ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617000977370

Ethics application status

Approved

Date submitted

3/07/2017

Date registered

6/07/2017

Date last updated

9/09/2019

Date data sharing statement initially provided

9/09/2019

Date results provided

9/09/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Investigating the feasibility and acceptability of Smooth Sailing: An online mental health service for depression and anxiety in high school students

Scientific title

Investigating the feasibility and acceptability of Smooth Sailing: An online mental health service for depression and anxiety in high school students

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Nil

Health condition

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

Depression

Anxiety

Suicidal Ideation

Condition category

Condition code

Mental Health

Depression

Mental Health

Anxiety

Mental Health

Suicide

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Smooth Sailing is an online mental health service designed and administered by the Black Dog Institute. It is based on the principles of “stepped care” such that the intensity of the recommended interventions is matched to individuals’ symptom severity and individuals “step up” if they have not responded to treatment after a set period of time. Exposure to Smooth Sailing involves (more detail outlined in Phase 2 Clinical Trial Protocol in Attachments section of ANZCTR record):
1. Registration & Mental Health Assessment. In class time, participants are given a slip of paper with the service URL and their unique identification code. They then use a school or personal internet device to visit this website and undertake registration. Before registration commences, participants are asked to complete the Gillick Competency measure which consists of X questions to further confirm their understanding of the service and study requirements. Upon correct completion of this, participants are invited to create a personal profile (name, date of birth, email address, mobile phone number, and gender, history of mental health issues, and use of the internet for mental health information). Once a personal profile is created, four questionnaires were used to measure the presence of depression, anxiety, help-seeking attitudes and behaviours (see Appendix B in Attachments section of ANZCTR record). This takes approximately 30 minutes to complete.
2. Step allocation. Based on the answers inputted during registration, Smooth Sailing allocates each participant to one of five “steps”. This is automatic and based on a clinical algorithm which accounts for the severity levels of the anxiety and depression symptoms as reported by the participant on the Generalised Anxiety Disorder Scale (GAD-7) and the Patient Health Questionnaire (PHQ-9). Each “step” matches a severity level and was based on clinical practice guidelines. The step allocations were: Nil/minimal (Step 0), Mild (Step 1), Moderate (Step 2), Moderately Severe (Step 3), and Severe (Step 4).
3. Delivery of tailored program. After step allocation, Smooth Sailing delivers a program of content that is tailored to each step. Steps 0 and 1 receive online psychoeducation. Step 2 receive online psychoeducation + online self-directed Cognitive Behavioural Therapy (CBT). Steps 3 and 4 receive online psychoeducation + online self-directed CBT + additional support from the School Counsellor. Any participant who was allocated to Step 3 or 4 triggered an electronic notification alert which was automatically sent to the school counsellor for further investigation. This allowed the school counsellor to facilitate a face-to-face session within 48 hours to provide the counselling or refer on to external services. The online psychoeducation consists of five modules on i) general mental health, ii) depression, iii) anxiety, iiii) seeking help for yourself, iv) seeking help for a friend. Each of these modules contains information about definitions of mental health terms, signs and symptoms, causes of mental health problems, what to do if needing help, and strategies and tips for what a young person can do immediately. Each module is complemented by animations and illustrations to depict key messages as well as hyperlinks to other credible youth mental health services and websites including Headspace, Reachout, Kids Helpline. This content was created specifically for this service, and was reviewed by clinicians. It is designed to be self-directed, such that the youth can read and return to it whenever they wish. The online CBT module consists of a single webpage that outlines two evidence-based self-directed online cognitive behavioural therapy programs: i) MoodGym (Australian National University) and ii) Brave Online (University of Queensland). MoodGym is an interactive self-help book which helps to learn and practise skills for managing symptoms of depression and anxiety. It consists of five modules alongside questionnaires, summaries and a personal workbook. BRAVE was developed for children and teenagers who experience Separation Anxiety Disorder, Social Phobia, Specific Phobia and Generalised Anxiety Disorder. This program helps young people to learn new ways to manage their anxiety and fears. It consists of 10 sessions and is effective for reducing social worries, anxiety about separating from loved ones, fears of specific objects or situation, worries about friendships, school performance or other everyday worries.
4. Monitoring and Feedback. At two points in the study (Day 15 and Day 22) participants received an automated 18-item “monitoring questionnaire” to assess how they were doing. This consisted of the Goldberg Depression and Anxiety Scales (answered using yes or no, see Appendix B in Attachments section of ANZCTR record) and was delivered via email or SMS. An automated thank you message was received alongside a reminder to use the program if participants completed this questionnaire.
5. Reassessment (Post-test/endpoint): At Day 43, researchers revisited the schools. Participants again logged onto the service using the same URL and unique ID codes and were delivered the final endpoint questionnaires. In theory, the results of these questionnaires would be used to determine whether a participant had responded to care or needed to be “stepped up”. In accordance with the Clinical Practice Guidelines for the Treatment of Depression in Young Adults, if a participant has not responded to their care within 43 days of their baseline allocation, they would be “stepped up” to the next level of care. Table 3 (in Phase 2 Clinical Trial Protocol in attachments section of the ANZCTR record) outlines the stepping matrix for depression and anxiety scores reported at 43 days. The matrix was designed such that a participant would not be stepped down, instead will either remain at the same step or step up. However, as the current trial ceased at 43 days, no stepping occurred during this trial. Instead, this trial was designed to provide the clinical data necessary to determine whether the steps are feasible for future trials.

Throughout the trial, participants will be obligated to use Smooth Sailing at pre-test (for registration and baseline measure collection) and again at post-test (for reassessment and final endpoint collection) only. Completion of the monitoring questionnaires and use of the other components is entirely voluntary, and will be a measured as part of the study.

Intervention code [1]

Early detection / Screening

Intervention code [2]

Behaviour

Intervention code [3]

Treatment: Other

Comparator / control treatment

No control group as it is an uncontrolled trial.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Help-seeking attitudes, as measured by the General Help-Seeking Questionnaire (GHSQ).

Timepoint [1]

6 weeks post baseline (i.e. Day 43).

Secondary outcome [1]

Help-seeking behaviour, measured using the Actual Help-Seeking Questionnaire (AHSQ).

Timepoint [1]

6 weeks post Baseline

Secondary outcome [2]

Depression levels as measured by the Patient Health Questionnaire (PHQ-9)

Timepoint [2]

6 weeks post Baseline

Secondary outcome [3]

Anxiety levels as measured by the Generalised Anxiety Disorder Scale (GAD-7)

Timepoint [3]

6 weeks post Baseline

Secondary outcome [4]

Acceptability and demand measured by:
- The number of youth and parents who consented to the study;
- The number of modules completed;
-The number of students who reported using the online CBT programs;
- The number of students who completed the fortnightly check-in questionnaires;

Satisfaction with the service was measured using a purpose-designed questionnaire consisting of 3 questionnaires: 1) An 11 item scale (answered "agree" vs "disagree") assessing young people's experience and satisfaction with the service; 2) An 18 item scale (answered "yes" or "no" which examined barriers and facilitators of service access); 3) one item question on "how helpful did you find smooth sailing?" (answered on a 5 point likert scale) with options to input free-text on reasons for why and why not. More detail on these measures can be found in Appendix B in Attachments section of ANZCTR record.

Timepoint [4]

6 weeks post Baseline

Secondary outcome [5]

Service satisfaction as measured by overall helpfulness of the service and scores on the purpose-designed service satisfaction questionnaire (see above, and Appendix B in Attachments section of ANZCTR record for more detail).

Timepoint [5]

6 weeks post Baseline

Eligibility

Key inclusion criteria

This study directly targeted young people aged 12 - 19 years, both males and females, who were currently attending high school at one of the participating schools. It was a requirement that students first had parent or guardian consent to participate, and that they satisfied the Gillick Competency test (Appendix C in Attachments section of the ANZCTR record) incorporated into the service that was included in the registration.

Minimum age

12 Years

Maximum age

19 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Students without parent/ guardian consent to participate;
Students that were not in the specific classes selected by the school for participation in the trial;
Students who did not correctly complete the Gillick Competency Test in the registration process.

Study design

Purpose of the study

Prevention

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation was not concealed.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Although this study was an uncontrolled acceptability trial, we are also examining differences pre and post-test. A recent systematic review of help-seeking interventions (Gulliver et al., 2012) reports an effect size of d = 0.12–0.53 for psycho-education interventions. As such, our sample size calculations are based on using an alpha of 0.05 and effect size of 0.50. As guided by Cohen (1992), 64 participants were needed to demonstrate this effect. Given that 40% were estimated to be likely to drop out, we needed to recruit approximately 106 participants for participation.

Data was collected using the Black Dog Institute e-health platform. Participant data was then exported to SPSS statistical software for analyses. Statistical analyses were performed using SPSS 21.0 (SPSS Inc., Chicago, Il, USA). The primary outcome measure (help-seeking) was analysed using mixed modelling which is similar to a repeated-measures analysis. This type of analysis was used to determine any significant differences in the scores reported at time 1 (pre) and then at time 2 (post). The primary hypothesis (that students would report higher levels of help-seeking behavior and attitudes) was evaluated by examining differences between pre and post scores on help-seeking questionnaires.

Secondary hypotheses were evaluated by pre and post comparisons of the depression and anxiety questionnaires, and descriptive analyses of the acceptability and feasibility questionnaires.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

13/02/2017

Date of last participant enrolment

Anticipated

Actual

9/05/2017

Date of last data collection

Anticipated

Actual

19/06/2017

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2440 - Kempsey

Recruitment postcode(s) [2]

2223 - Oatley

Recruitment postcode(s) [3]

2289 - Adamstown

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

HSBC Bank Australia

Address [1]

Level 36, Tower 1, International Towers Sydney, 100 Barangaroo Avenue, Sydney NSW 2000

Country [1]

Australia

Primary sponsor type

Charities/Societies/Foundations

Name

Black Dog Institute

Address

Hospital Road, Prince of Wales Hospital, Randwick, NSW 2031

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

UNSW Human Research Ethics Committee

Ethics committee address [1]

UNSW Research Ethics & Compliance Support
The University of New South Wales
Sydney NSW 2052 Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

31/08/2016

Approval date [1]

06/10/2016

Ethics approval number [1]

HC16724

Ethics committee name [2]

State Education Research Applications Process (SERAP)

Ethics committee address [2]

School Policy and Information Management (SERAP)
NSW Department of Education
Locked Bag 53
Darlinghurst NSW 1300

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

09/09/2016

Approval date [2]

07/02/2017

Ethics approval number [2]

SERAP 2016471

Summary

Brief summary

Background: Anxiety, depression, and suicidality are prevalent among high school youth aged 12 – 17 years and help-seeking is low. Current mental health services for this age group are overburdened and lack capacity for mild-moderate symptoms. Alternative service models are needed to improve rates of help-seeking, reduce pressure on current systems, to prevent escalation of mental illness, and reduce the associated morbidity and mortality. Online stepped-care presents a viable alternative. It is based on the premise that simple, cost-effective internet interventions are offered to youth with mild-moderate symptoms, while more costly, intensive face-to-face interventions are reserved for those with more severe and persistent symptoms. Internet interventions can be readily integrated into stepped-care as they are fully automated, acceptable to youth, preserve fidelity of care, and allow for ongoing monitoring and automated feedback.
School is an ideal setting for the implementation of online stepped-care as students spend much of their daily lives in school. However, schools currently have a “scattergun” approach to mental health, with some offering a school counsellor, some offering psycho-education programs, and others not having anything at all. The Black Dog Institute was awarded funds to design, build, and evaluate an online mental health clinic (referred to hereon in as “the e-clinic”) targeting help-seeking for depression and anxiety symptoms in high school students. Co-designed with students/schools/parents, the e-clinic delivers mental healthcare using a sophisticated internet program that triages students’ mental health, delivers treatment, monitors progress and links in with the school counsellor and wellbeing team. To reduce the stigma associated with mental illness, this e-clinic service has been named “Smooth Sailing”.
Procedure: High school students were recruited to participate in the 6-week long trial. During this time, they registered to the Smooth Sailing service, answered a series of baseline questionnaires, and were allocated to a "Step", corresponding to their level of depression/ anxiety severity. Students were able to log on and use Smooth Sailing over the course of the next 6 weeks, at which time they re-completed the questionnaires at the follow-up assessment. Students that were allocated to the moderately-severe or severe categories at Baseline were followed-up by the School Counsellor within 48 hours. All students were also sent monitoring questionnaires via SMS or email at 14-day intervals, to check-in with how they were feeling and provide a reminder of the Smooth Sailing service.
The main objectives of this trial were to:
* Evaluate the effectiveness of Smooth Sailing intervention for increasing help-seeking for depression and anxiety among high school students;
* Measure the acceptability, feasibility, and demand of this type of service model in high school settings.

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/372256-Appendix G - Parents and Students PICF_V.4 26.04.17.pdf (Participant information/consent)

Attachments [2]

/AnzctrAttachments/372256-UNSW HREC Approval 6-OCT-2016.Pdf (Ethics approval)

Attachments [3]

/AnzctrAttachments/372256-DOC17_107193_SERAP_2016471_Approval_Letter.pdf (Ethics approval)

Attachments [4]

/AnzctrAttachments/372256-Expression of Interest Letter for School Principal.pdf (Supplementary information)

Attachments [5]

/AnzctrAttachments/372256-Appendix C - Gillick Competency Test.pdf (Participant information/consent)

Attachments [6]

/AnzctrAttachments/372256-Phase 2 Clinical Trial Protocol.pdf (Protocol)

Attachments [7]

/AnzctrAttachments/372256-Appendix B - Outcome Measures (Revised).pdf (Supplementary information)

Attachments [8]

/AnzctrAttachments/372256-Detailed Procedure for Responding to Risk of harm.pdf (Supplementary information)

Contacts

Principal investigator

Name

Dr Bridianne O'Dea

Address

Black Dog Institute
Hospital Rd, Prince of Wales Hospital,
Randwick, NSW 2031

Country

Australia

Phone

+61293828509

Fax

b.odea@blackdog.org.au

Contact person for public queries

Name

Bridianne O'Dea

Address

Black Dog Institute
Hospital Rd, Prince of Wales Hospital,
Randwick, NSW 2031

Country

Australia

Phone

+61293828509

Fax

b.odea@blackdog.org.au

Contact person for scientific queries

Name

Bridianne O'Dea

Address

Black Dog Institute
Hospital Rd, Prince of Wales Hospital,
Randwick, NSW 2031

Country

Australia

Phone

+61293828509

Fax

b.odea@blackdog.org.au

Data sharing statement

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

No/undecided IPD sharing reason/comment

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
Other files	No		https://www.blackdoginstitute.org.au/research-proj... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Smooth Sailing: A Pilot Study of an Online, School-Based, Mental Health Service for Depression and Anxiety.	2019	https://dx.doi.org/10.3389/fpsyt.2019.00574

N.B. These documents automatically identified may not have been verified by the study sponsor.

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