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

NCT ID: NCT05621408

Last Updated: 2024-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-30

Study Completion Date

2024-12-20

Brief Summary

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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

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Conditions

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Depression, Anxiety Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Attention Training Techniqe

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

Group Type EXPERIMENTAL

Attention Training Technique

Intervention Type BEHAVIORAL

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

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Attention Training Technique

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role collaborator

University of Oslo

OTHER

Sponsor Role collaborator

The Hospital of Vestfold

OTHER

Sponsor Role collaborator

Vestre Viken Hospital Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital of Vestfold

Tønsberg, Vestfold and Telemark County, Norway

Site Status NOT_YET_RECRUITING

Vestre Viken Trust Drammen hospital

Drammen, Viken County, Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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John Munkhaugen, MD,PhD

Role: CONTACT

+4797524194

Toril Dammen, MD,PhD

Role: CONTACT

+4790163433

Facility Contacts

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Kari H Peersen, MD, PhD

Role: primary

John D Munkhaugen, MD, PhD

Role: primary

+4797524194

Toril Dammen, MD, PhD

Role: backup

+4790163433

References

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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.

Reference Type DERIVED
PMID: 40461992 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37790218 (View on PubMed)

Other Identifiers

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52002

Identifier Type: -

Identifier Source: org_study_id

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