Coronary Artery Disease, Depression, Anxiety
Conditions
Brief summary
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.
Interventions
BEHAVIORALAttention Training Technique
Attention Training Technique is a six weeks psychological intervention provided by trained professionals
Sponsors
Oslo University Hospital
University of Oslo
The Hospital of Vestfold
Vestre Viken Hospital Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Hospital Anxiety and Depression -anxiety subscale score and Hospital Anxiety and Depression -depression subscale score | Up to six weeks and six months after randomization | 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 |
| Differences in proportion with Hospital Anxiety and Depression -anxiety and Hospital Anxiety and Depression-depression subscale scores <8 | Up to six weeks and six months after randomization | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Positive Beliefs about Rumination Scale scores | Up to six weeks and six months after randomization | 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 |
| Changes in Negative Beliefs about Rumination Scale scores | Up to six weeks and six months after randomization | 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 |
| Changes in Metacognitions Questionnaire-30 scores | Up to six weeks and six months after randomization | 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 |
| Changes in rumination scores | Up to six weeks and six months after randomization | 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 |
| Changes in quality of life | Up to six weeks and six months after randomization | 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 |
| Changes in Bergen Insomnia Scale scores | Up to six weeks and six months after randomization | 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 |
| Changes in C-reactive Protein (CRP) | Up to six weeks and six months after randomization | 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 |
| Changes in type d personality and its traits negative affectivity and social inhibition | Up to six weeks and six months after randomization | 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 |
| Changes in worry scores | Up to six weeks and six months after randomization | 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 |
Countries
Norway
Contacts
Primary ContactJohn Munkhaugen, MD,PhD
Backup ContactToril Dammen, MD,PhD
Outcome results
None listed