Target at P75+ for not_applicable depression

Timeline

Completed

Started Sep 2013

Longer than P75 for not_applicable depression

Geographic Reach

1 country

25 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.3 years study duration

First Submitted

Initial submission to the registry

December 19, 2011

Completed

17 days until next milestone

First Posted

Study publicly available on registry

January 5, 2012

Completed

1.7 years until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed

4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed

Last Updated

October 29, 2020

Status Verified

October 1, 2020

Enrollment Period

4.3 years

First QC Date

December 19, 2011

Last Update Submit

October 27, 2020

Conditions

Depression Anxiety Myocardial Infarction

Keywords

myocardial infarctiondepressionanxietyInternet-based CBTgenetic disposition

Outcome Measures

Primary Outcomes (2)

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)
At baseline and 3 months later (after intervention)
Change in Anxiety (difference between the intervention and the control group)
Hospital Anxiety and Depression Scale (HADS) - anxiety ratings
At baseline and 3 months later (after intervention)

Secondary Outcomes (11)

Change in Quality of Life (difference between the intervention and the control group)
At baseline, during, after (3 months after baseline) and 7 months after treatment
Change in Perceived Social Support (difference between the intervention and the control group)
At baseline, after (3 months after baseline) and 7 months after treatment
Change in Stress behaviors (difference between the intervention and the control group)
At baseline, after (3 months after baseline) and 7 months after treatment
Change in Fatigue (difference between the intervention and the control group)
At baseline, after (3 months after baseline) and 7 months after treatment
Change in Cardiac Anxiety (difference between the intervention and the control group)
At baseline, after (3 months after baseline) and 7 months after treatment
+6 more secondary outcomes

Study Arms (2)

Internet-based CBT

EXPERIMENTAL

Randomized patients with symptoms of anxiety and/or depression after MI will participate in an Internet-based CBT-program.

Behavioral: Internet-based CBT

Treatment as usual (TAU)

NO INTERVENTION

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).

Interventions

Internet-based CBTBEHAVIORAL

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.

Internet-based CBT

Eligibility Criteria

AgeUp to 75 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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)

You may not qualify if:

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Uppsala Universitylead

Study Sites (25)

Ängelholms sjukhus

Ängelholm, Sweden

Location

Enköpings lassarett

Enköping, Sweden

Location

Falu Lasarett

Falun, 79129, Sweden

Location

Gävle sjukhus

Gävle, 80187, Sweden

Location

Sahlgrenska sjukhuset

Gothenburg, Sweden

Location

Hässleholms sjukhus

Hässleholm, Sweden

Location

Blekinge sjukhus

Karlskrona, Sweden

Location

Karlstad sjukhus

Karlstad, Sweden

Location

Kungälvs sjukhus

Kungälv, Sweden

Location

Skaraborgs sjukhus

Lidköping, Sweden

Location

Ljungby lasarett

Ljungby, Sweden

Location

Skånes universitetssjukhus

Malmo, Sweden

Location

Mora lassarett

Mora, Sweden

Location

Nyköpings sjukhus

Nyköping, Sweden

Location

Oskarshamns sjukhus

Oskarshamn, Sweden

Location

Universitetssjukhuset Örebro

Örebro, 70185, Sweden

Location

Piteå älvdals sjukhus

Piteå, Sweden

Location

Danderyds sjukhus

Stockholm, Sweden

Location

Karolinska sjukhuset i Huddinge

Stockholm, Sweden

Location

Karolinska sjukhuset i Solna

Stockholm, Sweden

Location

Södersjukhuset

Stockholm, Sweden

Location

Länssjukhuset Sundsvall-Härnösand

Sundsvall, Sweden

Location

Uppsala Akademiska sjukhus

Uppsala, 75185, Sweden

Location

Varberg sjukhus

Varberg, Sweden

Location

Växjö centrallasarett

Vaxjo, Sweden

Location

Related Publications (5)

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.
PMID: 36581833DERIVED
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.
PMID: 34028358DERIVED
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.
PMID: 30305255DERIVED
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.
PMID: 29519777DERIVED
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.
PMID: 25873137DERIVED

MeSH Terms

Conditions

DepressionAnxiety DisordersMyocardial Infarction

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

Louise von Essen, PhD
Uppsala University
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Programme Director for U-CARE

Study Record Dates

First Submitted

December 19, 2011

First Posted

January 5, 2012

Study Start

September 1, 2013

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

October 29, 2020

Record last verified: 2020-10

Locations

SE(25)

Internet-based Cognitive Behavior Therapy After Myocardial Infarction

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (11)

Study Arms (2)

Internet-based CBT

Treatment as usual (TAU)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (25)

Related Publications (5)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (11)

Study Arms (2)

Internet-based CBT

Treatment as usual (TAU)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (25)

Related Publications (5)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations