Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001382763
Ethics application status
Approved
Date submitted
20/10/2022
Date registered
28/10/2022
Date last updated
28/01/2024
Date data sharing statement initially provided
28/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The Momentum Program: Online Cognitive Behavioural Therapy (CBT) for Adolescent Depression and Sleep Comorbidity
Scientific title
Efficacy of Online CBT for Adolescent Depression and Sleep Comorbidity on Symptom Severity: A Randomised Controlled Trial of the Momentum Program
Secondary ID [1] 308223 0
None
Universal Trial Number (UTN)
U1111-1284-1203
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 327981 0
Sleep problems 327982 0
Condition category
Condition code
Mental Health 325038 325038 0 0
Depression
Mental Health 325039 325039 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The design involves a two-arm parallel-group RCT where adolescents aged 13-17 years with comorbid depression and sleep problems will be randomly assigned to either the online comorbid (COM) program condition targeting comorbid depression and sleep problems, or the online primary diagnosis (PRI) program condition targeting the primary presenting problem of depression. Both arms (i.e., Intervention Arm 1 and Intervention Arm 2) will receive an online intervention program.

The online programs will be accessed via the Momentum platform (https://momentumhub.org.au). The online interventions on the Momentum platform are self-directed and there is no contact with a therapist or a psychologist. The intervention program will be either 7 (PRI program) or 10 (COM program) sessions. The sessions will become available weekly. Each session does not have to be completed in one go, but each session will need to be completed before the participants move on to the next one. The users will receive automated reminders related to session availability. On the home page, the users will be able to monitor how far they are in their assigned program.

The Momentum program sessions have been co-designed with young people to ensure they are engaging and interactive. Sessions include the use of images, interactive elements, pop-up messages, and quizzes that provide immediate feedback. Each session comprises approximately 30 slides and takes an estimated 45 minutes to complete. The number of sessions will change depending on the intervention arm. Homework assignments can be completed online or can be printed out. Each session follows a similar format: (1) Feelings check-in (where the young person completes brief depression and sleep questionnaires); (2) A review of homework from the previous session; (3) A summary quiz of the previous session; (4) Presentation of the main content of the session (e.g., cognitive restructuring); (5) A quiz to see what they have learned from the session; and (6) Homework activities to be completed over the following week.

Intervention Arm 1 - Program targeting comorbid depression and sleep (COM):

This program will be provided to those participants with primary depression and secondary sleep problems, who have been allocated to the COM arm of the RCT. The COM program involves 10 sessions. The depression content of the PRI and COM programs is identical, with the only difference being that the COM program has an additional 3 sessions targeting sleep. These three sleep sessions are: 1) psychoeducation and sleep hygiene, 2) routine building and understanding the factors underpinning sleep problems, and 3) relapse prevention specific to depression and sleep.
Intervention code [1] 324681 0
Treatment: Other
Intervention code [2] 324682 0
Behaviour
Comparator / control treatment
Intervention Arm 2 - Program targeting primary depression (PRI)

The Momentum program sessions targeting primary problem have the same format and duration as the sessions targeting comorbidity (as described above). The sessions have been co-designed with young people to ensure they are engaging and interactive. Sessions include the use of images, interactive elements, pop-up messages, and quizzes that provide immediate feedback. Each session comprises approximately 30 slides and takes an estimated 45 minutes to complete. Number of sessions will change depending on the intervention arms. Homework assignments can be completed online or can be printed out. Each session follows a similar format: (1) Feelings check-in (where the young person completes brief depression and sleep questionnaires); (2) A review of homework from the previous session; (3) A summary quiz of the previous session; (4) Presentation of the main content of the session (e.g., cognitive restructuring); (5) A quiz to see what they have learned from the session; and (6) Homework activities to be completed over the following week.

This program will be provided to those participants with primary depression and secondary sleep problems, who have been allocated to the PRI arm of the RCT. The PRI program involves 7 sessions. Session 1 focuses on psychoeducation around depression. Sessions 2-4 focus on behavioural activation, relaxation and appreciation/gratitude. Sessions 5-6 focus on cognitive restructuring. Session 7 focuses on relapse prevention.
Control group
Active

Outcomes
Primary outcome [1] 332860 0
Youth depressive symptoms

Depressive symptoms will be assessed with the Centre for Epidemiological Studies Depression Scale for adolescents (CES-D; Radloff, 1991).
Timepoint [1] 332860 0
Pre-intervention
Post-completion of program (primary endpoint)
6-month post-baseline follow up
12-month post-baseline follow up
Primary outcome [2] 332861 0
Youth sleep problems

Sleep problems will be measured by the patient-reported outcomes measurement information system (PROMIS) paediatric sleep disturbance and sleep related impairment scale (Forrest et al., 2018).
Timepoint [2] 332861 0
Pre-intervention
Post-completion of program (primary endpoint)
6-month post-baseline follow up
12-month post-baseline follow up
Secondary outcome [1] 414889 0
Quality of life

Quality of life will be assessed with the Child Health Utility 9 Index (CHU9D; Ratcliff e et al., 2012).
Timepoint [1] 414889 0
Pre-intervention
Post-completion of program
6-month post-baseline follow up
12-month post-baseline follow up
Secondary outcome [2] 414890 0
Treatment satisfaction and acceptability

Treatment satisfaction and acceptability will be assessed at post-intervention with a 6-item questionnaire adapted from March et al. (2009), in which young people are asked to rate their program satisfaction on a 5-point scale.
Timepoint [2] 414890 0
Post- completion of program

Eligibility
Key inclusion criteria
Following registration and the initial assessment process that is part of the open access Momentum Platform, adolescents aged 13-17 years who are found to demonstrate comorbid depression and sleep problems will be invited to participate in the RCT. Participants must be willing to participate in either of the two conditions (COM or PRI).
Minimum age
13 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential participants will be excluded if the adolescent (i) has an intellectual or a developmental disorder (autism, developmental delay); (ii) is receiving other psychological/psychiatric treatment for their identified problem (depression or sleep); (iii) is not stabilised on a medication prior to enrolment into this study or alters their medication dosage during the trial (if the participant is using medication for depression or sleep problems); (iv) displays a high suicidal risk (i.e., a score >21 on the Suicidal Ideation Attributes Scale by Van Spijker et al. (2014)).

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)
Allocation concealment will be done by central randomisation by the Momentum Platform hosted by GreenAnt Networks secure servers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible participants will proceed on to the RCT and will be randomised in a 1:1 ratio to either the COM or PRI condition, using a central, web-based randomisation service hosted by GreenAnt Networks secure servers. Random allocation will occur after stratification by gender for the RCT. Following random allocation to condition, participants will be provided access to and be able to begin their relevant allocated program immediately.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All variables will be examined for outliers, inter- and intra-measure consistency, normality and for obviously erroneous data. Preliminary analyses will compare groups on demographic and clinical characteristics at baseline using linear (for continuous measures) or logistic (for categorical or severely skewed measures) regression. Due to randomisation, we anticipate no systematic between group differences in data other than that which has been hypothesised. However, if differences are detected we will investigate and report the extent to which the results are altered when these differences are statistically controlled for. To evaluate intervention effects, we will use mixed-effects linear regression to take into account repeated measurements within participants.

The power calculation is based on a 2 (Condition: COM vs PRI) x 2 (Time: pre-assessment, and post-intervention) repeated measures design. Considering the participants in both conditions are receiving active intervention programs, we have decided to calculate our sample size based on the small interaction effect (Cohen’s f=0.1). With 80% power and alpha at 0.05, according to a two-tailed hypothesis, we need 100 participants per condition to obtain a small significant interaction effect (200 participants in total). Our planned sample of 270 allows for the potential attrition of 35% of participants (Spence et al., 2017), and the proposed sample size will provide sufficient power to conduct the proposed analyses.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Other reasons/comments
Other reasons
Technological / IT delays
Date of first participant enrolment
Anticipated
1/02/2023
Actual
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
270
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 312477 0
Government body
Name [1] 312477 0
National Health and Medical Research Council - Medical Research Future Fund (MRFF)
Country [1] 312477 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
176 Messines Ridge Rd.
Mt Gravatt QLD 4122
Country
Australia
Secondary sponsor category [1] 314063 0
University
Name [1] 314063 0
University of Southern Queensland
Address [1] 314063 0
USQ Springfield
37 Sinnathamby Blvd.
Springfield Central
QLD 4300
Country [1] 314063 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311820 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 311820 0
Research Ethics
Office for Research
Griffith University
Nathan
QLD 4111
Ethics committee country [1] 311820 0
Australia
Date submitted for ethics approval [1] 311820 0
15/09/2022
Approval date [1] 311820 0
12/10/2022
Ethics approval number [1] 311820 0
GU Ref No: 2022/744

Summary
Brief summary
Depressive disorders are highly prevalent among adolescents, are often highly comorbid with problematic sleep. In fact, problematic sleep is one of nine possible criterions of a major depressive disorder diagnosis. These issues are often chronic if left untreated, and lead to numerous problematic consequences. Digital mental health programs increase access to evidence-based interventions and have been shown to be highly effective for numerous mental health problems in youth. However, the online programs developed for child and adolescent mental health issues to date do not account for comorbidity, and instead focus on only one disorder (e.g., depression OR sleep). Youth are therefore routinely provided with a digital mental health program targeting their primary presenting problem only (i.e., the problem that is causing them the most distress or is most interfering with their functioning). Typically, this means depression is routinely treated, but sleep is not.

This RCT will target adolescents with primary depression, who also suffer with a comorbid sleep issue, by comparing an online program targeting BOTH depression and sleep, with one that will target only the primary presenting problem of depression. We expect that compared to the program targeting ONLY depression, the program directly targeting BOTH depression and sleep will lead to better and longer-lasting mental health outcomes not only for the depression, but also for the comorbid sleep problem.
Trial website
https://momentumhub.org.au/
Trial related presentations / publications
Public notes
Potential participants will register for the online Momentum platforms at: https://momentumhub.org.au/
Note. The site is yet to be published.
Following registration and the initial assessment process that is part of the open access Momentum Platform, adolescents aged 13-17 years who are found to demonstrate comorbid depression and sleep problems will be invited to participate in the RCT.

Contacts
Principal investigator
Name 122482 0
Prof Caroline Donovan
Address 122482 0
School of Applied Psychology
Griffith University
Mt Gravatt Campus
176 Messines Ridge Rd.
Mt Gravatt QLD 4122
Country 122482 0
Australia
Phone 122482 0
+61 737353401
Fax 122482 0
Email 122482 0
c.donovan@griffith.edu.au
Contact person for public queries
Name 122483 0
Prof Caroline Donovan
Address 122483 0
School of Applied Psychology
Griffith University
Mt Gravatt Campus
176 Messines Ridge Rd.
Mt Gravatt QLD 4122
Country 122483 0
Australia
Phone 122483 0
+61 737353401
Fax 122483 0
Email 122483 0
c.donovan@griffith.edu.au
Contact person for scientific queries
Name 122484 0
Prof Caroline Donovan
Address 122484 0
School of Applied Psychology
Griffith University
Mt Gravatt Campus
176 Messines Ridge Rd.
Mt Gravatt QLD 4122
Country 122484 0
Australia
Phone 122484 0
+61 737353401
Fax 122484 0
Email 122484 0
c.donovan@griffith.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data pertaining to primary and secondary outcomes may be shared. De-identified data will be shared with researchers under circumstances where the researchers have appropriate ethics approvals and appropriate research questions.
When will data be available (start and end dates)?
Data will only become available after all data has been analysed and results published from the trial. This includes both primary research questions, secondary research questions and those arising from the study later. The start and end dates for when the data will or will not be available are to be determined.
Available to whom?
This de-identified data may be available to other researchers who hold suitable ethical clearance and wish to collaborate with the investigator team.
Available for what types of analyses?
The de-identified data may be available for review and meta-analytic purposes or other analyses on request.
How or where can data be obtained?
The data can be obtained from the primary investigator at c.donovan@griffith.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17405Ethical approval  c.donovan@griffith.edu.au
17426Informed consent form  c.donovan@griffith.edu.au



Results publications and other study-related documents

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