Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000608369
Ethics application status
Approved
Date submitted
5/04/2017
Date registered
28/04/2017
Date last updated
22/05/2019
Date data sharing statement initially provided
22/05/2019
Date results information initially provided
22/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Sweet Spot: five levels of support for an anxiety and depression course plus usual care, compared to usual care alone
Scientific title
The Sweet Spot: A randomised controlled trial comparing five levels of support for an anxiety and depression course plus usual care, to usual care alone
Secondary ID [1] 291628 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety in adults (aged 18+) 302751 0
Depression in adults (aged 18+) 302752 0
Condition category
Condition code
Mental Health 302269 302269 0 0
Anxiety
Mental Health 302270 302270 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This RCT aims to compare, in people with depression or anxiety or both, the efficacy of an internet-delivered cognitive behavioural therapy (iCBT) with one of five levels of support plus usual care, to usual care alone to establish the superiority over usual care alone and to calculate the cost effectiveness of each level of support.

The iCBT program for depression and anxiety consists of six online lessons representing best practice CBT, as well as regular homework assignments and access to supplementary resources delivered over the course of 12 weeks. Each lesson was designed using a cartoon narrative and included: psycho-education, behavioral activation, cognitive restructuring, graded exposure, problem solving, assertiveness skills, and relapse prevention.

The present study is the first to compare the efficacy and adherence of iCBT for anxiety and depression (6 lessons + homework + automated reminders) with one of five levels of support plus usual care, compared with usual care alone. The six groups are:

1. Self-help only, no personal reminders or contact to these participants
2. Technician contact upon request, participants are able to contact a technician with a query and the technician will possess a script of how to respond to these queries (a lesson by lesson script)
3. Scheduled technician contact after each lesson (6 contacts in total), enquiring how the participant found the lesson and if they have any questions
4. Clinician contact upon request, participants are able to contact a clinician with a query
5. Scheduled clinician contact after each lesson, (6 contacts in total)
6. Usual care control group, after completing three sets of questionnaires, these participants will assess the iCBT program unsupervised (for no cost to the participant) via a secure website

‘Technician’ = health worker
‘Clinician’ = Mental health clinician
Usual Care = permission to access GP, use medications and other psychological help for anxiety and depression as desired.
Intervention code [1] 297701 0
Treatment: Other
Intervention code [2] 297859 0
Behaviour
Comparator / control treatment
Treatment as usual (TAU) - usual access of GP services, medications, and/or other psychological help for anxiety and depression as desired.

All participants randomised to the control group (TAU) will receive usual care with their GP or health practitioner. Over the 24-week waiting period, participants will be required to complete 3 sets of online questionnaires, which enquire about their mental health (e.g. anxiety, depression, days out of role etc.). At conclusion of the 24-week waiting period, participants will be offered access to the iCBT Mixed Anxiety and Depression Program via a secure website.

The TAUl group, after completing three sets of questionnaires, will receive the iCBT program unsupervised (for no cost to the participant) via a secure website. They will receive the same level of support as the self-help group (i.e. self-help only, no personal reminders or contact to these participants).
Control group
Active

Outcomes
Primary outcome [1] 301678 0
Anxiety severity: Change in scores from baseline on the Generalised Anxiety Disorder 7-point scale (GAD-7).
Timepoint [1] 301678 0
Post-treatment (Week 12); 3-month follow-up; 6-month follow-up.
Primary outcome [2] 301679 0
Depression severity: Change in scores from baseline on the Patient Health Questionnaire (PHQ-9).
Timepoint [2] 301679 0
Post-treatment (Week 12); 3-month follow-up; 6-month follow-up.
Primary outcome [3] 301680 0
Cost effectiveness: Time X salary costs of staff giving support after 12 weeks.
Timepoint [3] 301680 0
Post-treatment (Week 12); 1-month follow-up
Secondary outcome [1] 333546 0
Days out of role: Changes in scores from baseline on the Service Utilisation module of the National Survey of Mental Health and Well-Being (SUDOR)
Timepoint [1] 333546 0
Post-treatment (Week 12); 1-month follow-up
Secondary outcome [2] 333547 0
Acceptability of the intervention: Change scores from baseline on the Credibility/Expectancy Questionnaire (CEQ)
Timepoint [2] 333547 0
Post-treatment (Week 12); 1-month follow-up
Secondary outcome [3] 333548 0
Service Utilization: Changes in scores from baseline on the Service Utilisation module of the National Survey of Mental Health and Well-Being (SUDOR)
Timepoint [3] 333548 0
Post-treatment (Week 12); 1-month follow-up

Eligibility
Key inclusion criteria
People aged over 18 years old who score 10-24 on the PHQ-9 and/or >9 on the GAD-7. Participants must be prepared to provide their name, age, gender, level of education, phone number and information on health service utilisation. Participants are required to have English language skills equivalent to a School Certificate level, access to a phone and a computer with a printer, and must provide electronic informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People with a self-reported diagnosis of schizophrenia, bipolar disorder, substance dependence and/or taking benzodiazepines on a daily basis; and/or a score of < 9 on the PHQ-9 or GAD-7; of 2 or 3 on Item 9 of the PHQ-9 and/or >24 on the PHQ-9 (i.e. sub-threshold anxiety or depression; very severe depression or frequent suicidal ideation).

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)
Participants will be enrolled in the study once eligibility criteria is met. Participants will be randomised by computer generated software to one of the six groups in equal proportions. Participants will be notified of their allocation on screen after providing informed consent and being screened and randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequence will be generated via 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
A pre-to-post-treatment improvement of effect size (ES)>1.0 is expected for the intervention groups on the co-primary measures (PHQ-9; GAD-7). These groups are also expected to improve more than the waitlist control group by an ES of 0.6. Sample size is powered to have an 80% chance of detecting 0.6SD differences at p<.05.

All analyses will be undertaken using intention to treat linear mixed model analyses. Relationships between observations at different occasions will be modelled with the appropriate covariance matrix. Planned contrasts will be used to compare changes between pre-treatment and post-treatment, and 3-month follow-ups. Planned pairwise comparisons will be used to compare between-groups at post-treatment, and follow-up and effect sizes will be calculated (Hedges g) to measure the size of the between-groups difference on primary and secondary outcome measures.

Cost Effectiveness: The cost of each staff intervention (salary cost by duration of intervention) will be recorded and the mean cost per group calculated. The mean health gain in each group will be calculated from the cumulative effect size change in PHQ-9 and GAD-7 transformed into DALYs using the Sanderson and Andrews formula. The Cost effectiveness is the ratio between cost and health gain in each group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/06/2017
Actual
19/05/2017
Date of last participant enrolment
Anticipated
4/12/2017
Actual
31/01/2018
Date of last data collection
Anticipated
31/10/2018
Actual
5/11/2018
Sample size
Target
700
Accrual to date
Final
713
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 7775 0
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 15708 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 296118 0
Other
Name [1] 296118 0
Clinical Research Unit for Anxiety and Depression
Country [1] 296118 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Sydney
Address
390 Victoria Street, Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 295016 0
None
Name [1] 295016 0
Address [1] 295016 0
Country [1] 295016 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297376 0
St Vincent's Hospital HREC (EC00140)
Ethics committee address [1] 297376 0
St Vincent’s Hospital Translational Research Centre
97-105 Boundary Street
Darlinghurst NSW 2010
Ethics committee country [1] 297376 0
Australia
Date submitted for ethics approval [1] 297376 0
14/04/2016
Approval date [1] 297376 0
10/05/2016
Ethics approval number [1] 297376 0
HREC/16/SVH/100

Summary
Brief summary
Major depressive disorder ranks second amongst the most important causes of disability in Australia. Anxiety disorders also rank in the top ten causes of disability. One problem is that the benefits of antidepressant medication, the most widely used remedy for both these disorders, are small and the harms are significant. There is a swing towards the use of psychological treatments, of which cognitive behaviour therapy (CBT) is the best researched. However CBT has many out of pocket costs (average >$60 per visit), quality is not assured, and therapy is not widely available outside major city centres. Internet delivered automated cognitive behaviour therapy (iCBT) on the other hand, produces the same benefit and freedom from harms as face to face CBT, but has advantages of low cost, high fidelity and wide distribution at levels comparable to medication.

In iCBT studies, however, adherence varies markedly according to the amount of encouragement or clinical guidance provided. In our research, adherence varied from 33% for a group who received no support, to 68% for those who received automated reminders, to 81% for the group who received telephone reminders from a technician. A later comparison of technician reminders with coaching by a clinician showed no difference in adherence or efficacy. The two levels of support were therefore comparable but the costs to the health system were not.

The primary purpose of this trial is to examine the efficacy and adherence of iCBT for anxiety and depression (6 lessons + homework + automated reminders) across five varying levels of support plus usual care, compared with usual care alone. Eligible participants will be randomly allocated to one of six groups with varying levels of support: 1) Self-help only; 2) Technician contact upon request; 3) Scheduled technician contact after each lesson; 4) Clinician contact upon request; 5) Scheduled clinician contact after each lesson; or 6) Treatment as usual (TAU) control group.

The main hypotheses to be tested are:

1. iCBT at all 5 levels of support will significantly reduce symptoms of anxiety, depression, distress and disability compared to a TAU control group.
2. The efficacy will be related to the frequency of support.
3. The adherence rate will be related to frequency of support.
4. The most cost effective (staff cost per unit of health gain) will be technician support on request.

It is hoped that the findings of this trial will provide further information regarding (1) the adherence rates and treatment effects that are associated with various levels of clinician or technician support, (2) the cost effectiveness that is characteristic of each level of intervention, (3) whether certain levels of intervention are not sufficiently effective to be attractive to a health service, and (4) whether there are levels of intervention that are not sufficiently more cost effective than a lower cost intervention to be attractive to a health service.
Trial website
www.virtualclinic.org.au
Trial related presentations / publications
Nil as yet
Public notes

Contacts
Principal investigator
Name 73846 0
Prof Gavin Andrews
Address 73846 0
Clinical Research Unit for Anxiety and Depression (CRUfAD)
Level 4, The O'Brien Centre,
St Vincent's Hospital,
394-404 Victoria St,
Darlinghurst NSW 2010
Country 73846 0
Australia
Phone 73846 0
+61 2 8382 1400
Fax 73846 0
+61 2 8382 1401
Email 73846 0
gavina@unsw.edu.au
Contact person for public queries
Name 73847 0
Mrs Ashlee Grierson
Address 73847 0
Clinical Research Unit for Anxiety and Depression (CRUfAD)
Level 4, The O'Brien Centre,
St Vincent's Hospital,
394-404 Victoria St,
Darlinghurst NSW 2010
Country 73847 0
Australia
Phone 73847 0
+61 2 8382 1421
Fax 73847 0
+61 2 8382 1401
Email 73847 0
ashlee.grierson@svha.org.au
Contact person for scientific queries
Name 73848 0
Mrs Ashlee Grierson
Address 73848 0
Clinical Research Unit for Anxiety and Depression (CRUfAD)
Level 4, The O'Brien Centre,
St Vincent's Hospital,
394-404 Victoria St,
Darlinghurst NSW 2010
Country 73848 0
Australia
Phone 73848 0
+61 2 8382 1421
Fax 73848 0
+61 2 8382 1401
Email 73848 0
ashlee.grierson@svha.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
PISCF did not state that data sharing was involved. Privacy of participant individual data will remain protected.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3162Plain language summaryNo In progress. Will update when available.
3831Basic resultsNo 372697-(Uploaded-14-09-2020-13-57-27)-Basic results summary.docx

Documents added automatically
No additional documents have been identified.