Eating DisordersTAY-MentorsNCT05543044
Impact of Peer Mentors on Individuals Transitioning to Adult Eating Disorder Treatment
A study testing Peer mentor intervention in people with Eating Disorders, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
Participants will be males and females aged 16-24 with an eating disorder (ED) diagnosis who are transitioning to adult-oriented ED treatment in Nova Scotia, New Brunswick, or Prince Edward Island. Read more about this study
- Who is it for?
- Ages 16 to 24 years
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Peer mentor intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- 28 Mar 2023to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
TAY Inclusion Criteria:
- Meets one of the following criteria:
- 'Aging out' of youth-oriented ED treatment at 19 years-old and unlikely to achieve remission prior to leaving the program (as determined by their clinician[s])
- Have been deemed incompatible with traditional youth-oriented ED treatment (based on established youth-oriented ED treatment criteria, and determined by their clinician[s])
- Have requested and/or had a carer request a transition to adult-oriented ED treatment
- Have been self-referred or referred to adult ED treatment by a clinician (even if they have not been involved in youth-oriented ED treatment)
- Aged 16-24 years old
- Meets criteria for DSM-5 diagnosis of an ED, as confirmed by the Structured Clinical Interview for DSM-5 Research Version (SCID-5-RV)
- Virtually signed informed consent form
TAY Exclusion Criteria:
- Insufficient knowledge of English
- Moderate to high suicide risk rating at screening as assessed by the Columbia Suicide Severity Rating Scale (CSSRS; at the discretion of the PI)
Carer Inclusion Criteria:
- Identified by a TAY participant as a carer
- Aged 18 or older
- Virtually signed informed consent form
Carer Exclusion Criteria:
- Insufficient knowledge of English
PM Inclusion Criteria:
- Certified PM with EDNS
- Providing PM support to TAY study participants
- Virtually signed informed consent form
PM Exclusion Criteria:
- Insufficient knowledge of English
Trial locations and contacts
1 site in 1 country.
Canada1 site
Abbie J Lane Memorial Building - QEII
Halifax, Nova Scotia, B3H 2E2
About this study
Official title: Examining the Impact of Peer Mentors on Individuals Transitioning to Adult Eating Disorder Treatment: A Feasibility Study
Participants will be males and females aged 16-24 with an eating disorder (ED) diagnosis who are transitioning to adult-oriented ED treatment in Nova Scotia, New Brunswick, or Prince Edward Island. Youth participants will be recruited from community-based clinics, hospital programs, and private practices where ED treatment is delivered. Youth who are interested in participating and provide written consent will be invited to take part in a screening meeting to determine eligibility to participate. Eligible participants will be paired with a peer mentor for a 3-6 month intervention to guide them through the transition to adult-oriented ED treatment. Participants will be asked to complete questionnaire packages before beginning the intervention, after completing the intervention, and 12 months after beginning the intervention. Some youth participants, as well as some of their carers and the peer mentors, will be asked to participate in one-on-one interviews about their experiences with transitions in ED care and the peer mentor intervention. The investigators are conducting this study to determine whether the use of peer mentors is an effective and acceptable means of transition support for youth with EDs. The investigators are also interested in better understanding the experiences of carers and peer mentors who are supporting youth with EDs during their transition in care.
Read the detailed description
This feasibility study will incorporate quantitative and qualitative methods and utilizes an uncontrolled pretest-posttest quasi-experimental design to examine the effectiveness and acceptability of a peer mentor delivered intervention that aims to improve transitions to adult-oriented care for patients with eating disorders (EDs) aged 16-24.
Youth will be recruited from community-based clinics, hospital programs, and private practices where youth- or adult-oriented ED treatment is delivered across Nova Scotia, New Brunswick, and Prince Edward Island. Clinicians in these settings will be asked to identify potentially eligible youth who will be transitioning to adult-oriented ED care. Potential participants who are interested in participating and provide written consent will meet with a research team member for a screening meeting to determine their eligibility status. Screening will involve the Structured Clinical Interview for DSM-5 Research Version (SCID-5-RV) and the Columbia Suicide Severity Rating Scale (C-SSRS). All screening information will be reviewed by the PI (Dr. Keshen). Participants who are not interested in the study or who fail to meet the eligibility criteria will be given standard options available to treatment age youth.
Youth participants who are found eligible will be connected with a trained peer mentor for a 3-6 month transition intervention. Youth and their peer mentor will meet weekly, bi-weekly, or monthly depending on the phase of the intervention and the needs of the youth. The intervention is divided into 3 phases: phase 1 includes building a sense of trust, rapport, and motivation, as well as the identification of goals, strengths, challenges and barriers related to transition; phase 2 focuses on self-reflection, problem-solving, and transition planning; and phase 3 involves the gradual tapering off and conclusion of the peer mentor relationship.
Youth participants will be asked to complete questionnaire packages before beginning the intervention, after completing the intervention, and 12 months after beginning the intervention. Some youth will also be asked to participate in one-on-one interviews with a research team member at these same time-points. Some youth participants will be asked if they would like to involve a carer in the study, as well. Carers will be invited to participate in a one-on-one interview with a research team member 12 months after the youth they are caring for began the intervention. Peer mentors will be invited to participate in one-on-one interviews at the end of the study. The aim of the interviews is to understand experiences with eating disorder treatment, transitions in care, and the peer mentor intervention.
- Conditions
- Eating Disorders
- Being tested
- Peer mentor intervention
- Keywords
- Eating Disorders, Peer Mentors, Youth, Feasibility
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer mentor interventionBehavioural
Peer mentor delivered intervention for transitions to adult-oriented treatment for eating disorders
| Study group | Role | What they receive |
|---|---|---|
| TAY receiving peer mentor intervention | Experimental | Transition age youth with EDs (n=50) will receive a peer mentor delivered transition intervention Receives: Behavioral: Peer mentor intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Autonomous Motivation
This will be measured at Baseline, Post-Intervention, and 12-Month Follow-Up, using The Treatment Self-Regulation Questionnaire (TSRQ; Levesque et al., 2007). The TSRQ is a reliable and valid self-report questionnaire that assesses the type of motivation patients use (autonomous or external/controlled) when engaging in a health behaviour or treatment. The TSRQ consists of 12 questions with scores ranging from 1 ("strongly disagree") to 7 ("strongly agree"). The TSRQ can be modified to measure specific health care outcomes (e.g., ED related). Further, the TSRQ has previously been used to detect changes in autonomous motivation before and after health-related interventions, including over six-month timeframes (e.g., Stamp et al., 2016; Knittle et al., 2015). A recent scoping review determined that there are no validated quantitative measures for specifically evaluating mental health related transition interventions for TAY (Cleverly et al., 2018).
Measured: Baseline, 3-6 months, 12 months
Secondary outcomes (2)
Completed Transitions
Engagement in adult-oriented service could include: a) one session (or more) of individual psychotherapy aimed at treating the ED (as determined by the PI); b) an admission into AEDP (i.e., group-based Day Program or Inpatient); and c) the youth is on the wait-list to start adult treatment. Initiation of adult services can be through referral from any clinician or self-referral. Although our measurement of a completed transition is a dichotomous variable, we will also collect exploratory data to examine the degree of service uptake in the adult-oriented treatment (low, medium, and high use as defined by McClelland et al., 2020). This will allow us to explore not only whether the youth transitioned or not, but also to what degree they engaged in an adult service after the transition.
Measured: 12 months
Patient acceptability
This will be measured at Baseline, Post-Intervention, and 12-Month Follow-Up, using the Health Care Climate Questionnaire (HCCQ; Williams, et al., 1996) at Baseline, Post-Intervention, and 12-Month Follow-Up. The HCCQ measures the extent to which patients feel that providers take full account of their perspective, offer choice and information, encourage self-initiation, provide rationale, and accept patient decisions. The HCCQ is a companion scale to the TSRQ, and has been positively associated with autonomous motivation and treatment adherence (Williams et al., 2006; Chan et al., 2009). The HCCQ is a valid and reliable 6-item self-report questionnaire with scores ranging from 1 ("strongly disagree") to 7 ("strongly agree").
Measured: Throughout study completion, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start28 Mar 2023
- Primary completion5 Feb 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Keshen, Nova Scotia Health Authority
- Investigators
- Aaron K Keshen, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543044
- Sponsor's protocol ID
- 1028566
- Acronym
- TAY-Mentors
- Status last verified
- Oct 2026
- First submitted
- 9 Sep 2022
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Austin A, Flynn M, Richards K, Hodsoll J, Duarte TA, Robinson P, Kelly J, Schmidt U. Duration of untreated eating disorder and relationship to outcomes: A systematic review of the literature. Eur Eat Disord Rev. 2021 May;29(3):329-345. doi: 10.1002/erv.2745. Epub 2020 Jun 23.
PubMed 32578311Beveridge J, Phillipou A, Jenkins Z, Newton R, Brennan L, Hanly F, Torrens-Witherow B, Warren N, Edwards K, Castle D. Peer mentoring for eating disorders: results from the evaluation of a pilot program. J Eat Disord. 2019 Jun 3;7:13. doi: 10.1186/s40337-019-0245-3. eCollection 2019.
PubMed 31171969Bohn, K., & Fairburn, C. G. (2008). The clinical impairment assessment questionnaire (CIA). Cognitive behavioral therapy for eating disorders, 1-3
Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3, 77-101. doi:10.1191/1478088706qp063oa
Broad, B. (1999). Improving the health of children and young people leaving care. Adoption & Fostering, 23(1), 40-48
Burke NL, Schaefer LM, Hazzard VM, Rodgers RF. Where identities converge: The importance of intersectionality in eating disorders research. Int J Eat Disord. 2020 Oct;53(10):1605-1609. doi: 10.1002/eat.23371. Epub 2020 Aug 28.
PubMed 32856342Clausen L, Lubeck M, Jones A. Motivation to change in the eating disorders: a systematic review. Int J Eat Disord. 2013 Dec;46(8):755-63. doi: 10.1002/eat.22156. Epub 2013 Jul 11.
PubMed 23847134Cleverley K, Rowland E, Bennett K, Jeffs L, Gore D. Identifying core components and indicators of successful transitions from child to adult mental health services: a scoping review. Eur Child Adolesc Psychiatry. 2020 Feb;29(2):107-121. doi: 10.1007/s00787-018-1213-1. Epub 2018 Oct 8.
PubMed 30294756Research design: qualitative, quantitative and mixed methods approaches Research design: qualitative, quantitative and mixed methods approaches Creswell John W Sage 320 pound29 0761924426 0761924426 [Formula: see text]. Nurse Res. 2004 Sep 1;12(1):82-83. doi: 10.7748/nr.12.1.82.s2.
PubMed 28718745Crocker, C., Cox, A., Abidi, S., Ursuliak, Z., Epstein, N., Hughes, J., Crown, M. & Tibbo, P. (2020). M238. Creation Of A Peer Support Program To Support Transitions In Care From Early Intervention Services For Psychosis. Schizophrenia Bulletin, 46(Supplement_1), S226-S226.
Culbert KM, Racine SE, Klump KL. Research Review: What we have learned about the causes of eating disorders - a synthesis of sociocultural, psychological, and biological research. J Child Psychol Psychiatry. 2015 Nov;56(11):1141-64. doi: 10.1111/jcpp.12441. Epub 2015 Jun 19.
PubMed 26095891Deci, E., & Ryan, R. M. (1985). Intrinsic motivation and self-determination in human behavior. Springer Science & Business Media.
Dimitropoulos G, Toulany A, Herschman J, Kovacs A, Steinegger C, Bardsley J, Sandhu S, Gregory C, Colton P, Anderson J, Kaufman M. A qualitative study on the experiences of young adults with eating disorders transferring from pediatric to adult care. Eat Disord. 2015;23(2):144-62. doi: 10.1080/10640266.2014.976106. Epub 2014 Nov 17.
PubMed 25402167Dimitropoulos G, Tran AF, Agarwal P, Sheffield B, Woodside B. Navigating the transition from pediatric to adult eating disorder programs: perspectives of service providers. Int J Eat Disord. 2012 Sep;45(6):759-67. doi: 10.1002/eat.22017. Epub 2012 Mar 19.
PubMed 22431280Dimitropoulos G, Tran AF, Agarwal P, Sheffield B, Woodside B. Challenges in making the transition between pediatric and adult eating disorder programs: a qualitative study from the perspective of service providers. Eat Disord. 2013;21(1):1-15. doi: 10.1080/10640266.2013.741964.
PubMed 23241086
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Impact of Peer Mentors on Individuals Transitioning to Adult Eating Disorder Treatment: A Feasibility Study
- ClinicalTrials.gov ID
- NCT05543044
- Acronym / sponsor ID
- TAY-Mentors / 1028566
- Conditions
- Eating Disorders
- Keywords
- Eating Disorders, Peer Mentors, Youth, Feasibility
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 5 Feb 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants will be males and females aged 16-24 with an eating disorder (ED) diagnosis who are transitioning to adult-oriented ED treatment in Nova Scotia, New Brunswick, or Prince Edward Island. Youth participants will be recruited from community-based clinics, hospital programs, and private practices where ED treatment is delivered. Youth who are interested in participating and provide written consent will be invited to take part in a screening meeting to determine eligibility to participate. Eligible participants will be paired with a peer mentor for a 3-6 month intervention to guide them through the transition to adult-oriented ED treatment. Participants will be asked to complete questionnaire packages before beginning the intervention, after completing the intervention, and 12 months after beginning the intervention. Some youth participants, as well as some of their carers and the peer mentors, will be asked to participate in one-on-one interviews about their experiences with transitions in ED care and the peer mentor intervention. The investigators are conducting this study to determine whether the use of peer mentors is an effective and acceptable means of transition support for youth with EDs. The investigators are also interested in better understanding the experiences of carers and peer mentors who are supporting youth with EDs during their transition in care.
Detailed description
This feasibility study will incorporate quantitative and qualitative methods and utilizes an uncontrolled pretest-posttest quasi-experimental design to examine the effectiveness and acceptability of a peer mentor delivered intervention that aims to improve transitions to adult-oriented care for patients with eating disorders (EDs) aged 16-24.
Youth will be recruited from community-based clinics, hospital programs, and private practices where youth- or adult-oriented ED treatment is delivered across Nova Scotia, New Brunswick, and Prince Edward Island. Clinicians in these settings will be asked to identify potentially eligible youth who will be transitioning to adult-oriented ED care. Potential participants who are interested in participating and provide written consent will meet with a research team member for a screening meeting to determine their eligibility status. Screening will involve the Structured Clinical Interview for DSM-5 Research Version (SCID-5-RV) and the Columbia Suicide Severity Rating Scale (C-SSRS). All screening information will be reviewed by the PI (Dr. Keshen). Participants who are not interested in the study or who fail to meet the eligibility criteria will be given standard options available to treatment age youth.
Youth participants who are found eligible will be connected with a trained peer mentor for a 3-6 month transition intervention. Youth and their peer mentor will meet weekly, bi-weekly, or monthly depending on the phase of the intervention and the needs of the youth. The intervention is divided into 3 phases: phase 1 includes building a sense of trust, rapport, and motivation, as well as the identification of goals, strengths, challenges and barriers related to transition; phase 2 focuses on self-reflection, problem-solving, and transition planning; and phase 3 involves the gradual tapering off and conclusion of the peer mentor relationship.
Youth participants will be asked to complete questionnaire packages before beginning the intervention, after completing the intervention, and 12 months after beginning the intervention. Some youth will also be asked to participate in one-on-one interviews with a research team member at these same time-points. Some youth participants will be asked if they would like to involve a carer in the study, as well. Carers will be invited to participate in a one-on-one interview with a research team member 12 months after the youth they are caring for began the intervention. Peer mentors will be invited to participate in one-on-one interviews at the end of the study. The aim of the interviews is to understand experiences with eating disorder treatment, transitions in care, and the peer mentor intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAY receiving peer mentor intervention | Experimental | Behavioral: Peer mentor interventionTransition age youth with EDs (n=50) will receive a peer mentor delivered transition intervention |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer mentor interventionPeer mentor delivered intervention for transitions to adult-oriented treatment for eating disorders | Behavioural | TAY receiving peer mentor intervention |
Primary outcome
Change in Autonomous Motivation
Time frame: Baseline, 3-6 months, 12 months
This will be measured at Baseline, Post-Intervention, and 12-Month Follow-Up, using The Treatment Self-Regulation Questionnaire (TSRQ; Levesque et al., 2007). The TSRQ is a reliable and valid self-report questionnaire that assesses the type of motivation patients use (autonomous or external/controlled) when engaging in a health behaviour or treatment. The TSRQ consists of 12 questions with scores ranging from 1 ("strongly disagree") to 7 ("strongly agree"). The TSRQ can be modified to measure specific health care outcomes (e.g., ED related). Further, the TSRQ has previously been used to detect changes in autonomous motivation before and after health-related interventions, including over six-month timeframes (e.g., Stamp et al., 2016; Knittle et al., 2015). A recent scoping review determined that there are no validated quantitative measures for specifically evaluating mental health related transition interventions for TAY (Cleverly et al., 2018).
2 secondary outcomes
Completed Transitions
Time frame: 12 months
Patient acceptability
Time frame: Throughout study completion, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Background: PubMed 32578311Austin A, Flynn M, Richards K, Hodsoll J, Duarte TA, Robinson P, Kelly J, Schmidt U. Duration of untreated eating disorder and relationship to outcomes: A systematic review of the literature. Eur Eat Disord Rev. 2021 May;29(3):329-345. doi: 10.1002/erv.2745. Epub 2020 Jun 23.
- Background: PubMed 31171969Beveridge J, Phillipou A, Jenkins Z, Newton R, Brennan L, Hanly F, Torrens-Witherow B, Warren N, Edwards K, Castle D. Peer mentoring for eating disorders: results from the evaluation of a pilot program. J Eat Disord. 2019 Jun 3;7:13. doi: 10.1186/s40337-019-0245-3. eCollection 2019.
- BackgroundBohn, K., & Fairburn, C. G. (2008). The clinical impairment assessment questionnaire (CIA). Cognitive behavioral therapy for eating disorders, 1-3
- BackgroundBraun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3, 77-101. doi:10.1191/1478088706qp063oa
- BackgroundBroad, B. (1999). Improving the health of children and young people leaving care. Adoption & Fostering, 23(1), 40-48
- Background: PubMed 32856342Burke NL, Schaefer LM, Hazzard VM, Rodgers RF. Where identities converge: The importance of intersectionality in eating disorders research. Int J Eat Disord. 2020 Oct;53(10):1605-1609. doi: 10.1002/eat.23371. Epub 2020 Aug 28.
- Background: PubMed 23847134Clausen L, Lubeck M, Jones A. Motivation to change in the eating disorders: a systematic review. Int J Eat Disord. 2013 Dec;46(8):755-63. doi: 10.1002/eat.22156. Epub 2013 Jul 11.
- Background: PubMed 30294756Cleverley K, Rowland E, Bennett K, Jeffs L, Gore D. Identifying core components and indicators of successful transitions from child to adult mental health services: a scoping review. Eur Child Adolesc Psychiatry. 2020 Feb;29(2):107-121. doi: 10.1007/s00787-018-1213-1. Epub 2018 Oct 8.
- Background: PubMed 28718745Research design: qualitative, quantitative and mixed methods approaches Research design: qualitative, quantitative and mixed methods approaches Creswell John W Sage 320 pound29 0761924426 0761924426 [Formula: see text]. Nurse Res. 2004 Sep 1;12(1):82-83. doi: 10.7748/nr.12.1.82.s2.
- BackgroundCrocker, C., Cox, A., Abidi, S., Ursuliak, Z., Epstein, N., Hughes, J., Crown, M. & Tibbo, P. (2020). M238. Creation Of A Peer Support Program To Support Transitions In Care From Early Intervention Services For Psychosis. Schizophrenia Bulletin, 46(Supplement_1), S226-S226.
- Background: PubMed 26095891Culbert KM, Racine SE, Klump KL. Research Review: What we have learned about the causes of eating disorders - a synthesis of sociocultural, psychological, and biological research. J Child Psychol Psychiatry. 2015 Nov;56(11):1141-64. doi: 10.1111/jcpp.12441. Epub 2015 Jun 19.
- BackgroundDeci, E., & Ryan, R. M. (1985). Intrinsic motivation and self-determination in human behavior. Springer Science & Business Media.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron K Keshen principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer mentor intervention in people with Eating Disorders, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Autonomous Motivation (time frame: Baseline, 3-6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05543044, which also lists 42 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.