Eligibility, any sex, with Stress Disorders, Post-Traumatic or Brain Injuries, Traumatic. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Depression - Patient Health Questionnaire - 9 (PHQ-9)Primary· 6 months
The PHQ-9 has 9 items based on the DSM-IV depression diagnostic criteria. Time Frame: All questions refer to the past two weeks. Scaling: 0 (not at all) to 3 (nearly every day). On the PHQ-9, major depressive syndrome is suggested if #1 or #2 and 5 or more items are ranked positive (at least "more than half the days," count #9 if present at all). Other Depressive Syndrome suggested if #1 or #2 and two, three, or four of #1-9 are at least "More than half the days" (count #9 if present at all).
Score ranges from 0-27. Higher scores indicate greater depression. Scores are summed to characterize
Group
Value
95% CI
REACH Individual Session
4.4
± 3.4
Education Webinar
6.3
± 4.9
Anxiety - Generalized Anxiety Disorder (GAD-7). Time Frame: All Questions Refer to the Past Two Weeks.Primary· 6 months
the GAD-7 contains a 7-item checklist of symptoms of GAD. All questions refer to the past two weeks. Scaling: 0 (not at all) to 3 (nearly every day)
\# of Items: 7-items. Scaling: 0 (not at all) to 3 (nearly every day).
Scoring for each item ranges from 0 (not at all) to 3 (nearly every day) for an overall score of 0 to 21; higher scores equal more anxiety. Several cut points have been put forward for different purposes. A cut point of 10 identifies cases of generalized anxiety disorder. Cut points of 5, 10, and 15 represent mild, moderate and severe anxiety.
\# of items: 12 items Scaling: 0 (Never) to 4 (Nearly Always) Total score ranges from 0-48, Higher scores indicate greater burden with \> 17 indicating severe/high burden.
Group
Value
95% CI
REACH Individual Session
13.4
± 8.5
Education Webinar
16.1
± 9.7
Sponsor's own description
This randomized clinical trial will test a behavioral caregiving intervention that has been used successfully for dementia and spinal cord injury caregivers to provide services to stressed and burdened parent caregivers of post 9/11 service members/veterans. This intervention is six intensive individual sessions that will teach problem solving, cognitive restructuring and stress reduction targeted to an individual assessment of the care dyad's needs. It will be compared to another method of delivering content, education webinar sessions, which are analogous to the usual standard of care and will function as an attention control arm. The objective of the study is to determine which of these delivery mechanisms is more effective at helping parent caregivers of injured post 9/11 returning troops to improve their depression, anxiety, and burden, and to determine the feasibility of using individual sessions with this population of caregivers.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Memphis VA Medical Center
Last refreshed: 23 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03309046.