Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 90DPTB0005 | Other Grant/Funding Number | NIDILRR |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Disability, Independent Living, and Rehabilitation Research | FED |
Not provided
Not provided
Not provided
Not provided
Not provided
The aims of this traumatic brain injury (TBI) study are:
Participants will be assigned to either of two treatment groups: (1) Resilience and Adjustment Intervention (RAI), or (2) RAI+. After randomization, a second appointment will be scheduled. All participants will begin the 7-session treatment during their second appointment. The intervention consists of seven 60-minute sessions scheduled over seven weeks (see attached RAI Implementation Manual). The intervention will be implemented by experienced, licensed therapists (Ph.D. level Interventionists). Participants will be randomly assigned to one of the therapists.
The RAI and RAI+ groups will both complete the post-treatment measures immediately after the seventh treatment session and then 3, 4, and 9 months later. Data collection at 3, 4, and 9 months post-treatment will be completed via phone.
Furthermore, the RAI+ group will complete 3 booster sessions, spaced approximately 7-10 days apart, beginning 3 months after completion of the seventh treatment session (booster sessions will occur between the 3 and 4 month data collection described above).
Data will be analyzed to identify any therapist effects, as well as treatment effects. For the RAI and RAI+ groups, demographic, injury severity, and history information will be collected at intake using standard procedures and protocols. All participants will complete the 4 outcome measures (Connor-Davidson Resilience Scale, CD-RISC; Mayo Portland Adaptability Inventory-4, MPAI-4; 13 Item Stress Test; and Brief Symptom Inventory-18, BSI-18) at 5 time points (intake, post-treatment, and 3, 4 and 9 month follow-up).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resilience/Adjustment Counseling | Active Comparator | Intervention to promote resilience and adjustment (RAI) - The RAI was developed based upon considerable clinical experience and research review. The RAI is a structured approach to helping individuals after traumatic brain injury address issues related to resilience and adjustment to injury. The RAI is implemented in seven, 60-minute, virtual sessions. |
|
| Resilience/Adjustment Counseling with Booster Sessions | Experimental | Intervention to promote resilience and adjustment (RAI) is implemented in seven, 60-minute, virtual sessions; however individuals within this study arm will receive three additional 60-minute, virtual sessions three months after completing the seven initial sessions. The three booster sessions provide an opportunity for individuals to review course content, consolidate gains, and discuss challenges. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resilience/Adjustment Counseling | Behavioral | The Resilience and Adjustment Intervention (RAI) consists of seven 60-minute sessions scheduled over seven weeks. Before the first session, participants will be mailed an empty loose-leaf binder to store and organize completed self-assessments, reading materials, and homework assignments from each session. They will be asked to review materials and complete worksheets between sessions. The RAI will be implemented by experienced, licensed therapists. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Completing the Two Structured Outpatient Intervention Programs Resilience and Adjustment Intervention (RAI) vs. RAI With Follow-up Booster Sessions (RAI+) on Resilience | Evaluate the short and long-term efficacy of two structured outpatient intervention programs Resilience and Adjustment Intervention (RAI) vs. RAI with follow-up booster sessions (RAI+) on resilience. The RAI is implemented in a seven-session format with two or three topics covered during each 60-minute session. Sessions focus on skill-building to help clients enhance existing skills and develop new skills; psychological support through offering empathy, encouragement, and hope; and education via instruction and discussion. This measure is being quantitatively measured by the number of subjects that completed the assessment for each arm. | Data collection will be after the 7th treatment session and at 3,4 and 9 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Mayo Portland Adaptability Inventory-4 (MPAI-4) | Adjustment Subscale reflects emotional self-regulation; items relate to anxiety, depression, irritability, anger, social interaction, and self-awareness. Raw scores range from 0-46. Ability Subscale reflects cognitive and physical abilities, including verbal and nonverbal communication and problem-solving abilities. Raw scores range from 0-47. Adjustment Subscale: higher scores indicate greater severity. Ability Subscale: higher scores indicate greater problem severity. T scores between 40 and 60 would be considered average of people involved in rehabilitation following brain injury. T-scores between 40 and 50 may be considered in the mild to moderate range of overall severity compared to other people with ABI.; T-scores between 50 and 60, in the moderate to severe range. T-scores above 60 would suggest severe limitations even as compared to other people with ABI. T-scores between 30 and 40 suggest mild limitations. T-scores below 30 represent relatively good outcomes. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nancy HSU | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Resilience/Adjustment Counseling | Intervention to promote resilience and adjustment (RAI) - The RAI was developed based upon considerable clinical experience and research review. The RAI is a structured approach to helping individuals after traumatic brain injury address issues related to resilience and adjustment to injury. The RAI is implemented in seven, 60-minute, virtual sessions. Resilience/Adjustment Counseling: The Resilience and Adjustment Intervention (RAI) consists of seven 60-minute sessions scheduled over seven weeks. Before the first session, participants will be mailed an empty loose-leaf binder to store and organize completed self-assessments, reading materials, and homework assignments from each session. They will be asked to review materials and complete worksheets between sessions. The RAI will be implemented by experienced, licensed therapists. |
| FG001 | Resilience/Adjustment Counseling With Booster Sessions | Intervention to promote resilience and adjustment (RAI) is implemented in seven, 60-minute, virtual sessions; however individuals within this study arm will receive three additional 60-minute, virtual sessions three months after completing the seven initial sessions. The three booster sessions provide an opportunity for individuals to review course content, consolidate gains, and discuss challenges. Resilience/Adjustment Counseling with Booster Sessions: The Resilience and Adjustment Intervention (RAI) consists of seven 60-minute sessions scheduled over seven weeks. Before the first session, participants will be mailed an empty loose-leaf binder to store and organize completed self-assessments, reading materials, and homework assignments from each session. They will be asked to review materials and complete worksheets between sessions. For the "RAI+" participants, three booster sessions will be implemented. The three weekly booster sessions will be scheduled to start three months following completion of Session 7 of the RAI. The program will be implemented by experienced, licensed therapists. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Subjects enrolled
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Resilience/Adjustment Counseling | Intervention to promote resilience and adjustment (RAI) - The RAI was developed based upon considerable clinical experience and research review. The RAI is a structured approach to helping individuals after traumatic brain injury address issues related to resilience and adjustment to injury. The RAI is implemented in seven, 60-minute, virtual sessions. Resilience/Adjustment Counseling: The Resilience and Adjustment Intervention (RAI) consists of seven 60-minute sessions scheduled over seven weeks. Before the first session, participants will be mailed an empty loose-leaf binder to store and organize completed self-assessments, reading materials, and homework assignments from each session. They will be asked to review materials and complete worksheets between sessions. The RAI will be implemented by experienced, licensed therapists. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects Completing the Two Structured Outpatient Intervention Programs Resilience and Adjustment Intervention (RAI) vs. RAI With Follow-up Booster Sessions (RAI+) on Resilience | Evaluate the short and long-term efficacy of two structured outpatient intervention programs Resilience and Adjustment Intervention (RAI) vs. RAI with follow-up booster sessions (RAI+) on resilience. The RAI is implemented in a seven-session format with two or three topics covered during each 60-minute session. Sessions focus on skill-building to help clients enhance existing skills and develop new skills; psychological support through offering empathy, encouragement, and hope; and education via instruction and discussion. This measure is being quantitatively measured by the number of subjects that completed the assessment for each arm. | Number of participants who have completed the treatment sessions for each arm | Posted | Count of Participants | Participants | Data collection will be after the 7th treatment session and at 3,4 and 9 months post-treatment |
|
Through the intervention (seven weeks) and an additional 12 months for follow-up
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Resilience/Adjustment Counseling | Intervention to promote resilience and adjustment (RAI) - The RAI was developed based upon considerable clinical experience and research review. The RAI is a structured approach to helping individuals after traumatic brain injury address issues related to resilience and adjustment to injury. The RAI is implemented in seven, 60-minute, virtual sessions. Resilience/Adjustment Counseling: The Resilience and Adjustment Intervention (RAI) consists of seven 60-minute sessions scheduled over seven weeks. Before the first session, participants will be mailed an empty loose-leaf binder to store and organize completed self-assessments, reading materials, and homework assignments from each session. They will be asked to review materials and complete worksheets between sessions. The RAI will be implemented by experienced, licensed therapists. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nancy Hsu, PsyD, PI | Virginia Commonwealth University | 804-327-1166 | nancy.hsu@vcuhealth.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 17, 2018 | Mar 7, 2025 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 27, 2021 | Feb 10, 2025 | ICF_003.pdf |
Not provided
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Resilience/Adjustment Counseling with Booster Sessions | Behavioral | The Resilience and Adjustment Intervention (RAI) consists of seven 60-minute sessions scheduled over seven weeks. Before the first session, participants will be mailed an empty loose-leaf binder to store and organize completed self-assessments, reading materials, and homework assignments from each session. They will be asked to review materials and complete worksheets between sessions. For the "RAI+" participants, three booster sessions will be implemented. The three weekly booster sessions will be scheduled to start three months following completion of Session 7 of the RAI. The program will be implemented by experienced, licensed therapists. |
|
|
| Change from Baseline to Follow-Up (11 months after Baseline) |
| Brief Symptom Inventory-18 (BSI-18), 18-item Self-report Instrument Was Developed to Quantify Psychological Distress in the General Population | The BSI-18 is used because of its sound psychometric properties, and global assessment of psychological issues commonly found in individuals with TBI. Frequency ratings for items in three primary symptom dimensions (Somatization, Depression, and Anxiety) are added to yield the Global Severity Index (GSI). The GSI score reflects the overall distress level and is the focus of the present investigation. Frequency ratings for items in three primary symptom dimensions (Somatization, Depression, and Anxiety) are added to yield the Global Severity Index (GSI). T-scores are calculated based on community norms (50 indicates the population mean with a standard deviation of 10). Higher T scores are indicative of greater symptom severity. Somatization subscale: (Raw scores range from 0-19+), Depression subscale: (Raw scores range from 0-23+), Anxiety subscale: (Raw scores range from 0-20+), Global Severity Index: (Raw scores range from 0-53+) | Change from Baseline to Follow-Up (11 months after Baseline) |
| 13 Item Stress Test | This self-report measure was developed more than a decade ago for clinical research studies on stress management with survivors and caregiving family members. Sample items include, "I have more to do than I can handle," "I'm pushing myself too hard," and "I can't stand living like this." Items are rated as True (+1) or False (0) with higher scores indicating higher stress levels. The measure has been shown to be sensitive to family intervention after TBI.63,64 The Total Score is the measure of interest in the present investigation. Total raw score ranges from 0-13. Higher raw scores are indicative of increased distress. There are no subscales used in this measure. | Change from Baseline to Follow-Up (11 months after Baseline) |
| Incarcerated |
|
| Inpt Treatment Facility |
|
| Virtual Platform Issues |
|
| BG001 | Resilience/Adjustment Counseling With Booster Sessions | Intervention to promote resilience and adjustment (RAI) is implemented in seven, 60-minute, virtual sessions; however individuals within this study arm will receive three additional 60-minute, virtual sessions three months after completing the seven initial sessions. The three booster sessions provide an opportunity for individuals to review course content, consolidate gains, and discuss challenges. Resilience/Adjustment Counseling with Booster Sessions: The Resilience and Adjustment Intervention (RAI) consists of seven 60-minute sessions scheduled over seven weeks. Before the first session, participants will be mailed an empty loose-leaf binder to store and organize completed self-assessments, reading materials, and homework assignments from each session. They will be asked to review materials and complete worksheets between sessions. For the "RAI+" participants, three booster sessions will be implemented. The three weekly booster sessions will be scheduled to start three months following completion of Session 7 of the RAI. The program will be implemented by experienced, licensed therapists. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| Resilience/Adjustment Counseling |
Intervention to promote resilience and adjustment (RAI) - The RAI was developed based upon considerable clinical experience and research review. The RAI is a structured approach to helping individuals after traumatic brain injury address issues related to resilience and adjustment to injury. The RAI is implemented in seven, 60-minute, virtual sessions. Resilience/Adjustment Counseling: The Resilience and Adjustment Intervention (RAI) consists of seven 60-minute sessions scheduled over seven weeks. Before the first session, participants will be mailed an empty loose-leaf binder to store and organize completed self-assessments, reading materials, and homework assignments from each session. They will be asked to review materials and complete worksheets between sessions. The RAI will be implemented by experienced, licensed therapists. |
| OG001 | Resilience/Adjustment Counseling With Booster Sessions | Intervention to promote resilience and adjustment (RAI) is implemented in seven, 60-minute, virtual sessions; however individuals within this study arm will receive three additional 60-minute, virtual sessions three months after completing the seven initial sessions. The three booster sessions provide an opportunity for individuals to review course content, consolidate gains, and discuss challenges. Resilience/Adjustment Counseling with Booster Sessions: The Resilience and Adjustment Intervention (RAI) consists of seven 60-minute sessions scheduled over seven weeks. Before the first session, participants will be mailed an empty loose-leaf binder to store and organize completed self-assessments, reading materials, and homework assignments from each session. They will be asked to review materials and complete worksheets between sessions. For the "RAI+" participants, three booster sessions will be implemented. The three weekly booster sessions will be scheduled to start three months following completion of Session 7 of the RAI. The program will be implemented by experienced, licensed therapists. |
|
|
| Secondary | Mayo Portland Adaptability Inventory-4 (MPAI-4) | Adjustment Subscale reflects emotional self-regulation; items relate to anxiety, depression, irritability, anger, social interaction, and self-awareness. Raw scores range from 0-46. Ability Subscale reflects cognitive and physical abilities, including verbal and nonverbal communication and problem-solving abilities. Raw scores range from 0-47. Adjustment Subscale: higher scores indicate greater severity. Ability Subscale: higher scores indicate greater problem severity. T scores between 40 and 60 would be considered average of people involved in rehabilitation following brain injury. T-scores between 40 and 50 may be considered in the mild to moderate range of overall severity compared to other people with ABI.; T-scores between 50 and 60, in the moderate to severe range. T-scores above 60 would suggest severe limitations even as compared to other people with ABI. T-scores between 30 and 40 suggest mild limitations. T-scores below 30 represent relatively good outcomes. | Subjects | Posted | Mean | Standard Deviation | Change in BSI T-scores (mean=50, sd=10) | Change from Baseline to Follow-Up (11 months after Baseline) |
|
|
|
| Secondary | Brief Symptom Inventory-18 (BSI-18), 18-item Self-report Instrument Was Developed to Quantify Psychological Distress in the General Population | The BSI-18 is used because of its sound psychometric properties, and global assessment of psychological issues commonly found in individuals with TBI. Frequency ratings for items in three primary symptom dimensions (Somatization, Depression, and Anxiety) are added to yield the Global Severity Index (GSI). The GSI score reflects the overall distress level and is the focus of the present investigation. Frequency ratings for items in three primary symptom dimensions (Somatization, Depression, and Anxiety) are added to yield the Global Severity Index (GSI). T-scores are calculated based on community norms (50 indicates the population mean with a standard deviation of 10). Higher T scores are indicative of greater symptom severity. Somatization subscale: (Raw scores range from 0-19+), Depression subscale: (Raw scores range from 0-23+), Anxiety subscale: (Raw scores range from 0-20+), Global Severity Index: (Raw scores range from 0-53+) | Posted | Mean | Standard Deviation | Change in BSI T-scores (mean= 50; SD=10) | Change from Baseline to Follow-Up (11 months after Baseline) |
|
|
|
| Secondary | 13 Item Stress Test | This self-report measure was developed more than a decade ago for clinical research studies on stress management with survivors and caregiving family members. Sample items include, "I have more to do than I can handle," "I'm pushing myself too hard," and "I can't stand living like this." Items are rated as True (+1) or False (0) with higher scores indicating higher stress levels. The measure has been shown to be sensitive to family intervention after TBI.63,64 The Total Score is the measure of interest in the present investigation. Total raw score ranges from 0-13. Higher raw scores are indicative of increased distress. There are no subscales used in this measure. | Posted | Mean | Standard Deviation | units on a scale | Change from Baseline to Follow-Up (11 months after Baseline) |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Resilience/Adjustment Counseling With Booster Sessions | Intervention to promote resilience and adjustment (RAI) is implemented in seven, 60-minute, virtual sessions; however individuals within this study arm will receive three additional 60-minute, virtual sessions three months after completing the seven initial sessions. The three booster sessions provide an opportunity for individuals to review course content, consolidate gains, and discuss challenges. Resilience/Adjustment Counseling with Booster Sessions: The Resilience and Adjustment Intervention (RAI) consists of seven 60-minute sessions scheduled over seven weeks. Before the first session, participants will be mailed an empty loose-leaf binder to store and organize completed self-assessments, reading materials, and homework assignments from each session. They will be asked to review materials and complete worksheets between sessions. For the "RAI+" participants, three booster sessions will be implemented. The three weekly booster sessions will be scheduled to start three months following completion of Session 7 of the RAI. The program will be implemented by experienced, licensed therapists. | 0 | 26 | 0 | 26 | 0 | 26 |
Not provided
Not provided
Not provided
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |