Please select the eligibility criteria that correspond to the clinical trial below.
Title: ASCEND: A Trial of Sertraline vs. CBT for End-stage Renal Disease Patients With Depression
Brief Summary: Patients whose kidneys fail generally require dialysis treatments to sustain life. The ability of patients to make major adjustments in their lives for dialysis is hampered by depression that affects almost one-quarter of such individuals. There are no studies that have adequately tested whether treatment of depression is effective in dialysis patients and if there is any difference between the response to the two most commonly available forms of treatment, psychotherapy and anti-depressant drug therapy.

To fill this important gap in the investigators knowledge, the investigators propose to undertake (1) a randomized controlled clinical trial of 200 patients to test whether an engagement interview will result in a higher proportion of dialysis patients accepting treatment for depression; and (2) a randomized controlled clinical trial of 120 patients to determine whether there is any difference in the likelihood of improvement of depressive symptoms with psychotherapy or drug therapy among dialysis patients with depression. Patients in these studies will be enrolled from among individuals receiving care in 50 dialysis facilities in three metropolitan areas - Seattle, Dallas, and Albuquerque. The research proposal has been developed with the support of patients, caregivers, and stakeholders to ensure that the findings from the study are relevant to them and can be readily implemented in day-to-day clinical practice. Hence, the engagement interview and psychotherapy will be delivered in a dialysis facility to ease the burden on patients, and the dose of the study drug will be changed in partnership with the study participants. In addition to depressive symptoms, the effect of treatment on other meaningful outcomes such as fatigue and sleep will be determined.

The two forms of treatment for depression being tested in this clinical trial are very different from each other and patients differ with regards to the treatment option preferable and/or available to them. Successful completion of the clinical trial will provide patients, caregivers, and other stakeholders with the information that they would need when faced with a diagnosis of depression in patients undergoing hemodialysis. This will allow patients to select evidence-based treatments to improve outcomes that are relevant to them.


Options:
A: Inclusion Criteria:

* Undergoing thrice-weekly maintenance hemodialysis for ≥ 3 months
* Able to speak English
* ISI score ≥ 10 at pre-screening with sleep disturbances for ≥ 3 nights per week for ≥ 3 months

Exclusion Criteria:

* Severe cognitive impairment on Mini-COG cognitive test (score \< 3)
* Severe depression assessed by Patient Health Questionnaire (PHQ)-2 and if appropriate, PHQ-9
* Suicidal Ideation
* Alcohol abuse on CAGE alcohol assessment questionnaire (score ≥ 2) or substance abuse on Drug Abuse Screening Test (DAST)-10 questionnaire (score \> 5)
* Severe restless leg syndrome
* Treatment with trazodone in the past one month
* Known allergy to trazodone (self-report or by chart review)
* Current treatment with monoamine oxidase inhibitors or in the preceding 14 days
* Current treatment with linezolid (self-report or by chart review)
* Current treatment with other drugs that are inhibitors of CYP3A4 (e.g., itraconazole, clarithromycin, voriconazole), or known to prolong QT interval including Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class 3 antiarrhythmics (e.g., amiodarone, sotalol), antipsychotic medications (ziprasidone, chlorpromazine, thioridazine), and quinolone antibiotics
* Pregnancy, or lactation, or women of childbearing potential not willing to use adequate birth control
* Life Expectancy \< 3 months
* Expected to receive a kidney transplant or transition to home dialysis (peritoneal dialysis or home hemodialysis) within 6 months
* Any other condition that, in the opinion of the investigator, should preclude patient participation in the clinical trial
B: Inclusion Criteria:

1. Age ≥ 21 years;
2. Undergoing thrice-weekly maintenance HD for ≥ 3 months;
3. Able to speak either English or Spanish;
4. BDI-II score ≥ 15; and
5. Meets diagnostic criteria for either current major depressive episode or dysthymia on the MINI.

Exclusion Criteria:

1. Active suicidal intent;
2. Ongoing psychotherapy or current treatment with certain anti-depressant drugs;
3. Evidence of cognitive impairment on Mini-Cog;
4. Present or past psychosis or bipolar disorder I or II on the MINI;
5. Alcohol or substance abuse diagnosed on the MINI or history of such abuse in the past three months;
6. Life expectancy \< 3 months, in the judgment of the site principal investigator;
7. Anticipated to receive living related donor kidney transplantation within 3 months;
8. Pregnancy, or lactation, or women of childbearing age not willing to use adequate birth control;
9. Clinical and/or laboratory evidence of chronic liver disease;
10. History of significant active bleeding in the past three months, such as hospitalization for gastrointestinal bleeding;
11. Current use of class I anti-arrhythmic medications (e.g., propafenone, flecainide), pimozide, monoamine oxidase inhibitors, reserpine, guanethidine, cimetidine, tri-cyclic anti-depressants, triptans, tramadol, linezolid, tryptophan, and St. John's wort; and
12. Known hypersensitivity to sertraline.
C: Inclusion Criteria:

* Candidate on the United Network for Organ Sharing (UNOS) wait list for a kidney or kidney-pancreas or evaluated as eligible for candidacy at the UMN
* Aged 18 or older
* English-speaking
* Literate
* Mentally intact
* Able to use the telephone to participate in 6 weekly teleconferences
* Able to attend 2 in-person classes in a Minnesota Metro area
* Able to comply with study monitoring requirements
* Receiving standard medical follow-up care
* Willing to complete the informed consent process

Exclusion Criteria:

* Prior transplant
* Medically unstable (a hospital admission for non-elective purposes in the last 3 months or major non-transplant surgery planned in the next 3 months)
* Serious preexisting mental health issues: suicidality or thought disorder/psychosis; or delirium or substance abuse
* Not expected to be on the waiting list \> 3 months (e.g., acceptable living donor has been identified and scheduled)
* Prior MBSR class or regularly practicing mindfulness meditation (twice a week or more)
* Not receiving standard medical care.
D: Inclusion Criteria:

* Clinically stable ESRD patients receiving regular hemodialysis treatment for at least 3 months,
* adequate dialysis delivery Kt/V \>1.1
* good compliance of dialysis treatment
* serum albumin \>2.5 g/dL
* hemoglobin ≥11g/dL.

Exclusion Criteria:

* Patients with a reason to be in a catabolic state,
* hyperthyroidism,
* active vasculitis,
* malignancies,
* pregnancy
* HIV,
* opportunistic infections,
* musculoskeletal contraindication to exercise,
* requirement for systemic anticoagulation,
* participant or participated in an investigational drug or medical device study within 30 days,
* active inflammations, that required intravenous antibiotics within 3 months prior to enrollment,
* diabetics receiving insulin therapy,
* New York Heart Association grade IV heart failure,
* mental incapacity to consent.

Answer: B