Attention Training Technique in Treatment of Anxiety and Depression in Coronary Heart Disease Patients -a Randomized Controlled Trial With 6 Months Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 4
- 主要终点
- Changes in Hospital Anxiety and Depression -anxiety subscale score and Hospital Anxiety and Depression -depression subscale score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Changes in Hospital Anxiety and Depression -anxiety subscale score and Hospital Anxiety and Depression -depression subscale score
时间窗: 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
时间窗: 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
次要结局
- Changes in Metacognitions Questionnaire-30 scores(Up to six weeks and six months after randomization)
- Changes in quality of life(Up to six weeks and six months after randomization)
- Changes in Negative Beliefs about Rumination Scale scores(Up to six weeks and six months after randomization)
- Changes in type d personality and its traits negative affectivity and social inhibition(Up to six weeks and six months after randomization)
- Changes in rumination scores(Up to six weeks and six months after randomization)
- Changes in worry scores(Up to six weeks and six months after randomization)
- Changes in Positive Beliefs about Rumination Scale scores(Up to six weeks and six months after randomization)
- Changes in C-reactive Protein (CRP)(Up to six weeks and six months after randomization)
- Changes in Bergen Insomnia Scale scores(Up to six weeks and six months after randomization)