Eating DisordersNCT02700620
Individually Tailored Web-based Cbt for Eating Disorders and the Role of Knowledge Acquisition
A study testing Internet-delivered CBT in people with Eating Disorders and Bulimia, run by Linkoeping University.
Trial summary
Background: Previous studies on Internet-based treatment with eating disorders have shown promising results. Objective: The first aim of this study was to investigate the effects of a tailored therapist guided internet-based treatment for individuals with eating disorders. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Disorders, Bulimia
- What is being tested?
- Internet-delivered CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Dec 2017
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have reoccurring eating disorder uns or bulimia
- BMI above 17,5
Who cannot join
- Suicide prone
- Ongoing psychological treatment
About this study
Background: Previous studies on Internet-based treatment with eating disorders have shown promising results.
Objective: The first aim of this study was to investigate the effects of a tailored therapist guided internet-based treatment for individuals with eating disorders. The second aim was to examine the role of knowledge acquisition.
Method: 138 participants were recruited. Screening consisted of online questionnaires followed by a telephone interview. A total of 92 participants were included after a semi-structured diagnostic interview and randomized to an 8 week treatment program (n=46) or to a control condition (n=46). Treatment consisted of individually prescribed cognitive behaviour therapy text modules in conjunction with online therapist guidance. The control group consisted of a waitlist who later received treatment.
Read the detailed description
As above
- Conditions
- Eating Disorders, Bulimia
- Being tested
- Internet-delivered CBT
- Keywords
- emotional eating, restrictive eating, body dissatisfaction
- Medical subject headings
- Feeding and Eating Disorders, Bulimia, Emotional Eating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered CBTBehavioural
Guided internet treatment
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Internet-delivered CBT Receives: Behavioral: Internet-delivered CBT |
| Control group | No intervention | Waitlist control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Disorders Examination Questionnaire
Measured: post (8 weeks)
Secondary outcomes (6)
Quality of Life Inventory (QOLI)
Measured: Pre and post (8 weeks)
Body Shape Questionnaire (BSQ)
Measured: post (8 weeks)
Patient Health Questionnaire (PHQ-9)
Measured: post (8 weeks)
Generalised Axiety Disorder Assessment (GAD-7)
Measured: post (8 weeks)
Satisfaction With Life Scales (SWLS)
Measured: post (8 weeks)
Expectancy/Credibility Questionnaire (CEQ)
Measured: post (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study startJan 2015
- Primary completionJun 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gerhard Andersson, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700620
- Sponsor's protocol ID
- 2014-426-31
- Status last verified
- Dec 2023
- First submitted
- 26 Oct 2015
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Primary outcomes and background info on request.
Publications
Strandskov SW, Ghaderi A, Andersson H, Parmskog N, Hjort E, Warn AS, Jannert M, Andersson G. Effects of Tailored and ACT-Influenced Internet-Based CBT for Eating Disorders and the Relation Between Knowledge Acquisition and Outcome: A Randomized Controlled Trial. Behav Ther. 2017 Sep;48(5):624-637. doi: 10.1016/j.beth.2017.02.002. Epub 2017 Mar 2.
PubMed 28711113
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individually Tailored Web-based Cbt for Eating Disorders and the Role of Knowledge Acquisition
- ClinicalTrials.gov ID
- NCT02700620
- Acronym / sponsor ID
- 2014-426-31
- Conditions
- Eating Disorders, Bulimia
- Keywords
- emotional eating, restrictive eating, body dissatisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- Jan 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 7 Mar 2016 (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.
Background: Previous studies on Internet-based treatment with eating disorders have shown promising results.
Objective: The first aim of this study was to investigate the effects of a tailored therapist guided internet-based treatment for individuals with eating disorders. The second aim was to examine the role of knowledge acquisition.
Method: 138 participants were recruited. Screening consisted of online questionnaires followed by a telephone interview. A total of 92 participants were included after a semi-structured diagnostic interview and randomized to an 8 week treatment program (n=46) or to a control condition (n=46). Treatment consisted of individually prescribed cognitive behaviour therapy text modules in conjunction with online therapist guidance. The control group consisted of a waitlist who later received treatment.
Detailed description
As above
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Behavioral: Internet-delivered CBTInternet-delivered CBT |
| Control group | No intervention | –Waitlist control |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have reoccurring eating disorder uns or bulimia
- BMI above 17,5
Key exclusion criteria (2 listed)
- Suicide prone
- Ongoing psychological treatment
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 |
|---|---|---|
| Internet-delivered CBTGuided internet treatment | Behavioural | Treatment group |
Primary outcome
Eating Disorders Examination Questionnaire
Time frame: post (8 weeks)
6 secondary outcomes
Quality of Life Inventory (QOLI)
Time frame: Pre and post (8 weeks)
Body Shape Questionnaire (BSQ)
Time frame: post (8 weeks)
Patient Health Questionnaire (PHQ-9)
Time frame: post (8 weeks)
Generalised Axiety Disorder Assessment (GAD-7)
Time frame: post (8 weeks)
Satisfaction With Life Scales (SWLS)
Time frame: post (8 weeks)
Expectancy/Credibility Questionnaire (CEQ)
Time frame: post (8 weeks)
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 14 Dec 2023.
- Derived from this study: PubMed 28711113Strandskov SW, Ghaderi A, Andersson H, Parmskog N, Hjort E, Warn AS, Jannert M, Andersson G. Effects of Tailored and ACT-Influenced Internet-Based CBT for Eating Disorders and the Relation Between Knowledge Acquisition and Outcome: A Randomized Controlled Trial. Behav Ther. 2017 Sep;48(5):624-637. doi: 10.1016/j.beth.2017.02.002. Epub 2017 Mar 2.
- Individual participant dataSharing planned: Yes. Primary outcomes and background info on request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-delivered CBT in people with Eating Disorders and Bulimia, run by Linkoeping University.
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 2 inclusion and 2 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 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Eating Disorders Examination Questionnaire (time frame: post (8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02700620, which also lists 1 linked publication.
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 14 Dec 2023.