Published September 8, 2023 | Version v2
Dataset Restricted

The ACTonHEART Study: a Randomized Controlled Clinical Trial of a short intervention based on Acceptance and Commitment Therapy vs. usual care for cardiac rehabilitation patients with coronary heart disease.

  • 1. 1 Department of Clinical and Experimental Medicine, University of Messina, Italy.
  • 2. 2 Department of Medicine and Surgery, University of Parma, Parma, Emilia-Romagna, Italy.
  • 3. 3 EPIMED Research Center, Department of Medicine and Surgery, University of Insubria, Varese, Italy
  • 4. 4 Department of Psychology Renzo Canestrari, Alma Mater Studiorum, University of Bologna, Italy
  • 5. 5 VA Boston Healthcare System
  • 6. 2Istituto Auxologico Italiano IRCCS, Psychology Research Laboratory, Milan, Italy,
  • 7. 8 Istituto Auxologico Italiano, IRCCS, Dipartimento di Scienze Cardiovascolari, Neurologiche, Metaboliche, UO di Riabilitazione cardiologica, Ospedale S. Luca, Milano, Ital

Description

The ACTonHEART study evaluates the effectiveness of adding an ACT-based intervention to usual secondary prevention care of coronary heart disease, in order to promote healthy lifestyle changes and improve psychological wellbeing and quality of life among CR patients; psychological flexibility was a hypothesized mechanism of change.

Ninety-two patients were enrolled and randomized, following an unbalanced randomization ratio of 2:1, to the ACT group (N= 59) and the control group (N= 33). The control group completed standard CR (Usual Care; UC) and the experimental subjects participated in the ACTonHEART group intervention in addition to standard CR.  The ACTonHEART intervention consisted of three, two-hour, group sessions, focused on integrating acceptance and mindfulness skills into educational topics on heart-healthy behaviors. The primary study hypothesis is that the ACTonHEART group is superior to the UC group in the following primary outcome measures: LDL-cholesterol, resting systolic blood pressure, body mass index, and psychological wellbeing.

Participants were assessed at baseline and at the end of the rehabilitation period. Linear mixed models analyses were used to detect the group x time interaction. Across all outcome variables, no time x treatment effect was found. The results of this study may inform the future implementations of ACT in the cardiac rehabilitation context.

Corresponding author: Chiara Spatola (chiara.spatola@unime.it)

Files

Restricted

The record is publicly accessible, but files are restricted. <a href="https://zenodo.org/account/settings/login?next=https://zenodo.org/records/10925257">Log in</a> to check if you have access.