Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT01094951
Eligibility Criteria:
Inclusion Criteria:
* Age 60 years and older.
* Positive screen for major depression (PHQ-9 greater than 10): We chose standard PHQ-9 screening to correspond to routine procedures within each House that identify seniors in need of evaluation for treatment.
* Capacity to provide written consent for both research assessment and treatment. This criterion is necessary because subjects must be able to participate meaningfully in the interventions offered by the study and the assessment procedures.
* Working knowledge of English. Fluency in English sufficient for comprehending questionnaires of the study and/or for understanding the case worker. English does not have to be the subject's first language.
Exclusion Criteria:
* MMSE score \< 24 or clinical diagnosis of dementia. Dementia, or cognitive impairment at this level may limit the senior's ability to participate in the intervention.
* Psychotic or manic symptoms or alcohol or substance dependence. These symptoms and disorders will be determined by the SCID assessment and require alternative interventions than those offered by the study. We focus in this project on seniors with depressive symptoms given existing Neighborhood House procedures for standard depression screening, and given difficulties in training case worker staff on screening for other psychiatric disorders. If this project is successful, we may then expand our efforts to target other disorders such as psychotic, manic, and alcohol and substance abuse and dependence disorders.
* Antidepressant medication or psychotherapy in the 4 weeks prior to baseline evaluation. The intervention is focused on linking depressed seniors who are in need of mental health services rather than those currently receiving treatment.
* Acute or severe medical illness: i.e., delirium, metastatic cancer, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction during the three months prior to entry; or drugs often causing depression, e.g., steroids, reserpine, alpha-methyl-dopa, tamoxifen, vincristine.
* Antisocial personality by DSM-IV: This disorder will possibly interfere with adherence to research procedures and treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT01094951
Study Brief:
Protocol Section:
NCT01094951