N/A
Completed N=163
Interventions for Parent Caregivers of Injured Military/Veteran Personnel
Stress Disorders, Post-Traumatic · Brain Injuries, Traumatic
Source: ClinicalTrials.gov NCT03309046 ↗
Enrolled (actual)
163
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcomePrimary: Depression - Patient Health Questionnaire - 9 (PHQ-9) — 4.4; 6.3 units on a scale
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Depression - Patient Health Questionnaire - 9 (PHQ-9) |
4.4; 6.3 | — |
| PRIMARY Anxiety - Generalized Anxiety Disorder (GAD-7). Time Frame: All Questions Refer to the Past Two Weeks. |
5.3; 6.8 | — |
| PRIMARY Burden - Zarit Burden Interview (ZBI-12) |
13.4; 16.1 | — |
Eligibility Criteria
Inclusion Criteria
- Identify as a parent who serves as the primary/main caregiver for a post 9/11 service member or veteran with a diagnosis of traumatic brain injury or post traumatic stress disorder or physical injury and at least 1 activity of daily living limitation or 2 or more instrumental of daily living limitations;
- provide 3 hours or more of care per day for at least 6 months;
- endorse at least 2 caregiving stress behaviors (overwhelmed, often needing to cry, angry/frustrated, cut off from family/friends, moderate/high levels of stress, and declining health); and
- have a telephone.
- Internet access is desirable but not mandatory.
Exclusion Criteria
- current diagnosis of schizophrenia or other major mental illness; or
- auditory impairment that would make telephone use difficult
Data sourced from ClinicalTrials.gov (NCT03309046). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.