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

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

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Behavioral: ACT-based intervention; Behavioral: usual care

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 Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy, 20149
    • San Luca Hospital, Istituto Auxologico Italiano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: ACT-based intervention; Behavioral: usual care
Active Comparator: Usual care; Usual care is based on current guidelines for the long-term multi-disciplinary rehabilitation and prevention of cardiac patients.	Behavioral: usual care

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological inflexibility	Change from baseline psychological inflexibility. It will be measured through the Acceptance and Action Questionnaire-II, a self-report 10-item scale.	Baseline and 12 months

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano
• Investigators: Principal Investigator: Gianluca Castelnuovo, PhD, PsyD, Istituto Auxologico Italiano

Publications and helpful links

General Publications

• Goodwin CL, Forman EM, Herbert JD, Butryn ML, Ledley GS. A pilot study examining the initial effectiveness of a brief acceptance-based behavior therapy for modifying diet and physical activity among cardiac patients. Behav Modif. 2012 Mar;36(2):199-217. doi: 10.1177/0145445511427770. Epub 2011 Nov 30.
• Spatola CA, Manzoni GM, Castelnuovo G, Malfatto G, Facchini M, Goodwin CL, Baruffi M, Molinari E. The ACTonHEART study: rationale and design of a randomized controlled clinical trial comparing a brief intervention based on Acceptance and Commitment Therapy to usual secondary prevention care of coronary heart disease. Health Qual Life Outcomes. 2014 Feb 19;12:22. doi: 10.1186/1477-7525-12-22.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: July 17, 2013
• First Submitted That Met QC Criteria: July 23, 2013
• First Posted (Estimated): July 26, 2013

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Acceptance and Commitment Therapy; Cardiac rehabilitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 03C301