Please select the eligibility criteria that correspond to the clinical trial below.
Title: Invested in Diabetes: Comparing Patient-Centered Outcomes of Standardized Versus Patient-Driven Diabetes Shared Medical Appointments (PCORI IHS-1609-36322)
Brief Summary: In this study, the investigators will compare the effectiveness of patient-driven diabetes Shared Medical Appointments (SMAs) to standardized diabetes SMAs. The curriculum to be used is Targeted Training for Illness Management (TTIM), a 6-session modular group intervention for chronic illness self-management, and has been tested in diabetes. The standardized group visit model will consist of diabetes SMAs with the full TTIM 6-session curriculum, led by a health educator.


Options:
A: General Inclusion Criteria:

* current age 15 or older (Best Practice Pathway) or 18 years or older (Randomized Care Pathways);
* able to give informed consent for data to be harvested;
* meet DSM-IV criteria for Bipolar I Disorder, Bipolar II Disorder, Bipolar Disorder NOS, or Cyclothymic Disorder;
* undergo a complete standard evaluation including clinical interview, self ratings, and laboratory studies;
* meet with Clinical Specialist as scheduled;
* able to complete all Study Registry Forms within 3 months of registration.

General Exclusion Criteria:

* unwilling or unable to adhere to basic study requirements (i.e., complete rating forms, or attend scheduled evaluations);
* not competent to give informed consent in the opinion of the investigator (e.g., psychotic).

Participants will be asked to remain in the study for up to five years so that the investigators can document and evaluate long-term treatment outcome. Participants will meet with their STEP-BD psychiatrist for periodic evaluations and/or treatment adjustments during the course of the study, fill out various self-rating forms, and when applicable, participate in psychotherapy. One of the psychotherapy options, Family-Focused Therapy, will require participants and their families to attend counseling sessions together. Overall, the estimated amount of time required from participants in the study is 2 to 4 hours per month.
B: Inclusion Criteria:

* Patients must be:

  1. at least 18 years old,
  2. have Type II Diabetes, and
  3. receive care in a participating practice.
* For a practice to be eligible, they must be;

  1. a Federally Qualified Health Center,
  2. a private primary care practice, or
  3. Community Mental Health Center with primary care,
  4. They need to have

     1. a current panel of at least 150 adult patients with Type 2 Diabetes, and
     2. access to health educators, Behavioral Health Professionals, and diabetes peer mentors.

Exclusion Criteria:

* Are currently pregnant or plan to become pregnant in the next six months,
* Have limited cognitive ability due to dementia or a developmental disorder,
* Less than one year of life expectancy, or
* Plan to leave the area in the next year.
C: Inclusion Criteria:

* 18-75 Years of age.
* Current major depression, panic, and/or generalized anxiety disorder on PRIME-MD.
* At least a moderate level of mood and/or anxiety symptoms (PHQ-9 ≥ 10 or a GAD-7 ≥ 10).
* Not receiving treatment for a mood or anxiety disorder from a mental health specialist.
* Has a telephone, e-mail address, and reliable access to the Internet.
* Stable medical condition and life expectancy greater than one year.

Exclusion Criteria:

* Active suicidal ideation or psychotic disorder.
* History of bipolar disorder.
* Alcohol dependence or other substance abuse disorder within the past three months.
* Plans to leave present source of care over the following year.
* Non-English speaking, illiterate, or having a visual or auditory barrier limiting ability to participate in telephone assessments, interventions, or provide signed, informed consent.
D: Inclusion criteria for phase 1

* Participant in the ongoing Butajira SMD cohort study (at baseline (between 1998 and 2001), cohort participants were aged between 15 and 49 years, resident in the area for at least six months and had a DSM-IV (SCAN) diagnosis of schizophrenia or schizoaffective disorder, bipolar disorder or major depressive disorder)
* Ongoing need for continuing mental health care due to:

  1. being on psychotropic medication at assessment or,
  2. not on medication but symptomatic at the time of assessment, or
  3. have experienced partial or full relapse within the two years preceding the assessment
* Stable clinical condition: either in remission from SMD or with residual symptoms that have been stable over the preceding three months.
* Planning to stay resident in the area for 18 months.
* Able to communicate in Amharic, the official language of Ethiopia.
* Willing to be randomised to either of the service models as described in the protocol.
* Has capacity to consent to participation or permission given by guardian and not refusing to participate
* Resident in catchment area of TaSCS health centres (excluding Butajira health centre)

Exclusion criteria for phase 1

* Suicide attempt within the preceding three months
* Current active suicide intent
* Prescribed Thioridazine, Valproate, Lithium or second generation antipsychotic medications (Risperidone and Olanzapine), as these medications are not be available in psychiatric nurse-led units or PHC settings in Ethiopia. Within the Butajira SMD cohort, only people who have received care from psychiatrist-led units in the capital city, Addis Ababa, might be receiving these medications. At present, fewer than 10 patients are known to be taking one of these medications.
* Prescribed depot medication
* Complex or unstable medical condition interfering with management of psychiatric disorder or requiring ongoing medical treatment from Butajira hospital
* Alcohol or khat dependence or abuse within the last 12 months
* Pregnant or breast-feeding
* Restrained at home
* Refusing to participate in the study

Inclusion criteria for Phase 2 As for Phase 1, but if we are unable to recruit enough participants from the existing Butajira SMD cohort then we will expand recruitment to people with SMD attending the psychiatric out-patient clinic at Butajira hospital. A semi-structured diagnostic interview will be carried out to determine diagnostic eligibility (DSM-IV diagnosis of schizophrenia or schizoaffective disorder, bipolar disorder or major depressive disorder). For participants recruited from Butajira hospital psychiatric out-patient clinic, the minimum age will be 25 years and the participants should have had their first contact with specialist mental health services at least two years prior to recruitment into the trial to ensure comparability with the Butajira SMD cohort sample.

Exclusion criteria for Phase 2

* Current active suicide intent
* Prescribed Thioridazine, Valproate, Lithium or second generation antipsychotic medications (Risperidone and Olanzapine).
* Pregnant or breast-feeding and prescribed depot
* Refusing to participate in the study
* Medical condition requiring ongoing medical treatment from Butajira hospital

Answer: B