Ignite Creation Date:
2024-05-06 @ 9:25 AM
Last Modification Date:
2024-10-26 @ 12:14 PM
Study NCT ID:
NCT02978742
Status:
WITHDRAWN
Last Update Posted:
2018-01-26
First Post:
2016-11-29
Brief Title:
Evaluating and Implementing a Smartphone Application Treatment Program for Bulimia Nervosa and Binge Eating Disorder
Sponsor:
Nova Scotia Health Authority
Organization:
Nova Scotia Health Authority
Study Overview
Official Title:
Evaluating and Implementing a Smartphone Application Treatment Program for Bulimia Nervosa and Binge Eating Disorder
Status:
WITHDRAWN
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study not funded
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Bulimia nervosa and binge eating disorder pose a public health concern due to their high co-occurrence with other psychiatric disorders and poor physical health outcomes It is therefore concerning that less than half of these patients seek treatment for their condition People may be reluctant to seek treatment due to not wanting to disclose symptoms to family members Even for those who do wish to seek help treatment is often inaccessible due to the geographic centralization of eating disorder specialists and a low ratio of specialists to patients Therefore the aim of this study is to test a potential solution to these problems and make eating disorder care more private and accessible
One possible way to improve the accessibility of treatment is through smartphone applications or apps We are testing an app called Recovery Record which is primarily a tool used to self-monitor eating habits where patients record their meals and related thoughts feelings emotions and behaviours eg binge eatingpurging The app also offers additional features such as discrete reminders to log meals positive reinforcement social support coping strategy suggestions and linking users with clinicians for real-time feedback and suggestions The application is scientifically supported and has been tested with positive results
Recently app developers have created a computer-automated 8-week treatment program that uses the patients data to provide a tailored and individualized treatment program This program aims to mimic the process of therapy by checking in with users reminding them of their reasons for wanting to recover and working towards goals We will be testing this automated app treatment program comparing it both with and without input from a trained coach providing individualized feedback to users
One possible way to improve the accessibility of treatment is through smartphone applications or apps We are testing an app called Recovery Record which is primarily a tool used to self-monitor eating habits where patients record their meals and related thoughts feelings emotions and behaviours eg binge eatingpurging The app also offers additional features such as discrete reminders to log meals positive reinforcement social support coping strategy suggestions and linking users with clinicians for real-time feedback and suggestions The application is scientifically supported and has been tested with positive results
Recently app developers have created a computer-automated 8-week treatment program that uses the patients data to provide a tailored and individualized treatment program This program aims to mimic the process of therapy by checking in with users reminding them of their reasons for wanting to recover and working towards goals We will be testing this automated app treatment program comparing it both with and without input from a trained coach providing individualized feedback to users
Detailed Description:
The prevalence of bulimia nervosa BN is approximately 10-15 among women With consistently higher prevalence rates binge eating disorder BED affects up to 35 of women and 15 of men These eating disorders represent a public health concern due to the high comorbidity of BN and BED with other psychiatric disorders and the association with poor physical health outcomes
Given this public health impact it is concerning that less than half of BN and BED patients seek treatment for their eating disorder This is especially concerning since a greater duration of untreated illness is associated with a poorer prognosis Individuals reluctance to seek treatment is likely due to factors such as an avoidance of disclosing symptoms to family members or clinicians For example one study reported that 27 of adolescents with BN declined participation because they did not want their families involved Even for those who do wish to engage treatment is often inaccessible due to the geographic centralization of eating disorder specialists and a low ratio of specialists to patients
Given the ubiquity of smartphone devices among adults and adolescents one possible way to improve treatment accessibility and privacy is to offer it through a smartphone app In recent development an evidence-based smartphone app called Recovery Record RR has been conceived for use by people suffering from eating disorders as an adjunct to clinical treatment This tool allows patients to self-monitor eating behaviours connect with their clinician directly through the app and provides other therapeutic features eg cues coping skill use Preliminary findings suggest that the app is feasible with 67 of users continuing to log meals at 30 days As well RR is currently the most downloaded most rated and highest rated app of its kind which suggests it is highly acceptable among users
In support of these findings one study demonstrated that 26 of app users in a clinically severe range at baseline demonstrated clinically significant reductions in eating disorder symptoms at least 28 days later which is consistent with other forms of self-help for BN Moreover 89 of users reported that using Recovery Record helped their condition from getting worse and a majority reported improvements to the frequency of disordered behaviours reported urges and mood
App developers have outfitted the app with an adaptive 8-week program that automatically uses patient data to tailor treatment for individual users ie an automated pure self-help course of treatment Although pure self-help is efficacious for BN and BED self-help augmented by coaching from a health care profession has been associated with even better outcomes with a moderate effect size Given the support for this smartphone app and this potential avenue for providing private and accessible care to Nova Scotians the aim of this study is to assess the efficacy of this adaptive smartphone app program both coached and uncoached for BN and BED patients
Given this public health impact it is concerning that less than half of BN and BED patients seek treatment for their eating disorder This is especially concerning since a greater duration of untreated illness is associated with a poorer prognosis Individuals reluctance to seek treatment is likely due to factors such as an avoidance of disclosing symptoms to family members or clinicians For example one study reported that 27 of adolescents with BN declined participation because they did not want their families involved Even for those who do wish to engage treatment is often inaccessible due to the geographic centralization of eating disorder specialists and a low ratio of specialists to patients
Given the ubiquity of smartphone devices among adults and adolescents one possible way to improve treatment accessibility and privacy is to offer it through a smartphone app In recent development an evidence-based smartphone app called Recovery Record RR has been conceived for use by people suffering from eating disorders as an adjunct to clinical treatment This tool allows patients to self-monitor eating behaviours connect with their clinician directly through the app and provides other therapeutic features eg cues coping skill use Preliminary findings suggest that the app is feasible with 67 of users continuing to log meals at 30 days As well RR is currently the most downloaded most rated and highest rated app of its kind which suggests it is highly acceptable among users
In support of these findings one study demonstrated that 26 of app users in a clinically severe range at baseline demonstrated clinically significant reductions in eating disorder symptoms at least 28 days later which is consistent with other forms of self-help for BN Moreover 89 of users reported that using Recovery Record helped their condition from getting worse and a majority reported improvements to the frequency of disordered behaviours reported urges and mood
App developers have outfitted the app with an adaptive 8-week program that automatically uses patient data to tailor treatment for individual users ie an automated pure self-help course of treatment Although pure self-help is efficacious for BN and BED self-help augmented by coaching from a health care profession has been associated with even better outcomes with a moderate effect size Given the support for this smartphone app and this potential avenue for providing private and accessible care to Nova Scotians the aim of this study is to assess the efficacy of this adaptive smartphone app program both coached and uncoached for BN and BED patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None