Clinical trial NCT01909102: The ACTonHEART Study: Design of a Randomized Controlled Clinical Trial of Acceptance and Commitment Therapy for Cardiac Patients
Official title: The ACTonHEART Study: a Randomized Controlled Clinical Trial of Acceptance and Commitment Therapy in Cardiac Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Acceptance and Commitment Therapy
Cardiac rehabilitation
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2013-07-26
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Low-density lipoprotein (LDL)cholesterol
timeFrame: Baseline and 12 months
measure: Blood pressure
timeFrame: baseline and 12 months
measure: Body Mass Index
timeFrame: baseline and 12 months
measure: Psychological Well-Being
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Health-related quality of life
timeFrame: Baseline and 12 months
measure: Dietary habits
timeFrame: Baseline and 12 months
measure: Physical activity
timeFrame: Baseline anf 12 months
measure: Smoking cessation
timeFrame: At 1-year follow-up
measure: Adherence to medication
timeFrame: Baseline and 12 months
measure: Exercise capability
timeFrame: Baseline and 12 months
Other outcomes:
measure: Psychological inflexibility
timeFrame: Baseline and 12 months
Locations:
city: Milano
country: Italy
facility: San Luca Hospital, Istituto Auxologico Italiano
Study officials:
affiliation: Istituto Auxologico Italiano
name: Gianluca Castelnuovo, PhD, PsyD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.