Clinical trial NCT04582734: Screening and Intervention Reducing Anxiety in Patients With Cardiac Disease
Official title: Screening and Intervention Reducing Anxiety in Patients With Cardiac Disease: The Heart & Mind Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cognitive Therapy
Anxiety Disorders
Heart Diseases
Keywords: Cognitive Therapy
Anxiety
Heart diseases
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Herlev and Gentofte Hospital
name: Aalborg University Hospital
name: Aarhus University Hospital
First posted: 2020-10-09
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The hypothesis is that there is a significant difference in anxiety scores between intervention and usual care group after intervention. The aim of Heart \& Mind Trial is (I) to determine the type of anxiety in cardiac patients and (ii) to investigate the effect of individual cognitive behavioural therapeutic intervention to reduce anxiety in patients with cardiac disease and anxiety compared to usual care.

Detailed description: The Heart \& Mind Trial is an investigator-initiated randomised clinical superiority trial with blinded outcome assessment, including four university hospitals, with 1:1 randomisation to cognitive therapy plus usual care or usual care alone.

The intervention: all patients receive usual care. Patients in the intervention group will receive an intervention based on cognitive behavioral therapy.

The intervention consists of three steps: (1) screening of hospitalised and outpatient cardiac patients at four university hospitals using the Hospital Anxiety and Depression Scale (HADS), scores ≥8 are invited to participate. (2) Assessment of type of anxiety by Structured Clinical Interview for DSM Disorders (SCID). (3) Investigator-initiated randomised clinical superiority trial with blinded outcome assessment, with 1:1 randomisation to cognitive-behavioural therapy (CBT) performed by a cardiac nurse with (CBT) training, plus usual care or usual care alone.

Eligibility criteria: Inclusion Criteria:

* Patients must be ≥18 years
* Diagnosed with cardiac disease
* Speak and understand Danish
* Score ≥8 on the Hospital Anxiety and Depression Scale - Anxiety (HADS-A)
* HADS-A score must exceed the HADS-D score
* Gives written informed consent.

Primary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS) Anxiety
timeFrame: 5 months
Secondary outcomes:
measure: Becks Anxiety Inventory (BAI)
timeFrame: Baseline, 5 months and 12 months
measure: Heart rate variability (HRV)
timeFrame: Baseline, 5 months
measure: Hospital Anxiety and Depression Scale (HADS) Anxiety
timeFrame: Baseline
Other outcomes:
measure: Cortisol level
timeFrame: Baseline, 5 months
measure: C-reactive protein (CRP)
timeFrame: Baseline, 5 months
measure: Heart Quality of Life (HeartQoL)
timeFrame: Baseline, 5 months and 12 months
measure: Health behaviour - Sleep quality
timeFrame: Baseline, 5 months and 12 months
measure: Health behaviour - Physical activity
timeFrame: Baseline, 5 months and 12 months
measure: Health behaviour - Alcohol
timeFrame: Baseline, 5 months and 12 months
measure: Health behaviour - Smoking
timeFrame: Baseline, 5 months and 12 months
measure: Health behaviour - Weight.
timeFrame: Baseline, 5 months and 12 months
measure: Number of participants with admissions, readmissions and number of patients who died during the trial period.
timeFrame: 12 months
measure: Hospital Anxiety and Depression Scale (HADS) Depression
timeFrame: Baseline, (intervention group: every CBT session), 5 months and 12 months
measure: Hospital Anxiety and Depression Scale (HADS) Anxiety
timeFrame: 12 months
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen O
country: Denmark
facility: Rigshospitalet
city: Hellerup
country: Denmark
facility: Herlev and Gentofte Hospital
Study officials:
affiliation: Copenhagen University Hospital, Rigshospitalet, Denmark.
name: Selina K Berg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berg SK, Herning M, Schjodt I, Thorup CB, Juul C, Svendsen JH, Jorgensen MB, Risom SS, Christensen SW, Thygesen L, Rasmussen TB. The heart & mind trial: intervention with cognitive-behavioural therapy in patients with cardiac disease and anxiety: randomised controlled trial protocol. BMJ Open. 2021 Dec 3;11(12):e057085. doi: 10.1136/bmjopen-2021-057085.