Internet-based Cognitive Behavior Therapy After Myocardial Infarction

Depression Clinical Trial

— U-CARE: Heart  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01504191
• Other study ID #: U-CARE: Heart
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: December 2017

Study information

• Verified date: October 2020
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder
• Infarction
• Myocardial Infarction

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Sweden	Ängelholms sjukhus	Ängelholm
Sweden	Enköpings lassarett	Enköping
Sweden	Falu Lasarett	Falun
Sweden	Gävle sjukhus	Gävle
Sweden	Sahlgrenska sjukhuset	Göteborg
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	Malmö
Sweden	Mora lassarett	Mora
Sweden	Nyköpings sjukhus	Nyköping
Sweden	Universitetssjukhuset Örebro	Örebro
Sweden	Oskarshamns sjukhus	Oskarshamn
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	Växjö

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Change in Quality of Life (difference between the intervention and the control group)	Ratings on EQ5d and Ladder of Life (LL)	At baseline, during, after (3 months after baseline) and 7 months after treatment
Secondary	Change in Perceived Social Support (difference between the intervention and the control group)	ENRICHED Social Support Inventory (ESSI)-ratings	At baseline, after (3 months after baseline) and 7 months after treatment
Secondary	Change in Stress behaviors (difference between the intervention and the control group)	Everyday Life Stress Scale (ELSS)-ratings	At baseline, after (3 months after baseline) and 7 months after treatment
Secondary	Change in Fatigue (difference between the intervention and the control group)	Maastricht Questionnaire (MQ)-ratings	At baseline, after (3 months after baseline) and 7 months after treatment
Secondary	Change in Cardiac Anxiety (difference between the intervention and the control group)	Cardiac Anxiety Questionnaire (CAQ)-ratings	At baseline, after (3 months after baseline) and 7 months after treatment
Secondary	Change in Sleeping Problems (difference between the intervention and the control group)	Insomnia Severity Index (ISI)-ratings	At baseline, after (3 months after baseline) and 7 months after treatment
Secondary	Change in Posttraumatic Stress (difference between the intervention and the control group)	Posttraumatic Stress Disorder Checklist- Civilian Version (PCL-C)-ratings	At baseline, after (3 months after baseline) and 7 months after treatment
Secondary	Change in Posttraumatic Growth (difference between the intervention and the control group)	The Posttraumatic Growth Inventory - Short Form (PTGI-SF)-ratings	At baseline, after (3 months after baseline) and 7 months after treatment
Secondary	Quality of the Intervention	Behavioral Activation for Depression Scale (BADS)-ratings	At baseline, after (3 months after baseline) and 7 months after treatment
Secondary	Change to Follow-up in Anxiety (difference between the intervention and the control group)	Hospital Anxiety and Depression Scale (HADS) - anxiety ratings	At baseline, after (3 months after baseline) and 7 months after treatment
Secondary	Change to Follow-up 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, after (3 months after baseline) and 7 months after treatment

External Links

•   U-CARE