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Cardiovascular DiseasesACTonHEARTNCT01909102

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

A study testing ACT-based intervention in people with Cardiovascular Diseases, run by Istituto Auxologico Italiano at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Cardiovascular Diseases
What is being tested?
ACT-based intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteItaly
Study dates
Aug 2015to Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • cognitive impairment
  • severe psychiatric disorders according to Diagnostic and Statistical Manual-IV TR criteria (APA, 2000).

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • San Luca Hospital, Istituto Auxologico Italiano

    Milan, 20149

Other trials in Italy

About this study

Official title: 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

Read the 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.

Being tested
ACT-based intervention, usual care
Keywords
Acceptance and Commitment Therapy, Cardiac rehabilitation
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACT-based interventionBehavioural

  • usual careBehavioural

Study groups in NCT01909102
Study groupRoleWhat they receive
ACT-based interventionExperimentalThe 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.
Receives: Behavioral: ACT-based intervention; Behavioral: usual care
Usual careActive comparatorUsual care is based on current guidelines for the long-term multi-disciplinary rehabilitation and prevention of cardiac patients.
Receives: Behavioral: usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Low-density lipoprotein (LDL)cholesterol

    Change from baseline LDL cholesterol level

    Measured: Baseline and 12 months

  2. Blood pressure

    Change from baseline resting blood pressure (the mean of 2 measures taken 2 minutes apart with a manual sphygmomanometer)

    Measured: baseline and 12 months

  3. Body Mass Index

    Change from baseline Body Mass Index. It is calculated as weight in kilograms divided by height in meters squared

    Measured: baseline and 12 months

  4. 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.

    Measured: Baseline and 12 months

Secondary outcomes (6)

  1. 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.

    Measured: Baseline and 12 months

  2. 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).

    Measured: Baseline and 12 months

  3. 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.

    Measured: Baseline anf 12 months

  4. Smoking cessation

    Self-report of smoking status

    Measured: At 1-year follow-up

  5. 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.

    Measured: Baseline and 12 months

  6. 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.

    Measured: Baseline and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2013 (estimated)
  2. Study startAug 2015
  3. Primary completionMar 2022
  4. Study completionApr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01909102
Sponsor's protocol ID
03C301
Acronym
ACTonHEART
Status last verified
Feb 2024
First submitted
17 Jul 2013
Last updated
20 Feb 2024
Results posted
No
Data monitoring committee
No

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.

    PubMed 22133992

  • Spatola CAM, Rapelli G, Giusti EM, Cattivelli R, Goodwin CL, Pietrabissa G, Malfatto G, Facchini M, Cappella EAM, Varallo G, Martino G, Castelnuovo G. Effects of a brief intervention based on Acceptance and Commitment Therapy versus usual care for cardiac rehabilitation patients with coronary heart disease (ACTonHEART): a randomised controlled trial. BMJ Open. 2024 Jun 12;14(6):e084070. doi: 10.1136/bmjopen-2024-084070.

    PubMed 38866567

  • 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.

    PubMed 24552555

Questions about this trial

What is this clinical trial studying?

A study testing ACT-based intervention in people with Cardiovascular Diseases, run by Istituto Auxologico Italiano at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Low-density lipoprotein (LDL)cholesterol (time frame: Baseline and 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01909102, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.

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