A Trial of Sertraline vs. CBT for End-stage Renal Disease Patients With Depression {ASCEND}

PHASE3CompletedINTERVENTIONAL
Enrollment

184

Participants

Timeline

Start Date

March 23, 2015

Primary Completion Date

November 15, 2017

Study Completion Date

December 15, 2017

Conditions
DepressionEnd Stage Renal Disease
Interventions
BEHAVIORAL

Engagement Interview

An Engagement Interview will comprise a one-on-one session with the patient, during which the health-care provider will use reflective statements and non-judgmental listening techniques, will explore barriers to treatment, and will help patient articulate ambivalence about engaging in treatment. This session will be enhanced with a 40-minute DVD that the subject will watch with the therapist in the dialysis facility. The subject will be encouraged to take the DVD home with them and watch it with their family members as well.

BEHAVIORAL

Cognitive Behavioral Therapy

Cognitive Behavioral Therapy (CBT) is a short-term psychotherapy that will focus on how the individual is thinking, behaving, and communicating today rather than on their childhood experience. The therapist will assist the patient in identifying specific distortions (cognitive assessment) and biases in thinking and will provide guidance on how to change this thinking. During the course of intervention, study subjects will undergo assessment of severity of depressive symptoms using Quick Inventory of Depressive Symptoms - Self-Report (QIDS-SR) every two weeks for the first six weeks (weeks 0, 2, 4, and 6) and every three weeks for the next six weeks (weeks 9 and 12).

DRUG

Antidepressant Drug Therapy

The site investigators will prescribe sertraline drug at a starting dose of 25 mg oral tablets. Dose titration will be implemented using standardized assessments of depressive symptoms and drug side effects; and the research team and the patient make joint decisions to maintain, increase, or decrease the dose. This will help establish the highest effective but tolerable dose tailored for each patient. The QIDS-SR scale will be used to assess the clinical response for dose titration. The FIBSER scale will be used to assess side effects and the degree to which they interfere with day-to-day functions. The participant-specific dose at week 6, up to a maximum of 200 mg/d, will be continued for the remaining 6 weeks.

Trial Locations (3)

75390

University of Texas Southwestern, Dallas

87131

University of New Mexico, Albuquerque

98195

University of Washington, Seattle

All Listed Sponsors
collaborator

University of Texas

OTHER

collaborator

University of New Mexico

OTHER

collaborator

Patient-Centered Outcomes Research Institute

OTHER

lead

University of Washington

OTHER

NCT02358343 - A Trial of Sertraline vs. CBT for End-stage Renal Disease Patients With Depression {ASCEND} | Biotech Hunter | Biotech Hunter