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  • 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

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Cardiovascular medicine
Original research
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
  1. Chiara A M Spatola1,
  2. Giada Rapelli2,
  3. Emanuele Maria Giusti3,
  4. Roberto Cattivelli2,
  5. Christina L Goodwin4,5,
  6. Giada Pietrabissa6,
  7. Gabriella Malfatto7,
  8. Mario Facchini7,
  9. Emanuele A M Cappella8,
  10. Giorgia Varallo9,
  11. Gabriella Martino1,
  12. Gianluca Castelnuovo6,8
  1. 1 Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy
  2. 2 Department of Psychology Renzo Canestrari, Alma Mater Studiorum University of Bologna, Bologna, Italy
  3. 3 Department of Medicine and Surgery, University of Insubria, Varese, Italy
  4. 4 Cooper University Health Care, Camden, New Jersey, USA
  5. 5 Cooper University Medical School of Rowan University, Camden, New Jersey, USA
  6. 6 IRCCS Istituto Auxologico Italiano, Clinical Psychology Research Laboratory, Milan, Italy
  7. 7 Istituto Auxologico Italiano IRCCS, Dipartimento di Scienze Cardiovascolari, Neurologiche, Metaboliche, Ospedale San Luca, Milano, Italy
  8. 8 Catholic University of the Sacred Heart, Milano, Italy
  9. 9 Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Modena, Italy
  1. Correspondence to Dr Chiara A M Spatola; chiara.spatola{at}unime.it

Abstract

Objectives The main objective of the study is to investigate the short-term efficacy of Acceptance and Commitment Therapy (ACT) on the simultaneous modification of biological indicators of risk and psychological well-being in patients with coronary heart disease attending cardiac rehabilitation (CR).

Design This was a two-arm randomised controlled trial comparing a brief, manualised, ACT-based intervention with usual care (UC).

Setting The study was conducted in an outpatient CR unit in Italy. Data collection took place from January 2016 to July 2017.

Participants Ninety-two patients were enrolled and randomised, following an unbalanced randomisation ratio of 2:1 to the ACT group (n=59) and the control group (n=33). Eighty-five patients completed the ACT (n=54) and the UC (n=31) interventions and were analysed.

Interventions The control group received UC, a 6 weeks multidisciplinary outpatient CR programme, encompassing exercise training, educational counselling and medical examinations. The experimental group, in addition to UC, participated in the Acceptance and Commitment Therapy on HEART disease (ACTonHEART) intervention encompassing three group sessions based on ACT.

Outcomes The primary outcomes were Low Density Lipoproteins (LDL)cholesterol, resting systolic blood pressure, body mass index (BMI) and psychological well-being measured by the Psychological General Well-Being Index (PGWBI). Outcome measures were assessed at baseline and at the end of CR.

Results Based on linear mixed models, no significant group × time interaction was observed for either the primary outcomes (β, 95% CI: PGWBI =−1.13, –6.40 to –4.14; LDL cholesterol =−2.13, –11.02 to –6.76; systolic blood pressure =−0.50, –10.76 to –9.76; diastolic blood pressure =−2.73, –10.12 to –4.65; BMI =−0.16, –1.83 to –1.51, all p values >0.05) or the secondary outcomes (all p values >0.05). A significant time effect was found for the PGWBI total (beta=4.72; p=0.03).

Conclusions Although analyses revealed null findings, the results can inform the design of future ACT-based CR interventions and can help researchers to strike a balance between the idealised implementation of an ACT intervention and the structural limitations of existing CR programmes.

Trial registration number NCT01909102.

  • quality of life
  • ischaemic heart disease
  • coronary heart disease
  • psychosocial intervention
  • randomized controlled trial
  • stress, psychological

Data availability statement

Data are available in a public, open access repository. The raw data of this study are available at the following link: https://zenodo.org/records/10925257.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2024-084070

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    Data availability statement

    Data are available in a public, open access repository. The raw data of this study are available at the following link: https://zenodo.org/records/10925257.

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    Footnotes

    • GM and GC contributed equally.

    • Contributors Conceptualisation: CAMS, CLG, GR, RC and EAMC. Methodology, formal analysis: CAMS, EMG, GR and EAMC. Writing—original draft preparation: CAMS, GR, CLG and EMG. Writing—review and editing: CAMS, GR, RC, GMalfatto, GMartino, GP and GV. Supervision: GC, GMartino, GMalfatto and MF. Guarantor: CAMS. All authors have read and agreed to the published version of the manuscript.

    • Funding This work was supported by Italian Ministry of Health-Ricerca Corrente.

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.