Eating Disorders Clinical Trial
Official title:
Examining the Impact of Peer Mentors on Individuals Transitioning to Adult Eating Disorder Treatment: A Feasibility Study
| NCT number | NCT05543044 |
| Other study ID # | 1028566 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 28, 2023 |
| Est. completion date | March 1, 2026 |
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.
| Status | Recruiting |
| Enrollment | 49 |
| Est. completion date | March 1, 2026 |
| Est. primary completion date | March 1, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 16 Years to 24 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Abbie J Lane Memorial Building - QEII | Halifax | Nova Scotia |
| Lead Sponsor | Collaborator |
|---|---|
| Nova Scotia Health Authority |
Canada,
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. — View Citation
Beveridge 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. — View Citation
Bohn, 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. — View Citation
Clausen 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. — View Citation
Cleverley 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. — View Citation
Crocker, 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. — View Citation
Deci, 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. — View Citation
Dimitropoulos 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. — View Citation
Dimitropoulos 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. — View Citation
Embrett MG, Randall GE, Longo CJ, Nguyen T, Mulvale G. Effectiveness of Health System Services and Programs for Youth to Adult Transitions in Mental Health Care: A Systematic Review of Academic Literature. Adm Policy Ment Health. 2016 Mar;43(2):259-69. doi: 10.1007/s10488-015-0638-9. — View Citation
Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70. — View Citation
Gilmer TP, Ojeda VD, Leich J, Heller R, Garcia P, Palinkas LA. Assessing needs for mental health and other services among transition-age youths, parents, and providers. Psychiatr Serv. 2012 Apr;63(4):338-42. doi: 10.1176/appi.ps.201000545. — View Citation
Gopalan G, Lee SJ, Harris R, Acri MC, Munson MR. Utilization of peers in services for youth with emotional and behavioral challenges: A scoping review. J Adolesc. 2017 Feb;55:88-115. doi: 10.1016/j.adolescence.2016.12.011. Epub 2017 Jan 7. — View Citation
Griffiths S, Mond JM, Murray SB, Touyz S. The prevalence and adverse associations of stigmatization in people with eating disorders. Int J Eat Disord. 2015 Sep;48(6):767-74. doi: 10.1002/eat.22353. Epub 2014 Sep 5. — View Citation
Guss CE, Williams DN, Reisner SL, Austin SB, Katz-Wise SL. Disordered Weight Management Behaviors, Nonprescription Steroid Use, and Weight Perception in Transgender Youth. J Adolesc Health. 2017 Jan;60(1):17-22. doi: 10.1016/j.jadohealth.2016.08.027. Epub 2016 Oct 28. — View Citation
Hanly F, Torrens-Witherow B, Warren N, Castle D, Phillipou A, Beveridge J, Jenkins Z, Newton R, Brennan L. Peer mentoring for individuals with an eating disorder: a qualitative evaluation of a pilot program. J Eat Disord. 2020 Jul 1;8:29. doi: 10.1186/s40337-020-00301-8. eCollection 2020. — View Citation
Hoek HW. Incidence, prevalence and mortality of anorexia nervosa and other eating disorders. Curr Opin Psychiatry. 2006 Jul;19(4):389-94. doi: 10.1097/01.yco.0000228759.95237.78. — View Citation
Jones BA, Haycraft E, Bouman WP, Brewin N, Claes L, Arcelus J. Risk Factors for Eating Disorder Psychopathology within the Treatment Seeking Transgender Population: The Role of Cross-Sex Hormone Treatment. Eur Eat Disord Rev. 2018 Mar;26(2):120-128. doi: 10.1002/erv.2576. Epub 2018 Jan 10. — View Citation
le Grange D. Family therapy for adolescent anorexia nervosa. J Clin Psychol. 1999 Jun;55(6):727-39. doi: 10.1002/(sici)1097-4679(199906)55:63.0.co;2-3. — View Citation
Mahon, J. (2000). Dropping out from psychological treatment for eating disorders: What are the issues?. European Eating Disorders Review: the Professional Journal of the Eating Disorders Association, 8(3), 198-216. https://doi.org/10.1002/(SICI)1099-0968(200005)8:3%3C198::AID-ERV356%3E3.0.CO;2-3
McClelland J, Hodsoll J, Brown A, Lang K, Boysen E, Flynn M, Mountford VA, Glennon D, Schmidt U. A pilot evaluation of a novel First Episode and Rapid Early Intervention service for Eating Disorders (FREED). Eur Eat Disord Rev. 2018 Mar;26(2):129-140. doi: 10.1002/erv.2579. — View Citation
McClelland J, Simic M, Schmidt U, Koskina A, Stewart C. Defining and predicting service utilisation in young adulthood following childhood treatment of an eating disorder. BJPsych Open. 2020 Apr 6;6(3):e37. doi: 10.1192/bjo.2020.13. — View Citation
Munoz-Solomando A, Townley M, Williams R. Improving transitions for young people who move from child and adolescent mental health services to mental health services for adults: lessons from research and young people's and practitioners' experiences. Curr Opin Psychiatry. 2010 Jul;23(4):311-7. doi: 10.1097/YCO.0b013e32833a51e2. — View Citation
Murray SB, Nagata JM, Griffiths S, Calzo JP, Brown TA, Mitchison D, Blashill AJ, Mond JM. The enigma of male eating disorders: A critical review and synthesis. Clin Psychol Rev. 2017 Nov;57:1-11. doi: 10.1016/j.cpr.2017.08.001. Epub 2017 Aug 2. — View Citation
Murray SB. Gender Identity and Eating Disorders: The Need to Delineate Novel Pathways for Eating Disorder Symptomatology. J Adolesc Health. 2017 Jan;60(1):1-2. doi: 10.1016/j.jadohealth.2016.10.004. Epub 2016 Nov 10. No abstract available. — View Citation
Pottick KJ, Bilder S, Vander Stoep A, Warner LA, Alvarez MF. US patterns of mental health service utilization for transition-age youth and young adults. J Behav Health Serv Res. 2008 Oct;35(4):373-89. doi: 10.1007/s11414-007-9080-4. Epub 2007 Nov 17. — View Citation
Research 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. — View Citation
Sansfacon J, Gauvin L, Fletcher E, Cottier D, Rossi E, Kahan E, Israel M, Steiger H. Prognostic value of autonomous and controlled motivation in outpatient eating-disorder treatment. Int J Eat Disord. 2018 Oct;51(10):1194-1200. doi: 10.1002/eat.22901. Epub 2018 Sep 1. — View Citation
Singh SP, Paul M, Ford T, Kramer T, Weaver T, McLaren S, Hovish K, Islam Z, Belling R, White S. Process, outcome and experience of transition from child to adult mental healthcare: multiperspective study. Br J Psychiatry. 2010 Oct;197(4):305-12. doi: 10.1192/bjp.bp.109.075135. — View Citation
Steiger H, Sansfacon J, Thaler L, Leonard N, Cottier D, Kahan E, Fletcher E, Rossi E, Israel M, Gauvin L. Autonomy support and autonomous motivation in the outpatient treatment of adults with an eating disorder. Int J Eat Disord. 2017 Sep;50(9):1058-1066. doi: 10.1002/eat.22734. Epub 2017 Jun 14. — View Citation
Strauss, A., & Corbin, J. (1998). Basics of qualitative research: Procedures and techniques for developing grounded theory.
Thapliyal P, Hay P, Conti J. Role of gender in the treatment experiences of people with an eating disorder: a metasynthesis. J Eat Disord. 2018 Aug 13;6:18. doi: 10.1186/s40337-018-0207-1. eCollection 2018. — View Citation
Thomas, D. R. (2006). A general inductive approach for analyzing qualitative evaluation data. American Journal of Evaluation, 27(2), 237-246.
Treasure J, Schmidt U, Hugo P. Mind the gap: service transition and interface problems for patients with eating disorders. Br J Psychiatry. 2005 Nov;187:398-400. doi: 10.1192/bjp.187.5.398. — View Citation
Wagner R, Stevens JR. Clinical Barriers to Effective Treatment of Eating Disorders and Co-occurring Psychiatric Disorders in Transgendered Individuals. J Psychiatr Pract. 2017 Jul;23(4):284-289. doi: 10.1097/PRA.0000000000000248. — View Citation
Williams, G. C., Gagné, M., Ryan, R. M., & Deci, E. L. (1999). Supporting autonomy to motivate smoking cessation: A test of self-determination theory. Unpublished manuscript, University of Rochester, New York.
Winston AP, Paul M, Juanola-Borrat Y. The same but different? Treatment of anorexia nervosa in adolescents and adults. Eur Eat Disord Rev. 2012 Mar;20(2):89-93. doi: 10.1002/erv.1137. Epub 2011 Sep 13. — View Citation
* Note: There are 42 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Change in eating disorder symptomatology | This will be measured at Baseline, Post-Intervention, and 12-Month Follow-Up, using the Eating Disorder Examination Questionnaire (EDE-Q; Fairburn & Beglin, 1994), a validated and reliable 28-item self-report questionnaire. | Baseline, 3-6 months, 12 months | |
| Other | Change in clinical impairment | This will be measured at Baseline, Post-Intervention, and 12-Month Follow-Up, using the Clinical Impairment Assessment (CIA; Bohn & Fairburn, 2008), which is a reliable and validated 16-item self-report questionnaire that measures functional impairment over the last 28 days. Higher scores on the CIA indicate more impairment. | Baseline, 3-6 months, 12 months | |
| Other | Change in feelings of competence about participating in eating disorder treatment | This will be measured at Baseline, Post-Intervention, and 12-Month Follow-Up using the Perceived Competence Scale (PCS; Williams et al., 1995), a companion scale in a questionnaire package that includes the TSRQ. The PCS is a valid and reliable tool that evaluates feelings of competence about participating in a health behaviour or treatment. The PCS is a 4-item self-report questionnaire with scores ranging from 1 ("not at all true") to 7 ("very true"). | Baseline, 3-6 months, 12 months | |
| Primary | 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). | Baseline, 3-6 months, 12 months | |
| Secondary | 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. | 12 months | |
| Secondary | 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"). | Throughout study completion, 12 months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05656859 -
Prevalence of Eating Disorders Among Patients in the Department of Health Promotion
|
||
| Completed |
NCT04085861 -
Mental Health in Dancers; an Intervention Study
|
N/A | |
| Recruiting |
NCT05651295 -
A Precision Medicine Approach to Target Engagement for Emotion Regulation
|
N/A | |
| Enrolling by invitation |
NCT04174703 -
Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing
|
N/A | |
| Terminated |
NCT04278755 -
Binge Eating & Birth Control
|
Phase 2 | |
| Withdrawn |
NCT03050632 -
Effects of Cognitive and Emotional Functioning on Treatment Outcomes
|
N/A | |
| Completed |
NCT02567890 -
Swedish Body Project for Prevention of Eating Disorders
|
N/A | |
| Completed |
NCT02484794 -
Augmenting Specialty Eating Disorder Clinical Treatment With a Smartphone Application
|
N/A | |
| Completed |
NCT02252822 -
Improving Treatment Engagement for Adolescents With Bulimia Nervosa
|
N/A | |
| Completed |
NCT02021344 -
Mental Health First Aid for College Students
|
N/A | |
| Completed |
NCT00601354 -
Adding Guided Self-Help Group Therapy to the Alli Weight Loss Program in Treating Binge Eating Disorder
|
N/A | |
| Completed |
NCT00418977 -
Comparing the Effectiveness of Two Therapies to Treat Signs of Anorexia Nervosa in Adolescents
|
N/A | |
| Completed |
NCT00304187 -
Effectiveness of Antibiotic Treatment for Reducing Binge Eating and Improving Digestive Function in Bulimia Nervosa
|
Phase 2 | |
| Completed |
NCT00733525 -
Effectiveness of Stepped Care Versus Best Available Care for Bulimia Nervosa
|
N/A | |
| Active, not recruiting |
NCT04779216 -
Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa
|
Phase 3 | |
| Completed |
NCT04433663 -
Eating Disorders, Self Regulation and Mentalization
|
N/A | |
| Recruiting |
NCT05509257 -
Naltrexone Neuroimaging in Teens With Eating Disorders
|
Early Phase 1 | |
| Completed |
NCT04509531 -
Building Resilience in Cyberbullying Victims
|
N/A | |
| Recruiting |
NCT05730348 -
Mealtime Anxiety in Eating Disorders
|
||
| Enrolling by invitation |
NCT05814653 -
A Study to Evaluate Primary Care Treatment for Adolescent Eating Disorders
|
N/A |