The ACTonHEART Study: a Randomized Controlled Clinical Trial of Acceptance and Commitment Therapy in Cardiac Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Istituto Auxologico Italiano
- Enrollment
- 92
- Locations
- 2
- Primary Endpoint
- Low-density lipoprotein (LDL)cholesterol
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
ACT-based intervention
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.
Intervention: ACT-based intervention (Behavioral)
ACT-based intervention
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.
Intervention: usual care (Behavioral)
Usual care
Usual care is based on current guidelines for the long-term multi-disciplinary rehabilitation and prevention of cardiac patients.
Intervention: usual care (Behavioral)
Outcomes
Primary Outcomes
Low-density lipoprotein (LDL)cholesterol
Time Frame: Baseline and 12 months
Change from baseline LDL cholesterol level
Blood pressure
Time Frame: baseline and 12 months
Change from baseline resting blood pressure (the mean of 2 measures taken 2 minutes apart with a manual sphygmomanometer)
Body Mass Index
Time Frame: baseline and 12 months
Change from baseline Body Mass Index. It is calculated as weight in kilograms divided by height in meters squared
Psychological Well-Being
Time Frame: Baseline and 12 months
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.
Secondary Outcomes
- Physical activity(Baseline anf 12 months)
- Smoking cessation(At 1-year follow-up)
- Adherence to medication(Baseline and 12 months)
- Exercise capability(Baseline and 12 months)
- Health-related quality of life(Baseline and 12 months)
- Dietary habits(Baseline and 12 months)