Brain Injuries, Traumatic, Stress Disorders, Post-Traumatic
Conditions
Keywords
Parents, Caregivers, Veterans
Brief 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.
Interventions
OTHERREACH Individual Session
Individual telephone session with parent
OTHEREducation Webinar
Videos with information on caregiving
Sponsors
U.S. Army Medical Research and Development Command
Memphis VA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression - Patient Health Questionnaire - 9 (PHQ-9) | 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 depression as minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), or high/severe (20-27). |
| Anxiety - Generalized Anxiety Disorder (GAD-7). Time Frame: All Questions Refer to the Past Two Weeks. | 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. |
| Burden - Zarit Burden Interview (ZBI-12) | 6 months | \# 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
REACH Individual Session: Individual telephone session with parent | 82 |
| 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.
Education Webinar: Videos with information on caregiving | 81 |
| Total | 163 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 4 | 17 |
Baseline characteristics
| Characteristic | REACH Individual Session | Total | Education Webinar |
|---|---|---|---|
| Age, Continuous | 60.2 years STANDARD_DEVIATION 7.3 | 60.2 years STANDARD_DEVIATION 6.8 | 60.1 years STANDARD_DEVIATION 6.3 |
| Anxiety | 6.6 units on a scale STANDARD_DEVIATION 4.7 | 6.9 units on a scale STANDARD_DEVIATION 4.7 | 7.2 units on a scale STANDARD_DEVIATION 4.6 |
| Burden | 15.7 units on a scale STANDARD_DEVIATION 8.6 | 16.8 units on a scale STANDARD_DEVIATION 8.8 | 17.9 units on a scale STANDARD_DEVIATION 8.9 |
| Depression | 6.0 units on a scale STANDARD_DEVIATION 4.3 | 6.6 units on a scale STANDARD_DEVIATION 5.2 | 7.3 units on a scale STANDARD_DEVIATION 5.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 6 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 76 Participants | 157 Participants | 81 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 26 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 59 Participants | 129 Participants | 70 Participants |
| Region of Enrollment United States | 82 participants | 163 participants | 81 participants |
| Sex: Female, Male Female | 74 Participants | 146 Participants | 72 Participants |
| Sex: Female, Male Male | 8 Participants | 17 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 82 | 0 / 81 |
| other Total, other adverse events | 0 / 82 | 0 / 81 |
| serious Total, serious adverse events | 0 / 82 | 0 / 81 |
Outcome results
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.
Time frame: 6 months
Population: intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| REACH Individual Session | Anxiety - Generalized Anxiety Disorder (GAD-7). Time Frame: All Questions Refer to the Past Two Weeks. | 5.3 units on a scale | Standard Deviation 4.3 |
| Education Webinar | Anxiety - Generalized Anxiety Disorder (GAD-7). Time Frame: All Questions Refer to the Past Two Weeks. | 6.8 units on a scale | Standard Deviation 5.1 |
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.
Time frame: 6 months
Population: intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| REACH Individual Session | Burden - Zarit Burden Interview (ZBI-12) | 13.4 units on a scale | Standard Deviation 8.5 |
| Education Webinar | Burden - Zarit Burden Interview (ZBI-12) | 16.1 units on a scale | Standard Deviation 9.7 |
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).
Time frame: 6 months
Population: intention-to-treat, with participants analyzed according to initial arm assignments
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| REACH Individual Session | Depression - Patient Health Questionnaire - 9 (PHQ-9) | 4.4 units on a scale | Standard Deviation 3.4 |
| Education Webinar | Depression - Patient Health Questionnaire - 9 (PHQ-9) | 6.3 units on a scale | Standard Deviation 4.9 |