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Completed

NCT Number: NCT01909102

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

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Luca Hospital, Istituto Auxologico Italiano

Milan, 20149, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

ACT-based intervention

Behavioral

Usual Care

Behavioral

Primary outcomes

  1. Low-density lipoprotein (LDL)cholesterol

    Time frame: Baseline and 12 months

    Change from baseline LDL cholesterol level

  2. 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)

  3. 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

  4. 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

  1. Health-related quality of life

    Time frame: Baseline and 12 months

    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.

  2. Dietary habits

    Time frame: Baseline and 12 months

    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).

  3. Physical activity

    Time frame: Baseline anf 12 months

    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.

  4. Smoking cessation

    Time frame: At 1-year follow-up

    Self-report of smoking status

  5. Adherence to medication

    Time frame: Baseline and 12 months

    Change from baseline adherence to medication. The Modified Morisky Scale will be used. It is a eight-item self-reported measure of medication taking.

  6. Exercise capability

    Time frame: Baseline and 12 months

    Change from baseline exercise capability. The exercise capability will be considered as the maximal power (in Watts) reached during an incremental bicycle stress test.

Other outcomes

  1. Psychological inflexibility

    Time frame: Baseline and 12 months

    Change from baseline psychological inflexibility. It will be measured through the Acceptance and Action Questionnaire-II, a self-report 10-item scale.

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Registry information

Official study title

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

Acronym: ACTonHEART

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Jul 26, 2013
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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