Eating Disorders Clinical Trial
Official title:
Early Identification and Treatment of Anorexia Nervosa
This study will compare the effectiveness of two therapies to treat early signs of anorexia nervosa in adolescents.
Eating disorders often result in serious illness and can lead to prolonged health
complications, including heart and kidney problems, digestive disorders, nerve damage, and
low blood pressure. Anorexia nervosa is a type of eating disorder in which a person does not
eat enough for fear of becoming overweight, resulting in extreme weight loss. Women are at a
greater risk of developing this disease, particularly when they are between the ages of 12
and 24. Treatments for anorexia nervosa typically include nutrition counseling,
psychotherapy, and medication. The purpose of this study is to compare the effectiveness of
two therapies to treat adolescents who have signs of anorexia nervosa but have not fully
developed the disease.
Potential participants will attend 2 screening visits during which parents and children will
complete separate questionnaires and undergo 3 interviews regarding eating behaviors and
changes in mood. Once screening evaluations have been completed, eligible participants will
be randomly assigned to 1 of 2 treatment groups. Participants assigned to the first group
will receive 14 family therapy sessions. All family members living with the child will be
asked to attend these sessions with the child. Family members will learn strategies to help
the child eat enough at home and will address various issues concerning family
relationships. Children will learn how to eat well on their own and will also discuss topics
related to family dynamics. Participants assigned to the second group will receive 14
individual therapy sessions that will focus on the child and not include family members.
Before each treatment session, parents will speak with the therapist to discuss progress and
any new concerns or issues regarding the child's condition. The therapist will then work
directly with the child to discuss what may be causing the child's signs of anorexia nervosa
and how to handle difficult emotions associated with the disorder. Participants in both
treatment groups will attend 1-hour therapy sessions that will occur weekly for 8 sessions,
then biweekly for 4 sessions, and monthly for the last 2 sessions. Evaluations, lasting 3 to
4 hours, will occur before treatment begins, immediately following treatment, and 6 and 12
months post-treatment. Evaluations will consist of interviews and questionnaires used to
assess whether treatment was effective in preventing participants from developing anorexia
nervosa.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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