This trial is active, not recruiting.

Condition diabetic retinopathy
Treatment behavioral activation
Sponsor Thomas Jefferson University
Collaborator Wills Eye
Start date May 2014
End date December 2016
Trial size 40 participants
Trial identifier NCT02121340, R34EY024299


In this feasibility/pilot study, we will develop, refine, and evaluate the feasibility of a novel mental health/ophthalmologic intervention called, "Collaborative Care for Depression and Diabetic Retinopathy" (CC-DDR), which aims to treat depression and lower HbA1C in older African Americans with mild-to-moderate diabetic retinopathy (DR) and comorbid depression.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
CC-DDR is a novel mental health/ophthalmologic intervention that we are designing to treat depression and lower HbA1C levels in older AAs with mild-to-moderate DR and comorbid depression. Community Health Workers, who match participants in race and cultural background, will work with ophthalmologists in the retina clinic to educate participants on the links between depression, HbA1C, and DR, and will extend care into the home where they will use Behavioral Activation to treat depression and improve diabetes self-management skills.
behavioral activation
(No Intervention)
Usual Care

Primary Outcomes

Hemoglobin A1c
time frame: 12 months

Eligibility Criteria

Male or female participants at least 65 years old.

Inclusion Criteria: 1. African-American race 2. age ≥ 65 years 3. type 2 diabetes 4. mild or moderate nonproliferative DR with or without macular edema 5. depressive symptoms (i.e., Patient Health Questionnaire-9 score ≥5) 6. HbA1C ≥ 7.0% Exclusion Criteria: 1. treated proliferative DR 2. global cognitive impairment (i.e., Mini Mental Status score ≤ 20) 3. psychiatric diagnosis other than depression 4. treatment for depression started in the previous 3 months 5. life expectancy under 2 years

Additional Information

Official title Collaborative Care for Depression and Diabetic Retinopathy in African Americans
Principal investigator Barry Rovner, MD
Description The Specific Aims are: 1. To develop the CC-DDR treatment protocol. This will involve: 1. Creating an initial version of the CC-DDR treatment protocol. 2. Refining the protocol based on input from an expert panel with expertise in DR, depression, and culturally relevant interventions for diabetes in older African Americans. 3. Developing a tool to assess interventionist treatment adherence and competence. 2. To conduct an open trial of CC-DDR with 40 participants who have poorly controlled diabetes, depression, and mild or moderate DR. During this open trial we will: 1. Evaluate the feasibility of CC-DDR. 2. Refine the CC-DDR treatment protocol by incorporating feedback from participants, community health care workers (CHWs), ophthalmologists, and the expert panel. 3. Refine procedures for recruitment and retention, outcome assessment, monitoring treatment fidelity, CHW training and supervision, quality assurance, and study administration, based on input from investigators, CHWs, participants, and the expert panel. 4. Examine CC-DDR's impact on depression severity; diabetes self-management practices; HbA1C level; blood pressure; adherence to the ophthalmologist treatment plan; vision function; quality of life; and satisfaction with CC-DDR. 3. To complete a Manual of Procedures that characterizes all aspects of the planned efficacy trial of CC-DDR.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Thomas Jefferson University.