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OPTIMA: Psychological Distress and the Effect of Intensive Group Based Cognitive Therapy in Patients With Newly Diagnosed Ischemic Heart Disease

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ClinicalTrials.gov Identifier: NCT04254315
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Hanne Kruuse Rasmusen, University Hospital Bispebjerg and Frederiksberg

Brief 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 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).

Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Heart Valve Diseases Psychological Distress Behavioral: Group based cognitive therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
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
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cardiac rehabilitation+cognitive therapy

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.

Behavioral: Group based cognitive therapy

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.


No Intervention: Cardiac rehabilitation
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. .
No Intervention: Control group without psychological distress
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. .



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Adherence to cardiac rehabilitation, health-related quality of life measured by HeartQoL [ Time Frame: 3 months follow-up ]
    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.

  2. Adherence to cardiac rehabilitation, health-related quality of life measured by HeartQoL [ Time Frame: 6 months follow-up ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HADS score > 8 for HADS-A or HADS-D
  • Age < 65 years
  • Able to speak and understand Danish

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04254315


Contacts
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Contact: Annette Holdgaard, Nurse +4522218260 annette.holdgaard@regionh.dk
Contact: Hanne Kruuse Rasmusen, MD hanne.kruuse.rasmusen@regionh.dk

Locations
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Denmark
Cardiology department, Bispebjerg-Frederiksberg Hospital Recruiting
Frederiksberg, Denmark, 2000
Contact: Annette Holdgaard, Nurse    +4522218260    annette.holdgaard@regionh.dk   
Contact: Hanne Kruuse Rasmusen, MD       hanne.kruuse.rasmusen@regionh.dk   
Sponsors and Collaborators
University Hospital Bispebjerg and Frederiksberg
Publications:

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Responsible Party: Hanne Kruuse Rasmusen, Associate Professor, University Hospital Bispebjerg and Frederiksberg
ClinicalTrials.gov Identifier: NCT04254315    
Other Study ID Numbers: H-16042832
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hanne Kruuse Rasmusen, University Hospital Bispebjerg and Frederiksberg:
Group based cognitive therapy
Ischemic Heart Disease
Heart Valve Diseases
Psychological Distress
Additional relevant MeSH terms:
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Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Heart Valve Diseases
Ischemia
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases