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Trial registered on ANZCTR


Registration number
ACTRN12615000555550
Ethics application status
Approved
Date submitted
28/04/2015
Date registered
29/05/2015
Date last updated
2/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Cardiovascular Health in Anxiety or Mood Problems Study (CHAMPS): A feasability study of transdiagnostic treatment for emotional disorders among cardiac patients
Scientific title
Cardiovascular Health in Anxiety or Mood Problems Study (CHAMPS): A feasability study of transdiagnostic treatment for emotional disorders among cardiac patients
Secondary ID [1] 286599 0
Nil known
Universal Trial Number (UTN)
U1111-1169-6415
Trial acronym
CHAMPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiovascular disease 294907 0
coronary heart disease 295016 0
anxiety 295017 0
depression 295018 0
Condition category
Condition code
Cardiovascular 295154 295154 0 0
Coronary heart disease
Mental Health 295155 295155 0 0
Depression
Mental Health 295156 295156 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 291726 0
Treatment: Other
Comparator / control treatment
Randomization to the enhanced usual care group will receive an education package delivered by the study coordinator consisting of the beyondblue fact sheet regarding anxiety, depression and coronary heart disease. Participants and their general physician will be informed of the baseline distress results and directed to available clinical
services (psychologist or psychiatrist), advising participants to seek assistance for achieving mental wellbeing with the support of their general physician. This conforms with the National Heart Foundation of Australia’s depression screening guidelines for CHD. There will be no restrictions on usual care.
Control group
Active

Outcomes
Primary outcome [1] 294919 0
The primary outcome is change in depression symptoms. Depression symptoms will be measured by the 9-item Patient Health Questionnaire (PHQ-9). A clinical treatment response is indicated by a 50% reduction or total PHQ scores <10.
Timepoint [1] 294919 0
Depression symptoms measured by the PHQ-9 at 6 months after randomisation.
Primary outcome [2] 294920 0
The primary outcome is change in anxiety symptoms. Anxiety symptoms will be measured by the 7-item Generalized Anxiety Disorder (GAD-7) questionnaire. A clinical treatment response is indicated by a 50% reduction or total GAD-7 scores <7.
Timepoint [2] 294920 0
Anxiety symptoms measured by the GAD-7 at 6 months after randomisation.
Secondary outcome [1] 314349 0
Anxiety avoidance and severity will be measured by the Overall Anxiety and Severity Impairment Scale (OASIS), a 5 item brief measure. Scores >8 are indicative of severe anxiety, a 50% reduction in considered a clinically relevant treatment response.
Timepoint [1] 314349 0
Anxiety scores measured by the OASIS scale at 6 months after randomisation.
Secondary outcome [2] 314350 0
Stress will be measured by the Depression, Anxiety and Stress Scales (DASS-21), a 21 item clinical measure commonly used in Australia, validated in adults to age 90 years and in previous studies in the cardiac surgery population. Mild distress for the Stress scale is >8.
Timepoint [2] 314350 0
DASS-21 stress subscale scores at 6 months after randomisation.
Secondary outcome [3] 314351 0
Physical quality of life measured by the SF-12.
Timepoint [3] 314351 0
Physical quality of life measured by the SF-12 at 6 months after randomisation.
Secondary outcome [4] 314352 0
Mental quality of life measured by the SF-12.
Timepoint [4] 314352 0
Mental quality of life measured by the SF-12 at 6 months after randomisation.
Secondary outcome [5] 314353 0
Emotion Driven Behaviors targeted by the UP intervention;
Tobacco smoking – Questions from the Global Adult Tobacco Survey, relating to lifetime and current tobacco use.
Alcohol use – AUDIT-C – this survey asks 3 questions relating to recent alcohol use that provide favourable sensitivity and specificity for the detection of problematic drinking.
Physical Activity: The physical activity questions from the Australian National Health Surveys were used to classify participants as sedentary or having low, moderate, or high levels of physical activity calculated with metabolic equivalents.

Timepoint [5] 314353 0
Emotion Driven Behaviors at 6 months after randomisation.
Secondary outcome [6] 314354 0
Adherence measured with 5 items from the Medical Outcomes Study Specific Adherence Scale. The items used in CHAMPS cover adherence to diet, exercise, stress management, cardiac rehabilitation and medication.
Timepoint [6] 314354 0
Adherence at 6 months after randomisation.
Secondary outcome [7] 314355 0
Medical Outcomes include fatal or non-fatal major adverse cardiac event (MACE) or unplanned hospital admission for any; myocardial infarction, stroke, coronary revascularization, cardiac failure, arrhythmia (determined with relevant International Classification of Disease Criteria Codes I00-I99) and psychiatric causes (ICD Codes F00-F99) or suicide attempt or deliberate self-harm.
Timepoint [7] 314355 0
MACE at 6 months after randomisation.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Blinded assessors will determine depression and anxiety disorders with structured interview to maintain trial fidelity. Confirmation of eligibility will be obtained by the study coordinator and then randomized after the participant has completed baseline assessments.
Patients will be randomized by statistician generated sequence who is "off-site". Allocation will be concealed in sequentially numbered, opaque, sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be block randomized to one of the two study arms according to a random number generator in alternating block sizes (randomization sequence determined by the study statistician).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Planned Statistical analysis: Analyses will be performed blinded via numerical code according to intention-to-treat principles. The psychosocial battery will be analyzed with SAS mixed models procedures comparing between-group differences (randomization arm), incorporating data collected at multiple time points and random effects. These analyses account for individual differences in baseline severity and change in trajectory over time in the primary outcomes (depression and anxiety) and secondary psychosocial outcomes. Importantly, we will be able to model effects for treatment group, time, and their interaction terms. Primary depression and anxiety disorder response determined by blinded MINI rating, and psychosocial measures, will be analyzed using logistic binomial models and calculated numbers-needed-to-treat. Rates of patient MACE will be compared with log-binomial models presenting risk ratios with 95% confidence intervals.

The results of two systematic reviews in chronic diseases suggest that effect sizes d = 0.40 would be of clinical interest for this interventions’ impact on psychological health. The proposed sample for this feasibility study of 50 patients (25 in each arm) was set to detect a difference between UP and EUC arms in depression and anxiety outcome at a = 0.05 with 40% power to detect a 0.5 SD difference in means between groups on self-report psychosocial measures, which is the cut-off for clinical importance. In terms of emotional disorder remission the study is powered to detect a difference of .30 between UP and EUC assuming a 70% vs. 30% remission rate. This study is not sufficiently powered to detect a reduction in MACE, however this CVD endpoint is standard practice in recent psychosocial RCTs.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 3735 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 9609 0
5011 - Woodville South

Funding & Sponsors
Funding source category [1] 291170 0
Charities/Societies/Foundations
Name [1] 291170 0
National Heart Foundation of Australia
Address [1] 291170 0
155-159 Hutt Street
Adelaide SA 5000
Country [1] 291170 0
Australia
Funding source category [2] 291171 0
Charities/Societies/Foundations
Name [2] 291171 0
The Menzies Foundation
Address [2] 291171 0
The Menzies Foundation
Clarendon Terrace
210 Clarendon Street
East Melbourne VIC 3002
Country [2] 291171 0
Australia
Funding source category [3] 296103 0
Charities/Societies/Foundations
Name [3] 296103 0
Freemason's Foundation Centre for Men's health
Address [3] 296103 0
Faculty of Health Sciences, The University of Adelaide
Ground Floor, 254 North Terrace
GPO Box 498, Adelaide SA 5005
Country [3] 296103 0
Australia
Primary sponsor type
Individual
Name
Dr Phillip Tully
Address
Freemasons Foundation Centre for Men’s Health
Faculty of Health Sciences, The University of Adelaide
Ground Floor, 254 North Terrace
GPO Box 498, Adelaide SA 5005
Country
Australia
Secondary sponsor category [1] 289850 0
Individual
Name [1] 289850 0
Prof Gary Wittert
Address [1] 289850 0
Freemasons Foundation Centre for Men’s Health
Faculty of Health Sciences, The University of Adelaide
Ground Floor, 254 North Terrace
GPO Box 498, Adelaide SA 5005
Country [1] 289850 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292744 0
The Queen Elizabeth Hospital
Ethics committee address [1] 292744 0
The Queen Elizabeth Hospital
Ethics: DX465101
Ground Floor, Basil Hetzel Institute
28 Woodville Road
WOODVILLE SOUTH SA 5011
Ethics committee country [1] 292744 0
Australia
Date submitted for ethics approval [1] 292744 0
04/06/2015
Approval date [1] 292744 0
04/06/2015
Ethics approval number [1] 292744 0
HREC/15/TQEH/47

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56818 0
Dr Phillip Tully
Address 56818 0
Freemasons Foundation Centre for Men’s Health
Faculty of Health Sciences, The University of Adelaide
Ground Floor, 254 North Terrace
GPO Box 498, Adelaide SA 5005
Country 56818 0
Australia
Phone 56818 0
+618 8313 0514
Fax 56818 0
Email 56818 0
phillip.tully@adelaide.edu.au
Contact person for public queries
Name 56819 0
Dr Phillip Tully
Address 56819 0
Freemasons Foundation Centre for Men’s Health
Faculty of Health Sciences, The University of Adelaide
Ground Floor, 254 North Terrace
GPO Box 498, Adelaide SA 5005
Country 56819 0
Australia
Phone 56819 0
+618 8313 0514
Fax 56819 0
Email 56819 0
phillip.tully@adelaide.edu.au
Contact person for scientific queries
Name 56820 0
Dr Phillip Tully
Address 56820 0
Freemasons Foundation Centre for Men’s Health
Faculty of Health Sciences, The University of Adelaide
Ground Floor, 254 North Terrace
GPO Box 498, Adelaide SA 5005
Country 56820 0
Australia
Phone 56820 0
+618 8313 0514
Fax 56820 0
Email 56820 0
phillip.tully@adelaide.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary