Developing a Peer Support Model for Depression Care in Patients With Diabetes Mellitus, and Testing it's Efficacy on Patient Outcomes; a Randomized Control Trial Protocal

Methods: This will be a pragmatic randomized control trial with a 1:1 allocation ratio between cases and controls.

Study Setting: This project will be implemented at the DM clinic of Nsambya Hospital in Kampala City. The clinic, which is staffed by three nurses, a medical officer and a specialist physician, is open once a week. The nurses provide most of the DM care including eliciting symptoms, providing medication refills, as well as referring complicated cases to the medical officer (MO) and specialist physician. The medical officer and specialist physician manage referrals and complications of DM.

Identification of depressed patients to participate in a peer support feasibility study: In the first four weeks of the study, all clinic attendees will be screened for depression by a trained lay health care worker(TLHW) using the PHQ-2 at triage. Screen positive cases (PHQ-2≥3) will be sent to the MO who will conduct a depression diagnostic interview using the Mini International Neuropsychiatric Interview (MINI) till 10 depressed patients are identified. All depressed patients will be initiated on either Imipramine 75mg/day or Fluoxetine 20mg/day, and then reassessed at week 4 and week 6 for side effects and symptom remission using the Hamilton Depression Rating scale (HAM-D).

Conducting qualitative interviews to assess feasibility of peer support: When the 10 patients are in remission (˜ 6-8 weeks) the investigators will conduct qualitative interviews with them, hospital administrators (n=2), and medical personel at the DM clinic (n=5). During the interview, the investigators will assess the participant's perceptions about the feasibility and acceptability of engaging experienced DM patients to provide peer support to patients newly diagnosed with depression. Informed consent will be sought from all participants.

Interview procedure: Dr Elialilia Okello will conduct the qualitative interviews. The participants will be asked about whom in the DM clinic would be a suitable candidate to provide peer support to newly diagnosed depressed patients. The peer support model will be presented to participants so that they can internalize/appreciate the concept, Interview guide: The interviews will be based on a guide with detailed standard probes to ensure that key questions are addressed, and to allow comparisons across individuals and categories of respondents. Questions will be open-ended to allow not only the exploration of new leads but also generation of rich narratives. All interviews will be tape recorded, translated in English (in cases where Luganda, the local language is used) and transcribed verbatim.