Back to resultsEngaging Self-regulation Targets to Improve Mood and Weight and Understand Mechanism in Depressed and Obese Adults
Primary Purpose
Obesity, Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
I-CARE2
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Institute for Health Research and Policy (IHRP), Center for Health Behavior Research
- UIMC Advanced Imaging Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
I-CARE2 Intervention
Usual Care
Arm Description
Participants should continue with their usual medical care. Additionally, participant receive the I-CARE2 intervention. Trained health coaches deliver the I-CARE2 intervention over 6 months. The intervention provides 9 individual counseling sessions on problem solving treatment and behavior counselling to manage mood and lose weight (4 weekly, 2 biweekly, and then 3 monthly; 1 hour each), 11 home-viewed GLB videos (weekly; 20-30 minutes each), and self-study and self-monitoring activities. Throughout the intervention, participants are asked to wear and sync a study-provided Fitbit pedometer, and to log their weight, minutes of physical activity, and dietary intake using the Fitbit website or mobile app.
Participants should continue with their Usual Medical Care. Additionally, participants receive information on wellness and behavioral health promotion at UI Health and a Fitbit pedometer.
Outcomes
Primary Outcome Measures
Change in Depression Symptom Checklist 20 items (SCL-20) at 6 months
The SCL-20 is a valid, reliable measure of depression severity, scores ranging from 0 (best) to 4 (worst). SCL-20 cutoff points of 1.5 and 2.0 correspond to moderate and severe depression, respectively. It has been used in numerous depression treatment trials in primary care and community settings, making it particularly useful for cross-study comparisons and data synthesis in meta-analyses.
Change in Boby Mass Index (BMI) at 6 months
BMI will be calculated based on height and weight measured per standard protocols
Secondary Outcome Measures
Anxiety
Anxiety is measured using Panic Disorder module of the Mini-International Neuropsychiatric Interview (MINI).
Self-regulation of emotion, cognition, and self-reflection
fMRI scan will be used to evaluate self-regulation of emotion, cognition, and self-reflection
Change in Depression Symptom Checklist 20 items (SCL-20) at 2 months
The SCL-20 is a valid, reliable measure of depression severity, scores ranging from 0 (best) to 4 (worst). SCL-20 cutoff points of 1.5 and 2.0 correspond to moderate and severe depression, respectively. It has been used in numerous depression treatment trials in primary care and community settings, making it particularly useful for cross-study comparisons and data synthesis in meta-analyses.
Change in Body Mass Index (BMI) at 2 months
BMI will be calculated based on height and weight measured per standard protocols
Anxiety
Anxiety is measured using Generalized Anxiety Disorder Scale (GAD-7).
Dietary Intake
Dietary intake will be recorded using 24-hours dietary recalls
Fruit, vegetable, fat and fiber intake
17-item fruit, vegetable, fat, and fiber screener will be used.
Physical activity (PA)
PA will be measured using 7-day Physical Activity Recall
Steps
Steps will be calculated using Fitbit
Problem solving
Problem Solving will be evaluated using Social Problem-Solving Inventory-Revised: Short Form
Depression Response
This will be evaluated using depression symptom checklist SCL-20 (50% decline in SCL-20 scores from baseline)
Complete Depression Remission
Evaluated using depression symptom checklist SCL-20 (SCL-20 <0.5)
Weight (kg)
Measured using a weight scale. Missing study-measured weight may be replaced with weight from electronic health records or self-reported weight.
Clinically significant weight change from baseline
Dichotomous variable based on if participants reaching 5% weight loss from baseline.
Blood pressure
The American Heart Association recommendations for BP measurement will be followed. BP will be measured in the seated position after at least a 5-minute rest in a separate, quiet room where no other activity is taking place and where temperature fluctuations are minimal. At baseline, both arms will be measured once and 2 more times on the arm with higher systolic reading using standard equipment. This same arm will be measured 3 times at each follow-up assessment. Wait 1 minute between each measurement.
Waist circumference
Waist circumference will be measured using a study-provided body tape measure placed on bare skin in a horizontal plane around the abdomen at the uppermost lateral border of the right iliac crest. Waist circumference will be measured to the nearest 0.1 centimeters. Two measurements will be taken, and if the measurements differ by 1.0 cm or more, then take a third.
Sleep and wake function
Sleep quality will be assessed on the 8-item Patient-Reported Outcomes Measurement Information System (PROMIS™) sleep disturbance (SD) and sleep-related impairment (SRI) scales short forms. The former measures symptoms of insomnia and the latter measures symptoms of daytime sleepiness. Each item is scaled from 1 (not at all) to 5 (very much). Correlation between the SD short form and the Pittsburgh Sleep Quality Index (PSQI, hypothesized to measure similar attributes) is 0.83 and correlation between the SRI short form and the Epworth Sleepiness Scale (ESS, hypothesized to measure a related but slightly different construct, the propensity to doze during activities) is 0.46, similar to the correlations between the SD full banks and PSQI (0.85) and between SRI full banks and the ESS (0.45).
Perceived stress
Perceived stress is measured using Perceived stress scale (PSS). PSS measures the perception of stress (i.e., the degree to which situations in one's life are appraised as stressful). PSS contains 14 items, rated on a 5-point scale ranging from "never" to "very often." After reversing the scores on 7 positive items, a sum of score is calculated with higher score indicating higher perceived stress. Cronbach's alpha ranged from 0.84 to 0.86.
Disability
Disability is measured using Sheehan Disability Scale. The Sheehan Disability Scale is a validated questionnaire that measures functional disability and is sensitive to treatment effects in clinical trials. Patients rate the extent to which their symptoms impair work/school, social, and family life on a visual analog scale from0 to 10 and answer the number of days when their symptoms cause them to miss work/school and be unproductive at work/school.
Generic health related quality of life
Generic health related quality of life is measured using SF-8 Health Survey. The SF-8 is an 8-item version of the SF-36 that measures overall health-related quality of life. Physical and mental health composite scores are computed using the scores of 8 questions and range from 0 to 100, with 0 indicating the lowest level of health and 100 indicating the highest level of health. Correlation between the SF-8 and the SF-36 is 0.825 for physical health component and 0.881 for mental health component.
Obesity-specific health related questions
The Obesity-Related Problem Scale specifically measures the impact of obesity on psychosocial functioning. The 8-item scale has high internal reliability and sound test-retest reliability, correlates strongly with a wide range of theoretically related constructs, and is responsive to weight loss intervention.
Posttraumatic stress disorder
Posttraumatic stress disorder is measured using the 17-item PTSD checklist - Civilian Version (PCL-C) that has high reliability and validity.
Pain interference and intensity
Pain is measured using PROMIS SF - Pain Interference 4a and Numeric Rating Scale - Pain Intensity 1a.
Binge eating severity
Binge eating severity is measured using the Binge eating severity scale.
Use of general wellness programs and services questionnaire
This questionnaire asks participants if they have received a list of wellness programs and services for general physical and mental well-being in the past 6 months.
Self-regulation of emotion, cognition, & self-reflection
BiAffect (Smart phone passive data collection) will be used, as an alternative, to evaluate self-regulation of emotion, cognition, and self-reflection
Full Information
NCT ID
NCT03841682
First Posted
February 2, 2019
Last Updated
October 13, 2021
Sponsor
University of Illinois at Chicago
Collaborators
Stanford University, University of Washington, National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT03841682
Brief Title
Engaging Self-regulation Targets to Improve Mood and Weight and Understand Mechanism in Depressed and Obese Adults
Official Title
Engaging Self-Regulation Targets to Understand the Mechanism of Behavior Change and Improve Mood and Weight Outcomes- Second Phase (ENGAGE-2)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
August 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
Stanford University, University of Washington, National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 depression and obesity are critical given the high prevalence and worsened outcomes for patients with both conditions.
ENGAGE-2 is a pilot randomized controlled trial (RCT). The objective is to investigate the outcomes and mechanisms of an integrated depression and obesity intervention that combines collaborative stepped depression treatment and evidence-based behavioral weight loss treatment. The Integrated Coaching for Better Mood and Weight-2 (I-CARE2) intervention synergistically integrates 2 proven national programs: the Program to Encourage Active and Rewarding Lives (PEARLS) for depression care and the Group Lifestyle Balance (GLB) program for weight loss and cardiometabolic risk reduction.
In Phase 1 of the ENGAGE project, investigators developed a new protocol to quantify activation and connectivity of the Affective, Cognitive Control, and Default Mode brain circuits from functional magnetic resonance imaging (fMRI) among 108 depressed obese patients. Investigators implement the same fMRI protocol in this second phase of the project to examine the mechanistic role of these brain circuits as potential neural targets in treatment engagement and response in the I-CARE2 intervention. A new sample of 105 depressed obese patients are randomized in a 2:1 ratio to receive the I-CARE2 intervention (n=70) or usual care (n=35). Study assessments occur at 0 (baseline), 2 and 6 months. Investigators hypothesize that 1 or more of the neural targets under study will moderate (baseline state) and/or mediate (change at follow-up) the effect of the I-CARE2 intervention versus usual care on health behaviors (problem-solving ability, dietary intakes, physical activity) and clinical outcomes (weight loss, depression, anxiety).
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 will be randomly assigned to receive intervention or usual care control.
The I-CARE2 intervention synergistically integrates the PEARLS program for depression care the GLB program for weight loss. The PEARLS program provides problem-solving therapy (PST) as first-line for treating depression, with as-needed antidepressant medication intensification. Adapted from the original Diabetes Prevention Program, the GLB program promotes healthy lifestyle change for weight loss and increased physical activity. For combination treatment, the I-CARE2 intervention provides 9 individual counseling sessions (4 weekly, 2 biweekly, and then 3 monthly; 1 hour each) and participant self-study materials (GLB videos, handouts, weight and activity tracking) over 6 months.
In response to the funding mechanism for this project, the specific aim of the ENGAGE-2 pilot study is to test the degree to which engaging the validated self-regulation target(s) produces desired behavior change important for weight management and mood.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I-CARE2 Intervention
Arm Type
Experimental
Arm Description
Participants should continue with their usual medical care. Additionally, participant receive the I-CARE2 intervention.
Trained health coaches deliver the I-CARE2 intervention over 6 months. The intervention provides 9 individual counseling sessions on problem solving treatment and behavior counselling to manage mood and lose weight (4 weekly, 2 biweekly, and then 3 monthly; 1 hour each), 11 home-viewed GLB videos (weekly; 20-30 minutes each), and self-study and self-monitoring activities. Throughout the intervention, participants are asked to wear and sync a study-provided Fitbit pedometer, and to log their weight, minutes of physical activity, and dietary intake using the Fitbit website or mobile app.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants should continue with their Usual Medical Care. Additionally, participants receive information on wellness and behavioral health promotion at UI Health and a Fitbit pedometer.
Intervention Type
Behavioral
Intervention Name(s)
I-CARE2
Intervention Description
I-CARE2 intervention synergistically integrates 2 proven national programs: the Program to Encourage Active and Rewarding Lives (PEARLS) for depression care and the Group Lifestyle Balance (GLB) program for weight loss and cardiometabolic risk reduction.
The PEARLS program provides problem-solving therapy (PST) as first-line for treating depression, with as-needed antidepressant medication intensification. Adapted from the original Diabetes Prevention Program, the GLB program promotes healthy lifestyle change for weight loss and increased physical activity.
Primary Outcome Measure Information:
Title
Change in Depression Symptom Checklist 20 items (SCL-20) at 6 months
Description
The SCL-20 is a valid, reliable measure of depression severity, scores ranging from 0 (best) to 4 (worst). SCL-20 cutoff points of 1.5 and 2.0 correspond to moderate and severe depression, respectively. It has been used in numerous depression treatment trials in primary care and community settings, making it particularly useful for cross-study comparisons and data synthesis in meta-analyses.
Time Frame
Baseline, 6 months
Title
Change in Boby Mass Index (BMI) at 6 months
Description
BMI will be calculated based on height and weight measured per standard protocols
Time Frame
Baseline, 6 months
Secondary Outcome Measure Information:
Title
Anxiety
Description
Anxiety is measured using Panic Disorder module of the Mini-International Neuropsychiatric Interview (MINI).
Time Frame
Baseline, 6 months
Title
Self-regulation of emotion, cognition, and self-reflection
Description
fMRI scan will be used to evaluate self-regulation of emotion, cognition, and self-reflection
Time Frame
Baseline, 2 months, 6 months
Title
Change in Depression Symptom Checklist 20 items (SCL-20) at 2 months
Description
The SCL-20 is a valid, reliable measure of depression severity, scores ranging from 0 (best) to 4 (worst). SCL-20 cutoff points of 1.5 and 2.0 correspond to moderate and severe depression, respectively. It has been used in numerous depression treatment trials in primary care and community settings, making it particularly useful for cross-study comparisons and data synthesis in meta-analyses.
Time Frame
Baseline, 2 months
Title
Change in Body Mass Index (BMI) at 2 months
Description
BMI will be calculated based on height and weight measured per standard protocols
Time Frame
Baseline, 2 months
Title
Anxiety
Description
Anxiety is measured using Generalized Anxiety Disorder Scale (GAD-7).
Time Frame
Baseline, 2 months, 6 months
Title
Dietary Intake
Description
Dietary intake will be recorded using 24-hours dietary recalls
Time Frame
Baseline, 2 months, 6 months
Title
Fruit, vegetable, fat and fiber intake
Description
17-item fruit, vegetable, fat, and fiber screener will be used.
Time Frame
Baseline, 2 months, 6 months
Title
Physical activity (PA)
Description
PA will be measured using 7-day Physical Activity Recall
Time Frame
Baseline, 2 months, 6 months
Title
Steps
Description
Steps will be calculated using Fitbit
Time Frame
Baseline, 2 months, 6 months
Title
Problem solving
Description
Problem Solving will be evaluated using Social Problem-Solving Inventory-Revised: Short Form
Time Frame
Baseline, 2 months, 6 months
Title
Depression Response
Description
This will be evaluated using depression symptom checklist SCL-20 (50% decline in SCL-20 scores from baseline)
Time Frame
2 months, 6 months
Title
Complete Depression Remission
Description
Evaluated using depression symptom checklist SCL-20 (SCL-20 <0.5)
Time Frame
2 months, 6 months
Title
Weight (kg)
Description
Measured using a weight scale. Missing study-measured weight may be replaced with weight from electronic health records or self-reported weight.
Time Frame
Baseline, 2 months, 6 months
Title
Clinically significant weight change from baseline
Description
Dichotomous variable based on if participants reaching 5% weight loss from baseline.
Time Frame
2 months, 6 months
Title
Blood pressure
Description
The American Heart Association recommendations for BP measurement will be followed. BP will be measured in the seated position after at least a 5-minute rest in a separate, quiet room where no other activity is taking place and where temperature fluctuations are minimal. At baseline, both arms will be measured once and 2 more times on the arm with higher systolic reading using standard equipment. This same arm will be measured 3 times at each follow-up assessment. Wait 1 minute between each measurement.
Time Frame
Baseline, 2 months, 6 months
Title
Waist circumference
Description
Waist circumference will be measured using a study-provided body tape measure placed on bare skin in a horizontal plane around the abdomen at the uppermost lateral border of the right iliac crest. Waist circumference will be measured to the nearest 0.1 centimeters. Two measurements will be taken, and if the measurements differ by 1.0 cm or more, then take a third.
Time Frame
Baseline, 2 months, 6 months
Title
Sleep and wake function
Description
Sleep quality will be assessed on the 8-item Patient-Reported Outcomes Measurement Information System (PROMIS™) sleep disturbance (SD) and sleep-related impairment (SRI) scales short forms. The former measures symptoms of insomnia and the latter measures symptoms of daytime sleepiness. Each item is scaled from 1 (not at all) to 5 (very much). Correlation between the SD short form and the Pittsburgh Sleep Quality Index (PSQI, hypothesized to measure similar attributes) is 0.83 and correlation between the SRI short form and the Epworth Sleepiness Scale (ESS, hypothesized to measure a related but slightly different construct, the propensity to doze during activities) is 0.46, similar to the correlations between the SD full banks and PSQI (0.85) and between SRI full banks and the ESS (0.45).
Time Frame
Baseline, 2 months, 6 months
Title
Perceived stress
Description
Perceived stress is measured using Perceived stress scale (PSS). PSS measures the perception of stress (i.e., the degree to which situations in one's life are appraised as stressful). PSS contains 14 items, rated on a 5-point scale ranging from "never" to "very often." After reversing the scores on 7 positive items, a sum of score is calculated with higher score indicating higher perceived stress. Cronbach's alpha ranged from 0.84 to 0.86.
Time Frame
Baseline, 6 months
Title
Disability
Description
Disability is measured using Sheehan Disability Scale. The Sheehan Disability Scale is a validated questionnaire that measures functional disability and is sensitive to treatment effects in clinical trials. Patients rate the extent to which their symptoms impair work/school, social, and family life on a visual analog scale from0 to 10 and answer the number of days when their symptoms cause them to miss work/school and be unproductive at work/school.
Time Frame
Baseline, 6 months
Title
Generic health related quality of life
Description
Generic health related quality of life is measured using SF-8 Health Survey. The SF-8 is an 8-item version of the SF-36 that measures overall health-related quality of life. Physical and mental health composite scores are computed using the scores of 8 questions and range from 0 to 100, with 0 indicating the lowest level of health and 100 indicating the highest level of health. Correlation between the SF-8 and the SF-36 is 0.825 for physical health component and 0.881 for mental health component.
Time Frame
Baseline, 6 months
Title
Obesity-specific health related questions
Description
The Obesity-Related Problem Scale specifically measures the impact of obesity on psychosocial functioning. The 8-item scale has high internal reliability and sound test-retest reliability, correlates strongly with a wide range of theoretically related constructs, and is responsive to weight loss intervention.
Time Frame
Baseline, 6 months
Title
Posttraumatic stress disorder
Description
Posttraumatic stress disorder is measured using the 17-item PTSD checklist - Civilian Version (PCL-C) that has high reliability and validity.
Time Frame
Baseline, 6 months
Title
Pain interference and intensity
Description
Pain is measured using PROMIS SF - Pain Interference 4a and Numeric Rating Scale - Pain Intensity 1a.
Time Frame
Baseline, 6 months
Title
Binge eating severity
Description
Binge eating severity is measured using the Binge eating severity scale.
Time Frame
Baseline, 6 months
Title
Use of general wellness programs and services questionnaire
Description
This questionnaire asks participants if they have received a list of wellness programs and services for general physical and mental well-being in the past 6 months.
Time Frame
6 months
Title
Self-regulation of emotion, cognition, & self-reflection
Description
BiAffect (Smart phone passive data collection) will be used, as an alternative, to evaluate self-regulation of emotion, cognition, and self-reflection
Time Frame
Baseline, 2 months, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Ma, MD,PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Health Research and Policy (IHRP), Center for Health Behavior Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
Facility Name
UIMC Advanced Imaging Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35398399
Citation
Kannampallil T, Dai R, Lv N, Xiao L, Lu C, Ajilore OA, Snowden MB, Venditti EM, Williams LM, Kringle EA, Ma J. Cross-trial prediction of depression remission using problem-solving therapy: A machine learning approach. J Affect Disord. 2022 Jul 1;308:89-97. doi: 10.1016/j.jad.2022.04.015. Epub 2022 Apr 7.
Results Reference
derived
PubMed Identifier
32621905
Citation
Lv N, Ajilore OA, Ronneberg CR, Venditti EM, Snowden MB, Lavori PW, Xiao L, Goldstein-Piekarski AN, Wielgosz J, Wittels NE, Barve A, Patel AS, Eckley TL, Stetz P, Gerber BS, Smyth JM, Simmons JM, Rosas LG, Williams LM, Ma J. The ENGAGE-2 study: Engaging self-regulation targets to understand the mechanisms of behavior change and improve mood and weight outcomes in a randomized controlled trial (Phase 2). Contemp Clin Trials. 2020 Aug;95:106072. doi: 10.1016/j.cct.2020.106072. Epub 2020 Jul 2.
Results Reference
derived
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Engaging Self-regulation Targets to Improve Mood and Weight and Understand Mechanism in Depressed and Obese Adults
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