Interventions for Parent Caregivers of Injured Military/Veteran Personnel

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

Interventions for Parent Caregivers of Injured Military/Veteran Personnel

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03309046
• Other study ID #: 14029002
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: March 31, 2020

Study information

• Verified date: October 2023
• Source: Memphis VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: March 31, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. 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;

2. provide 3 hours or more of care per day for at least 6 months;

3. 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

4. have a telephone.

5. Internet access is desirable but not mandatory.

Exclusion Criteria:

1. current diagnosis of schizophrenia or other major mental illness; or

2. auditory impairment that would make telephone use difficult

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Stress Disorders, Post-Traumatic

Intervention

Other:
• REACH Individual Session
Individual telephone session with parent
• Education Webinar
Videos with information on caregiving

Locations

Country	Name	City	State
United States	Memphis VA Medical Center	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Memphis VA Medical Center	U.S. Army Medical Research and Development Command

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression - Patient Health Questionnaire - 9 (PHQ-9)	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 depression as minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), or high/severe (20-27).	6 months
Primary	Anxiety - Generalized Anxiety Disorder (GAD-7). Time Frame: All Questions Refer to the Past Two Weeks.	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.	6 months
Primary	Burden - Zarit Burden Interview (ZBI-12)	# 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.	6 months