The ACTonHEART Study: Design of a Randomized Controlled Clinical Trial of Acceptance and Commitment Therapy for Cardiac Patients

Study Overview
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Brief Summary
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The study will determine whether a brief intervention program based on Acceptance and Commitment Therapy can be effective for the reduction of modifiable risk factors and improvement of psychological well-being in patients referred to cardiac rehabilitation

Detailed Description
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The Acceptance and Commitment Therapy is a mindfulness-based intervention which efficacy has been proven in the treatment of depression and anxiety, in stress reduction and in the modification of health- related behaviors in patients with several physical conditions. The application of an acceptance-based program in cardiac patients has revealed high treatment satisfaction and initial evidences of effectiveness in increasing heart-healthy behaviour. The purpose of the trial is to evaluate the efficacy of a brief group-administered program based on Acceptance and Commitment Therapy in improving patients' ability to address modifiable multiple cardiovascular risk factors and overall psychological well-being, compared with the usual care.

Official Title
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The ACTonHEART Study: a Randomized Controlled Clinical Trial of Acceptance and Commitment Therapy in Cardiac Patients

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Behavioral: ACT-based intervention
* Behavioral: usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: having a current diagnosis of ischemic heart disease (IHD) being affected by major modifiable cardiovascular risk factors that will be assessed through the INTERHEART Modifiable Risk Score. Only subjects with a full score >9 will be included in the study. between the ages of 18 and 70 years fluency in spoken and written Italian language expression of written informed consent. Exclusion Criteria: cognitive impairment severe psychiatric disorders according to Diagnostic and Statistical Manual-IV TR criteria (APA, 2000).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACT-based intervention<br>The ACT-based intervention integrates educational topics on heart healthy behaviours with mindfulness and acceptance training regarding difficult thoughts and feelings, clarification of health-related values and commitment to behave in the valued direction while contacting difficult experiences. | Behavioral: ACT-based intervention<br> <br> Behavioral: usual care<br> <br> |
| Active Comparator: Usual care<br>Usual care is based on current guidelines for the long-term multi-disciplinary rehabilitation and prevention of cardiac patients. | Behavioral: usual care<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low-density lipoprotein (LDL)cholesterol | Change from baseline LDL cholesterol level | Baseline and 12 months | 
| Blood pressure | Change from baseline resting blood pressure (the mean of 2 measures taken 2 minutes apart with a manual sphygmomanometer) | baseline and 12 months | 
| Body Mass Index | Change from baseline Body Mass Index. It is calculated as weight in kilograms divided by height in meters squared | baseline and 12 months | 
| Psychological Well-Being | Change from baseline Psychological Well-Being. It will be measured by the Psychological General Well-Being Inventory. The PGWBI is a self-administered questionnaire composed by six sub-scales: anxiety, depression, positive well-being, self-control, general health and vitality. Higher scores indicate better health. | Baseline and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life | Change from baseline Health-related quality of life. The Short Form-36 questionnaire for evaluation of Quality Of Life is widely used and gives valuable information on Quality Of Life related to health. The patients' Quality Of Life will be assessed through the following eight fractions: physical function, physical role, general health, social function, experience of pain, mental health, emotional role and vitality. | Baseline and 12 months | 
| Dietary habits | Change from baseline dietary habits. They will be assessed through the Mediterranean diet score, a large-scale diet score based on the inherent characteristics of Mediterranean dietary pattern. Questions focused on the frequency of usual consumption of 11 main components of the Mediterranean diet (nonrefined cereals, fruits, vegetables, potatoes, legumes, olive oil, fish, red meat, poultry, full fat dairy products and alcohol). | Baseline and 12 months | 
| Physical activity | Change from baseline physical activity. It will be measured by The International Physical Activity Questionnaire (IPAQ), a self-report questionnaire that assesses the number of days per week and the number of times per day an individual spends doing specific activities. | Baseline anf 12 months | 
| Smoking cessation | Self-report of smoking status | At 1-year follow-up | 
| Adherence to medication | Change from baseline adherence to medication. The Modified Morisky Scale will be used. It is a eight-item self-reported measure of medication taking. | Baseline and 12 months | 
| Exercise capability | Change from baseline exercise capability. The exercise capability will be considered as the maximal power (in Watts) reached during an incremental bicycle stress test. | Baseline and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acceptance and Commitment Therapy, Cardiac rehabilitation