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Improving Treatment Engagement for Adolescents With Bulimia Nervosa

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ClinicalTrials.gov Identifier: NCT02252822
Recruitment Status : Completed
First Posted : September 30, 2014
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
Aaron Keshen, Nova Scotia Health Authority

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Eating Disorders Behavioral: Overcoming Bulimia Online Programme Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does Offering Adolescents Anonymous Access to Online CBT Self-Help for Bulimia Nervosa Improve Engagement in Treatment-Pilot Study
Study Start Date : September 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : May 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: The Overcoming Bulimia Online Programme
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


Outcome Measures
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Primary Outcome Measures :
  1. Recruitment [ Time Frame: 4 months ]
    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.

  2. Treatment completion [ Time Frame: 2 months ]
    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.

  3. Informed consent [ Time Frame: Baseline ]
    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.


Secondary Outcome Measures :
  1. Eating Disorder Examination-Questionnaire Version (EDE-Q) [ Time Frame: Baseline, 8weeks (post-intervention), 3-month follow-up ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adolescents with symptoms of BN (full threshold or subthreshold) defined by self-reported symptoms of binging and compensatory behaviours (self-induced vomiting, laxative abuse, diet pills, and diuretics). Excessive exercise and fasting will not be included due to the potential for subjectively in a self-report format.
  • Ages of 16-18.
  • Consent from the adolescent.

Exclusion Criteria:

  • Adolescent is actively engaged in psychological treatment for bulimia nervosa.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02252822


Locations
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Canada, Nova Scotia
Capital Health District Health Authority
Halifax, Nova Scotia, Canada, B3H2E2
Sponsors and Collaborators
Nova Scotia Health Authority
Investigators
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Principal Investigator: Aaron Keshen, MD, FRCPC Capital Health, Canada
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Aaron Keshen, Psychiatrist, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT02252822    
Other Study ID Numbers: 59093006
First Posted: September 30, 2014    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016
Keywords provided by Aaron Keshen, Nova Scotia Health Authority:
Eating Disorders
Self Help
Anonymous CBT
Additional relevant MeSH terms:
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Bulimia
Feeding and Eating Disorders
Bulimia Nervosa
 Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive