ANZCTR - Registration

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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 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]

NIL

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Anxiety in adults (aged 18+)

Depression in adults (aged 18+)

Condition category

Condition code

Mental Health

Anxiety

Mental Health

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]

Treatment: Other

Intervention code [2]

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]

Anxiety severity: Change in scores from baseline on the Generalised Anxiety Disorder 7-point scale (GAD-7).

Timepoint [1]

Post-treatment (Week 12); 3-month follow-up; 6-month follow-up.

Primary outcome [2]

Depression severity: Change in scores from baseline on the Patient Health Questionnaire (PHQ-9).

Timepoint [2]

Post-treatment (Week 12); 3-month follow-up; 6-month follow-up.

Primary outcome [3]

Cost effectiveness: Time X salary costs of staff giving support after 12 weeks.

Timepoint [3]

Post-treatment (Week 12); 1-month follow-up

Secondary outcome [1]

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]

Post-treatment (Week 12); 1-month follow-up

Secondary outcome [2]

Acceptability of the intervention: Change scores from baseline on the Credibility/Expectancy Questionnaire (CEQ)

Timepoint [2]

Post-treatment (Week 12); 1-month follow-up

Secondary outcome [3]

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]

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?

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]

St Vincent's Private Hospital (Darlinghurst) - Darlinghurst

Recruitment postcode(s) [1]

2010 - Darlinghurst

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Clinical Research Unit for Anxiety and Depression

Address [1]

Clinical Research Unit for Anxiety and Depression
Level 4, O'Brien Centre
390 Victoria Street
Darlinghurst NSW 2010

Country [1]

Australia

Primary sponsor type

Hospital

Name

St Vincent's Hospital Sydney

Address

390 Victoria Street, Darlinghurst NSW 2010

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincent's Hospital HREC (EC00140)

Ethics committee address [1]

St Vincent’s Hospital Translational Research Centre
97-105 Boundary Street
Darlinghurst NSW 2010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/04/2016

Approval date [1]

10/05/2016

Ethics approval number [1]

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

Prof Gavin Andrews

Address

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

Australia

Phone

+61 2 8382 1400

Fax

+61 2 8382 1401

gavina@unsw.edu.au

Contact person for public queries

Name

Ashlee Grierson

Address

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

Australia

Phone

+61 2 8382 1421

Fax

+61 2 8382 1401

ashlee.grierson@svha.org.au

Contact person for scientific queries

Name

Ashlee Grierson

Address

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

Australia

Phone

+61 2 8382 1421

Fax

+61 2 8382 1401

ashlee.grierson@svha.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		In progress. Will update when available.
Basic results	No			372697-(Uploaded-14-09-2020-13-57-27)-Basic results summary.docx

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No additional documents have been identified.

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