None listed
Conditions
Brief summary
The objective of CHAMPS is to perform a feasibility trial to determine whether treatment of common mental health problems in cardiovascular diseases (CVDs) is feasible by comparison to enhanced usual care (EUC). The treatment arm concerns cognitive-behavioural therapy, specifically a type of transdiagnostic treatment of common mental health problems known as the Unified Protocol (UP). The findings will establish an estimate of treatment effect size to inform a larger definitive RCT. We hypothesize that the CHAMPS intervention arm will reduce symptoms of anxiety, depression, stress, reduce the number of psychiatric disorders, improve quality of life and cardiac endpoints in comparison to EUC at six months post-baseline (post-treatment in the treatment). The study seeks to randomise 25 persons to each study arm transdiagnostic UP vs. EUC. The CHAMPS intervention arm will consist of 12 to 18 weeks transdiagnostic cognitive-behavioural therapy. The EUC arm will consist of information regarding depression in CVDs provided to patient and physician, in accordance with the National Heart Foundation of Australia's recommendations. A secondary objective of CHAMPS is to determine the incidence of emotional problems such as affective disorders in persons without mental health problems at baseline. Therefore a cohort of patients will also be recruited whom have no emotional distress at baseline, and this particular group will serve as a non-distressed control group in order to evaluate the incidence of mental health problems in CVD patients. This methodology is similar to recent depression RCTs in CVD populations. Importantly, the non-distressed control group will form a reference population to determine whether longer term emotional functioning and other aspects of CVD functioning in the UP and EUC groups is comparable to a group who were not-distressed during hospitalization for CVD.
Interventions
The intervention consists of a type of psychotherapy known as the transdiagnostic Unified Protocol for the treatment of emotional disorders. The intervention is designed for 1 hour duration sessions on a weekly basis to a maximum of 18 sessions. The intervention will be delivered one-to-one by a qualified Masters level psychologist.
The transdiagnostic Unified Protocol for the treatment of emotional disorders is comprised by seven modules: (1) a preliminary module focusing on enhancing motivat
The intervention consists of a type of psychotherapy known as the transdiagnostic Unified Protocol for the treatment of emotional disorders. The intervention is designed for 1 hour duration sessions on a weekly basis to a maximum of 18 sessions. The intervention will be delivered one-to-one by a qualified Masters level psychologist. The transdiagnostic Unified Protocol for the treatment of emotional disorders is comprised by seven modules: (1) a preliminary module focusing on enhancing motivation and readiness for change and treatment engagement, as well as an introductory module educating patients on the nature of emotions and providing a framework for understanding their emotional experiences, (2) increasing present focused emotion awareness, (3) increasing cognitive flexibility, (4) identifying and preventing patterns of emotion avoidance and maladaptive emotion-driven behaviors (EDBs), (5) increasing awareness and tolerance of emotion-related physical sensations, and (6) interoceptive and situation-based emotion focused exposure, and (7) the final module is devoted to summarizing the relevant techniques attained and developing relapse prevention strategies. Each module may take 2-3 sessions to complete, duration will vary and will be carried at discretion of the psychologist in collaboration with the participant.
Sponsors
Dr Phillip Tully
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 100 No limit
Healthy volunteers
No
Inclusion criteria
Eligibility Criteria in Study Population: Eligible participants will; 1) be aged 18 years or older, 2) have primary hospital admission for CVD (specified by relevant International Classification of Disease codes for coronary artery disease, myocardial infarction, heart failure, atrial fibrillation, other ventricular or atrial arrhythmia, coronary revascularization intervention, symptomatic heart disease including angina pectoris, heart valve disease), 3) have a MINI Psychiatric diagnosis by randomisation naïve assessors of any; major depression, dysthymia, generalized anxiety disorder, panic disorder, agoraphobia, social anxiety/phobia, post-traumatic stress disorder or be above the severity threshold for Depression PHQ scores >= 10 or anxiety threshold GAD scores >= 7.
Exclusion criteria
1) have a psychosis diagnosis determined by medical history or randomisation naïve assessors or, 2) suicidal thought and intent, 3) observed cognitive impairment or dementia impeding delivery of psychotherapy, 4) receiving psychologist treatment elsewhere, 5) have a diagnosis of drug and alcohol dependence or abuse determined by randomisation naïve assessors, 6) medical condition likely to be fatal within 1 year, 7), in receipt of GP or psychiatrist counselling for psychological problems.
Outcome results
None listed