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Title: Cardiovascular Health in Anxiety or Mood Problems Study (CHAMPS): study protocol for a randomized controlled trial
Contributor(s): Tully, Phillip J  (author)orcid ; Turnbull, Deborah A (author); Horowitz, John D (author); Beltrame, John F (author); Selkow, Terina (author); Baune, Bernhard T (author); Markwick, Elizabeth (author); Sauer-Zavala, Shannon (author); Baumeister, Harald (author); Cosh, Suzanne  (author)orcid ; Wittert, Gary A (author)
Publication Date: 2016-01-11
Open Access: Yes
DOI: 10.1186/s13063-015-1109-z
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Abstract: Background: Previous psychological and pharmacological interventions have primarily focused on depression disorders in populations with cardiovascular diseases (CVDs) and the efficacy of anxiety disorder interventions is only more recently being explored. Transdiagnostic interventions address common emotional processes and the full range of anxiety and depression disorders often observed in populations with CVDs. The aim of CHAMPS is to evaluate the feasibility of a unified protocol (UP) for the transdiagnostic treatment of emotional disorders intervention in patients recently hospitalized for CVDs. The current study reports the protocol of a feasibility randomized controlled trial to inform a future trial. Methods/Design: This is a feasibility randomized, controlled trial with a single-center design. A total of 50 participants will be block-randomized to either a UP intervention or enhanced usual care. Both groups will receive standard CVD care. The UP intervention consists of 1) enhancing motivation, readiness for change, and treatment engagement; (2) psychoeducation about emotions; (3) increasing present focused emotion awareness; (4) increasing cognitive flexibility; (5) identifying and preventing patterns of emotion avoidance and maladaptive emotion-driven behaviors (EDBs, including tobacco smoking, and alcohol use); (6) increasing tolerance of emotion-related physical sensations; (7) interoceptive and situation-based emotion-focused exposure; and (8) relapse prevention strategies. Treatment duration is 12 to 18 weeks. Relevant outcomes include the standard deviation of self-rated anxiety, depression and quality of life symptoms. Other outcomes include intervention acceptability, satisfaction with care, rates of EDBs, patient adherence, physical activity, cardiac and psychiatric readmissions. Parallel to the main trial, a nonrandomized comparator cohort will be recruited comprising 150 persons scoring below the predetermined depression and anxiety severity thresholds. Discussion: CHAMPS is designed to evaluate the UP for the transdiagnostic treatment of emotional disorders targeting emotional disorder processes in a CVD population. The design will provide preliminary evidence of feasibility, attrition, and satisfaction with treatment to design a definitive trial. If the trial is feasible, it opens up the possibility for interventions to target broader emotional processes in the precarious population with CVD and emotional distress.
Publication Type: Journal Article
Grant Details: NHMRC/1053578
Source of Publication: Trials, v.17, p. 1-10
Publisher: BioMed Central Ltd
Place of Publication: United Kingdom
ISSN: 1745-6215
Field of Research (FoR) 2008: 170106 Health, Clinical and Counselling Psychology
110201 Cardiology (incl. Cardiovascular Diseases)
Field of Research (FoR) 2020: 520302 Clinical psychology
520303 Counselling psychology
520304 Health psychology
320101 Cardiology (incl. cardiovascular diseases)
Socio-Economic Objective (SEO) 2008: 920209 Mental Health Services
920410 Mental Health
Socio-Economic Objective (SEO) 2020: 200305 Mental health services
200409 Mental health
Peer Reviewed: Yes
HERDC Category Description: C1 Refereed Article in a Scholarly Journal
Description: This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (, which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated.
Appears in Collections:Journal Article
School of Psychology

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