Please select the eligibility criteria that correspond to the clinical trial below.
Title: Behavioral Activation Therapy for Rural Veterans With Diabetes and Depression
Brief Summary: This clinical trial will compare the effectiveness of the Healthy Outcomes through Patient Empowerment (HOPE) intervention to enhanced usual care (EUC) for diabetes and depression at 6 and 12 month follow-up. The proposed study is a randomized controlled trial enrolling 242 largely rural Veterans with uncontrolled diabetes and clinically-significant depressive symptoms. Both groups will receive screening, education, and notification of clinical findings along with follow-up in usual primary care. HOPE participants will also receive behavioral coaching telephone sessions over a six month period. Patients in the control group will be screened, and providers will be notified of high risk patients' status and need for intervention. Both groups will receive only usual primary care during the subsequent 6 month maintenance period. Study measurements using self-report questionnaires will also be collected at baseline, 6 and 12 months follow-up. The investigators will also conduct chart reviews to evaluate usual care blood tests for diabetes control. Changes in measurements from baseline will be compared between groups. This intervention will reach Veterans in rural setting where community-based primary care is needed, especially care that blends treatment strategies for physical and emotional health.


Options:
A: Inclusion Criteria:

* Have family physician-identified type 2 diabetes
* 18 years of age or older
* Score \>=10 on the PHQ-9
* Speak English and have adequate hearing to complete phone interviews
* Be willing and able to provide written informed consent to participate

Exclusion Criteria:

* Severe and/or terminal physical illness
* Serious and/or severe mental or psychiatric illness
* Pregnant or breastfeeding
* Live in long term care facility
* Already participating in other clinical trials
B: Inclusion Criteria:

* 80 years and older or 65 to 79 years and having at least one chronic disease and being dependent in at least one activity of daily living

Exclusion Criteria:

* acute severely sick who immediately needs the assessment of a physician (within ten minutes)
* those with diagnosis of dementia (or severe cognitive impairment)
* patients in palliative care
C: Inclusion Criteria:

* Age 18 years or older
* Presence of one or more concurrent clinical conditions requiring chronic treatment (ie, daily treatment lasting one month or longer)
* At least one clinically relevant adverse event attributable to the present treatment(s) and/or a clinically relevant drug interaction; for the purposes of this study, a clinically relevant adverse event is any symptom and/or clinical and/or laboratory sign requiring treatment change; a clinically relevant drug interaction is an interaction requiring active monitoring and/or treatment change
* The treatment schedule can be modified to eliminate adverse event(s) and/or risky drug interactions; the decision to modify the treatment is left to the caring physician's judgment

Exclusion Criteria:

* Age younger than 18 years
* Absence of concurrent chronic treatments
* Presence of polytherapy with AEDs unassociated to treatments for concurrent (non-epileptic) disorders
* The treatment schedule cannot be changed even at the presence of clinically relevant adverse events
* Patient is unable to understand or comply with an educational plan; the application of this exclusion criterion is left to the caring physician's judgment
* Patient or caregiver is unwilling to release a written informed consent
D: Inclusion Criteria:

* Veterans with comorbid diabetes and depressive symptoms receiving primary care services at VA CBOCs throughout Southeast Texas
* as well as MEDVAMC patients living \>20 miles from the hospital who face similar distance related treatment barriers

Participants must have:

* a diagnosis of diabetes mellitus
* an average HbA1c level \>7.5% in the prior 6 months
* clinically significant symptoms of depression
* Verification of diabetes mellitus diagnoses will be based on data collected from the VA data warehouse.
* To verify that participants meet the depression criteria, the investigators will use participant self-report of clinically significant depressive symptoms according to the PHQ-9, where a score of greater than/equal to 10 on the PHQ-9 will signify a clinically meaningful symptom burden.

Exclusion Criteria:

* The investigators will exclude potential participants only for clinical factors that would render a telephone-based behavioral activation intervention inappropriate.
* Specific exclusion criteria are:

  * lack of regular access to a telephone
  * significant cognitive impairment (three or more errors) on an established six-item screening exam
  * meeting criteria for bipolar, psychotic, or substance-abuse disorders
  * presence of uncorrected hearing or vision impairment
  * their medical chart recommends not titrating therapy due to prior history of significant hypoglycemic events
  * they live within 20 miles of the MEDVAMC.
* Patients will be secondarily excluded if their HbA1C level falls below 7.5% at baseline assessment, or if they report suicidal ideation on the PHQ-9 at baseline assessment.
* Patients receiving mental health services at the time of study recruitment will not be excluded.
* All mental health treatments and health service-use characteristics will be included in study analyses as covariates.

Answer: D