Design and methods for a randomized clinical trial treating comorbid obesity and major depressive disorder
Authors
Schneider, Kristin L.Bodenlos, Jamie S.
Ma, Yunsheng
Olendzki, Barbara C.
Oleski, Jessica
Merriam, Philip A.
Crawford, Sybil L.
Ockene, Ira S.
Pagoto, Sherry L.
UMass Chan Affiliations
Department of Medicine, Division of Cardiovascular MedicineDepartment of Medicine, Division of Preventive and Behavioral Medicine
Document Type
Journal ArticlePublication Date
2008-09-17Keywords
AdultAged
*Behavior Therapy
Comorbidity
Depressive Disorder, Major
Female
Follow-Up Studies
Humans
Male
Middle Aged
Obesity
Research Design
Young Adult
Life Sciences
Medicine and Health Sciences
Metadata
Show full item recordAbstract
BACKGROUND: Obesity is often comorbid with depression and individuals with this comorbidity fare worse in behavioral weight loss treatment. Treating depression directly prior to behavioral weight loss treatment might bolster weight loss outcomes in this population, but this has not yet been tested in a randomized clinical trial. METHODS AND DESIGN: This randomized clinical trial will examine whether behavior therapy for depression administered prior to standard weight loss treatment produces greater weight loss than standard weight loss treatment alone. Obese women with major depressive disorder (N = 174) will be recruited from primary care clinics and the community and randomly assigned to one of the two treatment conditions. Treatment will last 2 years, and will include a 6-month intensive treatment phase followed by an 18-month maintenance phase. Follow-up assessment will occur at 6-months and 1- and 2 years following randomization. The primary outcome is weight loss. The study was designed to provide 90% power for detecting a weight change difference between conditions of 3.1 kg (standard deviation of 5.5 kg) at 1-year assuming a 25% rate of loss to follow-up. Secondary outcomes include depression, physical activity, dietary intake, psychosocial variables and cardiovascular risk factors. Potential mediators (e.g., adherence, depression, physical activity and caloric intake) of the intervention effect on weight change will also be examined. DISCUSSION: Treating depression before administering intensive health behavior interventions could potentially boost the impact on both mental and physical health outcomes. TRIAL REGISTRATION: NCT00572520.Source
BMC Psychiatry. 2008 Sep 15;8:77. Link to article on publisher's siteDOI
10.1186/1471-244X-8-77Permanent Link to this Item
http://hdl.handle.net/20.500.14038/39221PubMed ID
18793398Related Resources
Link to Article in PubMedae974a485f413a2113503eed53cd6c53
10.1186/1471-244X-8-77