Adapting and Adopting Highly Specialized Pediatric Eating Disorder Treatment to Virtual Care: Implementation Research for the COVID-19 Context and Beyond

NCT04678843 | Completed Early Phase 1

• 1 other identifier: 12722
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 4

Brief Summary

The COVID-19 pandemic has had detrimental effects on mental health. Individuals with eating disorders (EDs) are no exception, exhibiting increased symptoms and exacerbated feelings of isolation and anxiety. Across Canada, in-person outpatient services have been quickly replaced with virtual care, yet practitioners and patients have noted substantial challenges in adapting ED-related care virtually. Given the success of our previous research on Family-Based Treatment (FBT) for EDs, as well as the rapid transition to virtual care during COVID-19, there is an urgent need to adapt FBT to virtual formats and adopt it in the ED network. Using a multi-site case study with a mixed method pre/post design, this study aims to examine the implementation of virtual FBT (vFBT) as well as its impact within six ED programs in Ontario, building on the investigator's previous work, and further developing capacity in the system. The investigator will develop implementation teams at each site and provide a virtual training workshop on vFBT, with ongoing consultation during initial implementation. The investigator proposes to examine implementation success by studying fidelity to vFBT, as well as team and patient/family experience with virtual care, and patient outcomes. These findings for virtual care will not only be important in the COVID-19 context but are also vital in the North, where access to specialized services is extremely limited.

Conditions

Anorexia Nervosa

Keywords

anorexia nervosa; youth; adolescents; eating disorders; family-based treatment

Outcome Measures

Primary Outcomes (2)

• Key components of FBT

  Measured by a self-report questionnaire entitled Key Measure of Therapist Behaviours and Self-Efficacy in FBT (an indicator of therapist adherence to the key components of standard FBT within the vFBT model)

  Completed after session 4 of treatment, approximately 4 months

• Fidelity

  Fidelity to vFBT, measured by FBT fidelity ratings of the first four sessions of vFBT using the FBT Fidelity and Adherence Check (experts in FBT fidelity rating will rate the recordings).

  Completed after the session 4 of treatment, approximately 4 months

Secondary Outcomes (6)

• Qualitative experience of participants

  Completed after session 4 of treatment, approximately 4 months

• Change in Weight

  At baseline before treatment, and at 1 week, 2 weeks, 3 weeks, and 4 weeks.

• Change in Number of Binge/Purge Episodes

  At baseline before treatment, and at 1 week, 2 weeks, 3 weeks, and 4 weeks.

• Therapists' Change in Readiness

  At baseline, after training (approx. 1 month), and after 4 sessions of treatment (approx. 4 months)

• Therapists' Change in Attitudes about Evidence Based Practice

  At baseline, after training (approx. 1 month), and after 4 sessions of treatment (approx. 4 months)

Study Arms (1)

Virtual Family-Based Treatment

EXPERIMENTAL

Family-based treatment is the gold standard treatment for youth and adolescents with anorexia nervosa. A therapist works with the family to help parents take charge of the process of re-feeding their child, and with progress this control is gradually given back to the youth/adolescent. Other developmental issues are discussed in order to help the youth/adolescent get back to normal development.

Behavioral: Virtual Family-Based Treatment

Interventions

Virtual Family-Based Treatment BEHAVIORAL

Treatment involving the youth/adolescent who has been diagnosed with anorexia nervosa and their family, delivered virtually via videoconferencing.

Virtual Family-Based Treatment

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Youth must be under 18 years of age in order to participate
• Youth must have a diagnosis of Anorexia Nervosa in order to participate
• Must have the capacity to write, speak, and understand English
• Must have access to a computer and the internet.

You may not qualify if:

• Individuals 18 years of age and older are unable to participate
• Youth without a diagnosis of Anorexia Nervosa are unable to participate
• Individuals who cannot write, speak and understand English are unable to participate
• Individuals who do not have access to a computer and the internet are unable to participate

Sponsors & Collaborators

• Jennifer Couturier: lead

Study Sites (4)

Southlake Regional Health Centre

Newmarket, Ontario, L3Y 2P9, Canada

Location

St. Joseph's Care Group

Thunder Bay, Ontario, P7B 5G7, Canada

Location

North York General Hospital

Toronto, Ontario, M2J 0B1, Canada

Location

CMHA Waterloo Wellington

Waterloo, Ontario, N2J 4M1, Canada

Location

Related Publications (3)

• Couturier J, Pellegrini D, Grennan L, Nicula M, Miller C, Agar P, Webb C, Anderson K, Barwick M, Dimitropoulos G, Findlay S, Kimber M, McVey G, Lock J. Multidisciplinary implementation of family-based treatment delivered by videoconferencing (FBT-V) for adolescent anorexia nervosa during the COVID-19 pandemic. Transl Behav Med. 2023 Feb 28;13(2):85-97. doi: 10.1093/tbm/ibac086.

  PMID: 36327378 DERIVED

• Couturier J, Pellegrini D, Grennan L, Nicula M, Miller C, Agar P, Webb C, Anderson K, Barwick M, Dimitropoulos G, Findlay S, Kimber M, McVey G, Paularinne R, Nelson A, DeGagne K, Bourret K, Restall S, Rosner J, Hewitt-McVicker K, Pereira J, McLeod M, Shipley C, Miller S, Boachie A, Engelberg M, Martin S, Holmes-Haronitis J, Lock J. A qualitative evaluation of team and family perceptions of family-based treatment delivered by videoconferencing (FBT-V) for adolescent Anorexia Nervosa during the COVID-19 pandemic. J Eat Disord. 2022 Jul 26;10(1):111. doi: 10.1186/s40337-022-00631-9.

  PMID: 35883167 DERIVED

• Couturier J, Pellegrini D, Miller C, Agar P, Webb C, Anderson K, Barwick M, Dimitropoulos G, Findlay S, Kimber M, McVey G, Lock J. Adapting and adopting highly specialized pediatric eating disorder treatment to virtual care: a protocol for an implementation study in the COVID-19 context. Implement Sci Commun. 2021 Apr 8;2(1):38. doi: 10.1186/s43058-021-00143-8.

  PMID: 33832543 DERIVED

MeSH Terms

Conditions

Anorexia Nervosa; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer Couturier, MD MSc

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: We study a blended implementation approach for Family-Based Treatment delivered via videoconferencing (FBT-V)

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 22, 2020
• Study Start: February 9, 2021
• Primary Completion: July 31, 2021
• Study Completion: August 1, 2021
• Last Updated: September 10, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)