Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05621408
Other study ID # 52002
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT06030596 - SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
Completed NCT04080700 - Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
Recruiting NCT03810599 - Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study N/A
Recruiting NCT06002932 - Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions. N/A
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT05308719 - Nasal Oxygen Therapy After Cardiac Surgery N/A
Recruiting NCT04242134 - Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions N/A
Completed NCT04556994 - Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients. N/A
Recruiting NCT05846893 - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease N/A
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Recruiting NCT05023629 - STunning After Balloon Occlusion N/A
Completed NCT04941560 - Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
Completed NCT04006288 - Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease Phase 4
Completed NCT01860274 - Meshed Vein Graft Patency Trial - VEST N/A
Recruiting NCT06174090 - The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients N/A
Completed NCT03968809 - Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
Terminated NCT03959072 - Cardiac Cath Lab Staff Radiation Exposure
Recruiting NCT05065073 - Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography Phase 4
Recruiting NCT04566497 - Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up. N/A
Completed NCT05096442 - Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions N/A