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Trial registered on ANZCTR


Trial ID
ACTRN12613001113741
Ethics application status
Approved
Date submitted
26/09/2013
Date registered
4/10/2013
Date last updated
10/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Internet cognitive behavioural therapy (iCBT) for depression in older individuals with comorbid depression and cardiovascular disease
Scientific title
Internet cognitive behavioural therapy (iCBT) for depression in older individuals with comorbid depression and cardiovascular disease
Secondary ID [1] 283316 0
None
Universal Trial Number (UTN)
U1111-1148-5282
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 290203 0
Heart failure 290204 0
Condition category
Condition code
Mental Health 290596 290596 0 0
Depression
Cardiovascular 290597 290597 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All intervention participants will separately complete 6 lessons of Internet based treatment about the management of symptoms of depression. One lesson will be completed every 7 to 14 days (it will become available after the preceding lesson has been completed, with a minimum of 7 days between lessons and a maximum of 14 days). Each lesson will take about 15 minutes to complete. Group 1 participants will have access to summaries of each lesson, homework exercises, extra resources, weekly reminder emails, and one-on-one contact with the Clinician (Clinical Psychologist) by telephone or email in the first 2 weeks, then as required. The participant receives a template email from the clinician twice in the first two weeks congratulating the participant on their progress. The participant is also able to email or phone the clinician at any point during the trial as required. The participant completes a measure of psychological distress before each lesson and if their scores increase by one or more standard deviations the clinician is automatically alerted and contact with the participant either by phone or email is initiated. We’ve found that people who get the most out of our programs spend about 3-4 hours a week completing the homework tasks and applying the new skills they’re learning on a daily basis. The treatment materials are based on cognitive behavioural techniques. Strategies used to improved adherence to intervention protocols and procedures for monitoring adherence include: automated email reminders, monitoring the downloading of homework, collection of data on how long participants spent reading lessons and practising skills
Intervention code [1] 288035 0
Behaviour
Intervention code [2] 288073 0
Treatment: Other
Comparator / control treatment
Waitlist control group (receiving usual care). These participants remain on the waitlist until the treatment groups have completed their treatment (12 weeks). At that time (12 weeks) the waitlist group will be offered the choice of completing the online intervention.
Control group
Active

Outcomes
Primary outcome [1] 290606 0
Reductions in the Patient Health Questionnaire – 9-Item (PHQ-9)
Timepoint [1] 290606 0
Baseline, mid-treatment (week 4), immediately post-treatment (week 10), and 3 months after post-treatment (week 22)
Secondary outcome [1] 304891 0
Improvements in adherence to CVD treatment as measured by the Medical Outcomes Study Measures of Patient Adherence Scale
Timepoint [1] 304891 0
Baseline, mid-treatment (4 weeks), immediately post-treatment (10 weeks) and 3 month follow up (22 weeks)
Secondary outcome [2] 304892 0
Improvements in biomarkers of CVD: pro-inflammatory proteins: CRP, TNF, IL-8, MIC-1, as well fasting glucose and cholesterol will be determine via collection of blood samples
Timepoint [2] 304892 0
Baseline and immediately post-treatment (10 weeks)
Secondary outcome [3] 304893 0
Improvements in physical activity as measured by the Physical Activity Scale
Timepoint [3] 304893 0
Baseline, mid-treatment (4 weeks), immediately post-treatment (10 weeks) and 3 month follow up (22 weeks)
Secondary outcome [4] 304894 0
Reductions in risky drinking as measured by the Alcohol Use Disorders Identification Test—Consumption (AUDIT-C)
Timepoint [4] 304894 0
Baseline, mid-treatment (4 weeks), immediately post-treatment (10 weeks) and 3 month follow up (22 weeks)
Secondary outcome [5] 304895 0
Improvements in cognitive and emotional representations of illness according to The Brief Illness Perception Questionnaire
Timepoint [5] 304895 0
Baseline, mid-treatment (4 weeks), immediately post-treatment (10 weeks) and 3 month follow up (22 weeks)
Secondary outcome [6] 304896 0
Improvements in psychological distress according to the Kessler 10
Timepoint [6] 304896 0
Baseline, mid-treatment (4 weeks), immediately post-treatment (10 weeks) and 3 month follow up (22 weeks)
Secondary outcome [7] 304897 0
Reductions in disability according to the World Health Organisation Disability Assessment Schedule (WHODAS-II)
Timepoint [7] 304897 0
Baseline, mid-treatment (4 weeks), immediately post-treatment (10 weeks) and 3 month follow up (22 weeks)
Secondary outcome [8] 304898 0
Reductions in anxiety according to the Generalized Anxiety Disorder 7-Item (GAD-7)
Timepoint [8] 304898 0
Baseline, mid-treatment (4 weeks), immediately post-treatment (10 weeks) and 3 month follow up (22 weeks)
Secondary outcome [9] 304899 0
Reductions in disability and impairment according to the Sheehan Disability Scale
Timepoint [9] 304899 0
Baseline, mid-treatment (4 weeks), immediately post-treatment (10 weeks) and 3 month follow up (22 weeks)

Eligibility
Key inclusion criteria
A diagnosis of Major Depressive Disorder (MDD) according to the Mini International Neuropsychiatric Interview Version 5.0.0; self-reported heart failure confirmed by a clinician at St Vincent's Heart and Lung Outpatients Clinic; aged over 50; prepared to provide name, phone number and address, and to provide the name and address of a local general practitioner, and to provide written informed consent; English language skills equivalent to a School Certificate level; access to a phone and a computer with internet and a printer.
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Psychosis, bipolar disorder, substance abuse or dependence.
Severe depression (PHQ-9 >24) and/ or current suicidality (PHQ-9 Q9=2 or 3) will require a risk assessment with a clinician before being admitted into the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (www.random.org).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
We would expect pre-post improvement of ES 1.0 for the iCBT group on the primary MDD measure. We also expect the iCBT group to improve more than the waitlist group by an ES of 0.8. Sample size is powered to have an 80% chance of detecting differences at p<.05. All analyses will be undertaken using mixed-model repeated measures (MMRM) ANOVA with measurement occasion as a within-groups factor and intervention as a between-groups factor. Relationships between observations at different occasions will be modelled with an unstructured covariance matrix. For each experimental group, planned contrasts will be used to compare changes from baseline to post-test, 3- and 6-month follow-up.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
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)
NSW
Recruitment hospital [1] 1549 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 7386 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 288048 0
Hospital
Name [1] 288048 0
St Vincent's Hospital, Sydney
Address [1] 288048 0
390 Victoria St
Darlinghurst NSW 2010
Country [1] 288048 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
390 Victoria St
Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 286773 0
Individual
Name [1] 286773 0
Professor Gavin Andrews
Address [1] 286773 0
Clinical Research Unit for Anxiety and Depression
390 Victoria St
Darlinghurst NSW 2010
Country [1] 286773 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289974 0
St Vincent's Hospital
Ethics committee address [1] 289974 0
St Vincent's Hospital
390 Victoria St
Darlinghurst NSW 2010
Ethics committee country [1] 289974 0
Australia
Date submitted for ethics approval [1] 289974 0
13/06/2013
Approval date [1] 289974 0
28/08/2013
Ethics approval number [1] 289974 0
HREC/13/SVH/192

Summary
Brief summary
Cardiovascular Disease (CVD) and Major Depressive Disorder (MDD) are the two leading causes of disease burden in developed countries. Both conditions are highly prevalent amongst older Australians, and frequently co-occur. In patients with comorbid CVD and depression, treatment for depression is effective in improving depressive and cardiac symptoms, as well as reducing mortality risks. The current study aims to determine whether a novel internet-delivered treatment for major depression, which is cost-effective and amenable to widespread dissemination, is similarly effective. The current study will also be the first to explore the causal pathways underlying reductions in cardiac events and mortality risk following treatment for depression.
In order to address these aims, older (>50 years) individuals with comorbid CVD and depression will be recruited from the St Vincent’s Hospital Heart and Lung Outpatients Clinic. Participants will be randomly assigned to receive clinician-assisted internet-delivered cognitive behavioural therapy (iCBT) for depression (n=50) or treatment as usual (n=50). Relative reductions in depressive and cardiac symptoms between the intervention group and control group will be compared immediately post-treatment, whilst 6 month follow up of the intervention group will establish longer term benefits of the intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43326 0
Prof Gavin Andrews
Address 43326 0
Clinical Research Unit for Anxiety and Depression
390 Victoria St
Darlinghurst NSW 2010
Country 43326 0
Australia
Phone 43326 0
+61 2 8382 1405
Fax 43326 0
Email 43326 0
gavina@unsw.edu.au
Contact person for public queries
Name 43327 0
Prof Gavin Andrews
Address 43327 0
Clinical Research Unit for Anxiety and Depression
390 Victoria St
Darlinghurst NSW 2010
Country 43327 0
Australia
Phone 43327 0
+61 2 8382 1405
Fax 43327 0
Email 43327 0
gavina@unsw.edu.au
Contact person for scientific queries
Name 43328 0
Prof Gavin Andrews
Address 43328 0
Clinical Research Unit for Anxiety and Depression
390 Victoria St
Darlinghurst NSW 2010
Country 43328 0
Australia
Phone 43328 0
+61 2 8382 1405
Fax 43328 0
Email 43328 0
gavina@unsw.edu.au