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

NCT05621408 | Recruiting

• 1 other identifier: 52002
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression, Anxiety; Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• 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 Negative Beliefs about Rumination Scale scores

  Up to six weeks and six months after randomization

• Changes in Metacognitions Questionnaire-30 scores

  Up to six weeks and six months after randomization

Study Arms (2)

Attention Training Techniqe

EXPERIMENTAL

The treatment manual will consist of up to six weekly group sessions with 45-90 minutes duration.

Behavioral: Attention Training Technique

Wait-list control

NO INTERVENTION

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

Interventions

Attention Training Technique BEHAVIORAL

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

Attention Training Techniqe

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vestre Viken Hospital Trust: lead
• Oslo University Hospital: collaborator
• University of Oslo: collaborator
• The Hospital of Vestfold: collaborator

Study Sites (2)

Hospital of Vestfold

Tønsberg, Vestfold and Telemark County, 3103, Norway

NOT YET RECRUITING

Vestre Viken Trust Drammen hospital

Drammen, Viken County, 3004, Norway

RECRUITING

Related Publications (2)

• Tunheim K, Papageorgiou C, Lie HC, Munkhaugen J, Dammen T. Experiences of the attention training technique delivered in groups as treatment for anxiety and depression in patients with coronary heart disease: a qualitative study. BMC Psychiatry. 2025 Jun 3;25(1):573. doi: 10.1186/s12888-025-07027-4.

  PMID: 40461992 DERIVED

• Dammen T, Tunheim K, Munkhaugen J, Klungsoyr O, Papageorgiou C. Attention training technique delivered in groups as treatment for anxiety and depression in patients with coronary heart disease: study protocol for a waiting-list randomized controlled trial. Front Psychol. 2023 Sep 18;14:1226539. doi: 10.3389/fpsyg.2023.1226539. eCollection 2023.

  PMID: 37790218 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

John Munkhaugen, MD,PhD

CONTACT

+4797524194; johmun@vestreviken.no

Toril Dammen, MD,PhD

CONTACT

+4790163433; toril.dammen@medisin.uio.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 18, 2022
• Study Start: November 30, 2022
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)