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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05621408
• Other study ID #: 52002
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2022
• Est. completion date: December 20, 2024

Study information

• Verified date: May 2024
• Source: Vestre Viken Hospital Trust
• Contact: John Munkhaugen, MD,PhD
• Phone: +4797524194
• Email: johmun[@]vestreviken.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: December 20, 2024
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Coronary Artery Disease
• Coronary Disease
• Depression
• Depression, Anxiety
• Depressive Disorder
• Heart Diseases
• Myocardial Ischemia

Intervention

Behavioral:
• Attention Training Technique
Attention Training Technique is a six weeks psychological intervention provided by trained professionals

Locations

Country	Name	City	State
Norway	Vestre Viken Trust Drammen hospital	Drammen	Viken County
Norway	Hospital of Vestfold	Tønsberg	Vestfold And Telemark County

Sponsors (4)

Lead Sponsor	Collaborator
Vestre Viken Hospital Trust	Oslo University Hospital, The Hospital of Vestfold, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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