Ischemic Heart DiseaseNCT04254315
OPTIMA: Psychological Distress and the Effect of Intensive Group Based Cognitive Therapy in Patients With Newly Diagnosed Ischemic Heart Disease
A study testing Group based cognitive therapy in people with Ischemic Heart Disease and Heart Valve Diseases, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
Trial summary
The overall objectives of the Optima project is to: (1) Compare the effect of standardized group based cognitive therapy and cardiac rehabilitation versus usual cardiac rehabilitation in patients with sign of psychological distress measured by a questionnaire (HADS score), (2) To investigate spontaneous variation in… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ischemic Heart Disease, Heart Valve Diseases, Psychological Distress
- What is being tested?
- Group based cognitive therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2019to 1 Apr 2022
- 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
- HADS score > 8 for HADS-A or HADS-D
- Age < 65 years
- Able to speak and understand Danish
Who cannot join
- Participation in rehabilitation program within the last 2 years
- Ejection Fraction (EF) < 35%
- Other serious comorbidity that are expected to have a serious impact on life expectancy
- Known abuse of alcohol or euphoric drugs. Known more serious psychopathology such as schizophrenia, bipolar disorder, severe personality disorder, and treatment with psychoactive drugs
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Cardiology department, Bispebjerg-Frederiksberg Hospital
Frederiksberg, 2000
About this study
Official title: OPTIMA: Psychological Distress and the Effect of Intensive Group Based Cognitive Therapy in Patients With Newly Diagnosed Ischemic Heart Disease: A Randomised Controlled Trial Protocol
The overall objectives of the Optima project is to: (1) Compare the effect of standardized group based cognitive therapy and cardiac rehabilitation versus usual cardiac rehabilitation in patients with sign of psychological distress measured by a questionnaire (HADS score), (2) To investigate spontaneous variation in psychological distress with HADS over time in order to optimize time of measuring HADS. (3) To investigate if the intervention can be implemented to other cardiac rehabilitation sites with the same effect as on BFH (that it is not person dependent).
Read the detailed description
HYPOTHESIS: There will be a significant difference in anxiety and depression score between intervention and usual care groups after intervention, in favor of the intervention group.
METHODS: Optima is a multi-center, prospective, randomized clinical trial in patients with newly diagnosed ischemic heart disease (IHD) or heart valve replacement, and concomitant significant score of psychological distress using the Hospital Anxiety and Depression Score (HADS) (HADS A(Anxiety) /D(Depression) ≥8 or HADS>15), age <65 years. Patients with HADS D≥11 and Beck Depression Inventory (BDI)>17 are evaluated by psychiatrists to offer the best treatment. 148 patients will be randomized to either intervention or control group. All patients are offered usual cardiac rehabilitation, and in addition, the intervention group is offered standardized group based cognitive therapy with the participation of maximum four patients, consisting of 5 sessions (each 2 hours) performed by a trained cardiac rehabilitation nurse. The intervention was developed on experiences from a Liaison nurse, who offered up to five individual consultations to patients with psychological distress. Together with a psychologist specialized in cognitive therapy the investigators developed a program based on cognitive behavioral methods from cognitive therapy as well as Acceptance and commitment therapy (ACT). Each session consists of specific cognitive models, which the patient can use in everyday life.
INTERVENTION: Patients are informed about the Optima program in the inclusion interview, and patients are participating in groups of maximum 4 persons. Each of the 5 session has a duration of 1,5 - 2 hours.
The psychologist have developed the content of each session, with attention to thoughts and feelings regarding the current situation after a heart-condition, and the effects on life conditions. Patients get the tools to overcoming the difficulties, they experience, f.x. anxiety and stress.
When other hospitals are joining the Optima project, the project nurse and psychologist are training the hospital staff as well as supervising.
The session are planned as follows Session 1: Identifying your values
- What is important in my life?
- How has my heart-condition effected my life?
- Where do I want to be in my life? And what challenges it? Session 2: Anxiety and techniques to reduce anxiety
- What is anxiety?
- Anxiety and heart symptoms
- Circle of anxiety
- Techniques to reduce anxiety, relaxation and breathing Session 3: Consequences of own behavior and behavioral analysis
- Behavior that reduces self-expression
- Heart disease and behavior
- Consequences of own behavior Session 4: Concerns and strategies for dealing with them
- What are concerns?
- The Worry Tree and how to use it.
- Strategies for handling concerns. Session 5: The balance between demands and capacity
- Thoughts about the future
- Working life, relations and family
Sessions are followed up with two interviews after 3 and 6 months, where the following are assessed:
- The Hospital Anxiety and Depression Scale (HADS) score
- Heart-related Quality of Life (HeartQoL)
- Blood samples
- Clinical assessment: Functional Classification of Angina (CCS), New York Heart Association (NYHA) score, Blood pressure, medical status, smoking/nonsmoking, weight, physical activity (self-assessment) cardiovascular readmissions
- Employment status
- return to work
- present psychosocial status
QUESTIONNAIRES: Questionnaires include validated assessment tools:
HADS: The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire that assesses anxiety and depression level in medically ill persons who are not admitted in psychiatric wards. The scale range is from 0 to 42, the lesser the score, the lesser signs of psychological distress. The scale offers two scores, HADS-A and HADS-D, and consists of seven questions to assess anxiety and seven questions to assess depression.
HeartQol: Heart-related Quality of Life is a disease-specific questionnaire that measures health-related quality of life in patients with heart disease. The questionnaire consists of 14 items and provides two subscales: a 10-item physical subscale and a 4-item emotional subscale, which are scored from 0 to 3. Higher scores indicating better HRQL.
Also, a questionnaire that measures present psychosocial status/situation is used. The questionnaire is based on clinical experience.
- Being tested
- Group based cognitive therapy
- Keywords
- Group based cognitive therapy, Ischemic Heart Disease, Heart Valve Diseases, Psychological Distress
- Medical subject headings
- Myocardial Ischemia, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group based cognitive therapyBehavioural
Patients are informed about the Optima program in the inclusion interview, and patients are participating in groups of maximum 4 persons. Each of the 5 session has a duration of 1,5 - 2 hours.
The psychologist have developed the content of each session, with attention to thoughts and feelings regarding the current situation after a heart-condition, and the effects on life conditions. Patients get the tools to overcoming the difficulties, they experience, f.x. anxiety and stress.
When other hospitals are joining the Optima project, the project nurse and psychologist are training the hospital staff as well as supervising.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac rehabilitation+cognitive therapy | Experimental | The intervention group receives usual cardiac rehabilitation, which consists of 8-wk supervised outpatient exercise with 2 weekly sessions of 1,5 hr with high-intensity interval and resistance training. The program was complemented with a weekly session of group-based patient education for 1,5 hr on heart disease, psychological issues and diet counseling. In addition, patients had one or more individual sessions with a cardiologist and a nurse respectively.
In addition, the intervention group follows a standardized group based cognitive therapy program with participation of maximum four patients, consisting of 5 sessions (each 2 hours) performed by a trained cardiac rehabilitation nurse. Receives: Behavioral: Group based cognitive therapy |
| Cardiac rehabilitation | No intervention | The control group receives usual cardiac rehabilitation, which consists of 8-wk supervised outpatient exercise with 2 weekly sessions of 1,5 hr with high-intensity interval and resistance training. The program was complemented with a weekly session of group-based patient education for 1,5 hr on heart disease, psychological issues and diet counseling. In addition, patients had one or more individual sessions with a cardiologist and a nurse respectively. . |
| Control group without psychological distress | No intervention | The control group receives usual cardiac rehabilitation, which consists of 8-wk supervised outpatient exercise with 2 weekly sessions of 1,5 hr with high-intensity interval and resistance training. The program was complemented with a weekly session of group-based patient education for 1,5 hr on heart disease, psychological issues and diet counseling. In addition, patients had one or more individual sessions with a cardiologist and a nurse respectively. . |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of the RCT is anxiety and depression measured by HADS
The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire that assesses anxiety and depression level in medically ill persons who are not admitted in psychiatric wards. The scale range is from 0 to 42, the lesser the score, the lesser signs of psychological distress.The scale offers two scores, HADS-A and HADS-D, and consists of seven questions to assess anxiety and seven questions to assess depression.
Measured: 3 months follow-up
The primary outcome of the RCT is anxiety and depression measured by HADS
The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire that assesses anxiety and depression level in medically ill persons who are not admitted in psychiatric wards. The scale range is from 0 to 42, the lesser the score, the lesser signs of psychological distress.The scale offers two scores, HADS-A and HADS-D, and consists of seven questions to assess anxiety and seven questions to assess depression.
Measured: 6 months follow-up
Secondary outcomes (2)
Adherence to cardiac rehabilitation, health-related quality of life measured by HeartQoL
Heart-related Quality of Life (HeartQoL) is a disease-specific questionnaire that measures health-related quality of life in patients with heart disease. The questionnaire consists of 14 items and provides two subscales: a 10-item physical subscale and a 4-item emotional subscale, which are scored from 0 to 3. Higher scores indicating better HRQL.Return to work, adherence to life style interventions, and cardiovascular readmissions. A questionnaire that measures present psychosocial status/situation. The questionnaire is based on clinical experience.
Measured: 3 months follow-up
Adherence to cardiac rehabilitation, health-related quality of life measured by HeartQoL
Heart-related Quality of Life (HeartQoL) is a disease-specific questionnaire that measures health-related quality of life in patients with heart disease. The questionnaire consists of 14 items and provides two subscales: a 10-item physical subscale and a 4-item emotional subscale, which are scored from 0 to 3. Higher scores indicating better HRQL.Return to work, adherence to life style interventions, and cardiovascular readmissions. A questionnaire that measures present psychosocial status/situation. The questionnaire is based on clinical experience.
Measured: 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Jan 2019
- Primary completion31 Dec 2021
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized study with * Intervention group * Control group with psychological distress * Control group without psychological distress (not part of randomization)
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanne Kruuse Rasmusen, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254315
- Sponsor's protocol ID
- H-16042832
- Status last verified
- Apr 2022
- First submitted
- 18 Jan 2020
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heran BS, Chen JM, Ebrahim S, Moxham T, Oldridge N, Rees K, Thompson DR, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD001800. doi: 10.1002/14651858.CD001800.pub2.
PubMed 21735386Damen NL, Versteeg H, Boersma E, Serruys PW, van Geuns RJ, Denollet J, van Domburg RT, Pedersen SS. Depression is independently associated with 7-year mortality in patients treated with percutaneous coronary intervention: results from the RESEARCH registry. Int J Cardiol. 2013 Sep 10;167(6):2496-501. doi: 10.1016/j.ijcard.2012.04.028. Epub 2012 May 3.
PubMed 22560933van Dijk MR, Utens EM, Dulfer K, Al-Qezweny MN, van Geuns RJ, Daemen J, van Domburg RT. Depression and anxiety symptoms as predictors of mortality in PCI patients at 10 years of follow-up. Eur J Prev Cardiol. 2016 Mar;23(5):552-8. doi: 10.1177/2047487315571889. Epub 2015 Feb 9.
PubMed 25665581Gulliksson M, Burell G, Vessby B, Lundin L, Toss H, Svardsudd K. Randomized controlled trial of cognitive behavioral therapy vs standard treatment to prevent recurrent cardiovascular events in patients with coronary heart disease: Secondary Prevention in Uppsala Primary Health Care project (SUPRIM). Arch Intern Med. 2011 Jan 24;171(2):134-40. doi: 10.1001/archinternmed.2010.510.
PubMed 21263103Blumenthal JA, Sherwood A, Smith PJ, Watkins L, Mabe S, Kraus WE, Ingle K, Miller P, Hinderliter A. Enhancing Cardiac Rehabilitation With Stress Management Training: A Randomized, Clinical Efficacy Trial. Circulation. 2016 Apr 5;133(14):1341-50. doi: 10.1161/CIRCULATIONAHA.115.018926. Epub 2016 Mar 21.
PubMed 27045127Zheng X, Zheng Y, Ma J, Zhang M, Zhang Y, Liu X, Chen L, Yang Q, Sun Y, Wu J, Yu B. Effect of exercise-based cardiac rehabilitation on anxiety and depression in patients with myocardial infarction: A systematic review and meta-analysis. Heart Lung. 2019 Jan;48(1):1-7. doi: 10.1016/j.hrtlng.2018.09.011. Epub 2018 Oct 23.
PubMed 30366575Holdgaard A, Eckhardt-Hansen C, Lund T, Lassen CF, Sibiliz KL, Hofsten DE, Prescott E, Rasmusen HK. Intensive group-based cognitive therapy in patients with cardiac disease and psychological distress-a randomized controlled trial protocol. Trials. 2021 Jul 16;22(1):455. doi: 10.1186/s13063-021-05405-3.
PubMed 34271952
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTIMA: Psychological Distress and the Effect of Intensive Group Based Cognitive Therapy in Patients With Newly Diagnosed Ischemic Heart Disease: A Randomised Controlled Trial Protocol
- ClinicalTrials.gov ID
- NCT04254315
- Acronym / sponsor ID
- H-16042832
- Keywords
- Group based cognitive therapy, Ischemic Heart Disease, Heart Valve Diseases, Psychological Distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 5 Feb 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 overall objectives of the Optima project is to: (1) Compare the effect of standardized group based cognitive therapy and cardiac rehabilitation versus usual cardiac rehabilitation in patients with sign of psychological distress measured by a questionnaire (HADS score), (2) To investigate spontaneous variation in psychological distress with HADS over time in order to optimize time of measuring HADS. (3) To investigate if the intervention can be implemented to other cardiac rehabilitation sites with the same effect as on BFH (that it is not person dependent).
Detailed description
HYPOTHESIS: There will be a significant difference in anxiety and depression score between intervention and usual care groups after intervention, in favor of the intervention group.
METHODS: Optima is a multi-center, prospective, randomized clinical trial in patients with newly diagnosed ischemic heart disease (IHD) or heart valve replacement, and concomitant significant score of psychological distress using the Hospital Anxiety and Depression Score (HADS) (HADS A(Anxiety) /D(Depression) ≥8 or HADS>15), age <65 years. Patients with HADS D≥11 and Beck Depression Inventory (BDI)>17 are evaluated by psychiatrists to offer the best treatment. 148 patients will be randomized to either intervention or control group. All patients are offered usual cardiac rehabilitation, and in addition, the intervention group is offered standardized group based cognitive therapy with the participation of maximum four patients, consisting of 5 sessions (each 2 hours) performed by a trained cardiac rehabilitation nurse. The intervention was developed on experiences from a Liaison nurse, who offered up to five individual consultations to patients with psychological distress. Together with a psychologist specialized in cognitive therapy the investigators developed a program based on cognitive behavioral methods from cognitive therapy as well as Acceptance and commitment therapy (ACT). Each session consists of specific cognitive models, which the patient can use in everyday life.
INTERVENTION: Patients are informed about the Optima program in the inclusion interview, and patients are participating in groups of maximum 4 persons. Each of the 5 session has a duration of 1,5 - 2 hours.
The psychologist have developed the content of each session, with attention to thoughts and feelings regarding the current situation after a heart-condition, and the effects on life conditions. Patients get the tools to overcoming the difficulties, they experience, f.x. anxiety and stress.
When other hospitals are joining the Optima project, the project nurse and psychologist are training the hospital staff as well as supervising.
The session are planned as follows Session 1: Identifying your values
- What is important in my life?
- How has my heart-condition effected my life?
- Where do I want to be in my life? And what challenges it? Session 2: Anxiety and techniques to reduce anxiety
- What is anxiety?
- Anxiety and heart symptoms
- Circle of anxiety
- Techniques to reduce anxiety, relaxation and breathing Session 3: Consequences of own behavior and behavioral analysis
- Behavior that reduces self-expression
- Heart disease and behavior
- Consequences of own behavior Session 4: Concerns and strategies for dealing with them
- What are concerns?
- The Worry Tree and how to use it.
- Strategies for handling concerns. Session 5: The balance between demands and capacity
- Thoughts about the future
- Working life, relations and family
Sessions are followed up with two interviews after 3 and 6 months, where the following are assessed:
- The Hospital Anxiety and Depression Scale (HADS) score
- Heart-related Quality of Life (HeartQoL)
- Blood samples
- Clinical assessment: Functional Classification of Angina (CCS), New York Heart Association (NYHA) score, Blood pressure, medical status, smoking/nonsmoking, weight, physical activity (self-assessment) cardiovascular readmissions
- Employment status
- return to work
- present psychosocial status
QUESTIONNAIRES: Questionnaires include validated assessment tools:
HADS: The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire that assesses anxiety and depression level in medically ill persons who are not admitted in psychiatric wards. The scale range is from 0 to 42, the lesser the score, the lesser signs of psychological distress. The scale offers two scores, HADS-A and HADS-D, and consists of seven questions to assess anxiety and seven questions to assess depression.
HeartQol: Heart-related Quality of Life is a disease-specific questionnaire that measures health-related quality of life in patients with heart disease. The questionnaire consists of 14 items and provides two subscales: a 10-item physical subscale and a 4-item emotional subscale, which are scored from 0 to 3. Higher scores indicating better HRQL.
Also, a questionnaire that measures present psychosocial status/situation is used. The questionnaire is based on clinical experience.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A randomized study with * Intervention group * Control group with psychological distress * Control group without psychological distress (not part of randomization)
| Arm | Type | Receives |
|---|---|---|
| Cardiac rehabilitation+cognitive therapy | Experimental | Behavioral: Group based cognitive therapyThe intervention group receives usual cardiac rehabilitation, which consists of 8-wk supervised outpatient exercise with 2 weekly sessions of 1,5 hr with high-intensity interval and resistance training. The program was complemented with a weekly session of group-based patient education for 1,5 hr on heart disease, psychological issues and diet counseling. In addition, patients had one or more individual sessions with a cardiologist and a nurse respectively. In addition, the intervention group follows a standardized group based cognitive therapy program with participation of maximum four patients, consisting of 5 sessions (each 2 hours) performed by a trained cardiac rehabilitation nurse. |
| Cardiac rehabilitation | No intervention | –The control group receives usual cardiac rehabilitation, which consists of 8-wk supervised outpatient exercise with 2 weekly sessions of 1,5 hr with high-intensity interval and resistance training. The program was complemented with a weekly session of group-based patient education for 1,5 hr on heart disease, psychological issues and diet counseling. In addition, patients had one or more individual sessions with a cardiologist and a nurse respectively. . |
| Control group without psychological distress | No intervention | –The control group receives usual cardiac rehabilitation, which consists of 8-wk supervised outpatient exercise with 2 weekly sessions of 1,5 hr with high-intensity interval and resistance training. The program was complemented with a weekly session of group-based patient education for 1,5 hr on heart disease, psychological issues and diet counseling. In addition, patients had one or more individual sessions with a cardiologist and a nurse respectively. . |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HADS score > 8 for HADS-A or HADS-D
- Age < 65 years
- Able to speak and understand Danish
Key exclusion criteria (4 listed)
- Participation in rehabilitation program within the last 2 years
- Ejection Fraction (EF) < 35%
- Other serious comorbidity that are expected to have a serious impact on life expectancy
- Known abuse of alcohol or euphoric drugs. Known more serious psychopathology such as schizophrenia, bipolar disorder, severe personality disorder, and treatment with psychoactive drugs
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 |
|---|---|---|
| Group based cognitive therapyPatients are informed about the Optima program in the inclusion interview, and patients are participating in groups of maximum 4 persons. Each of the 5 session has a duration of 1,5 - 2 hours. The psychologist have developed the content of each session, with attention to thoughts and feelings regarding the current situation after a heart-condition, and the effects on life conditions. Patients get the tools to overcoming the difficulties, they experience, f.x. anxiety and stress. When other hospitals are joining the Optima project, the project nurse and psychologist are training the hospital staff as well as supervising. | Behavioural | Cardiac rehabilitation+cognitive therapy |
Primary outcome
The primary outcome of the RCT is anxiety and depression measured by HADS
Time frame: 3 months follow-up
The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire that assesses anxiety and depression level in medically ill persons who are not admitted in psychiatric wards. The scale range is from 0 to 42, the lesser the score, the lesser signs of psychological distress.The scale offers two scores, HADS-A and HADS-D, and consists of seven questions to assess anxiety and seven questions to assess depression.
The primary outcome of the RCT is anxiety and depression measured by HADS
Time frame: 6 months follow-up
The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire that assesses anxiety and depression level in medically ill persons who are not admitted in psychiatric wards. The scale range is from 0 to 42, the lesser the score, the lesser signs of psychological distress.The scale offers two scores, HADS-A and HADS-D, and consists of seven questions to assess anxiety and seven questions to assess depression.
2 secondary outcomes
Adherence to cardiac rehabilitation, health-related quality of life measured by HeartQoL
Time frame: 3 months follow-up
Adherence to cardiac rehabilitation, health-related quality of life measured by HeartQoL
Time frame: 6 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Background: PubMed 21735386Heran BS, Chen JM, Ebrahim S, Moxham T, Oldridge N, Rees K, Thompson DR, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD001800. doi: 10.1002/14651858.CD001800.pub2.
- Background: PubMed 22560933Damen NL, Versteeg H, Boersma E, Serruys PW, van Geuns RJ, Denollet J, van Domburg RT, Pedersen SS. Depression is independently associated with 7-year mortality in patients treated with percutaneous coronary intervention: results from the RESEARCH registry. Int J Cardiol. 2013 Sep 10;167(6):2496-501. doi: 10.1016/j.ijcard.2012.04.028. Epub 2012 May 3.
- Background: PubMed 25665581van Dijk MR, Utens EM, Dulfer K, Al-Qezweny MN, van Geuns RJ, Daemen J, van Domburg RT. Depression and anxiety symptoms as predictors of mortality in PCI patients at 10 years of follow-up. Eur J Prev Cardiol. 2016 Mar;23(5):552-8. doi: 10.1177/2047487315571889. Epub 2015 Feb 9.
- Background: PubMed 21263103Gulliksson M, Burell G, Vessby B, Lundin L, Toss H, Svardsudd K. Randomized controlled trial of cognitive behavioral therapy vs standard treatment to prevent recurrent cardiovascular events in patients with coronary heart disease: Secondary Prevention in Uppsala Primary Health Care project (SUPRIM). Arch Intern Med. 2011 Jan 24;171(2):134-40. doi: 10.1001/archinternmed.2010.510.
- Background: PubMed 27045127Blumenthal JA, Sherwood A, Smith PJ, Watkins L, Mabe S, Kraus WE, Ingle K, Miller P, Hinderliter A. Enhancing Cardiac Rehabilitation With Stress Management Training: A Randomized, Clinical Efficacy Trial. Circulation. 2016 Apr 5;133(14):1341-50. doi: 10.1161/CIRCULATIONAHA.115.018926. Epub 2016 Mar 21.
- Background: PubMed 30366575Zheng X, Zheng Y, Ma J, Zhang M, Zhang Y, Liu X, Chen L, Yang Q, Sun Y, Wu J, Yu B. Effect of exercise-based cardiac rehabilitation on anxiety and depression in patients with myocardial infarction: A systematic review and meta-analysis. Heart Lung. 2019 Jan;48(1):1-7. doi: 10.1016/j.hrtlng.2018.09.011. Epub 2018 Oct 23.
- Derived from this study: PubMed 34271952Holdgaard A, Eckhardt-Hansen C, Lund T, Lassen CF, Sibiliz KL, Hofsten DE, Prescott E, Rasmusen HK. Intensive group-based cognitive therapy in patients with cardiac disease and psychological distress-a randomized controlled trial protocol. Trials. 2021 Jul 16;22(1):455. doi: 10.1186/s13063-021-05405-3.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group based cognitive therapy in people with Ischemic Heart Disease and Heart Valve Diseases, run by University Hospital Bispebjerg and Frederiksberg at 1 site 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary outcome of the RCT is anxiety and depression measured by HADS (time frame: 3 months follow-up). 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 NCT04254315, which also lists 7 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 22 Apr 2022.