Trial Review

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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] 291818 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Depression 303059 0
Anxiety 303913 0
Suicidal Ideation 303915 0
Condition category
Condition code
Mental Health 302519 302519 0 0
Depression
Mental Health 302520 302520 0 0
Anxiety
Mental Health 303279 303279 0 0
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] 297931 0
Early detection / Screening
Intervention code [2] 297932 0
Behaviour
Intervention code [3] 298542 0
Treatment: Other
Comparator / control treatment
No control group as it is an uncontrolled trial.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301933 0
Help-seeking attitudes, as measured by the General Help-Seeking Questionnaire (GHSQ).
Timepoint [1] 301933 0
6 weeks post baseline (i.e. Day 43).
Secondary outcome [1] 334293 0
Help-seeking behaviour, measured using the Actual Help-Seeking Questionnaire (AHSQ).
Timepoint [1] 334293 0
6 weeks post Baseline
Secondary outcome [2] 334294 0
Depression levels as measured by the Patient Health Questionnaire (PHQ-9)
Timepoint [2] 334294 0
6 weeks post Baseline
Secondary outcome [3] 334295 0
Anxiety levels as measured by the Generalised Anxiety Disorder Scale (GAD-7)
Timepoint [3] 334295 0
6 weeks post Baseline
Secondary outcome [4] 334347 0
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] 334347 0
6 weeks post Baseline
Secondary outcome [5] 334349 0
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] 334349 0
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
64
Accrual to date
Final
59
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 15866 0
2440 - Kempsey
Recruitment postcode(s) [2] 15867 0
2223 - Oatley
Recruitment postcode(s) [3] 16556 0
2289 - Adamstown

Funding & Sponsors
Funding source category [1] 295462 0
Commercial sector/Industry
Name [1] 295462 0
HSBC Bank Australia
Country [1] 295462 0
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] 295250 0
None
Name [1] 295250 0
Address [1] 295250 0
Country [1] 295250 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296796 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 296796 0
Ethics committee country [1] 296796 0
Australia
Date submitted for ethics approval [1] 296796 0
31/08/2016
Approval date [1] 296796 0
06/10/2016
Ethics approval number [1] 296796 0
HC16724
Ethics committee name [2] 297553 0
State Education Research Applications Process (SERAP)
Ethics committee address [2] 297553 0
Ethics committee country [2] 297553 0
Australia
Date submitted for ethics approval [2] 297553 0
09/09/2016
Approval date [2] 297553 0
07/02/2017
Ethics approval number [2] 297553 0
SERAP 2016471

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1677 1677 0 0
/AnzctrAttachments/372256-Appendix G - Parents and Students PICF_V.4 26.04.17.pdf (Participant information/consent)
Attachments [2] 1678 1678 0 0
/AnzctrAttachments/372256-UNSW HREC Approval 6-OCT-2016.Pdf (Ethics approval)
Attachments [3] 1679 1679 0 0
/AnzctrAttachments/372256-DOC17_107193_SERAP_2016471_Approval_Letter.pdf (Ethics approval)
Attachments [4] 1681 1681 0 0
/AnzctrAttachments/372256-Expression of Interest Letter for School Principal.pdf (Supplementary information)
Attachments [5] 1682 1682 0 0
/AnzctrAttachments/372256-Appendix C - Gillick Competency Test.pdf (Participant information/consent)
Attachments [6] 1864 1864 0 0
/AnzctrAttachments/372256-Phase 2 Clinical Trial Protocol.pdf (Protocol)
Attachments [7] 1865 1865 0 0
/AnzctrAttachments/372256-Appendix B - Outcome Measures (Revised).pdf (Supplementary information)
Attachments [8] 1866 1866 0 0
/AnzctrAttachments/372256-Detailed Procedure for Responding to Risk of harm.pdf (Supplementary information)

Contacts
Principal investigator
Name 72082 0
Dr Bridianne O'Dea
Address 72082 0
Black Dog Institute
Hospital Rd, Prince of Wales Hospital,
Randwick, NSW 2031
Country 72082 0
Australia
Phone 72082 0
+61293828509
Fax 72082 0
Email 72082 0
[email protected]
Contact person for public queries
Name 72083 0
Bridianne O'Dea
Address 72083 0
Black Dog Institute
Hospital Rd, Prince of Wales Hospital,
Randwick, NSW 2031
Country 72083 0
Australia
Phone 72083 0
+61293828509
Fax 72083 0
Email 72083 0
[email protected]
Contact person for scientific queries
Name 72084 0
Bridianne O'Dea
Address 72084 0
Black Dog Institute
Hospital Rd, Prince of Wales Hospital,
Randwick, NSW 2031
Country 72084 0
Australia
Phone 72084 0
+61293828509
Fax 72084 0
Email 72084 0
[email protected]

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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Other filesNo https://www.blackdoginstitute.org.au/research-proj... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSmooth Sailing: A Pilot Study of an Online, School-Based, Mental Health Service for Depression and Anxiety.2019https://dx.doi.org/10.3389/fpsyt.2019.00574
N.B. These documents automatically identified may not have been verified by the study sponsor.