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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Depression, Anxiety
• Intervention / Treatment: Behavioral: Attention Training Technique

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John Munkhaugen, MD,PhD; Phone Number: +4797524194; Email: johmun@vestreviken.no
• Study Contact Backup: Name: Toril Dammen, MD,PhD; Phone Number: +4790163433; Email: toril.dammen@medisin.uio.no

Study Locations

• Norway
  • Vestfold And Telemark County
    • Tønsberg, Vestfold And Telemark County, Norway, 3103
      • Not yet recruiting
      • Hospital of Vestfold
      • Contact: Kari H Peersen, MD, PhD; Email: kari.peersen@siv.no
  • Viken County
    • Drammen, Viken County, Norway, 3004
      • Recruiting
      • Vestre Viken Trust Drammen hospital
      • Contact: John D Munkhaugen, MD, PhD; Phone Number: +4797524194; Email: johmun@vestreviken.no
      • Contact: Toril Dammen, MD, PhD; Phone Number: +4790163433; Email: toril.dammen@medisin.uio.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Attention Training Techniqe; The treatment manual will consist of up to six weekly group sessions with 45-90 minutes duration.	Behavioral: Attention Training Technique; Attention Training Technique is a six weeks psychological intervention provided by trained professionals
No Intervention: Wait-list control; The wait-list control condition will not receive any psychological intervention during the six weeks waiting period. Subsequently, this group will also receive the intervention if the study entry criteria is still fulfilled

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Vestre Viken Hospital Trust
• Collaborators: University of Oslo; Oslo University Hospital; The Hospital of Vestfold

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2022
• Primary Completion (Estimated): December 20, 2024
• Study Completion (Estimated): December 20, 2024

Study Registration Dates

• First Submitted: November 2, 2022
• First Submitted That Met QC Criteria: November 9, 2022
• First Posted (Actual): November 18, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Mood Disorders; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Depression; Depressive Disorder; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Anxiety Disorders
• Other Study ID Numbers: 52002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No