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Trial registered on ANZCTR


Registration number
ACTRN12619001411134
Ethics application status
Approved
Date submitted
24/09/2019
Date registered
15/10/2019
Date last updated
23/10/2023
Date data sharing statement initially provided
15/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Enhancing Social Functioning in Young People at Ultra High Risk for Psychosis: Randomised Controlled Trial of a Novel Strengths-based Online Social Therapy
Scientific title
Enhancing Social Functioning in Young People at Ultra High Risk (UHR) for Psychosis: RCT of a Novel Strengths-based Online Social Therapy
Secondary ID [1] 297130 0
Nil known
Universal Trial Number (UTN)
U1111-1227-0067
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ultra-high risk for psychosis 311158 0
Condition category
Condition code
Mental Health 309780 309780 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive their usual treatment and have access a moderated online social networking system, called Momentum. Momentum is an online intervention specifically designed to enhance social functioning in young people at ultra-high risk for psychosis (UHR). The Momentum system is based on the Moderated Online Social Therapy (MOST) platform developed by eOrygen. Momentum includes therapeutic activities and information about mental health, mindfulness, personal strengths, and other topics relevant for UHR young people, in the form of text and comics designed by eOrygen specifically for this study. Momentum also includes a social network where participants can communicate via posts and comments in a newsfeed and a problem-solving forum.

The online platform will be moderated by experienced mental health workers based at Orygen Youth Health. Trained peer workers with lived experience of mental ill-health will also provide support to participants through the Momentum social network.

Following randomisation, participants allocated to the Momentum intervention will complete an online orientation and follow-up phone call with the online moderator. Participants will access Momentum (including individualised therapist support) for 12 months. During this period, participants may access Momentum as often as they like, at any time, from any internet-enabled device.

Momentum integrates online personal therapist support (by clinical psychologists). Their role is to provide guidance, monitor participant’s clinical status and ensure the safety of the social network. Each therapist is assigned a caseload, which they follow for the duration of the trial. Moderators send each client tailored content suggestions weekly (e.g. a module or action) based on their needs and interests. Clients can rate the helpfulness of the suggestions, which moderators use to recommend subsequent content.

To promote engagement, retention of participants, and behavioural change, Momentum was developed following persuasive system design including primary task support (i.e., modularisation and personalisation of content), social support (i.e., fully integrated, purpose-built social network) and dialogue support (i.e., reward provided by therapists, peer-supporters and automated functions).

Users will be invited by moderators to meet other users at ‘Momentum Workshops’, which will occur which will occur approximately every 3-4 months. Meet-ups will consist of an interactive 1-hour session on ‘how to make Momentum work for you’ and will provide users with the opportunity to ask questions and give feedback on the system. Participants will be reimbursed for their time.

In the event of a clinically significant deterioration of psychotic symptoms, transition to psychosis, increased risk or a hospital admission, the clinical moderators in conjunction with the CI team will perform an assessment to determine the risks and benefits of a temporary withdrawal from Momentum. Based on this assessment, and in consultation with the young person, the team will determine whether the account is temporarily suspended, or level of access restricted (e.g., participant can access therapeutic content and support from moderators, and view content in the social network, but cannot post comments or participate in existing threads within the social network). Following suspensions or restrictions to a user’s account, the study coordinator or moderator will contact the young person at fortnightly intervals to ascertain whether the account is to be reactivated.
Intervention code [1] 313397 0
Treatment: Other
Intervention code [2] 313398 0
Behaviour
Comparator / control treatment
Participants in the control group will receive treatment as usual. Treatment as usual (TAU) consists of a range of treatment options delivered by treating teams at the Personal Assessment and Crisis Evaluation Clinic (at Orygen Youth Health) or headspace prior to discharge or, after discharge, generic medical or mental health services typically available to young people in the absence of enrolement in the study. These can include follow-up by a general practitioner, private psychiatrist, primary care youth mental health services, or adult mental health services which deliver multidisciplinary psychiatric care (including medical follow-up, case management and acute psychiatric care as appropriate).
Control group
Active

Outcomes
Primary outcome [1] 318740 0
Social functioning - This will be measured by the Global Functioning Social Scale, a valid and reliable instrument designed to measure social functioning in Ultra High Risk (UHR) young people (Cornblatt et al., 2007)
Timepoint [1] 318740 0
Social functioning will be assessed at baseline and 4, 8, and 12 (primary timepoint) months post randomisation.
Secondary outcome [1] 365870 0
Transition to psychosis - This will be assessed via the Comprehensive Assessment of At Risk Mental State (CAARMS; Yung et al., 2005), a valid, reliable and widely used measure designed to determine UHR status as well as psychosis onset. Specifically, the following four positive sub-scales of the CAARMS will be used to assess psychosis onset: Unusual Thought Content, Non-Bizarre Ideas, Perceptual Abnormalities, and Disorganised Speech.
Timepoint [1] 365870 0
The CAARMS will be assessed at baseline and 4, 8 and 12 months post randomisation..
Secondary outcome [2] 365871 0
Attenuated psychotic symptoms - This will be also assessed via the CAARMS (as described in Secondary Outcome [1]).
Timepoint [2] 365871 0
The CAARMS will be assessed at baseline and 4, 8 and 12 months post randomisation..
Secondary outcome [3] 365872 0
Role functioning - This will be assessed using the Global Functioning Role Scale (Cornblatt et al., 2007).
Timepoint [3] 365872 0
Role functioning will be assessed at baseline and 4, 8 and 12 months post randomisation..
Secondary outcome [4] 365873 0
Vocational status - This will be determined by measuring vocational and educational status (e.g., enrolment in courses) at each assessment time point (including the participant’s report of employment and educational activities in between assessments). The Resource Use Questionnaire (RUQ) will be used to asses this.
Timepoint [4] 365873 0
Vocational status will be assessed at baseline and 4, 8 and 12 months post randomisation..
Secondary outcome [5] 365874 0
Depression - This will be assessed by the Quick Inventory of Depressive Symptoms (QIDS) instrument (Rush et al., 2003).
Timepoint [5] 365874 0
Depression will be assessed at baseline and 4, 8 and 12 months post randomisation..
Secondary outcome [6] 365875 0
Anxiety and stress - This will be assessed by the Generalized Anxiety Disorder 7-item (GAD-7) scale (Spitzer et al., 2006), and the Perceived Stress Scale (PSS; Cohen and Williamson, 1988).
Timepoint [6] 365875 0
Anxiety and Stress will be assessed at baseline and 4, 8 and 12 months post randomisation.
Secondary outcome [7] 365878 0
Loneliness - This will be assessed by the UCLA Loneliness Scale - Version 3 (Russell, 1996).
Timepoint [7] 365878 0
Loneliness will be assessed at baseline and 4, 8 and 12 months post randomisation..
Secondary outcome [8] 365879 0
Quality of life - This will be assessed by the Assessment of Quality of Life – Eight Dimension (AQoL 8D) scale (Richardson et al., 2011).
Timepoint [8] 365879 0
Quality of life will be assessed at baseline and 4, 8 and 12 months post randomisation..
Secondary outcome [9] 365880 0
Social anxiety - This will be measured by means of the Liebowitz Social Anxiety Scale (LSASl; Fresco et al., 2001).
Timepoint [9] 365880 0
Social anxiety will be assessed at baseline and 4, 8 and 12 months post randomisation..
Secondary outcome [10] 365881 0
Suicidal ideation and attempts - This will be measured by means of the Columbia-Suicide Severity Rating Scale (CSSRS; Posner et al., 2011). At follow-ups, assessing the 4-month time period since last assessments.
Timepoint [10] 365881 0
Suicide Ideation and attempts will be assessed at baseline and 4, 8 and 12 months post randomisation..
Secondary outcome [11] 365882 0
Psychological well-being - This will be assessed by the Basic Psychological Needs Satisfaction (BPNS) Questionnaire (Deci & Ryan, 2000; Gagné, 2003).
Timepoint [11] 365882 0
Psychological Well-being will be assessed at baseline and 4, 8 and 12 months post randomisation..
Secondary outcome [12] 365883 0
Social functioning and subjective well-being - This will be further measured using Ecological Momentary Assessment (EMA), the gold-standard for capturing experiences in daily life (Granholm, Ben-Zeev, Fulford, & Swendsen, 2013). EMA will be used to track patients’ appraisals of daily social interactions (i.e., social self-efficacy and social support), strengths use and momentary experiences of positive and negative affect. Brief surveys (approx. 2mins) will be sent to the participant’s smartphone once daily in the evening over the course of the study. EMA items have been drawn from previous research (Granholm et al., 2013). EMA will be administered via a smartphone application designed by CIs Alvarez, Gleeson and Koval. SEMA is available for iOS and Android-based smart phones, enables server-centred configuration (i.e. questionnaires, delivery times and data storage are configurable online) and stores data in real time in secure cloud storage, therefore minimizing loss of data.
Timepoint [12] 365883 0
Smartphone EMA surveys will be used to assess social functioning and subjective well-being once daily (approx. 2-mins per day) for the duration of the study (12-months).
Secondary outcome [13] 365886 0
Economic analysis - The AQoL 8D will be used to calculate quality-adjusted life years (Richardson et al., 2011). The actual cost of the Momentum intervention will be determined and captured using provider records including interviews with key budgetary personnel. A Resource Use Questionnaire (RUQ) will be used to determine the broader resource use of participants including treatment usage. Additionally, information from Medicare and the Pharmaceutical Benefits Schedule (PBS) will be accessed to collect routine data on the use of primary health care services. Data provided by the Centre for Victorian Data Linkage over 12 months follow-up on participant hospital admissions will also contribute to the economic analysis.
Timepoint [13] 365886 0
Economic Analyses will be assessed at baseline and 4, 8 and 12 months post randomisation..
Secondary outcome [14] 365887 0
Self-efficacy - This will be measured via the Self-Efficacy Scale (SES; Sherer & Adams, 1983).
Timepoint [14] 365887 0
Self-efficacy will be assessed at baseline and 4, 8 and 12 months post randomisation..
Secondary outcome [15] 365888 0
Social support - This will be assessed via the Social Provisions Scale (SPS; Cutrona & Russell, 1987) and the UCLA Loneliness Scale (as discussed in secondary outcome [7]).
Timepoint [15] 365888 0
Social support will be assessed at baseline and 4, 8 and 12 months post randomisation..
Secondary outcome [16] 365889 0
Subjective well-being - This will be measured by the Satisfaction With Life Scale (SWLS; (Diener, Emmons, Larsen, & Griffin, 1985) and balance of positive and negative affect (Diener, 2000) as measured using EMA (as discussed in secondary outcome [12])
Timepoint [16] 365889 0
The SWLS will be assessed at baseline and 4, 8 and 12 months post baseline assessment. EMA surveys will be assessed once daily for 12-months (see secondary outcome [12]).
Secondary outcome [17] 365890 0
Strengths use - This will be assessed via the Strengths Use Scale (SUS; Wood, Linley, Maltby, Kashdan, & Hurling, 2010).
Timepoint [17] 365890 0
Strengths use will be assessed at baseline and 4, 8 and 12 months post randomisation.
Secondary outcome [18] 365891 0
Self-esteem - This will be measured by the Rosenberg Self-Esteem Scale (RSES; Rosenberg, 1965).
Timepoint [18] 365891 0
Self-esteem will be assessed at baseline and 4, 8 and 12 months post randomisation..
Secondary outcome [19] 365892 0
Mindfulness skills and self-compassion- These will be assessed by the Freiburg Mindfulness Inventory (FMI; Walach, Buchheld, Buttenmuller, Kleinknecht, & Schmidt, 2006) and the Self-Compassion Scale short-form (SCS-SF; Raes, Pommier, Neff, & Van Gucht, 2011), respectively.
Timepoint [19] 365892 0
Mindfulness skills and self-compassion will be assessed at baseline and 4, 8 and 12 months post randomisation..
Secondary outcome [20] 365894 0
Sleep Quality - This will be measured using the Pittsburgh Sleep Quality Index (PSQI; Buysse, Reynolds, Monk, Berman, & Kupfer, 1989).
Timepoint [20] 365894 0
Sleep quality will be assessed at baseline and 4, 8 and 12 months post randomisation..
Secondary outcome [21] 365895 0
Digital phenotype - represented by data collected via a passive sensing application downloaded on the participant’s smartphone. Participants who opt into this aspect of the study will have the option to select precisely which smartphone sensors they want to activate as well as duration and timing of sensing (by turning the application on and off). The following sensors will be used in this study:
a. Applications: Captures the applications being used on the smartphone;
b. Communication: Captures the number of incoming/outgoing calls and SMS messages, without recording the content of these calls or messages;
c. Locations: Captures user geolocation;
d. Screen usage: Captures when users lock/unlock their phones and use the screen, including time and duration of phone use. This sensor does not capture what is on the screen at any time;
e. Screen interaction: Captures when a user uses the keyboard, without recording what is typed. This sensor also captures when a user clicks and scrolls on their smartphone.
Timepoint [21] 365895 0
If participant's opt in to this, passive sensing will be continuously assessed for the duration of the study (12-months), however participant's have complete control over what data they would like to smartphone app to collect, and can opt out at anytime.
Secondary outcome [22] 365899 0
Qualitative evaluation of intervention acceptability will be undertaken via semi-structured interview. This measure will only be presented to those in the intervention group of the study.
Timepoint [22] 365899 0
Evaluation of intervention acceptability will be assessed at the end of intervention (only for those within the intervention group).
Secondary outcome [23] 365900 0
Usage of Momentum will be measured by monitoring usage of the online system over 12 months follow-up (i.e. frequency, duration and patterns of use). This measure will only be presented to those in the intervention group of the study.
Timepoint [23] 365900 0
Continuously collected throughout the duration of the study (12-months) for those accessing the intervention platform (Momentum).
Secondary outcome [24] 365906 0
Therapeutic Alliance - This will be measured using the Working Alliance Inventory client version (WAI-C). The WAI is a measure of the therapeutic alliance that assesses three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. Moderators will be asked to complete the WAI therapist version (WAI-T) in order to examine and compare the nature of the therapeutic relationship. This measure will only be presented to those in the intervention group of the study.
Timepoint [24] 365906 0
Therapeutic alliance will be assessed at baseline and 4, 8 and 12 months post baseline assessment. This measure will only be presented to those in the intervention group of the study.
Secondary outcome [25] 374577 0
Adverse events, defined as any untoward medical occurrence, and serious adverse events (SAEs), defined as any untoward medical occurrence that:
• Results in death;
• Is life-threatening (Life-threatening in the definition of serious refers to an event in which the participant was at risk of death at the time of the event, it does not refer to an event which hypothetically might have caused death if it were more severe)
• Requires inpatient hospitalisation or prolongation of existing hospitalisation;
• Results in persistent or significant disability/incapacity;
• Is a congenital anomaly/birth defect;
• Is an important medical event that although not immediately life-threatening or result in death or hospitalisation, based upon appropriate medical and scientific judgement, may jeopardise the participant and/or require intervention to prevent one of the outcomes listed above.

AEs and SAEs may be derived from a number of sources such as clinical results/reports, medical file reviews, spontaneous reporting or via non-leading questioning to the participant. The AE/SAE description, start and stop dates, intensity, causality and outcome will be recorded, as well as any actions taken.
Timepoint [25] 374577 0
Adverse events data will be collected throughout the duration of the study.

Eligibility
Key inclusion criteria
1. Age 14 to 27 years inclusive;
2. Ability to read and converse in English;
3. Ability to provide informed consent;
4. Ability and willingness to nominate an emergency contact person, such as a close family member;
5. Meeting criteria for one or more UHR for psychosis groups (Vulnerability group, Attenuated Psychotic Symptoms group or Brief Limited Intermittent Psychotic Symptoms (BLIPS) group).
Minimum age
14 Years
Maximum age
27 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Past history of a psychotic episode of one week or longer;
2. Acute risk of self-harm requiring urgent intervention (i.e., suicidal ideation with a current plan and intent to enact this plan);
3. Inability to converse in, or read English;
4. Attenuated psychotic symptoms only present during acute intoxication.
5. Organic brain disease known to cause psychotic symptoms, e.g. temporal lobe epilepsy.
6. Any metabolic, endocrine or other physical illness, e.g. thyroid disease, with known neuropsychiatric consequences.
7. Diagnosis of a serious developmental disorder, e.g. Severe Autism Spectrum Disorder.
8. A documented history of developmental delay or intellectual disability.

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)
The randomisation schedule will be generated by a statistician independent of the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be generated by a statistician independent of the study. Randomisation will be carried out remotely according to the International Conference on Harmonization E9 Statistical Principles Guidelines (Lewis, 1999). Participants will be randomly assigned to the treatment condition using randomly permutated blocks. Patients will be stratified by treatment centre (PACE Clinic, headspace Glenroy, headspace Craigieburn, headspace Sunshine, headspace Werribee).
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
Safety/efficacy
Statistical methods / analysis
Sample size was determined by power analysis using G*Power 3. The primary outcome is difference in social functioning at 12 months. Our pilot study found a very large effect size improvement in social functioning from baseline to 2-months follow-up. This contrasts with follow-up and treatment studies in UHR patients, where social functioning has not improved over time (Fusar-Poli et al., 2013). Thus, we conservatively assume a medium treatment effect (Cohen's d=0.45), for which a total sample of 180 patients is required to achieve 85% power (alpha=0.05). The same applies for all continuous secondary outcome measures (e.g., depression, stress, quality of life). Regarding transition to psychosis, assuming a base-rate of 36% in the control group who transition to psychosis (Fusar-Poli et al., 2013) and a 54% reduction in rate of transition to psychosis in the treatment group (consistent with recent meta-analysis on the effectiveness of UHR interventions (van der Gaag et al., 2013)), a sample of 180 will ensure we have 81% power to detect a statistically significant difference in transition rates at p < .05. A total of 220 young people will be recruited, allowing for an 18% attrition rate following randomisation. This compares favourably with the attrition rates in the Momentum pilot (7%) and an ongoing 18-month follow-up RCT testing moderated online social therapy in young people with psychosis which recruited form OYHCP and headspace centres (15%).

Primary analyses will be undertaken on an intention-to-treat basis. Mixed-model repeated measures (MMRM) analyses will be used to compare change in social functioning between the two treatment groups over the 12-month follow-up. MMRM is the analysis of choice because assumptions of traditional data analysis methods (e.g., ANOVA, logistic regression) may be violated, such as the assumption of homogeneity of regression across time points (Brown & Prescott, 2015). MMRM will also be used to analyse change in the continuous secondary outcomes over 12 months. Group differences in risk of transition to psychosis will be tested using Fisher’s Exact Test, an alternative to the chi-square test more robust to small sample sizes (McDonald, 2014). Time to transition to psychosis will be assessed by survival analysis (using either proportional hazard or accelerated life-time models).

Mechanisms of action analyses will be conducted using a multilevel structural equation modelling (MSEM) framework to assess mediation. Specifically, person-specific slopes representing change over time in the proposed mechanism-of-action variables (self-efficacy, social support and subjective wellbeing) will be tested as mediators of the effect of treatment group (Momentum vs. TAU) on social functioning. MSEM will also be used to analyse passive sensing data collected by the AWARE mobile application, including the relationship between mobile data and study measures.

Economic evaluation will comprise a cost-consequences analysis whereby incremental costs of the intervention will be compared to the full spectrum of study outcomes. The evaluation will measure and value any change to the use of health care resources over the period of the study between the two treatment arms; and then compare any additional costs to the additional outcomes achieved. Standardised economic evaluation techniques including incremental analysis of mean differences and bootstrapping to determine confidence intervals will be used. If, as expected, the intervention is found to be effective, lifetime and population cost-effectiveness of the interventions will be determined using modelling techniques (Mihalopoulos, Vos, Pirkis, Smit, & Carter, 2010).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/10/2019
Actual
26/11/2019
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
220
Accrual to date
72
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment postcode(s) [1] 25434 0
3052 - Parkville
Recruitment postcode(s) [2] 25435 0
3064 - Craigieburn
Recruitment postcode(s) [3] 25436 0
3046 - Glenroy
Recruitment postcode(s) [4] 25437 0
3020 - Sunshine
Recruitment postcode(s) [5] 25438 0
3030 - Werribee
Recruitment postcode(s) [6] 37630 0
2022 - Bondi Junction
Recruitment postcode(s) [7] 37631 0
2500 - Wollongong

Funding & Sponsors
Funding source category [1] 301691 0
Government body
Name [1] 301691 0
National Health and Medical Research Council
Country [1] 301691 0
Australia
Primary sponsor type
Other
Name
Orygen, the National Centre of Excellence in Youth Mental Health
Address
35 Poplar Rd, Parkville, VIC, 3052
Country
Australia
Secondary sponsor category [1] 301411 0
Hospital
Name [1] 301411 0
Melbourne Health
Address [1] 301411 0
Office for Research
Level 2
South West
300 Grattan Street
Parkville Victoria
3052
Country [1] 301411 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302411 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 302411 0
Ethics committee country [1] 302411 0
Australia
Date submitted for ethics approval [1] 302411 0
29/10/2018
Approval date [1] 302411 0
06/03/2019
Ethics approval number [1] 302411 0
HREC/42964/MH-2018

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90150 0
Prof Mario Alvarez
Address 90150 0
Orygen, The National Centre of Excellence in Youth Mental Health
35 Poplar Rd,
Parkville, VIC, 3052
Country 90150 0
Australia
Phone 90150 0
+61 0401 772 668
Fax 90150 0
Email 90150 0
[email protected]
Contact person for public queries
Name 90151 0
Daniela Cagliarini
Address 90151 0
Orygen, The National Centre of Excellence in Youth Mental Health
35 Poplar Rd,
Parkville, VIC, 3052
Country 90151 0
Australia
Phone 90151 0
+61 0408 607 919
Fax 90151 0
Email 90151 0
[email protected]
Contact person for scientific queries
Name 90152 0
Daniela Cagliarini
Address 90152 0
Orygen, The National Centre of Excellence in Youth Mental Health
35 Poplar Rd,
Parkville, VIC, 3052
Country 90152 0
Australia
Phone 90152 0
+61 0408 607 919
Fax 90152 0
Email 90152 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?
All of the individual trial-related participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following publication for an indefinite time.
Available to whom?
Data will potentially be available to researchers from not-for profit organisations, commercial organisations or other based in any location. All data requests will be considered by the data custodian and the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. For further information, see Orygen data sharing policy
Available for what types of analyses?
Any approved protocol, IPD meta-analysis or systematic review. Assessed on a case-by-case basis.
How or where can data be obtained?
Access can be requested via the Health Data Australia catalogue (https://researchdata.edu.au/health). Search for the ACTRN number in the catalogue to find datasets associated with this trial


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4808Study protocol  [email protected]
4809Statistical analysis plan  [email protected]
4810Informed consent form  [email protected]



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