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

Cardiovascular Diseases Clinical Trial

— ACTonHEART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01909102
• Other study ID #: 03C301
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: April 2022

Study information

• Verified date: February 2024
• Source: Istituto Auxologico Italiano
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: April 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Behavioral:
• ACT-based intervention

• usual care

Locations

Country	Name	City	State
Italy	San Luca Hospital, Istituto Auxologico Italiano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Low-density lipoprotein (LDL)cholesterol	Change from baseline LDL cholesterol level	Baseline and 12 months
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Smoking cessation	Self-report of smoking status	At 1-year follow-up
Secondary	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
Secondary	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