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Depression, AnxietyNCT05621408

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

A study testing Attention Training Technique in people with Depression, Anxiety and Coronary Artery Disease, run by Vestre Viken Hospital Trust at 2 sites in Norway.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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%. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Depression, Anxiety, Coronary Artery Disease
What is being tested?
Attention Training Technique
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
2 sitesNorway
Study dates
30 Nov 2022to 20 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Current or past neurological illness
  • Traumatic brain injury
  • Current alcohol and/or substance dependency disorders
  • Psychotic disorders
  • Bipolar disorders
  • Developmental disorders
Show all 12Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

John Munkhaugen, MD,PhD contact

+4797524194

johmun@vestreviken.no

Toril Dammen, MD,PhD contact

+4790163433

toril.dammen@medisin.uio.no

Norway2 sites, 2 recruiting

  • Vestre Viken Trust Drammen hospital

    Drammen, Viken County, 3004

    John D Munkhaugen, MD, PhD, +4797524194, johmun@vestreviken.no

    Toril Dammen, MD, PhD, +4790163433, toril.dammen@medisin.uio.no

    Recruiting

  • Hospital of Vestfold

    Tønsberg, Vestfold and Telemark County, 3103

    Kari H Peersen, MD, PhD, kari.peersen@siv.no

    Not yet recruiting

Other trials in Norway

About this study

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

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.

Being tested
Attention Training Technique
Medical subject headings
Depression, Anxiety Disorders, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Attention Training TechniqueBehavioural

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

Study groups in NCT05621408
Study groupRoleWhat they receive
Attention Training TechniqeExperimentalThe treatment manual will consist of up to six weekly group sessions with 45-90 minutes duration.
Receives: Behavioral: Attention Training Technique
Wait-list controlNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to six weeks and six months after randomization

  2. 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

    Measured: Up to six weeks and six months after randomization

Secondary outcomes (9)

  1. 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

    Measured: Up to six weeks and six months after randomization

  2. 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

    Measured: Up to six weeks and six months after randomization

  3. 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

    Measured: Up to six weeks and six months after randomization

  4. 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

    Measured: Up to six weeks and six months after randomization

  5. 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

    Measured: Up to six weeks and six months after randomization

  6. 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

    Measured: Up to six weeks and six months after randomization

  7. 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

    Measured: Up to six weeks and six months after randomization

  8. 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

    Measured: Up to six weeks and six months after randomization

  9. 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

    Measured: Up to six weeks and six months after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2022
  2. Study start30 Nov 2022
  3. Primary completion20 Dec 2024 (estimated)
  4. Study completion20 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05621408
Sponsor's protocol ID
52002
Status last verified
May 2024
First submitted
2 Nov 2022
Last updated
16 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40461992

  • 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.

    PubMed 37790218

Questions about this trial

What is this clinical trial studying?

A study testing Attention Training Technique in people with Depression, Anxiety and Coronary Artery Disease, run by Vestre Viken Hospital Trust at 2 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact John Munkhaugen, MD,PhD (+4797524194, johmun@vestreviken.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Hospital Anxiety and Depression -anxiety subscale score and Hospital Anxiety and Depression -depression subscale score (time frame: Up to six weeks and six months after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05621408, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.

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