Improving Treatment Engagement for Adolescents With Bulimia Nervosa
Primary Purpose
Eating Disorders
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Overcoming Bulimia Online Programme
Sponsored by
About this trial
This is an interventional treatment trial for Eating Disorders focused on measuring Eating Disorders, Self Help, Anonymous CBT
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.
Sites / Locations
- Capital Health District Health Authority
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
The Overcoming Bulimia Online Programme
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT02252822
First Posted
June 26, 2014
Last Updated
November 17, 2016
Sponsor
Nova Scotia Health Authority
1. Study Identification
Unique Protocol Identification Number
NCT02252822
Brief Title
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
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Scotia Health Authority
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders
Keywords
Eating Disorders, Self Help, Anonymous CBT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The Overcoming Bulimia Online Programme
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Overcoming Bulimia Online Programme
Primary Outcome Measure Information:
Title
Recruitment
Description
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
Title
Treatment completion
Description
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
Title
Informed consent
Description
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
Secondary Outcome Measure Information:
Title
Eating Disorder Examination-Questionnaire Version (EDE-Q)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron Keshen, MD, FRCPC
Organizational Affiliation
Capital Health, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Capital Health District Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H2E2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Improving Treatment Engagement for Adolescents With Bulimia Nervosa
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