Attention Training Technique in Treatment of Anxiety and Depression in Coronary Heart Disease Patients

Study Overview
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Brief Summary
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Anxiety and depression are associated with work disability, lower participation rate in cardiac rehabilitation and unfavourable life style changes following a coronary heart disease (CHD) event. The prevalence of clinically significant symptoms of depression and anxiety in CHD patients has been estimated to 30-50%. Furthermore, depression and anxiety are associated with a significant increased risk of subsequent major adverse cardiovascular events and mortality in CHD patients. Psychological interventions for anxiety and depression in CHD patients have demonstrated small and uncertain effects of symptoms, and no effect on cardiovascular outcomes. Therefore, testing the effectiveness of specific psychological interventions that may affect central mechanisms for cardiovascular outcomes, has been requested. The Attention training (ATT) Study is a randomized controlled trial comparing group-attention training to wait-list control in 64 patients who experience significant anxiety and depression after a CHD event. It will also be explored whether reduction in psychological symptoms is correlated with changes in biological markers with a potential link to cardiovascular outcomes.

Official Title
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Attention Training Technique in Treatment of Anxiety and Depression in Coronary Heart Disease Patients -a Randomized Controlled Trial With 6 Months Follow-up

Conditions
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Depression, Anxiety, Coronary Artery Disease

Intervention / Treatment
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* Behavioral: Attention Training Technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Established coronary heart disease as main somatic disease >=8 on either HADS-anxiety or depression subscale Age 18 - 65 years The ability to understand and speak Norwegian language, Willingness and ability to give informed consent. Exclusion Criteria: Current or past neurological illness Traumatic brain injury Current alcohol and/or substance dependency disorders Psychotic disorders Bipolar disorders Developmental disorders Mental retardation Cognitive impairment which precludes informed consent/ability to participate Acute suicidality Life-expectancy less than 12 months Concurrent psychological intervention for emotional distress Antidepressant or anxiolytic medication initiated during previous 8 weeks

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Attention Training Techniqe<br>The treatment manual will consist of up to six weekly group sessions with 45-90 minutes duration. | Behavioral: Attention Training Technique<br>* Attention Training Technique is a six weeks psychological intervention provided by trained professionals<br>|
| No Intervention: Wait-list control<br>The wait-list control condition will not receive any psychological intervention during the six weeks waiting period. Subsequently, this group will also receive the intervention if the study entry criteria is still fulfilled | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Hospital Anxiety and Depression -anxiety subscale score and Hospital Anxiety and Depression -depression subscale score | Changes in Hospital Anxiety and Depression -anxiety subscale score and Hospital Anxiety and Depression -depression subscale scores within and between the two treatment arms. Scores range 0-21, higher scores indicate more symptoms | Up to six weeks and six months after randomization | 
| Differences in proportion with Hospital Anxiety and Depression -anxiety and Hospital Anxiety and Depression-depression subscale scores <8 | Differences in proportion with Hospital Anxiety and Depression -anxiety subscale and Hospital Anxiety and Depression -depression subscale scores <8 within and between the two treatment arms. Scores >=8 indicate signicant symptoms | Up to six weeks and six months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in rumination scores | Changes in rumination scores assessed by the Ruminative Response scale within and between the two treatment arms. Scores range from 22-88, higher scores indicate more symptoms | Up to six weeks and six months after randomization | 
| Changes in worry scores | Changes in worry scores assessed by the Penn State Worry Questionnaire within and between the two treatment arms. Scores range 16-80, higher scores indicate more symptoms | Up to six weeks and six months after randomization | 
| Changes in Positive Beliefs about Rumination Scale scores | Changes in Positive Beliefs about Rumination scores assessed by the Positive Beliefs about Rumination Questionnaire within and between the two treatment arms. Scores range 9-36, higher scores indicate stronger beliefs | Up to six weeks and six months after randomization | 
| Changes in Negative Beliefs about Rumination Scale scores | Changes in Negative Beliefs about Rumination scores assessed by the Negative Beliefs about Rumination Questionnaire within and between the two treatment arms. Scores range 13-52, higher scores indicate stronger beliefs | Up to six weeks and six months after randomization | 
| Changes in Metacognitions Questionnaire-30 scores | Changes in Metacognitions assessed by the Metacognitions Questionnaire-30 within and between the two treatment arms. Scores range 0-21, higher scores indicate more symptoms . Scores range 30-120, higher scores indicate stronger beliefs | Up to six weeks and six months after randomization | 
| Changes in type d personality and its traits negative affectivity and social inhibition | Changes in type d personality and its traits negative affectivity and social inhibition assessed by the Distressed Scale (DS)-14 within and between the two treatment arms. Scores range 0-28, higher scores indicate more symptoms | Up to six weeks and six months after randomization | 
| Changes in quality of life | Changes in quality of life assessed by the Short Form (SF) 12 within and between the two treatment arms. Scores range 1-100, lower scores indicate lower quality of life | Up to six weeks and six months after randomization | 
| Changes in Bergen Insomnia Scale scores | Changes in Bergen Insomnia Scale scores assessed by the Bergen Insomnia Scale within and between the two treatment arms. Scores range 0-42, higher scores indicate more symptoms | Up to six weeks and six months after randomization | 
| Changes in C-reactive Protein (CRP) | Changes in C-reactive Protein (CRP) measured in blood within and between the two treatment arms. Values range 0 to >20, higher values indicate more subclinical inflammation | Up to six weeks and six months after randomization |