Eating DisordersNCT02252822
Improving Treatment Engagement for Adolescents With Bulimia Nervosa
A study testing Overcoming Bulimia Online Programme in people with Eating Disorders, run by Nova Scotia Health Authority at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 16 to 18 years
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Overcoming Bulimia Online Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2014to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Adolescent is actively engaged in psychological treatment for bulimia nervosa.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Capital Health District Health Authority
Halifax, Nova Scotia, B3H2E2
About this study
Official title: Does Offering Adolescents Anonymous Access to Online CBT Self-Help for Bulimia Nervosa Improve Engagement in Treatment-Pilot Study
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.
Read more
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.
- Conditions
- Eating Disorders
- Being tested
- Overcoming Bulimia Online Programme
- Keywords
- Eating Disorders, Self Help, Anonymous CBT
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Overcoming Bulimia Online ProgrammeBehavioural
| Study group | Role | What they receive |
|---|---|---|
| The Overcoming Bulimia Online Programme | Experimental | 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. Receives: Behavioral: Overcoming Bulimia Online Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline
Secondary outcomes (1)
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).
Measured: Baseline, 8weeks (post-intervention), 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Keshen, Nova Scotia Health Authority
- Investigators
- Aaron Keshen, MD, FRCPC, Principal investigator, Capital Health, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252822
- Sponsor's protocol ID
- 59093006
- Status last verified
- Nov 2016
- First submitted
- 26 Jun 2014
- Last updated
- 18 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Offering Adolescents Anonymous Access to Online CBT Self-Help for Bulimia Nervosa Improve Engagement in Treatment-Pilot Study
- ClinicalTrials.gov ID
- NCT02252822
- Acronym / sponsor ID
- 59093006
- Conditions
- Eating Disorders
- Keywords
- Eating Disorders, Self Help, Anonymous CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 30 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Overcoming Bulimia Online Programme | Experimental | Behavioral: Overcoming Bulimia Online ProgrammeThis 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. |
Who may qualify
- Ages
- 16 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Adolescent is actively engaged in psychological treatment for bulimia nervosa.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Overcoming Bulimia Online Programme | Behavioural | The Overcoming Bulimia Online Programme |
Primary outcome
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.
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.
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.
1 secondary outcome
Eating Disorder Examination-Questionnaire Version (EDE-Q)
Time frame: Baseline, 8weeks (post-intervention), 3-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron Keshen, MD, FRCPC principal investigator
Capital Health, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Overcoming Bulimia Online Programme in people with Eating Disorders, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2016.