A Double Blind Clinical Trial of DCS for Food Anxiety
|ClinicalTrials.gov Identifier: NCT01996644|
Recruitment Status : Completed
First Posted : November 27, 2013
Results First Posted : March 27, 2018
Last Update Posted : March 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Anorexia and Bulimia Nervosa||Drug: Placebo vs Setraline Drug: Setraline||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Double Blind Clinical Trial of DCS for Food Anxiety for Patients With Anorexia and Bulimia Nervosa|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
250 mg DCS (setraline) versus placebo plus exposure
Placebo Comparator: placebo
Placebo group plus exposure
Drug: Placebo vs Setraline
Other Name: Placebo
- Anxiety as Measured by the Subjective Units of Distress (Ranging From 1 to 100). [ Time Frame: 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.
- Body Mass Index [ Time Frame: 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.
- Fear of Food Measure [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01996644
|United States, Missouri|
|Saint Louis, Missouri, United States, 63130|