title: 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.
abstract: BACKGROUND
  Modifiable risk factors, including life-style habits and psychological variables, have been increasingly demonstrated to have an important role in influencing morbidity and mortality in cardiovascular patients, and to account for approximately 90% of the population risk for cardiac events.Acceptance and Commitment Therapy (ACT) has shown effectiveness in promoting healthy behaviors, and improving psychological well-being in patients with chronic physical conditions. Moreover, a first application of an acceptance-based program in cardiac patients has revealed high treatment satisfaction and initial evidences of effectiveness in increasing heart-healthy behaviour. However, no clinical trial to date has evaluated the efficacy of an acceptance-based program for the modification of cardiovascular risk factors and the improvement of psychological well-being, compared to usual secondary prevention care.
  
  
  METHODS
  Approximately 168 patients will be recruited from an outpatient cardiac rehabilitation unit and randomly assigned to receive usual care or usual care + a brief ACT-based intervention. The ACT group will be administered five group therapy sessions integrating educational topics on heart-healthy behaviours with acceptance and mindfulness skills. Participants will be assessed at baseline, six weeks later (post treatment for the ACT condition), at six and twelve months follow-up.A partially-nested design will be used to balance effects due to clustering of participants into small therapy groups. Primary outcome measures will include biological indicators of cardiovascular risk and self-reported psychological well-being. Treatment effects will be tested via multilevel modeling after which the mediational role of psychological flexibility will be evaluated.
  
  
  CONCLUSIONS
  The ACTonHEART study is the first randomized clinical trial designed to evaluate the efficacy of a brief group-administered, ACT-based program to promote health behavior change and psychological well-being among cardiac patients. Results will address the effectiveness of a brief treatment created to simultaneously impact multiple cardiovascular risk factors. Conducted in the context of clinical practice, this trial will potentially offer empirical support to alternative interventions to improve quality of life and reduce mortality and morbidity rates among cardiac patients.
  
  
  BACKGROUND
  clinicaltrials.gov/ (NCT01909102).
authors.affiliation: Istituto Auxologico Italiano IRCCS, Psychology Research Laboratory, Milan, Italy. c.spatola@auxologico.it.
authors.forename: Chiara A M
authors.initials: CA
authors.lastname: Spatola
authors.forename: Gian Mauro
authors.initials: GM
authors.lastname: Manzoni
authors.forename: Gianluca
authors.initials: G
authors.lastname: Castelnuovo
authors.forename: Gabriella
authors.initials: G
authors.lastname: Malfatto
authors.forename: Mario
authors.initials: M
authors.lastname: Facchini
authors.forename: Christina L
authors.initials: CL
authors.lastname: Goodwin
authors.forename: Matteo
authors.initials: M
authors.lastname: Baruffi
authors.forename: Enrico
authors.initials: E
authors.lastname: Molinari
mesh_terms: D064869:Acceptance and Commitment Therapy / Q000379:methods*; D000293:Adolescent; D000328:Adult; D000368:Aged; D003327:Coronary Disease / Q000523:psychology / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006304:Health Status; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D011320:Primary Health Care; D011594:Psychometrics; D011788:Quality of Life; D012107:Research Design; D012307:Risk Factors; D055502:Secondary Prevention / Q000379:methods*; D016896:Treatment Outcome; D055815:Young Adult