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:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT01891734
Eligibility Criteria:
Inclusion Criteria:
* Veterans will be eligible if they are 18 years old or older,
* speak and understand English,
* are patients in the Central Arkansas Veterans Healthcare System Primary Care-Mental Health Integration,
* and have a current diagnosis of depression
* major depressive disorder, 296.2x and 296.3x
* dysthymic disorder, 300.4
* depressive disorder not otherwise specified, 311
* and/or anxiety
* panic disorder without agoraphobia, 300.01
* panic disorder with agoraphobia, 300.21
* specific phobia, 300.29
* social phobia, 300.23
* obsessive-compulsive disorder; 300.3
* posttraumatic stress disorder, 309.81
* acute stress disorder, 308.3
* generalized anxiety disorder, 300.02
* anxiety disorder not otherwise specified, 300.00
* We considered enrolling only those Veterans diagnosed with mild-to-moderate depression, but chose to include a range of anxiety and depression-related disorders in order to reflect the population of Veterans seen in Primary Care-Mental Health Integration.
* Additionally, Problem Solving Therapy is designed to treat a range of stress-related problems, including both anxiety and depressive disorders.
* Veterans taking prescribed anxiolytics or anti-depressants will be eligible if they are on a stable medication regimen.
Exclusion Criteria:
* Exclusionary criteria include any current suicidal ideation,
* substance dependence diagnosis and current use,
* any psychotic spectrum diagnoses or
* inability to provide informed consent.
* Diagnosis will be confirmed by chart review and Mini International Neuropsychiatric Interview.
* Acute suicidal ideation will be determined by the assessing or treating clinician.
* During the baseline and follow-up interviews, any Veteran who endorses a "1" or higher on item # 21 on the Depression Anxiety and Stress Scale "I feel that life isn't worthwhile" or item # 9 on the Patient Health Questionnaire-9 "thoughts that you would be better off dead or of hurting yourself" will be asked follow-up questions on the suicide risk protocol (see appendix 3).
* Current substance or alcohol use will be determined by the alcohol and substance use modules of the Mini International Neuropsychiatric Interview.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT01891734
Study Brief:
Protocol Section:
NCT01891734