Attention Training Technique in Treatment of Anxiety and Depression in Coronary Heart Disease Patients
- Conditions
- Coronary Artery DiseaseDepression, Anxiety
- Interventions
- Behavioral: Attention Training Technique
- Registration Number
- NCT05621408
- Lead Sponsor
- Vestre Viken Hospital Trust
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 64
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Attention Training Techniqe Attention Training Technique The treatment manual will consist of up to six weekly group sessions with 45-90 minutes duration.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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 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 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 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
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 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 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
Trial Locations
- Locations (2)
Vestre Viken Trust Drammen hospital
🇳🇴Drammen, Viken County, Norway
Hospital of Vestfold
🇳🇴Tønsberg, Vestfold And Telemark County, Norway