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

NCT01909102 | Completed

• 1 other identifier: 03C301
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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

Conditions

Cardiovascular Diseases

Keywords

Acceptance and Commitment Therapy; Cardiac rehabilitation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Health-related quality of life

  Baseline and 12 months

• Dietary habits

  Baseline and 12 months

• Physical activity

  Baseline anf 12 months

• Smoking cessation

  At 1-year follow-up

• Adherence to medication

  Baseline and 12 months

Other Outcomes (1)

• Psychological inflexibility

  Baseline and 12 months

Study Arms (2)

ACT-based intervention

EXPERIMENTAL

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

Usual care

ACTIVE COMPARATOR

Usual care is based on current guidelines for the long-term multi-disciplinary rehabilitation and prevention of cardiac patients.

Behavioral: usual care

Interventions

ACT-based intervention BEHAVIORAL

ACT-based intervention

usual care BEHAVIORAL

ACT-based intervention; Usual care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

San Luca Hospital, Istituto Auxologico Italiano

Milan, 20149, Italy

Location

Related Publications (3)

• 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.

  PMID: 22133992 BACKGROUND

• 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.

  PMID: 38866567 DERIVED

• 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.

  PMID: 24552555 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Gianluca Castelnuovo, PhD, PsyD

  Istituto Auxologico Italiano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2013
• First Posted: July 26, 2013
• Study Start: August 1, 2015
• Primary Completion: March 1, 2022
• Study Completion: April 1, 2022
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

IT (1)