Trial · NCT01996644
A Double Blind Clinical Trial of DCS for Food Anxiety
NCT01996644, Not applicable, Completed, Washington University School of Medicine; results first posted 2018-03-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Double Blind Clinical Trial of DCS for Food Anxiety. Trials, record NCT01996644. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01996644
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Double Blind Clinical Trial of DCS for Food Anxiety
- NCT number
- NCT01996644
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 47 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Anorexia and Bulimia Nervosa
- Interventions
- Placebo vs Setraline, Setraline
- First posted
- 2013-11-27
- Last updated
- 2018-03-27
- Results first posted
- 2018-03-27
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Anxiety as Measured by the Subjective Units of Distress (Ranging From 1 to 100). | Twice a week for two weeks | Anxiety will be measured at 4 sessions, twice a week for two weeks. Anxiety is combined in a repeated measures ANOVA to give total anxiety decreased across condition. Anxiety was measured using the Subjective Units of Distress (ranging from 1 to 100), where 1 is no anxiety and 100 is the most anxiety ever experienced. |
| Primary | Body Mass Index | twice a week for two weeks and at initial assessment | BMI will be measured twice a week for two weeks and once before starting the trial. BMI is combined in a repeated measures ANOVA to give total BMI difference across condition.Difference in BMI from Time 1 to Time 4 was outcome. |
| Other | Fear of Food Measure | Twice during 2 weeks | The Fear of Food Measure (FOFM) was designed to assess three cognitive behavioral components related to mealtime anxiety. All items are rated on a 1 to 7 Likert-type scale ranging from "not at all" to "very much so." Higher values indicate worse outcomes. The first subscale is the anxiety about eating subscale, which was designed to assess trait levels of fear and anxiety surrounding eating and food. This subscale will be measured once before and after the trial (twice in 2 weeks). Each item (8 items totaled, each scored 1-7; max possible score is 56; min possible score is 8) was added for each time point and time points were averaged together for all participants for both time points. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Anxiety as Measured by the Subjective Units of Distress (Ranging From 1 to 100). | Twice a week for two weeks | Units on a scale | MEAN | |
| PRIMARY | Body Mass Index | twice a week for two weeks and at initial assessment | kg/m^2 | MEAN | |
| OTHER_PRE_SPECIFIED | Fear of Food Measure | Twice during 2 weeks | All combined represents the total number of participants (n=40); however 4 participants withdrew. Analysis utilized data for 36 participants who started in participant flow, thus (n=36). | Units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Anxiety as Measured by the Subjective Units of Distress (Ranging From 1 to 100). | Setraline | 52.395 | Standard Deviation 5.493 | Units on a scale | |
| Anxiety as Measured by the Subjective Units of Distress (Ranging From 1 to 100). | Placebo | 58.983 | Standard Deviation 6.141 | Units on a scale | |
| Body Mass Index | Setraline | .385 | Standard Deviation .3 | kg/m^2 | |
| Body Mass Index | Placebo | .095 | Standard Deviation .3 | kg/m^2 | |
| Fear of Food Measure | Setraline | 19.55 | Standard Deviation 5.6 | Units on a scale | |
| Fear of Food Measure | Placebo | 21.22 | Standard Deviation 5.8 | Units on a scale | |
| Fear of Food Measure | All Combined | 20.01 | Standard Deviation 5.7 | Units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Setraline | 20 | |
| Overall Study | STARTED | Placebo | 16 | |
| Overall Study | COMPLETED | Setraline | 20 | |
| Overall Study | COMPLETED | Placebo | 16 | |
| Overall Study | NOT COMPLETED | Setraline | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Setraline | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Setraline | 0 | 20 |
| Total, other adverse events | Placebo | 0 | 16 |
| Total, serious adverse events | Setraline | 0 | 20 |
| Total, serious adverse events | Placebo | 0 | 16 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26132687 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| F31MH096433 | Shared Vulnerabilities of Social Anxiety and Eating Disorders | LEVINSON, CHERI ALICIA | WASHINGTON UNIVERSITY | NATIONAL INSTITUTE OF MENTAL HEALTH | 2011 to 2013 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Setraline vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01996644
GET https://conductscience.org/api/trials/v1/NCT01996644/registered