Please select the eligibility criteria that correspond to the clinical trial below.
Title: Development and Evaluation of a Diabetes-specific Cognitive Behavioural Treatment (DS-CBT) for Diabetic Patients With Subthreshold Depression
Brief Summary: This work is supported by the "Kompetenznetz Diabetes mellitus (Competence Network for Diabetes mellitus)" funded by the Federal Ministry of Education and Research (FKZ 01GI0809).

Approximately one third of diabetic patients has elevated depressive symptoms. The majority of these patients are suffering from a subthreshold depression. In spite of the fact that subthreshold depression has an equivalent negative impact on the prognosis of diabetes as clinical depression, there is no specific intervention tool. The main objective of this project is to develop a diabetes specific cognitive behavioural treatment (DS-CBT) for diabetic patients with subthreshold depression. In a randomized trail DS-CBT is compared to standard diabetes education. A total of 188 diabetic patients will be recruited and randomly assigned to the two treatment conditions. The expected main outcome is the reduction of subthreshold depression under DS-CBT in a 12 month follow up. Secondary variables are improvement of glycaemic control, quality of life, diabetes self-management as well as reduction of health care costs and modification of inflammatory parameters.


Options:
A: Inclusion Criteria:

* Diabetes mellitus
* Elevated depressive symptoms (regarding to CES-D)
* Age \>= 18 and \<=70
* Sufficient German language skills
* Informed consent

Exclusion Criteria:

* Current MDD
* Current schizophrenia/ psychotic disorder, eating disorder, bipolar disorder, addictive disorder, personality disorder
* Current antidepressive medication
* Current psychotherapy
* Severe physical illness (i.e. cancer)
* Being bedridden
* Guardianship
B: Inclusion Criteria:

* presence of a confirmed diagnosis of multiple sclerosis or epilepsy
* self-reported urge to be treated for depressive symptoms (no externally confirmed diagnosis necessary)
* informed consent (provided online in line with regulations by the Hamburg Department of Data Security)

Exclusion Criteria:

* unable to provide informed consent
* diagnosis of bipolar or schizophrenia spectrum disorders
* substantial neurocognitive impairment (e.g. dementia)
* acute suicidal tendencies as assessed with the Suicide Behaviors Questionnaire-Revised (SBQ-R). Subjects excluded for this reason are provided various emergency contacts and phone numbers.
C: Inclusion Criteria:

* Seeking treatment at the primary or specialty care site, and be planning to continue living in the area of that clinic for the duration of the study
* Meets clinical criteria for nonpsychotic MDD, recurrent (with the current episode being at least 2 months in duration), or chronic (current episode greater than 2 years) as defined by a clinical interview and confirmed by the MINI International Neuropsychiatric Interview (MINI)
* Screening 17 item HRSD score of 16 or greater
* Treatment with antidepressant medication combinations is clinically acceptable
* Patient with and without current suicidal ideation may be included in the study as long as outpatient treatment is clinically appropriate

Exclusion Criteria:

* Pregnant or breastfeeding
* Plans to become pregnant over the ensuing 8 months following study entry or are sexually active and not using adequate birth control
* History (lifetime) of psychotic depression, schizophrenia, bipolar (I, II, or NOS), schizoaffective, or other Axis I psychotic disorders
* Current psychotic symptom(s)
* History (within the last 2 years before study entry) of anorexia or bulimia
* Current primary diagnosis of obsessive compulsive disorder
* Current substance dependence that requires inpatient detoxification or inpatient treatment
* Requiring immediate hospitalization for a psychiatric disorder
* Definite history of intolerance or allergy (lifetime) to any protocol medication
* History of clear nonresponse to an adequate trial of an FDA-approved monotherapy in the current MDE if recurrent, or during the last 2 years before study entry if chronic
* History of clear nonresponse to an adequate trial of any study medication used as a monotherapy, or to one or more of the protocol combinations in the current or any prior MDE
* Currently taking any of the study medications at any dose
* Having taken Prozac (fluoxetine) or an MAOI in the 4 weeks before study entry
* Presence of an unstable general medical condition (GMC) that will likely require hospitalization or to be deemed terminal (life expectancy less than 6 months after study entry)
* Currently taking medications or have GMCs that contraindicate any study medications (e.g., seizure disorder)
* Requiring medications for GMCs that contraindicate any study medication
* Epilepsy or other conditions requiring an anticonvulsant
* Lifetime history of having a seizure including febrile or withdrawal seizures
* Receiving or have received vagus nerve stimulation (VNS), electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), or other somatic antidepressant treatments
* Currently taking or having taken within the 7 days before study entry any of the following exclusionary medications: antipsychotic medications, anticonvulsant medications, mood stabilizers, or central nervous system stimulants (antidepressant medication used for the treatment of depression or other purposes such as smoking cessation or pain are excluded since these agents may interfere with the testing of the major hypotheses under study)
* Uncontrolled narrow angle glaucoma
* Taking thyroid medication for hypothyroidism may be included only if stable on the medication for 3 months
* Using agents within the 7 days before study entry that are potential augmenting agents (e.g., T3 in the absence of thyroid disease, SAMe, St. John's Wort, lithium, buspirone)
* Therapy that is depression-specific
D: Inclusion Criteria:

* Patient of the participating FMGs
* Aged between 25 and 80 years
* Affected by chronic disease (diabetes, cardiovascular diseases, respiratory diseases, musculoskeletal diseases and/or chronic pain)
* Identified as a frequent user of health services (by a health care provider or/and a software)

Exclusion Criteria:

* Patient unable to provide consent
* With cognitive impairment
* With uncontrolled psychiatric illness
* Patient with a prognostic of less than one years

Answer: A