Anorexia NervosaEarly Phase 1vFBTNCT04678843
Adapting and Adopting Highly Specialized Pediatric Eating Disorder Treatment to Virtual Care: Implementation Research for the COVID-19 Context and Beyond
A Early Phase 1 study testing Virtual Family-Based Treatment in people with Anorexia Nervosa, run by Jennifer Couturier at 4 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Virtual Family-Based Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 4 sitesCanada
- Study dates
- 9 Feb 2021to 1 Aug 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9
St. Joseph's Care Group
Thunder Bay, Ontario, P7B 5G7
North York General Hospital
Toronto, Ontario, M2J 0B1
CMHA Waterloo Wellington
Waterloo, Ontario, N2J 4M1
About this study
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
- Being tested
- Virtual Family-Based Treatment
- Keywords
- anorexia nervosa, youth, adolescents, eating disorders, family-based treatment
- Medical subject headings
- Anorexia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Family-Based TreatmentBehavioural
Treatment involving the youth/adolescent who has been diagnosed with anorexia nervosa and their family, delivered virtually via videoconferencing.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Virtual Family-Based Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: Completed after the session 4 of treatment, approximately 4 months
Secondary outcomes (6)
Qualitative experience of participants
Experiences of the therapists, medical practitioners, administrators, and families in vFBT, qualitatively measured during semi-structured focus groups
Measured: Completed after session 4 of treatment, approximately 4 months
Change in Weight
Weight will be measured in kilograms.
Measured: At baseline before treatment, and at 1 week, 2 weeks, 3 weeks, and 4 weeks.
Change in Number of Binge/Purge Episodes
The number of binge/purge episodes each week will be recorded by patients/their families.
Measured: At baseline before treatment, and at 1 week, 2 weeks, 3 weeks, and 4 weeks.
Therapists' Change in Readiness
The Brief Individual Readiness to Change Scale will indicate how ready therapists feel they are to change. Higher scores indicate greater readiness to use research-based direct service techniques. Minimum score is 0, maximum score is 20.
Measured: At baseline, after training (approx. 1 month), and after 4 sessions of treatment (approx. 4 months)
Therapists' Change in Attitudes about Evidence Based Practice
Their attitudes about evidence-based practice will be assessed using the Evidence Based Practice Attitudes Scale (EBPAS). The subscales include requirements, appeal, openness and divergence. The score for each subscale is created by computing a mean score for the items that load on a given subscale. Minimum score for each subscale is 0, maximum score for each subscale is 4.
Measured: At baseline, after training (approx. 1 month), and after 4 sessions of treatment (approx. 4 months)
Therapists' Change in Confidence related to the Intervention
Their confidence related to the intervention will be assessed by administering an adapted version of the Perceived Attributes of the Principles of Effectiveness Scale (MPAS). Higher scores are indicative of more favorable perception for FBT content. The minimum score is 18, the maximum score is 90.
Measured: At baseline, after training (approx. 1 month), and after 4 sessions of treatment (approx. 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start9 Feb 2021
- Primary completion31 Jul 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- We study a blended implementation approach for Family-Based Treatment delivered via videoconferencing (FBT-V)
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennifer Couturier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jennifer Couturier, McMaster University
- Investigators
- Jennifer Couturier, MD MSc, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678843
- Sponsor's protocol ID
- 12722
- Acronym
- vFBT
- Status last verified
- Sep 2022
- First submitted
- 17 Dec 2020
- Last updated
- 10 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36327378Couturier 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.
PubMed 35883167Couturier 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.
PubMed 33832543
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting and Adopting Highly Specialized Pediatric Eating Disorder Treatment to Virtual Care: Implementation Research for the COVID-19 Context and Beyond
- ClinicalTrials.gov ID
- NCT04678843
- Acronym / sponsor ID
- vFBT / 12722
- Conditions
- Anorexia Nervosa
- Keywords
- anorexia nervosa, youth, adolescents, eating disorders, family-based treatment
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Jennifer CouturierUniversity, hospital or other
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 22 Dec 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- We study a blended implementation approach for Family-Based Treatment delivered via videoconferencing (FBT-V)
| Arm | Type | Receives |
|---|---|---|
| Virtual Family-Based Treatment | Experimental | Behavioral: Virtual Family-Based TreatmentFamily-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. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Virtual Family-Based TreatmentTreatment involving the youth/adolescent who has been diagnosed with anorexia nervosa and their family, delivered virtually via videoconferencing. | Behavioural | Virtual Family-Based Treatment |
Primary outcome
Key components of FBT
Time frame: Completed after session 4 of treatment, approximately 4 months
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)
Fidelity
Time frame: Completed after the session 4 of treatment, approximately 4 months
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).
6 secondary outcomes
Qualitative experience of participants
Time frame: Completed after session 4 of treatment, approximately 4 months
Change in Weight
Time frame: At baseline before treatment, and at 1 week, 2 weeks, 3 weeks, and 4 weeks.
Change in Number of Binge/Purge Episodes
Time frame: At baseline before treatment, and at 1 week, 2 weeks, 3 weeks, and 4 weeks.
Therapists' Change in Readiness
Time frame: At baseline, after training (approx. 1 month), and after 4 sessions of treatment (approx. 4 months)
Therapists' Change in Attitudes about Evidence Based Practice
Time frame: At baseline, after training (approx. 1 month), and after 4 sessions of treatment (approx. 4 months)
Therapists' Change in Confidence related to the Intervention
Time frame: At baseline, after training (approx. 1 month), and after 4 sessions of treatment (approx. 4 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
- Derived from this study: PubMed 36327378Couturier 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.
- Derived from this study: PubMed 35883167Couturier 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.
- Derived from this study: PubMed 33832543Couturier 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.
- Individual participant dataSharing planned: No
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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.
Jennifer Couturier, MD MSc principal investigator
McMaster University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Virtual Family-Based Treatment in people with Anorexia Nervosa, run by Jennifer Couturier at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. 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: finished, as of the sponsor's last update on 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Key components of FBT (time frame: Completed after session 4 of treatment, approximately 4 months). The study lists 2 primary outcomes in all. 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 NCT04678843, which also lists 3 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 10 Sep 2022.