Clinical trial NCT05621408: Attention Training Technique in Treatment of Anxiety and Depression in Coronary Heart Disease Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression, Anxiety
Coronary Artery Disease
Lead sponsor: Vestre Viken Hospital Trust
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: University of Oslo
name: The Hospital of Vestfold
First posted: 2022-11-18
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in Hospital Anxiety and Depression -anxiety subscale score and Hospital Anxiety and Depression -depression subscale score
timeFrame: Up to six weeks and six months after randomization
measure: Differences in proportion with Hospital Anxiety and Depression -anxiety and Hospital Anxiety and Depression-depression subscale scores <8
timeFrame: Up to six weeks and six months after randomization
Secondary outcomes:
measure: Changes in rumination scores
timeFrame: Up to six weeks and six months after randomization
measure: Changes in worry scores
timeFrame: Up to six weeks and six months after randomization
measure: Changes in Positive Beliefs about Rumination Scale scores
timeFrame: Up to six weeks and six months after randomization
measure: Changes in Negative Beliefs about Rumination Scale scores
timeFrame: Up to six weeks and six months after randomization
measure: Changes in Metacognitions Questionnaire-30 scores
timeFrame: Up to six weeks and six months after randomization
measure: Changes in type d personality and its traits negative affectivity and social inhibition
timeFrame: Up to six weeks and six months after randomization
measure: Changes in quality of life
timeFrame: Up to six weeks and six months after randomization
measure: Changes in Bergen Insomnia Scale scores
timeFrame: Up to six weeks and six months after randomization
measure: Changes in C-reactive Protein (CRP)
timeFrame: Up to six weeks and six months after randomization
Other outcomes:
Locations:
city: Tønsberg
country: Norway
facility: Hospital of Vestfold
state: Vestfold And Telemark County
city: Drammen
country: Norway
facility: Vestre Viken Trust Drammen hospital
state: Viken County
Study officials:
References: