Trial Outcomes & Findings for Comparing the Effectiveness of Two Therapies to Treat Signs of Anorexia Nervosa in Adolescents (NCT NCT00418977)
NCT ID: NCT00418977
Last Updated: 2015-12-23
Results Overview
Z-score was calculated using the Baylor College of Medicine Children's Nutrition Research Center's online BMI calculator
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
59 participants
Primary outcome timeframe
up to 1 year
Results posted on
2015-12-23
Participant Flow
Recruitment period Oct 2007 to Feb 2011 primarily via physicians and other clinicians/centers evaluating or treating children and adolescents with eating disorder symptoms.
Participant milestones
| Measure |
Family Based Therapy
Participants received family based therapy (FBT)
Family-Based Therapy ("Maudsley Method"): The goal of FBT is to resolve the eating disorder and return the patient to healthy psychosocial and physiological development through active family involvement across three treatment phases. In Phase I, therapy is focused on the disordered eating. The therapist primarily makes careful, persistent requests for united parental action toward re-feeding and/or regulating eating habits and directs the discussion so as to create and reinforce a strong parental alliance around their efforts at feeding their child. In Phase II, the goal is to gradually transfer control over eating back to the participant, with the parents still maintaining general oversight and responsibility for continued progression toward healthy habits. In Phase III, the central goal is establishment of a healthy child or adolescent relationship with the parents where disordered eating is not the basis of interaction.
|
Individual Supportive Psychotherapy
Participants received individual supportive psychotherapy (ISP)
Individual Supportive Psychotherapy: The goal of ISP is for the patient to understand and address the psychological issues underlying the origin and maintenance of the eating disorder. This work is done directly with the child/adolescent. In this treatment, eating disorders are seen as complicated (e.g., they tend to mask other underlying difficulties). In Phase I, the aims are to establish a sound therapeutic relationship, obtain a comprehensive description of the eating problem and its development, identify underlying problems that might be responsible for the disordered eating, and inform the patient about the dangers of eating disorders. Phase II encourages participants to explore underlying emotional problems, facilitates self-disclosure and expression of feelings, and fosters independence. Phase III focuses on how other underlying issues might affect future adjustment.
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|---|---|---|
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Overall Study
STARTED
|
43
|
16
|
|
Overall Study
COMPLETED
|
40
|
13
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing the Effectiveness of Two Therapies to Treat Signs of Anorexia Nervosa in Adolescents
Baseline characteristics by cohort
| Measure |
Family Based Therapy
n=43 Participants
Participants received family based therapy (FBT)
|
Individual Supportive Psychotherapy
n=16 Participants
Participants received individual supportive psychotherapy (ISP)
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.3 years
STANDARD_DEVIATION 2.0 • n=5 Participants
|
14.8 years
STANDARD_DEVIATION 2.0 • n=7 Participants
|
13.7 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 1 yearZ-score was calculated using the Baylor College of Medicine Children's Nutrition Research Center's online BMI calculator
Outcome measures
| Measure |
Family Based Therapy
n=40 Participants
Participants received family based therapy (FBT)
|
Individual Supportive Psychotherapy
n=13 Participants
Participants received individual supportive psychotherapy (ISP)
|
|---|---|---|
|
Body Mass Index (BMI) Z-score
|
-0.72 z-score
Standard Deviation .99
|
-0.02 z-score
Standard Deviation .94
|
SECONDARY outcome
Timeframe: up to 1 yearThis variable informs the calculation of the outcome variable of BMI Z-score.
Outcome measures
| Measure |
Family Based Therapy
n=40 Participants
Participants received family based therapy (FBT)
|
Individual Supportive Psychotherapy
n=13 Participants
Participants received individual supportive psychotherapy (ISP)
|
|---|---|---|
|
Height
|
61.3 inches
Standard Deviation 4.7
|
63.6 inches
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: up to 1 yearThis variable informs the calculation of the outcome variable of BMI Z-score.
Outcome measures
| Measure |
Family Based Therapy
n=40 Participants
Participants received family based therapy (FBT)
|
Individual Supportive Psychotherapy
n=13 Participants
Participants received individual supportive psychotherapy (ISP)
|
|---|---|---|
|
Weight
|
94.9 pounds
Standard Deviation 21.0
|
114.7 pounds
Standard Deviation 29.1
|
SECONDARY outcome
Timeframe: up to 1 yearbody mass index. This variable informs the calculation of the outcome variable of BMI Z-score.
Outcome measures
| Measure |
Family Based Therapy
n=40 Participants
Participants received family based therapy (FBT)
|
Individual Supportive Psychotherapy
n=13 Participants
Participants received individual supportive psychotherapy (ISP)
|
|---|---|---|
|
BMI
|
17.6 kg/m^2
Standard Deviation 2.0
|
19.7 kg/m^2
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: up to 1 yearBody Mass Index (BMI) percentile. This is not a primary outcome variable.
Outcome measures
| Measure |
Family Based Therapy
n=40 Participants
Participants received family based therapy (FBT)
|
Individual Supportive Psychotherapy
n=13 Participants
Participants received individual supportive psychotherapy (ISP)
|
|---|---|---|
|
BMI Percentile
|
30.1 percentile
Standard Deviation 22.5
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42.1 percentile
Standard Deviation 29.4
|
Adverse Events
Family Based Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Individual Supportive Psychotherapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Katharine Loeb, PhD
Icahn School of Medicine at Mount Sinai
Phone: 212-659-8724
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place