Improving Treatment Engagement for Adolescents With Bulimia Nervosa

Eating Disorders Clinical Trial

Official title:

Does Offering Adolescents Anonymous Access to Online CBT Self-Help for Bulimia Nervosa Improve Engagement in Treatment-Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02252822
• Other study ID #: 59093006
• Status: Completed
• Phase: N/A
• First received: June 26, 2014
• Last updated: November 17, 2016
• Start date: September 2014
• Est. completion date: May 2015

Study information

• Verified date: November 2016
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 18 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bulimia
• Bulimia Nervosa
• Eating Disorders
• Feeding and Eating Disorders

Intervention

Behavioral:
• Overcoming Bulimia Online Programme

Locations

Country	Name	City	State
Canada	Capital Health District Health Authority	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 months	No
Primary	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.	2 months	No
Primary	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.	Baseline	No
Secondary	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).	Baseline, 8weeks (post-intervention), 3-month follow-up	No