Cognitive TherapyNCT04582734
Screening and Intervention Reducing Anxiety in Patients With Cardiac Disease
A study testing Cognitive-behavioural therapy in people with Cognitive Therapy and Anxiety Disorders, run by Copenhagen University Hospital, Rigshospitalet at 4 sites in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive Therapy, Anxiety Disorders, Heart Diseases
- What is being tested?
- Cognitive-behavioural therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 4 sitesDenmark
- Study dates
- 1 Jun 2021to May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Aalborg University Hospital
Aalborg, 9000
Aarhus University Hospital
Aarhus N, 8200
Rigshospitalet
Copenhagen O, 2100
Herlev and Gentofte Hospital
Hellerup, 2900
About this study
Official title: Screening and Intervention Reducing Anxiety in Patients With Cardiac Disease: The Heart & Mind Trial
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.
Read the 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.
- Conditions
- Cognitive Therapy, Anxiety Disorders, Heart Diseases
- Being tested
- Cognitive-behavioural therapy
- Keywords
- Cognitive Therapy, Anxiety, Heart diseases
- Medical subject headings
- Anxiety Disorders, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioural therapyBehavioural
Cognitive-behavioural therapy intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention group - cognitive behavioral therapy | Experimental | The 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. Receives: Behavioral: Cognitive-behavioural therapy |
| Usual Care group | No intervention | The usual care group (control group) will receive usual care which consists cardiac disease control and treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 months
Secondary outcomes (3)
Becks Anxiety Inventory (BAI)
Becks Anxiety Inventory is a brief self-reported measure of anxiety with a focus on somatic symptoms of anxiety and was developed as a measure to discriminate between anxiety and depression. Respondents indicated how much each symptom has bothered them during the past week on a 4-point Likert scale ranging from 0 (not at all) to 3 (severely).
The BAI score ranges from 0-63.
Measured: Baseline, 5 months and 12 months
Heart rate variability (HRV)
HRV is measured using a Holter monitor. HRV are responsive to sympathetic activity, which can be increased by anxiety. HRV refers to the beat-to-beat variation in the RR interval and is a marker of autonomic nervous system activity.
Measured: Baseline, 5 months
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start1 Jun 2021
- Primary completion1 Nov 2023
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cognitive TherapyStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 336 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev and Gentofte Hospital, Aalborg University Hospital, Aarhus University Hospital
- Responsible party
- Principal investigator, Selina Kikkenborg Berg, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Selina K Berg, PhD, Principal investigator, Copenhagen University Hospital, Rigshospitalet, Denmark.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582734
- Sponsor's protocol ID
- The Heart & Mind Trial
- Status last verified
- Apr 2024
- First submitted
- 24 Sep 2020
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berg SK, Rasmussen LR, Thorup CB, Rasmussen TB, Christensen AV, Hammer CB, Jorgensen MB, Svendsen JH, Risom SS, Juul C, Schjodt I. Prevalence and types of anxiety disorders among patients with cardiac conditions and elevated HADS-A scores: findings from the initial screening phase of the Heart and Mind trial in Denmark. BMJ Open. 2026 May 8;16(5):e113682. doi: 10.1136/bmjopen-2025-113682.
PubMed 42103379Berg 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.
PubMed 34862302
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Intervention Reducing Anxiety in Patients With Cardiac Disease: The Heart & Mind Trial
- ClinicalTrials.gov ID
- NCT04582734
- Acronym / sponsor ID
- The Heart & Mind Trial
- Conditions
- Cognitive Therapy, Anxiety Disorders, Heart Diseases
- Keywords
- Cognitive Therapy, Anxiety, Heart diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 336 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Herlev and Gentofte Hospital, Aalborg University Hospital, Aarhus University Hospital
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- May 2024 (estimated)
- First posted
- 9 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group - cognitive behavioral therapy | Experimental | Behavioral: Cognitive-behavioural therapyThe 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 intervention | –The usual care group (control group) will receive usual care which consists cardiac disease control and treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-behavioural therapyCognitive-behavioural therapy intervention | Behavioural | Intervention group - cognitive behavioral therapy |
Primary outcome
Hospital Anxiety and Depression Scale (HADS) Anxiety
Time frame: 5 months
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.
3 secondary outcomes
Becks Anxiety Inventory (BAI)
Time frame: Baseline, 5 months and 12 months
Heart rate variability (HRV)
Time frame: Baseline, 5 months
Hospital Anxiety and Depression Scale (HADS) Anxiety
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Derived from this study: PubMed 42103379Berg SK, Rasmussen LR, Thorup CB, Rasmussen TB, Christensen AV, Hammer CB, Jorgensen MB, Svendsen JH, Risom SS, Juul C, Schjodt I. Prevalence and types of anxiety disorders among patients with cardiac conditions and elevated HADS-A scores: findings from the initial screening phase of the Heart and Mind trial in Denmark. BMJ Open. 2026 May 8;16(5):e113682. doi: 10.1136/bmjopen-2025-113682.
- Derived from this study: PubMed 34862302Berg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selina K Berg, PhD principal investigator
Copenhagen University Hospital, Rigshospitalet, Denmark.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-behavioural therapy in people with Cognitive Therapy and Anxiety Disorders, run by Copenhagen University Hospital, Rigshospitalet at 4 sites in Denmark.
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 6 inclusion and 0 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 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression Scale (HADS) Anxiety (time frame: 5 months). 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 NCT04582734, 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 15 Apr 2024.