Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000131752
Ethics application status
Approved
Date submitted
2/12/2021
Date registered
27/01/2022
Date last updated
13/07/2022
Date data sharing statement initially provided
27/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The MobiliseMe study: Testing the effect of different smartphone activities on young people's mental health
Scientific title
A randomised controlled trial evaluating the effectiveness of a CBT-based smartphone application for improving depressive symptoms and other mental health outcomes in young people
Secondary ID [1] 305858 0
None
Universal Trial Number (UTN)
U1111-1271-8519
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depressive symptoms 324395 0
Anxiety symptoms 324397 0
Psychological distress 324398 0
Emotional well-being 324399 0
Poor quality of life 324502 0
Excessive, repetitive negative thinking 324858 0
Poor emotion regulation 324859 0
Lack of perceived need for mental health care 324860 0
Condition category
Condition code
Mental Health 321882 321882 0 0
Depression
Mental Health 321883 321883 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial will examine the effectiveness of a new CBT smartphone application (ClearlyMe) for reducing depressive symptoms in in Australian adolescents (aged 12 to 17 years) when compared to guided use and an active-attention matched control condition.

This study will utilise a three-arm randomised controlled trial. Participants will be randomly allocated to receive one of three interventions: a new mental health smartphone application called ClearlyMe (Trial Arm 1), or the ClearlyMe smartphone application) and a weekly SMS chat delivered by trained research staff (Trial Arm 2), or weekly SMS tips and information for their mental health (Trial Arm 3). The duration and schedule of the interventions will be the same for all participants; all being instructed to spend 20 minutes per week for six weeks completing their allocated activity on their smartphone.

Trial Arm 1. Intervention 1 – Self-directed CBT smartphone application ClearlyMe: Participants allocated to this condition will receive ClearlyMe. ClearlyMe is a free, self-directed CBT-based smartphone application that provides therapeutic content and symptom management strategies to adolescents experiencing mild to moderate depressive and anxiety symptoms. The application was specifically designed for adolescents by a multidisciplinary team of psychologists, researchers, user experience designers and software developers at the Black Dog Institute. ClearlyMe is delivered as an autonomous, non-sequential CBT program consisting of 37 brief lessons (i.e., therapeutic content alongside activities). Lessons include the following evidence-based treatment components: psychoeducation, cognitive restructuring, emotion awareness and acceptance, goal setting, problem solving, activity scheduling, behavioural activation, exposure, relaxation, mindfulness, and values labelling. The lessons also encourage participants to practise the psychological skills in-between lessons and return to the app to reflect or access further content as needed. The lessons vary in length, taking between 5 to 10 minutes each to complete. To help navigate the program content, users are encouraged to complete the lessons via nine curated ‘collections’. A collection is defined as a structured selection of related lessons grouped together with a brief title and introduction. Each collection varies in length, taking approximately 20 minutes to complete. Users can also complete the individual lessons from a ‘show all’ list whereby they self-select lessons considered to be relevant to their individual needs. In this list, lessons are categorised into three groups depending on their target: ‘emotions’, ‘thoughts’, ‘behaviours’. The application also includes a Moodcheck (i.e., brief mood monitoring), Mind Hacks (i.e., quick strategies that help in the moment), and Stories (i.e., short videos of young peoples’ experience managing mental health symptoms and positive help-seeking experience) to provide users with additional pathways to accessing therapeutic content. For these features, specific lessons are recommended after the feature is accessed. ClearlyMe also includes in-application reminders, ‘saving’ and ‘favourite’ functions to support users to return to the application to reengage in content. In-application reminders include a ‘revisit the application’ reminder, which notifies all participants to use the application if they haven’t done so in the past 7 days. Users can also set an additional reminder to use the Moodcheck feature once a day for as many days as they wish. Due to the developer requirements of iOS and Google Play, smartphone application notifications must be able to be disabled in a user’s phone settings. The application also includes a ‘Get Help’ section that contains information of when and where to access additional mental health support services (e.g., Kid’s Helpline). To ensure compliance, participants who fail to download ClearlyMe within 7 days of randomisation will be sent an email and SMS reminder to download.

Trial Arm 2. Intervention 2 – Guided use of CBT smartphone application ClearlyMe: Participants allocated to this condition will receive the same intervention provided in Trial Arm 1, with the addition of a weekly guided support session. This will take place in the form of a SMS chat provided by the research team for the duration of the intervention period. Participants will be contacted via SMS on their mobile phone number at the times provided to participants after randomisation (3:30pm to 6pm Monday to Friday). Contact will be made weekly, with one additional attempt made for non-response (within two days of the initial attempt). In total, participants in this condition will receive 6 weekly support sessions in the intervention period. Personnel conducting the guided sessions will be research employees of the Black Dog Institute and will use a standard script, with a decision flow chart to direct the chat. The SMS chat will consist primarily of technical support with some low intensity motivational coaching. Research staff will be trained to conduct these sessions and will be supervised by a clinician. The clinician will be available during these sessions to support the RA if needed. The guided support sessions will be designed to be conducted in one sitting (i.e., within 20 minutes) but duration and script compliance will be recorded by the research assistants.

The interventions are not personalised, titrated, or adapted to individuals in any intervention arm.

Participants in Trial Arms 1 and 2 are instructed to complete the application content by undertaking at least one collection per week (approximately 20 minutes) for the intervention period. The study will collect research data associated with their use of the intervention to assess participants’ adherence. This information will be used to determine which aspects of the intervention are important for improved outcomes. This trial will collect the following usage data from the ClearlyMe app to determine adherence: lessons completed, collections completed, features accessed, total time spent in app, content liked/disliked, content saved, and individual responses to lesson activities.

Strategies to maintain intervention adherence will be implemented. For example, the ClearlyMe application (Trial Arms 1 and 2) includes automated reminders that prompt participants to use the application if they have not done so within 7 days. Those in Trial Arm 1 will also receive additional weekly SMS notifications regardless of their use of the application. Participants in Trial Arm 2 will receive guided supported (weekly SMS support sessions) to encourage engagement with and completion of ClearlyMe activities. In addition, participants in Trial Arms 1 and 2 who have failed to download the application within 7 days of completing the baseline assessment will also be sent a follow-up email and SMS reminding them to download the application.
Intervention code [1] 322254 0
Treatment: Other
Comparator / control treatment
Trial Arm 3. Active attention-matched control – SMS enabled, self-directed low intensity weekly psycho-education tips with self-care:
This study will utilise an active attention matched control condition. Participants allocated to this condition will receive 6 weekly psychoeducation modules delivered via SMS with handouts that can be accessed on their mobile device. The psycho-education consists of 6 topics: What is mental health, Feeling on Edge – Understanding Anxiety, Waves of Sadness – Understanding Depression, When it’s time to tell someone, When a friend needs a hand, and When friendships are complicated. Each module consists of information about mental health problems, links to credible Australian mental health organisations, and finishes with self-care suggestions for what a young person can do right now if they are feeling worried or down. These modules were developed by the Black Dog Institute, created by mental health professionals, researchers and young people. Each module takes approximately 20 minutes to complete. Participants allocated to this intervention arm will not receive any additional human contact from the research team unless technical support for the program (via email) is required. At the secondary endpoint, participants will receive one email that contains all of the psycho-education material in one collated document for future use.
Control group
Active

Outcomes
Primary outcome [1] 329643 0
Depressive Symptoms: This will be measured on 3 occasions using the 9-item self-report Patient Health Questionnaire: Adolescent version; PHQ-A (PHQ-A; Kroenke, 2001). The 9-item PHQ is a self-report scale that assesses the presence of depressive symptoms in the past two weeks. Item scores are summed to produce a total score, which can be used to indicate ‘nil to mild’ symptoms (scores: 0-9), ‘moderate’ symptoms (scores: 10-14), and ‘moderately severe’ to ‘severe’ symptoms (scores: 15+). The survey will available to participants for 7 days from the start of each time point.
Timepoint [1] 329643 0
Timepoint 1: Baseline (Day 1)
Timepoint 2: Post-intervention (Primary end-point; Day 42 post-baseline completion)
Timepoint 3: Follow-up (Day 120 post-baseline completion)
Secondary outcome [1] 403260 0
Anxiety Symptoms: This will be measured on 3 occasions using the 7-item self-report Generalised Anxiety Disorder Scale -7 (GAD-7; Spitzer, 2006). The GAD assesses the presence of anxiety symptoms in the past two weeks. Item scores are summed to produce a total score, which can be used to indicate ‘nil to mild’ symptoms (scores: 0-9), ‘moderate’ symptoms (scores: 10-14), and ‘moderately severe’ to ‘severe’ symptoms (scores: 15+). The survey will available to participants for 7 days from the start of each time point.
Timepoint [1] 403260 0
Timepoint 1: Baseline (Day 1)
Timepoint 2: Post-intervention (Day 42 post-baseline completion)
Timepoint 3: Follow-up (Day 120 post-baseline completion)
Secondary outcome [2] 403261 0
Psychological distress: This will be measured on 3 occasions using the Distress Questionnaire-5 (DQ-5; Batterham et al., 2016) is a brief 5-item screening measure describing symptoms of common mental disorders. The self-report tool assesses the frequency of psychological distress in the previous 30 days. Items are rated on a 5-point scale, ranging from “Never” (1) to “Always” (5). Total scores on the scale range from 5 to 25, with higher scores indicating greater psychological distress.
Timepoint [2] 403261 0
Timepoint 1: Baseline (Day 1)
Timepoint 2: Post-intervention (Day 42 post-baseline completion)
Timepoint 3: Follow-up (Day 120 post-baseline completion)
Secondary outcome [3] 403263 0
Emotional wellbeing: This will be measured on 3 occasions using the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS; Stewart-Brown et al., 2009; Tennant et al., 2007) is a 7-item scale designed to assess individuals’ wellbeing in the previous 2 weeks. Items are rated on a 5-point scale, ranging from “None of the time” (1) to “All of the time” (5), with total scores ranging from 7 to 35.
Timepoint [3] 403263 0
Timepoint 1: Baseline (Day 1)
Timepoint 2: Post-intervention (Day 42 post-baseline completion)
Timepoint 3: Follow-up (Day 120 post-baseline completion)
Secondary outcome [4] 403264 0
Quality of life: This will be measured on 2 occasions using the Child Health Utility 9D (CHU-9D; Stevens, 2009) is a 9-item scale designed to measure child and adolescent health related quality of life. The measure covers nine domains of adolescent functioning including: worry, sadness, pain, tiredness, annoyance, schoolwork/homework, sleep, daily routine and ability to join activities. Each domain is rated on a 5-point scale, with each level representing increasing levels of severity within each domain (e.g., I don’t feel worried today” to “I feel very worried today”).
Timepoint [4] 403264 0
Timepoint 1: Baseline (Day 1)
Timepoint 2: Post-intervention (Day 42 post-baseline completion)
Secondary outcome [5] 403265 0
Excessive, repetitive negative thinking: Rumination will be measured on 3 occasions using the Ruminative Responses Scale – short version (RRS; Treynor et al., 2003) is a 10-item scale adapted from the original 22-item scale developed by Nolen-Hoeksema (1991). The self-report instrument measures individuals’ tendency to engage in rumination. To assess ruminative response style, individuals are asked to rate each item in response to the statement “what you generally do, not what you think you should do when feel down, sad or depressed”. The scale is composed of two subscales; reflection (e.g., “Write down what you are thinking and analyse it”, and brooding (e.g., ‘Think “What am I doing to deserve this?”’), with 5-items relating to each factor. Each item is rated on a 4-point scale ranging from “almost never” (1) to “almost always” (4), with total scores ranging from 10 to 40. Higher scores reflect higher levels of ruminative response styles.
Timepoint [5] 403265 0
Timepoint 1: Baseline (Day 1)
Timepoint 2: Post-intervention (Day 42 post-baseline completion)
Timepoint 3: Follow-up (Day 120 post-baseline completion)
Secondary outcome [6] 403267 0
Poor emotion regulation: This will be measured on 3 occasions using the Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA; Gullone & Taffe, 2012) is a 10-item scale modified with simple item wording to assess the Emotion Regulation strategies of Cognitive Reappraisal (e.g., “When I want to feel happier about something‚ I change the way I’m thinking about it.”) and Expressive Suppression (e.g., “I keep my feelings to myself.”). Items are rated on a 7-point scale, ranging from “Strongly disagree” (1) to “Strongly agree” (5). The cognitive reappraisal subscale has 6-items with total scores ranging from 6 to 30. The expressive suppression 4-items with scores ranging from 4 to 20. Higher scores on each subscale reflect greater use of the corresponding emotion regulation skill.
Timepoint [6] 403267 0
Timepoint 1: Baseline (Day 1)
Timepoint 2: Post-intervention (Day 42 post-baseline completion)
Timepoint 3: Follow-up (Day 120 post-baseline completion)
Secondary outcome [7] 403621 0
Lack of perceived need for mental health care: The Perceived Need for Care Questionnaire is a four-item measure designed to reflect a conversation of perceived needs for mental health care. It will be assessed on 3 occassions. The instrument has demonstrated good validity and reliability in a specialist anxiety clinic (Meadows et al., 2000). The measure has been adapted in large representative samples of adolescents to understand perceived need across four domains of adolescent mental health care; counselling, medication, information, and skill training (Johnson et al., 2018; Schnyder et al., 2020). If the respondent indicates receiving help in the previous 12 months, the measure assesses whether the level of care was sufficient, and where they perceived they needed more help. For those who indicate they have not received help in the previous 12 months, the measure assesses their perceived need for help. Perceived need is classified as fully met, partially met, unmet, or no need.
Timepoint [7] 403621 0
Timepoint 1: Baseline (Day 1)
Timepoint 2: Post-intervention (Day 42 post-baseline completion)
Timepoint 3: Follow-up (Day 120 post-baseline completion)
Secondary outcome [8] 403630 0
Intervention (ClearlyMe) use - uptake: In the current study, ‘uptake’ is defined as the proportion of participants (%) who take up the app, measured by app downloads. This data will be extracted from the application analytics database within the application and Black Dog Institute Research Engine.
Timepoint [8] 403630 0
Timepoint 2: Post-intervention (Day 42 post-baseline completion)
Secondary outcome [9] 404762 0
SMS psycho-education use (Trial arm 3: control group): The number of times psycho-education content is accessed in the control group. This trial will use Google analytics to track the number of times the URL (linking to psycho-education) within the SMS is clicked on.
Timepoint [9] 404762 0
Timepoint 2: Post-intervention (Day 42 post-baseline completion)
Secondary outcome [10] 409499 0
Intervention (ClearlyMe) use – categorical adherence: ‘Adherence’ is defined as the proportion (%) of participants who followed the instructions for app use. This will be measured as a categorical variable (adherers vs. non-adherers) in which participants who complete at least one collection each week for the entire 6 weeks will be deemed ‘adherers’. This data will be extracted from the application analytics database within the application and Black Dog Institute Research Engine.
Timepoint [10] 409499 0
Timepoint 2: Post-intervention (Day 42 post-baseline completion)
Secondary outcome [11] 409500 0
Intervention (ClearlyMe) use – numerical adherence: Adherence will be measured as a numerical variable in which participants will earn 1 point for each week that they adhered to the instructions (i.e., completed at least one collection) resulting in a total adherence score (range: 0 to 6). This data will be extracted from the application analytics database within the application and Black Dog Institute Research Engine.
Timepoint [11] 409500 0
Timepoint 2: Post-intervention (Day 42 post-baseline completion)
Secondary outcome [12] 409501 0
Intervention (ClearlyMe) use – completions: 'Completions’ is used to describe participants’ exposure to the app content, measured as the number of lessons completed. All of this data will be extracted from the application analytics database within the application and Black Dog Institute Research Engine.
Timepoint [12] 409501 0
Timepoint 2: Post-intervention (Day 42 post-baseline completion)
Secondary outcome [13] 409502 0
Intervention (ClearlyMe) use –other: following data from individual participants will be collected and analysed as a composite measure: features accessed, total time spent in application, content liked/disliked, content saved, and individual responses to lesson activities.
Timepoint [13] 409502 0
Timepoint 2: Post-intervention (Day 42 post-baseline completion)

Eligibility
Key inclusion criteria
Aged 12 to 17 years (confirmed by self-report);
Located in Australia (confirmed by self-report);
Experiencing mild to moderately-severe depressive symptoms (as determined by a total score of 5-19 on the self-report Patient Health Questionnaire-9- Adolescent version);
Own or have access to a smartphone (for receipt of the study interventions);
Have access to the Internet, an active email address and mobile phone number (for receipt of study activities, invitations, reminders);
Comfortable with reading English at Year 7-8 level (to ensure comprehension of intervention content);
Have a parent or guardian who can provide consent for participation.
Minimum age
12 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Currently experiencing severe suicidal ideation (as determined by a score of greater than or equal to 2 on item 9 of the self-report Patient Health Questionnaire-9-Adolescent version).
Had serious suicidal ideation in the past month (as determined by self-report).
A suicide attempt in the past month (as determined by self-report).
Experiencing nil or severe depressive symptoms (as determined by a score total of less than or equal to 4 or greater than or equal to 20 on the self-report Patient Health Questionnaire).
Currently receiving OR about to start (in the next 2 weeks) any psychological treatment for feelings of low mood or depression from a psychologist, psychiatrist or other mental health professional
Currently taking OR about to start (in the next 2 weeks) any daily prescribed medication (e.g., anti-depressants) for their mental health (low mood, depression or anxiety).
Unable to gain parental consent to participate (as determined by failure to return parental consent form within their recruitment period).
Located outside of Australia, not within age range or fail to satisfy any of the other inclusion criteria (as determined by the self-report screener).

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)
Eligibility for the study will be determined by a self-report online questionnaire completed on the Black Dog Institute Research Engine. Randomisation to one of the three trial arms will be conducted immediately after completion of the baseline assessment using a computerised randomisation procedure within the Black Dog Institute Research Engine. No research personnel will be involved in the randomisation procedure.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be carried out according to the International Council for Harmonisation (ICH) guidelines. A stratified randomisation approach with a block size of 6 (1:1 ratio) will be used to ensure balance across the conditions in terms of age (12 to 14 years vs. 15 to 17 years), symptom severity (mild vs moderate to moderately-severe). Allocation will be fully automatic, conducted by the Black Dog Institute Research Engine, with no interference from the research team.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The total baseline sample size required for detecting change in the primary outcome is 489. This is based on calculations using a=0.05, power=0.8, small to medium effect sizes for psychoeducation (d=0.10), self-directed CBT (d=0.35), and guided CBT (d=0.65) on depressive outcomes at primary endpoint and a 20% attrition rate between baseline and primary endpoint.
Specifically, this sample size is comprised of the following sample sizes for each of the participant groups:
1. Trial Arm 1=163 participants
2. Trial Arm 2=163 participants
3. Trial Arm 3=163 participants.



Data collection and analysis:
Primary analyses will be conducted to determine the effect of the interventions on depressive symptoms at the primary and secondary endpoints. Analyses will be undertaken on an intention-to-treat basis, including all participants randomised, regardless of intervention received. The effectiveness of the trial interventions will be established by a change on the PHQ-9-A between baseline and 6-weeks post-baseline (primary endpoint) and 4-month follow-up (secondary endpoint), based on the interaction between time and condition, using a mixed-effects linear modelling with an unadjusted p value of 0.05. Effect sizes will be calculated based on differences in observed change scores between baseline and 6-weeks post-baseline, using standard deviations of the change scores pooled across conditions. This modelling will account for all available data, under the missing at random assumption. However, attrition analyses will be conducted to determine whether missing data is associated with any baseline demographics (age, gender), mental health status (symptom severity) or other descriptive variables. Any baseline variables identified as substantially imbalanced between groups will be added to the models on an exploratory basis to confirm the robustness of the findings to this imbalance. Where distributional assumptions cannot be satisfied, other modelling may be used to confirm the robustness of the findings. Similar models will be used for secondary outcomes. To analyse the effects of adherence on outcomes, the mixed-effects repeated measures linear modelling will be repeated for each intervention condition separately using the categorical adherence measure as a between group factor (adheres v non-adheres v control). These results will be published in the primary outcomes paper. Exploratory analyses will examine evidence for moderation, that is, whether the intervention was more effective for certain subgroups of the sample. Further, exploratory analyses will also examine evidence for mediation, that is whether the effects of the intervention were driven by other variables.

An additional file with free response data, matched with participant ID codes will be stored on UNSW OneDrive for qualitative analyses by the Chief Investigators, Trial Manager, and Research Officers/Assistants. Free-response questions will be analysed using thematic analysis to identify patterns across the responses. An inductive approach will be used to identify and group themes. The first stage of analysis will commence with familiarisation of the dataset by one researcher. Open coding will be used to summarise the data and create preliminary labels. Next, initial codes will be generated, and a coding framework will be created. A second researcher will then refine the codes and determine the final coding framework. Both researchers will recode the data using the finalised coding framework. An independent third researcher will review the data and themes to consolidate the findings. To support the validity of the analysis, analyst triangulation will be used whereby higher-order codes and final themes were determined by consensus among the researchers. The researchers coding the data will be instructed to regularly reflected on their personal reactions to ensure that they do not contaminate the data. The final themes will be presented in a separate paper on young people’s perceptions of the interventions.

For participants allocated to trial arm 1 and 2, the study will also collect research data associated with their use of the intervention. This information will be used to determine which aspects of the intervention are important for improved outcomes. This trial will collect the following usage data from the ClearlyMe app: lessons completed, collections completed, features accessed, total time spent in app, content liked/disliked, content saved, and individual responses to lesson activities. This data will be extracted automatically from individuals’ smartphones and transferred via the Internet to the Black Dog Institute Research Engine. This data will then be available for download (similar to the study assessment data) via the Black Dog Research Engine, connected to participants’ study assessments using their unique participant identification code. Participants responses will be analysed to determine their compliance and engagement with the content, including linguistic analysis of their free responses. For participants allocated to trial arm 3 (i.e., the control condition), the study will also collect research data associated with the total number of content click-throughs for the psychoeducation links, determined via Google Analytics on the URLs included in the weekly SMS content.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/05/2022
Actual
12/05/2022
Date of last participant enrolment
Anticipated
28/02/2023
Actual
Date of last data collection
Anticipated
31/05/2023
Actual
Sample size
Target
489
Accrual to date
52
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310210 0
Charities/Societies/Foundations
Name [1] 310210 0
Goodman Foundation
Country [1] 310210 0
Australia
Primary sponsor type
University
Name
University of New South Wales (UNSW)
Address
University of New South Wales
Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 311302 0
None
Name [1] 311302 0
Address [1] 311302 0
Country [1] 311302 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309892 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 309892 0
UNSW Research Ethics & Compliance Support
The University of New South Wales
Sydney
NSW 2052
Ethics committee country [1] 309892 0
Australia
Date submitted for ethics approval [1] 309892 0
25/10/2021
Approval date [1] 309892 0
26/11/2021
Ethics approval number [1] 309892 0
HC10889

Summary
Brief summary
This clinical trial aims to investigate the effectiveness of a Cognitive Behavioural Therapy (CBT) program delivered via a smartphone application (called ClearlyMe) for improving mental health outcomes in Australian adolescents (aged 12 to 17 years) with mild to moderate depressive symptoms.

This trial will examine the effectiveness of a new CBT smartphone application (ClearlyMe) for reducing depressive symptoms in adolescents when compared to guided use and an active-attention matched control condition.

The primary research questions that this trial seeks to address are:
1. What is the effectiveness of ClearlyMe (both self-directed and guided use) for reducing depressive symptoms?

Secondary research questions include:
2. What is the effectiveness of ClearlyMe for reducing anxiety symptoms, psychological distress, rumination, and improving emotional wellbeing, quality of life, emotion regulation, and CBT skill acquisition?
3. Does guided support lead to greater engagement with and completion of the ClearlyMe app when compared to self-directed use?
4. Do factors such as gender, age, baseline mental health history or symptom severity, perceived need for care, or openness to digital mental health moderate the improvements in depressive symptoms found among users of ClearlyMe?
5. Do factors such as rumination, emotion regulation, CBT skill acquisition, digital therapeutic alliance and program engagement/completion mediate the improvements in depressive symptoms found among users of ClearlyMe?
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115746 0
Dr Bridianne O'Dea
Address 115746 0
Black Dog Institute
Hospital Road
Prince of Wales Hospital
Randwick, NSW, 2031
Country 115746 0
Australia
Phone 115746 0
+61 2 9382 8509
Fax 115746 0
Email 115746 0
[email protected]
Contact person for public queries
Name 115747 0
Dr Bridianne O'Dea
Address 115747 0
Black Dog Institute
Hospital Road
Prince of Wales Hospital
Randwick, NSW, 2031
Country 115747 0
Australia
Phone 115747 0
+61 2 9382 8509
Fax 115747 0
Email 115747 0
[email protected]
Contact person for scientific queries
Name 115748 0
Dr Bridianne O'Dea
Address 115748 0
Black Dog Institute
Hospital Road
Prince of Wales Hospital
Randwick, NSW, 2031
Country 115748 0
Australia
Phone 115748 0
+61 2 9382 8509
Fax 115748 0
Email 115748 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The de-identified individual participant data underlying the study results will be available to be shared. This data will only include quantitative primary and secondary outcomes data and all identifiable information will be removed.
When will data be available (start and end dates)?
This data will become available after the study has been completed, primary and secondary outcomes data are analysed and results are published. Study findings are planned to be disseminated from April 2023, therefore we expect the data to be available for 15 years, from April 2023 until April 2038.
Available to whom?
Researchers seeking to conduct research related to the study’s general research topic will be able to seek access to the deidentified participant dataset. Access to the data will be based on the Principal Investigator/data custodian’s discretion and will be granted to researchers who provide a methodologically sound proposal and appropriate ethics approvals.
Available for what types of analyses?
Researchers seeking to conduct research related to the study’s general research topic of youth mental health and digital metnal health interventions will be able to seek access to the deidentified participant dataset. Researchers will be permitted to perform analyses of the data only to achieve the aims of a proposal approved by the study’s the Principal Investigator/data custodian.
How or where can data be obtained?
Researchers can contact the study’s Principal Investigator and data custodian, Dr Bridianne O’Dea to request access approval to the dataset. Dr Bridianne O'Dea’s contact email address is [email protected].


What supporting documents are/will be available?




Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProtocol for a randomised controlled trial evaluating the effectiveness of a CBT-based smartphone application for improving mental health outcomes in adolescents: the MobiliseMe study.2022https://dx.doi.org/10.1186/s12888-022-04383-3
N.B. These documents automatically identified may not have been verified by the study sponsor.