Please select the eligibility criteria that correspond to the clinical trial below.
Title: Step Up Wellness Program for Depression, Physical Inactivity, and Smoking
Brief Summary: This randomized pilot study will evaluate the feasibility and acceptability of a phone-based wellness program for improving mood, physical activity, and smoking abstinence rates among people with depression who also are physically inactive and smoke cigarettes.


Options:
A: Inclusion Criteria:

* Persistent depressive symptoms that may include the following: depressed mood; diminished interest or pleasure in activities; change in appetite; insomnia or hypersomnia; psychomotor agitation or retardation; fatigue or loss of energy; feelings of worthlessness or inappropriate guilt; diminished ability to think or concentrate; or recurrent thoughts of death or suicidal ideations
* Documented history of coronary heart disease (i.e., a prior heart attack, coronary artery bypass graft, or greater than 75% stenosis in at least one coronary artery)

Exclusion Criteria:

* Experienced an acute heart attack or any revascularization procedure (i.e., CABG or percutaneous transluminal coronary angioplasty) within 60 days of study entry
* Left ventricular ejection fraction \<30% with labile ECG changes prior to testing
* Currently using a pacemaker
* Resting blood pressure greater than 160/100 mmHg
* Left main disease \>50%
* Failure to meet our criteria for depression or achieve a score of ≥9 on the Beck Depression Inventory-II
* Any other concurrent psychiatric intervention
* Primary psychiatric diagnosis other than Major or Minor Depressive Episode
* Primary diagnosis of the following psychiatric disorders: schizophrenia, bipolar disorder, schizoaffective disorder, other psychotic disorder, dementia, current delirium, current obsessive compulsive disorder
* Experienced psychotic symptoms during the current depressive episode
* Current abuse or dependence on alcohol or other drugs
* Acute suicide risk
* Patients who, during the course of the study, would likely require treatment with additional psychotherapeutic agents
* Significant medical conditions that would make exercise or sertraline use medically inadvisable (e.g., unstable angina, heart attack within the 3 months prior to study entry, musculoskeletal problems, or congestive heart failure)
* Abnormal thyroid-stimulating hormone (TSH) level and glucose level greater than or equal to 126 mg/dL
* Patients who would not be able to be randomized to either the drug (e.g., adverse cardiac events such as prolonged QT interval, allergic responses) or exercise (e.g., musculoskeletal problems, abnormal cardiac response to exercise, such as exercise-induced VT, abnormal blood pressure response, etc.)
* Currently using medications that would make exercise or sertraline use medically inadvisable (e.g., clonidine, dicumarol, warfarin, anticonvulsants, or MAO inhibitors)
* Current uncontrolled medical condition that could be causing the depressive symptoms (e.g., thyroid dysfunction, anemia)
* Pregnant, planning to get pregnant during the study period, or lactating
* Herbal supplements with purported mood effects (e.g., St. John's wort, valerian, gingko)
* Current use of antidepressant medication
* Currently participating in psychotherapy
* Currently participating in regular aerobic exercise
* Documented failure to respond to sertraline therapy
B: Inclusion Criteria. Patients must meet all of the following criteria:

* Active Diabetes (Type 1 \& 2)
* Diagnosis of depression
* Using hypoglycemic medications
* At least 1 outpatient visit in last 12 months
* At least 21 years old

Exclusion Criteria. Patients who have any of the following will be excluded:

* Limited life expectancy (heart failure/ on oxygen/ advanced stage cancer/ dialysis)
* End stage renal disease
* Lung cancer
* Dementia
* Bipolar
* Schizophrenia
* Can't speak English
* Memory problems
* Alcohol problems
* Illegal drug use
* Minimal depressive symptoms
* Blood pressure 180/110 or higher
* Problems with loss of consciousness
* Can't walk 10 minutes on level surface
* Not planning to get their care at study site
* PCP not affiliated with study site
* Are not on a stable regimen (change in depression Rx in last 28-30 days)
* Type 1 diabetic if diagnosed before age 15
C: Inclusion Criteria:

* LVEF less than or equal to 35%
* New York Heart Association (NYHA) class II, III, or IV CHF diagnosis in the 3 months prior to study entry, with a minimum of 6 weeks of treatment
* Must be on optimal heart failure therapy according to American Heart Association (AHA), American College of Cardiology (ACC), and Heart Failure Society of America (HFSA) heart failure guidelines, including treatment with angiotensin II converting enzyme inhibitors (ACEI) and beta-blocker therapy, or have documentation justifying why optimal therapy is not being used, including intolerance, contraindication, participant preference, or physician's judgment
* Must be on stable doses of medications (e.g., beta-blocker, ACEI, and additional medications as listed in the study guidelines) for 6 weeks prior to study entry
* Must be in stable medical condition and able to begin an exercise program, as determined by study physician

Exclusion Criteria:

* Comorbid disease, behavioral limitations, or other limitations that would interfere with exercise training, or would prevent completion of 1 year of exercise training
* Pregnant or planning to become pregnant in the year following study entry
* Major heart event or heart procedure within the 6 weeks prior to study entry
* Heart procedure or hospitalization for any reason planned in the future
* Expecting to receive a heart transplant in the 6 months following study entry
* CHF caused by significant uncorrected primary valvular disease (except mitral regurgitation secondary to left ventricular dysfunction); if valve replacement has been performed, may not participate for 12 months following the procedure
* CHF caused by congenital heart disease or obstructive cardiomyopathy
* Performance of exercise training at regular intervals (more than once per week) at a moderate to vigorous intensity at any time in the 6 weeks prior to study entry
* Exercise testing results that would prevent safe exercise training, as defined by the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) guidelines, including abnormal blood pressure response, early ischemic changes, and unexpected life-threatening arrhythmia
* Use of fixed-rate pacemakers, pacemakers with inability to attain target heart rates, or automatic implantable cardioverter defibrillator (AICD) devices with heart rate limits set below the target heart rate for exercise training
* Use of an intracardiac device such as an implantable cardioverter defibrillator (ICD) or a cardiac resynchronization therapy pacemaker in the 6 months prior to study entry (must demonstrate stability for 6 weeks post-procedure)
* Primary physician considers placement of an intracardiac device such as an ICD or a cardiac resynchronization therapy pacemaker probable within 6 months of study entry; will be excluded until such device has been placed and 6 weeks of stabilization have passed
* Participation in another clinical trial that may interfere with study participation, follow-up, or data collection, or that may affect cardiovascular morbidity or mortality
D: Inclusion Criteria:

* Member of Group Health insurance plan
* Aged 18 to 75
* Experiencing at least moderate depressive symptoms
* Low physical activity defined as failure to meet Centers for Disease Control (CDC) guidelines for weekly activity OR low to moderate physical activity as assessed by International Physical Activity Questionnaire (IPAQ)
* Current smoker
* Has a phone
* Able to read and speak in English
* No mobility or physical impairments that would prevent engaging in moderate physical activity
* Without a hearing impairment that would prevent participation with the phone-based counseling or assessments

Exclusion Criteria:

* Self-report of bipolar disorder or schizophrenia
* Currently receiving specialty mental health care or smoking cessation treatment
* If on an antidepressant, has been taking it less than 30 days

Answer: D