Clinical trial NCT02252822: Improving Treatment Engagement for Adolescents With Bulimia Nervosa
Official title: Does Offering Adolescents Anonymous Access to Online CBT Self-Help for Bulimia Nervosa Improve Engagement in Treatment-Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorders
Keywords: Eating Disorders
Self Help
Anonymous CBT
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2014-09-30
Enrollment: 1
Sex: ALL
Minimum age (years): 16
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Recruitment
timeFrame: 4 months
measure: Treatment completion
timeFrame: 2 months
measure: Informed consent
timeFrame: Baseline
Secondary outcomes:
measure: Eating Disorder Examination-Questionnaire Version (EDE-Q)
timeFrame: Baseline, 8weeks (post-intervention), 3-month follow-up
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Capital Health District Health Authority
state: Nova Scotia
Study officials:
affiliation: Capital Health, Canada
name: Aaron Keshen, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: