An interventional study of Attention Training Technique in Depression, Anxiety and Coronary Artery Disease, sponsored by Vestre Viken Hospital Trust. Recruiting at 2 sites in Norway. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by Vestre Viken Hospital Trust · Not applicable, Interventional, and Treatment
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 64 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Vestre Viken Hospital Trust is the lead sponsor of 51 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The treatment manual will consist of up to six weekly group sessions with 45-90 minutes duration.
Behavioral: Attention Training Technique
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
Attention Training Technique is a six weeks psychological intervention provided by trained professionals
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
Time frame: 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
Time frame: Up to six weeks and six months after randomization
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to six weeks and six months after randomization
Plan to share: No
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Vestre Viken Hospital Trust