Interventions for Parent Caregivers of Injured Military/Veteran Personnel

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.

Study Overview

• Status: Completed
• Conditions: Stress Disorders, Post-Traumatic; Brain Injuries, Traumatic
• Intervention / Treatment: Other: REACH Individual Session; Other: Education Webinar

• Study Type: Interventional
• Enrollment (Actual): 163
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Memphis VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: REACH Individual Session; The individual sessions intervention focuses on education, skills building, and support. It will be delivered in six sessions by telephone over three months. A Caregiver Notebook will include comprehensive materials for all sessions and topics. Treatment fidelity will be monitored and ensured through assessment of intervention delivery, receipt, and enactment. The intervention is targeted and individualized to the concerns of the specific caregiver and care recipient through a risk assessment. The Risk Assessment (RA) assesses the main caregiving risk areas for the specific caregiving dyad. The RA is used to tailor the intervention for care recipient behaviors or safety issues and/or caregiver centered issues/concerns related to health, physical and emotional well being, and/or social support.	Other: REACH Individual Session; Individual telephone session with parent
Active Comparator: Education Webinar; For the education webinar sessions, topics addressing each of the caregiving risk factors topics but without the skills building or cognitive restructuring components present in the individual intervention sessions will be available online in webinars. The education webinar sessions will focus on general information about post 9/11 concerns, problem behaviors, caregiver health, caregiver emotional well-being, and red flags. Education webinar session participants will not receive the Caregiver Notebook until they have completed their 6 month interviews. Parents will be able to view all 6 webinars at any time during the first 3 months. Each session will last approximately thirty minutes through PowerPoint slide presentation format with a pre-recorded script.	Other: Education Webinar; Videos with information on caregiving

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Memphis VA Medical Center
• Collaborators: U.S. Army Medical Research and Development Command
• Investigators: Principal Investigator: Linda O Nichols, PhD, Memphis VAMC

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: October 5, 2017
• First Submitted That Met QC Criteria: October 12, 2017
• First Posted (Actual): October 13, 2017

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Veterans; Parents; Caregivers
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Brain Injuries; Stress Disorders, Post-Traumatic; Brain Injuries, Traumatic
• Other Study ID Numbers: 14029002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Aggregate data will be available if requested

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No