Status:
COMPLETED
Engaging Self-regulation Targets to Improve Mood and Weight and Understand Mechanism in Depressed and Obese Adults
Lead Sponsor:
University of Illinois at Chicago
Collaborating Sponsors:
Stanford University
University of Washington
Conditions:
Obesity
Depression
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Multimorbidity (i.e., the coexistence of 2 or more chronic conditions in an individual) is increasingly recognized as a pressing public health problem. Effective interventions targeting coexisting dep...
Detailed Description
Participants in this study are adult patients with comorbid depression and obesity from outpatient clinics in the University of Illinois Hospital and Health Sciences System (UI Health). Participants w...
Eligibility Criteria
Inclusion
- Age: ≥18 years
- Body mass index based on study measurements at baseline group orientation: ≥30.0 kg/m2 (≥27.0 if Asian), and weight \<350 pounds (due to fMRI scanner size limitations)
- Elevated depressive symptoms as per 9-item Patient Health Questionnaire (PHQ-9) scores ≥10 on study screening
- UI Health patient seen in primary care at least once in the preceding 18 months
- Able and willing to enroll and provide written informed consent
Exclusion
- Active suicidal ideation based on PHQ-9 or the 20-item depression symptom checklist (SCL-20) that includes active plan and/or intent
- Any other psychiatric disorder other than persistent depressive disorder and/or major depressive disorder, with the exception of any comorbid anxiety disorder
- Active Bulimia Nervosa within the past 3 months (however Binge Eating Disorder without purging is not an exclusionary condition)
- Active alcohol or substance use disorder (including prescription drugs)
- Currently under the care of a psychiatrist or licensed mental health therapist outside of UI Health
- Had bariatric surgery (e.g., bypass, banding, sleeve, or biliopancreatic diversion with duodenal switch) within the past 12 months or plan to undergo bariatric surgery during the study period
- Pre-existing diabetes (other than during pregnancy)
- Pre-existing cardiovascular disease: e.g., coronary heart disease (myocardial infarction, angina pectoris, percutaneous coronary intervention, and coronary artery bypass graft surgery), cerebrovascular disease (stroke, transient ischemic attack), peripheral vascular disease, heart failure, or aortic aneurysm.
- Diagnosis of cancer (other than non-melanoma skin cancer) that is/was active or treated with radiation or chemotherapy within the past year
- Severe medical comorbidities that require aggressive treatment, e.g., stage 4 or greater renal disease, and liver failure
- Diagnosis of a terminal illness and/or residence in a long-term care facility
- Cognitive impairment based on the Callahan 6-item screener
- MRI is contraindicated (weight over 350 pounds, traumatic brain injury, tumor or any other known structural abnormality in brain, bullet, shrapnel, or other projectile above the shoulder, not being able to lie down in an fMRI scanner for about an hour due to claustrophobia, personal history of epilepsy, convulsions, or seizures, have piercings that cannot be removed)
- Traumatic brain injury; Tumor or any other known structural abnormality in brain
- Inability to speak, read or understand English
- No reliable telephone service, or no regular Internet access via a computer and/or mobile device (e.g., smartphone)
- Plan to move out of the area or transfer care outside UI Health during the study period
- Currently pregnant, lactating, or planning to become pregnant during the study period
- Already enrolled, or planning to enroll, in another medical or behavioral intervention research study
- Family/household member of another participant or of a staff member
- Investigator discretion for clinical safety or protocol adherence reasons
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2021
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT03841682
Start Date
March 1 2019
End Date
August 31 2021
Last Update
October 21 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Institute for Health Research and Policy (IHRP), Center for Health Behavior Research
Chicago, Illinois, United States, 60608
2
UIMC Advanced Imaging Center
Chicago, Illinois, United States, 60612