Cardiovascular Health in Anxiety or Mood Problems Study (CHAMPS): study protocol for a randomized controlled trial

Abstract

BackgroundPrevious 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/DesignThis 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.DiscussionCHAMPS 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.Trial registrationACTRN12615000555550, registered on 29/05/2015

Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Medical Conditions: A Systematic Review

“…First, each protocol was developed in a different country. One, published in 2016, describes a study to be conducted in Australia [ 51 ]. The remaining two, published in 2020, describe studies to be performed in Spain [ 52 ] and the USA [ 53 ].…”

“…Each study protocol focuses on applying the UP in adults with emotional symptomatology or EDs, and different medical conditions; specifically, in people with obesity who undergo bariatric surgery [ 52 ], urinary problems [ 53 ], and cardiovascular diseases [ 51 ], respectively. The intended sample size for each study will range from 40 to 200 participants, who will be recruited in all the three cases in a hospital setting.…”

Identifying the Internalizing Disorder Clusters Among Recently Hospitalized Cardiovascular Disease Patients: A Receiver Operating Characteristics Study

“…All patients were followed-up for a repeat screening approximately 2 weeks later with the PHQ-9, GAD-7, OASIS, DASS-stress, and the MINI. Patients with a PHQ-9 total score ≥10 and/or GAD-7 total score ≥7 on both occasions, and a MINI depression or anxiety disorder, were deemed eligible for the feasibility study (Tully et al, 2016). Otherwise, participants were included in a non-distressed control group.…”

“…Data for this study were obtained from a single-blind randomized control trial to evaluate the feasibility of the unified protocol for the transdiagnostic treatment of emotional disorders in patients recently hospitalized for CVD (Tully et al, 2016). Participant recruitment took place from January 2016 until March 2017 at the Queen Elizabeth Hospital, a tertiary hospital in the Western urban area of Adelaide, South Australia.…”

Pengaruh Rehabilitasi: Jalan Kaki Enam Menit terhadap Peningkatan Kadar Hemoglobin pada Pasien Sindroma Koroner Akut

“…Pengaruh terhadap psikologis yaitu, mampu melakukan aktivitas fisik secara mandiri, menunjukkan kemampuan secara kognitif dan emosional. Sedangkan pengaruh terhadap fungsi sosial, yaitu saling mendukung dalam latihan, tumbuh kepercayaan diri, peningkatan status fungsi sosial, merasa berharga untuk orang lain, dapat melakukan aktivitas sosial, dan mendapatkan dukungan sosial yang tinggi dari keluarga maupun lingkungan sekitar (Rejeski et al, 2014;Tully, 2016 Distribusi rata-rata IMT pada kelompok kontrol dan kelompok intervensi adalah 25,0 Kg/m² dan 26,3 Kg/m², dengan standar deviasi 4,9 dan 3,8. Rata-rata tekanan darah sistolik pada kelompok kontrol dan kelompok intervensi adalah 129,8 mmHg dan 138,9 mmHg, dengan standar deviasi 8,8 dan 8,1.…”