Screening and Intervention Reducing Anxiety in Patients With Cardiac Disease
1 other identifier
interventional
336
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2021
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2020
CompletedFirst Posted
Study publicly available on registry
October 9, 2020
CompletedStudy Start
First participant enrolled
June 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedApril 15, 2024
April 1, 2024
2.4 years
September 24, 2020
April 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hospital Anxiety and Depression Scale (HADS) Anxiety
Primary outcome is anxiety measured by HADS-A. HADS is a 14 item questionnaire that assesses anxiety and depression level in medical ill persons who are not admitted in psychiatric wards. Scores of 0 to 7 for either subscale are regarded as normal and scores of 8 to 10 suggest the presence of a mood disorder. Scores of 11 and above suggest probable presence of a mood disorder.
5 months
Secondary Outcomes (3)
Becks Anxiety Inventory (BAI)
Baseline, 5 months and 12 months
Heart rate variability (HRV)
Baseline, 5 months
Hospital Anxiety and Depression Scale (HADS) Anxiety
Baseline
Other Outcomes (11)
Cortisol level
Baseline, 5 months
C-reactive protein (CRP)
Baseline, 5 months
Heart Quality of Life (HeartQoL)
Baseline, 5 months and 12 months
- +8 more other outcomes
Study Arms (2)
Intervention group - cognitive behavioral therapy
EXPERIMENTALThe intervention consists of three parts: 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.The intervention is considered finalized if the patient has a HADS-A score under 8 two times in a row. The intervention group will receive usual care as well.
Usual Care group
NO INTERVENTIONThe usual care group (control group) will receive usual care which consists cardiac disease control and treatment.
Interventions
Cognitive-behavioural therapy intervention
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rigshospitalet, Denmarklead
- Herlev and Gentofte Hospitalcollaborator
- Aalborg University Hospitalcollaborator
- Aarhus University Hospitalcollaborator
Study Sites (4)
Aalborg University Hospital
Aalborg, 9000, Denmark
Aarhus University Hospital
Aarhus N, 8200, Denmark
Rigshospitalet
Copenhagen O, 2100, Denmark
Herlev and Gentofte Hospital
Hellerup, 2900, Denmark
Related Publications (1)
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.
PMID: 34862302DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Selina K Berg, PhD
Copenhagen University Hospital, Rigshospitalet, Denmark.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Because of the conditions required for psycho-educational interventions, it is not possible to blind the intervention staff and patients. All baseline information and clinical interviews are collected and performed before randomization. Physical tests, data collection, data management and administration will be done by blinded staff. Statistical analysis of outcomes and conclusions from these will be blinded. Results of the trial are analysed by an independent statistician, and the results will be interpreted by the research group. The conclusion will be prepared in two versions, before the allocation code is broken, with the two arms alternately assumed as intervention (one that assumes that arm A is the intervention, and second, that assumes that the arm B intervention).
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 24, 2020
First Posted
October 9, 2020
Study Start
June 1, 2021
Primary Completion
November 1, 2023
Study Completion
May 1, 2024
Last Updated
April 15, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share