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

Istituto Auxologico Italiano

Status: Completed

Conditions: Cardiovascular Diseases

Treatments: Behavioral: usual care; Behavioral: ACT-based intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01909102

03C301

Details and patient eligibility

About

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

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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92 participants in 2 patient groups

ACT-based intervention

Experimental group

Description:

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.

Treatment:

Behavioral: ACT-based intervention

Behavioral: usual care

Usual care

Active Comparator group

Description:

Usual care is based on current guidelines for the long-term multi-disciplinary rehabilitation and prevention of cardiac patients.

Treatment:

Behavioral: usual care