An interventional study of Overcoming Bulimia Online Programme in Eating Disorders, sponsored by Nova Scotia Health Authority. Completed at 1 site in Canada. Open to participants aged 16 Years to 18 Years. Per ClinicalTrials.gov, last updated 2016-11-18.
Sponsored by Nova Scotia Health Authority · Not applicable, Interventional, and Treatment
Although 4.7% of adolescents suffer from symptoms of bulimia nervosa (BN), only 1/5 seek treatment. Hesitation to seek treatment is likely related to ego-syntonicity and fear of disclosing symptoms to parents and clinicians. Furthermore, the physical symptoms of BN often go unnoticed by parents and clinicians.
In order to eliminate the barriers that prevent adolescents from seeking treatment, this study will offer anonymous access to online self-help cognitive behavioral therapy (CBT) for BN. Online CBT (traditional, non-anonymous delivery) has been found to be effective and acceptable treatment for adolescents with BN. Furthermore, in adults, this method has been found to be as effective as specialized treatments, and more cost efficient.
To remain anonymous and accessible, the self-help approach in this study will be provided in a non-guided, or pure format (only online sessions). Studies support that a pure self-help methodology is as effective as a guided version.
Although anonymity may improve accessibility, this study design could also pose challenges in areas such as recruitment, treatment completion and obtaining adequate informed consent. Therefore, before embarking on a larger randomized control trail, we would like to propose a small, non-controlled feasibility study to assess potential issues in these areas.
Primary hypotheses:
Recruitment: Based on communication with public health nurses in the high schools we plan to recruit from, we hypothesize that it is feasible to recruit 1-5 adolescents over a 4-month period from each of the 5 schools, and 1-5 from social media outlets such as Instagram, Twitter, Facebook for a total of 5 participants over a 4-month period.
Treatment completion: Based on pervious studies of self-help for adolescent bulimia, we hypothesize that approximately 15% of participants will not complete any sessions, and many will only complete about half of the sessions.
Informed consent: Based on information from large randomized control studies in the UK, we hypothesize that adolescents will be capable of providing online consent, and that we will be able to adequately obtain consent without verbally communicating with participants.
Secondary hypothesis:
We hypothesize a non-guided (pure) version of online CBT-BN offered in an anonymous manner will decrease BN symptoms after treatment completion, and at 3-month follow-up compared to baseline.
319 studies on the registry are indexed under Bulimia; 53 are open to participants now.
This study's enrollment of 1 is below the median of 61 across 249 interventional studies indexed under Bulimia.
Browse Bulimia studies →Nova Scotia Health Authority is the lead sponsor of 255 studies on the registry; 76 are open to participants now.
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Exclusion Criteria:
This treatment incorporates a combination of cognitive-behavioral, motivational and education strategies. The program will be presented in 8 collaborative, multi-media, web based CBT sessions for BN.
Behavioral: Overcoming Bulimia Online Programme
Recruitment
The rate of recruitment per month will be compared to standard research recruitment rates, and extrapolation of these data will be a means of assessing feasibility for recruitment for a larger RCT.
Time frame: 4 months
Treatment completion
The medium number of completed online sessions will be compared to previous studies on self-help online CBT for BN in order to ensure at least comparable completion rates are achieved using our novel treatment design. Participants will be provided with a feedback form following treatment completion in order to assess treatment satisfaction and adherence.
Time frame: 2 months
Informed consent
The informed consent process will be evaluated based on the participants ability to effectively answer online questions aimed at determining an understanding of the consent process. Participants would need to answer all questions correctly in order to be deemed capable of consenting.
Time frame: Baseline
Eating Disorder Examination-Questionnaire Version (EDE-Q)
This measure will asses effectiveness of online self-help CBT-BN in improving BN symptoms. The EDE-Q measures 4 areas of eating disorder pathology (eating concern, weight concern, dietary restraint and shape concern).
Time frame: Baseline, 8weeks (post-intervention), 3-month follow-up
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Nova Scotia Health Authority