Obesity Clinical Trial
Official title:
Cognitive Therapy Via CD-Rom for Binge-Eating Disorder
The purpose of this study is to compare the efficacy of a CD-ROM-based cognitive-behavioral therapy (CBT) to traditional manual-based group therapy for obese individuals with binge-eating disorder (BED) and other unhealthy eating behaviors. A second goal is to encourage a healthy lifestyle in patients with BED.
Although eating and weight-related disorders are treatable, most afflicted individuals never
receive proper treatment.
CD-ROM-based CBT may be an efficacious and cost-effective intervention, a useful adjunct to
traditional psychotherapy, or an introductory step to treatment which familiarizes patients
with the principles and techniques of CBT and increases their comfort and motivation to seek
additional help.
Potential participants undergo a brief telephone screening to ensure their understanding of
the study. Individuals who meet preliminary criteria are then scheduled for an initial
assessment.
Patients are randomized to 1 of 3 groups. One group is given a copy of the CD-ROM program to
complete at home over 10 weeks. At the end of each week, these patients upload and transmit
their encrypted tracking data to the research coordinator. At the end of the treatment,
participants who have not improved are offered a course of traditional manual-based group
therapy, follow-up in an ongoing maintenance group in an eating disorders program, or an
alternative treatment.
A second group undergoes standard group CBT. Therapy is administered over 10 weeks in five
90-minute sessions. The key topics are similar to those covered in the CD-ROM group:
psychoeducation, developing a personal profile, standardizing meal times, recognizing
emotional eating, increasing daily activity, learning the language of CBT, identifying
automatic thoughts, restructuring thoughts, identifying cues and consequences, chaining,
"surfing the urge," and preventing relapses. Therapy sessions include a didactic section
followed by group interaction and discussion. All group sessions are audiotaped and
monitored.
Participants in the wait list control group undergo an initial assessment but receive no
active intervention for 10 weeks. After 10 weeks, these patients undergo post-treatment
assessment and are offered the opportunity to either enter group treatment in an eating
disorders program or enter other appropriate treatment. Three-month follow-up data are not
collected from these individuals.
Assessments occur at study start, at the end of treatment, and at a 3-month follow-up.
Assessments include height and weight measurements and measurements of changes in exercise-
and nonexercise-related activity. All participants are given tests and interviews to assess
eating disorder symptoms, depression, psychoactive substance abuse and dependence, and
functioning. Patients complete self-report questionnaires to assess their cognitive
restraint, hunger, disinhibition, strength of urges to binge, and degree of confidence in
their ability to resist a binge. Patients also rate the suitability of treatment both prior
to and following completion of the intervention.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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