The ACTonHEART Study: Design of a Randomized Controlled Clinical Trial of Acceptance and Commitment Therapy for Cardiac Patients
NCT ID: NCT01909102
Last Updated: 2024-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
92 participants
INTERVENTIONAL
2015-08-31
2022-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
ACT-based intervention
usual care
Usual care
Usual care is based on current guidelines for the long-term multi-disciplinary rehabilitation and prevention of cardiac patients.
usual care
Interventions
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ACT-based intervention
usual care
Eligibility Criteria
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Inclusion Criteria
* 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
* severe psychiatric disorders according to Diagnostic and Statistical Manual-IV TR criteria (APA, 2000).
18 Years
70 Years
ALL
No
Sponsors
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Istituto Auxologico Italiano
OTHER
Responsible Party
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Principal Investigators
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Gianluca Castelnuovo, PhD, PsyD
Role: PRINCIPAL_INVESTIGATOR
Istituto Auxologico Italiano
Locations
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San Luca Hospital, Istituto Auxologico Italiano
Milan, , Italy
Countries
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References
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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 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.
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.
Other Identifiers
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03C301
Identifier Type: -
Identifier Source: org_study_id
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