Omega-3 fatty acid supplementation and the recovery from anorexia nervosa and comorbid depressive and anxiety problems: a pilot study
- Conditions
- anorexia nervosa (anorexia)10014067
- Registration Number
- NL-OMON48430
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
* 10- to 19-years old (inclusive);
* diagnosed with anorexia nervosa;
* currently receiving inpatient or day treatment at De Bascule.
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
* mental incapacity;
* intellectual impairment as estimated or determined by a mental health
professional (intelligence quotient of <80);
* chronic psychosis or schizophrenia;
* insufficient mastery of the Dutch language by the adolescent and/or parents;
* substance dependence requiring detoxification;
* inability to take pills;
* current use of omega-3 supplements;
* known allergy of omega-3 supplement ingredients.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary parameters are inclusion rate, treatment adherence, and dropout rate.</p><br>
- Secondary Outcome Measures
Name Time Method <p>A complete overview of the assessments is provided in Table 1 of the C1<br /><br>research protocol. In addition to assessments that are completed as part of<br /><br>care as usual, we will monitor side effects at two time points. Furthermore,<br /><br>participants and one of their parents or legal guardians will be asked to<br /><br>complete two internationally validated assessment instruments at two time<br /><br>points (baseline and 8 weeks), namely:<br /><br>* the Dutch version of the Children*s Depression Inventory 2nd edition (CDI-2)<br /><br>(61), to assess depressive symptoms. The CDI-2 has adequate psychometric<br /><br>properties and has been validated in 8-21-year-old children and adolescents.<br /><br>* and the Dutch version of the Screen for Child Anxiety Related Emotional<br /><br>Disorders (SCARED-NL) (62), to assess anxiety symptoms. The SCARED-NL has<br /><br>adequate psychometric properties and has been validated in 7-19-year-old<br /><br>children and adolescents.</p><br>