Internet-based Cognitive Behavior Therapy After Myocardial Infarction

Not Applicable

Completed

• Conditions: Depression; Anxiety; Myocardial Infarction

• Registration Number: NCT01504191
• Lead Sponsor: Uppsala University

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.

Study Timeline

• Study First Submitted: 2011-12-19
• Study First Submitted QC: 2012-01-04
• Study First Posted: 2012-01-05
• Study Start: 2013-09
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-27
• Last Update Posted: 2020-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 239

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Anxiety (difference between the intervention and the control group)	At baseline and 3 months later (after intervention)	Hospital Anxiety and Depression Scale (HADS) - anxiety ratings
Change in Depression (difference between the intervention and the control group)	At baseline and 3 months later (after intervention)	Hospital Anxiety and Depression Scale (HADS) - depression ratings; Montgomery Åsberg Depression Rating Scale (MADRS)

Secondary Outcome Measures

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

Trial Locations

Locations (25)

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

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