Depression Clinical Trial
Official title:
Intervention to Improve Resilience and Mental Health in Veterans With Injury, Illness, and/or Disability
NCT number | NCT03563820 |
Other study ID # | 01620 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 15, 2018 |
Est. completion date | May 23, 2019 |
Verified date | January 2020 |
Source | VA Puget Sound Health Care System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
It is common for Veterans with injuries, illnesses, or physical disabilities to experience depression, post-traumatic stress disorder (PTSD), chronic pain, and other concerns. They may also have goals like becoming happier or better able to cope with challenges that life brings. The purpose of this research study is to learn whether Veterans like and benefit from a 5-week, group-based positive psychology program aimed at improving mental health, resilience, well-being, and quality of life. Participants will be asked to complete several assessments (surveys/interviews) over the course of the study that are not considered part of standard care. Additionally, participants will be asked to participate in a focus group at the end of the study to provide feedback about their experiences in the group.
Status | Completed |
Enrollment | 7 |
Est. completion date | May 23, 2019 |
Est. primary completion date | May 23, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Veteran status (defined as prior service in the US Armed Forces and eligible to receive health care services through Veterans Health Affairs) 2. 18 years of age or older 3. Enrolled, or eligible and willing to enroll, in the Resilience and Well-Being group treatment program (offered as part of standard clinical care in VA Puget Sound Rehabilitation Care Services) 4. Able to read, speak, and understand English 5. Has been seen at least once in the past 12 months in a VAPSHCS clinic that provides rehabilitation services to individuals with rehabilitation needs related to conditions including (but not limited to) multiple sclerosis (MS), traumatic brain injury (TBI), amyotrophic lateral sclerosis (ALS), spinal cord injury (SCI), stroke, myocardial infarction, limb loss, polytrauma, neuromuscular conditions, musculoskeletal problems, impairing but medically unexplained symptoms, and/or pain, OR has a diagnosis of such a condition 6. Positive screen for depression, PTSD, or chronic pain Exclusion Criteria: 1. Primary psychotic or major thought disorder as listed in participant's medical record or self-reported 2. Psychiatric or behavioral conditions in which symptoms were unstable or severe (e.g., current delirium, mania, psychosis, suicidal ideation, homicidal ideation, active substance use disorder, psychiatric hospitalization) as listed in participant's medical record or self-reported within the past six months 3. Any behavioral, cognitive, or psychiatric issues that would indicate the participant may be inappropriate in a group setting or for this particular group-format intervention, subject to clinician discretion 4. Difficulties or limitations communicating over the telephone |
Country | Name | City | State |
---|---|---|---|
United States | VA Puget Sound Health Care System | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
VA Puget Sound Health Care System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Depression from Pre-Group to 5-Weeks Post-Group | Change in depression will be measured using the PROMIS Depression Short Form-8A. Responses from each item will be summed to form a total raw score ranging from 8-40. Higher scores indicate higher self-reported levels of depression. | Pre-Group (up to 2-weeks prior to Session 1 of group program), Post-Group (immediately after Session 5 of group program, window open up to 4 weeks after), 5-Week Follow-Up (5 weeks after Session 5 of program, window open up to 4 weeks after) |
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