Please select the arm or intervention descriptions that belong 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: Arm Label: CBT-I; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Cognitive Behavioral Therapy for Insomnia | Arm Label: Medication- Trazodone; Type: ACTIVE_COMPARATOR; Interventions: Drug: Trazodone | Arm Label: Medication- Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: BEHAVIORAL; Name: Cognitive Behavioral Therapy for Insomnia; Assigned to Arm(s): CBT-I | Intervention Type: DRUG; Name: Trazodone; Assigned to Arm(s): Medication- Trazodone | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Medication- Placebo
B: Arm Label: Engagement Interview; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Engagement Interview | Arm Label: Control Visit; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Cognitive Behavioral Therapy; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Cognitive Behavioral Therapy | Arm Label: Antidepressant Drug Therapy; Type: ACTIVE_COMPARATOR; Interventions: Drug: Antidepressant Drug Therapy | Arm Label: Observational Cohort; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Engagement Interview; Assigned to Arm(s): Engagement Interview | Intervention Type: BEHAVIORAL; Name: Cognitive Behavioral Therapy; Assigned to Arm(s): Cognitive Behavioral Therapy | Intervention Type: DRUG; Name: Antidepressant Drug Therapy; Assigned to Arm(s): Antidepressant Drug Therapy
C: Arm Label: tMBSR; Type: EXPERIMENTAL; Interventions: Behavioral: tMBSR | Arm Label: Support Group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Support group | Intervention Type: BEHAVIORAL; Name: tMBSR; Assigned to Arm(s): tMBSR | Intervention Type: BEHAVIORAL; Name: Support group; Assigned to Arm(s): Support Group
D: Arm Label: Standard Dialysis; Type: PLACEBO_COMPARATOR; Interventions: Procedure: Typical Dialysis, Procedure: Exercise | Arm Label: Cold Dialysis; Type: EXPERIMENTAL; Interventions: Procedure: Cold Dialysis, Procedure: Exercise | Intervention Type: PROCEDURE; Name: Cold Dialysis; Assigned to Arm(s): Cold Dialysis | Intervention Type: PROCEDURE; Name: Typical Dialysis; Assigned to Arm(s): Standard Dialysis | Intervention Type: PROCEDURE; Name: Exercise; Assigned to Arm(s): Cold Dialysis, Standard Dialysis

Answer: B