Adding Guided Self-Help Group Therapy to the Alli Weight Loss Program in Treating Binge Eating Disorder
Information source: National Institute of Mental Health (NIMH)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Overweight; Eating Disorders
Intervention: Emotion regulation guided self-help group therapy (Behavioral); Orlistat/alli program (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: National Institute of Mental Health (NIMH) Official(s) and/or principal investigator(s):
Debra L. Safer, MD, Principal Investigator, Affiliation: Stanford University Department of Psychiatry
Summary
This study will evaluate the effectiveness of adding guided self-help group therapy to a
weight loss program in achieving weight loss and reducing binge eating in overweight binge
eaters.
Clinical Details
Official title: Comparing Orlistat/Alli to Orlistat/Alli Plus Guided Self-Help Group Therapy in Overweight Binge Eaters
Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Weight loss
Secondary outcome: Binge frequency
Detailed description:
Binge eating disorder is one of the most common eating disorders, with more than 4 million
Americans affected. Following a binge eating episode, in which a person eats an excessive
amount of food in a short period of time, the person often experiences feelings of guilt,
depression, embarrassment, and disgust. Beyond the emotional distress caused by binge eating,
people who binge eat are at a higher risk for more serious health problems associated with
weight gain. These health problems may include high blood pressure, diabetes, heart disease,
high cholesterol, and certain types of cancer. Thus, seeking effective treatment for binge
eating disorder is vital to an affected person's overall physical and mental well-being.
Managed weight loss programs, combined with certain forms of psychotherapy, have shown
success in providing the direction and proper motivation to eat healthily and to prevent
future binge eating episodes. This study will evaluate the effectiveness of adding guided
self-help group therapy to the alli weight loss program in achieving weight loss and reducing
binge eating in overweight binge eaters.
Participation in this single-blind study will last 36 weeks. Initial assessments will be
divided over two 1- to 2-hour sessions. These assessments will include a history of any
medical illness, height and weight measurements, and an eating disorder evaluation.
Participants will also answer several questionnaires about self-esteem, feelings of
depression, and emotion and eating. Participants will then be randomly assigned to one of two
treatment groups: the alli program with the use of the weight loss drug orlistat or the alli
program with the use of orlistat plus guided self-help group psychotherapy. All participants
will take the over-the-counter weight loss medication orlistat three times a day for 12 weeks
in conjunction with the alli program, a comprehensive weight loss program with online access.
Participants assigned to the psychotherapy group will also attend 12 weekly guided self-help
group psychotherapy sessions. These sessions will include behavioral support for adapting to
the lifestyle changes promoted by the alli weight loss program.
All participants will undergo 12 weeks of active participation, 12 weeks of maintenance, and
12 weeks of follow-up. At various intervals during the first 6 months of the study,
participants will answer a short group of questions concerning current binge eating habits;
adherence to prescribed food, activity, and medication plan; and emotional state. The initial
assessments will be repeated at Weeks 12, 24, and 36.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Body mass index greater than 27
- Binge eating at least two times per week during the 6 months prior to study entry
Exclusion Criteria:
- Current psychosis
- Current suicidal ideations
- Pregnant
- Receiving concurrent psychotherapy
- Unstable on psychotropic medications for 3 months prior to study entry
Locations and Contacts
Stanford University School of Medicine, Stanford, California 94305, United States
Additional Information
Starting date: October 2007
Ending date: September 2008
Last updated: February 7, 2008
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