Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000037202p
Ethics application status
Not yet submitted
Date submitted
30/11/2017
Date registered
12/01/2018
Date last updated
14/12/2018
Date data sharing statement initially provided
14/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Behavioral Activation for people with Depression attending Cardiac Rehabilitation
Scientific title
Behavioral Activation for people with Depression attending Cardiac Rehabilitation (BADCAR): feasibility trial
Secondary ID [1] 293496 0
None
Universal Trial Number (UTN)
U1111-1206-0159
Trial acronym
BADCAR
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Coronary heart disease 305680 0
Depression 305681 0
Condition category
Condition code
Cardiovascular 304901 304901 0 0
Coronary heart disease
Mental Health 304902 304902 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will receive 12, weekly, 1-to-1, sessions of behavioral activation, each lasting 45 minutes, delivered immediately preceding cardiac rehabilitation sessions. Sessions will be delivered in a private consulting room in the hospital. Patients will be determined to have completed treatment if they attend 50% of the behavioral activation sessions. We are using standard behavioral activation treatment protocols. These are based on previous trials, expert consensus opinion, NICE (National Institute for Health and Care Excellence) recommendations for the frequency and duration of behavioral activation.

The intervention will be provided by physiotherapists under the supervision of a clinical psychologist.

Specific behavioral activation techniques that will be applied include identification of depressed behaviors, analysis of the triggers and consequences of depressed behaviors, monitoring of activities, development of alternative goal-orientated behaviors, scheduling of activities and development of alternative behavioral reposes to rumination. The techniques used will be based on an initial assessment with the patient at the start of treatment.

Treatment fidelity will be determined by audio recording randomly selected (therapist, beginning, middle, end of treatment) sessions that will then be assessed by experienced psychologists using the quality of behavioral activation scale. We do not plan to provide feedback to therapists about fidelity to treatment.
Intervention code [1] 299733 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304095 0
Feasibility measures: number of patients (over 12 months) that attend the cardiac rehabilitation program that meet the study inclusion/exclusion criteria, the number of patients that we need to ask to get one to consent, the proportion of patients who complete treatment, the proportion of patient who complete the proposed outcome measures, proportion of patients that complete the trial, unexpected harms.
Timepoint [1] 304095 0
At completion of data collection from last study participant
Primary outcome [2] 304224 0
Depression symptoms measured using the (Patient Health Questionnaire) PHQ-9.
Timepoint [2] 304224 0
Outcome measures will be completed at the baseline (month 0) and 6-month follow up assessment appointments (typically the week preceding the start and week following completion of the cardiac rehabilitation program).
Secondary outcome [1] 340939 0
Remission of depression (defined as a post-treatment PHQ-9 score of less than or equal to 9 combined with improvement of 50%)
Timepoint [1] 340939 0
Six-month (from baseline appointment) follow-up assessment
Secondary outcome [2] 340944 0
Heart rate variability (beat to beat changes in resting heart rate), determined by a five-minute non-invasive ECG (electro cardiogram)
Timepoint [2] 340944 0
Baseline and 6-month follow up assessment appointments (typically the week preceding the start and following completion of the cardiac rehabilitation program)
Secondary outcome [3] 340945 0
The EuroQol 5 Dimension questionnaire (EQ-5D)
Timepoint [3] 340945 0
Baseline and 6-month follow up assessment appointments (typically the week preceding the start and following completion of the cardiac rehabilitation program)
Secondary outcome [4] 340946 0
The 12 Item Short Form Health Survey version 2 [SF-12v2]
Timepoint [4] 340946 0
Baseline and 6-month follow up assessment appointments (typically the week preceding the start and following completion of the cardiac rehabilitation program)
Secondary outcome [5] 340947 0
Self-Efficacy for Exercise Scale
Timepoint [5] 340947 0
Baseline and 6-month follow up assessment appointments (typically the week preceding the start and following completion of the cardiac rehabilitation program)
Secondary outcome [6] 340948 0
Positive well-being will be assessed using the Life Orientation Test
Timepoint [6] 340948 0
Baseline and 6-month follow up assessment appointments (typically the week preceding the start and following completion of the cardiac rehabilitation program)
Secondary outcome [7] 340949 0
The Multidimensional Scale of Perceived Social Support
Timepoint [7] 340949 0
Baseline and 6-month follow up assessment appointments (typically the week preceding the start and following completion of the cardiac rehabilitation program)
Secondary outcome [8] 340951 0
The Gratitude Questionnaire
Timepoint [8] 340951 0
Baseline and 6-month follow up assessment appointments (typically the week preceding the start and following completion of the cardiac rehabilitation program)
Secondary outcome [9] 340953 0
The Self-Compassion Short-Form
Timepoint [9] 340953 0
Baseline and 6-month follow up assessment appointments (typically the week preceding the start and following completion of the cardiac rehabilitation program)
Secondary outcome [10] 340954 0
The Positive and Negative Affect Schedule
Timepoint [10] 340954 0
Baseline and 6-month follow up assessment appointments (typically the week preceding the start and following completion of the cardiac rehabilitation program)
Secondary outcome [11] 340955 0
Physical activity: average number of steps per day.
Timepoint [11] 340955 0
We are going to ask patients to wear the activity monitor (FITBIT) for the six month duration of the trial. This will enable us to track physical activity in detail over time

Eligibility
Key inclusion criteria
A clinical diagnosis of coronary heart disease
Referred to a participating Healthscope cardiac rehabilitation program
A positive screen for depression (defined as a PHQ2 score >3) at the time of the cardiac rehabilitation assessment
Able to give written informed consent
Over 18 years of age
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Physically frail (as they may not be able to fully participate in the cardiac rehabilitation/behavioral activation program)
Experience mental confusion, cognitive impairment, or psychosis. These comorbidities may make it difficult to deliver the behavioral activation intervention.
Have serious co-existing diseases (e.g. cancer) because of the risk of hospitalization or death during the course of the study
Have previously attended a cardiac rehabilitation program as this may contaminate the effectiveness of the intervention.
Are currently receiving psychological or pharmacological (antidepressant) treatment for depression as this may limit the effectiveness of the behavioural activation intervention.
Are alcohol or drug dependent as patients may not be able to engage in treatment.
Are suicidal or have made a suicide attempt in the past month because this is an experimental intervention and patients should receive standard of care in this situation

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a feasibility study. Basic statistical methods will be used (means, proportions) to describe our data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9471 0
North Eastern Rehabilitation Centre - Ivanhoe
Recruitment postcode(s) [1] 18198 0
3079 - Ivanhoe

Funding & Sponsors
Funding source category [1] 298114 0
University
Name [1] 298114 0
La Trobe University
Country [1] 298114 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University, Science Drive, Melbourne, Australia, 3086
Country
Australia
Secondary sponsor category [1] 297196 0
None
Name [1] 297196 0
Address [1] 297196 0
Country [1] 297196 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 299133 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 299133 0
Ethics committee country [1] 299133 0
Australia
Date submitted for ethics approval [1] 299133 0
29/01/2018
Approval date [1] 299133 0
Ethics approval number [1] 299133 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79410 0
Prof Richard Gray
Address 79410 0
Rm 112, Health Sciences 1, La Trobe University, Science Drive, Melbourne, VIC, 3086
Country 79410 0
Australia
Phone 79410 0
+61 481 248 182
Fax 79410 0
Email 79410 0
[email protected]
Contact person for public queries
Name 79411 0
Richard Gray
Address 79411 0
Rm 112, Health Sciences 1, La Trobe University, Science Drive, Melbourne, VIC, 3086
Country 79411 0
Australia
Phone 79411 0
+61 481 248 182
Fax 79411 0
Email 79411 0
[email protected]
Contact person for scientific queries
Name 79412 0
Richard Gray
Address 79412 0
Rm 112, Health Sciences 1, La Trobe University, Science Drive, Melbourne, VIC, 3086
Country 79412 0
Australia
Phone 79412 0
+61 481 248 182
Fax 79412 0
Email 79412 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Approval from the hospital ethics committee required.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.