Traumatic Brain InjuryNCT03421964
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
A study testing Resilience/Adjustment Counseling and Resilience/Adjustment Counseling with Booster Sessions in people with Traumatic Brain Injury, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The aims of this traumatic brain injury (TBI) study are: 1. to 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 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Resilience/Adjustment Counseling and Resilience/Adjustment Counseling with Booster Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2018to 31 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild, moderate, or severe TBI defined as: damage to brain tissue caused by an external mechanical force as evidenced by loss of consciousness due to brain trauma, post-traumatic amnesia (PTA), skull fracture, or objective neurological findings that can be reasonably attributed to TBI on physical examination or mental status examination.
- At least 3 months post-TBI.
Who cannot join
- Active substance abusers (e.g., intoxicated at arrival to intake).
- Individuals at imminent risk of psychiatric hospitalization, or in imminent danger of hurting themselves or others, as judged by the investigators, will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
The aims of this traumatic brain injury (TBI) study are:
- to 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
- to evaluate the short and long-term impact of intervention on emotional well-being and postinjury adjustment with the RAI vs. the RAI+
- to evaluate the short and long-term impact of the RAI and the RAI+ on abilities including problem solving, communication, and stress management
- to determine if demographic, lifestyle, injury, or treatment response information can predict maintenance of gains
Read the detailed description
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).
- Conditions
- Traumatic Brain Injury
- Being tested
- Resilience/Adjustment Counseling, Resilience/Adjustment Counseling with Booster Sessions
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resilience/Adjustment CounselingBehavioural
Also called RAI
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.
Resilience/Adjustment Counseling with Booster SessionsBehavioural
Also called RAI+
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Resilience/Adjustment Counseling |
| 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. Receives: Behavioral: Resilience/Adjustment Counseling with Booster Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Data collection will be after the 7th treatment session and at 3,4 and 9 months post-treatment
Secondary outcomes (3)
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.
Measured: 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+)
Measured: 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.
Measured: Change from Baseline to Follow-Up (11 months after Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start16 Feb 2018
- Primary completion25 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Sponsor
- Investigators
- Nancy HSU, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421964
- Sponsor's protocol ID
- HM20011840
- Other IDs
- 90DPTB0005
- Status last verified
- Mar 2025
- First submitted
- 29 Jan 2018
- Last updated
- 27 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
- ClinicalTrials.gov ID
- NCT03421964
- Acronym / sponsor ID
- HM20011840
- Conditions
- Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 16 Feb 2018 (actual)
- Primary completion
- 25 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Posted 27 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aims of this traumatic brain injury (TBI) study are:
- to 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
- to evaluate the short and long-term impact of intervention on emotional well-being and postinjury adjustment with the RAI vs. the RAI+
- to evaluate the short and long-term impact of the RAI and the RAI+ on abilities including problem solving, communication, and stress management
- to determine if demographic, lifestyle, injury, or treatment response information can predict maintenance of gains
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resilience/Adjustment Counseling | Active comparator | Behavioral: Resilience/Adjustment CounselingIntervention 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 | Behavioral: Resilience/Adjustment Counseling with Booster SessionsIntervention 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mild, moderate, or severe TBI defined as: damage to brain tissue caused by an external mechanical force as evidenced by loss of consciousness due to brain trauma, post-traumatic amnesia (PTA), skull fracture, or objective neurological findings that can be reasonably attributed to TBI on physical examination or mental status examination.
- At least 3 months post-TBI.
Key exclusion criteria (2 listed)
- Active substance abusers (e.g., intoxicated at arrival to intake).
- Individuals at imminent risk of psychiatric hospitalization, or in imminent danger of hurting themselves or others, as judged by the investigators, will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resilience/Adjustment CounselingAlso: RAIThe 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. | Behavioural | Resilience/Adjustment Counseling |
| Resilience/Adjustment Counseling with Booster SessionsAlso: RAI+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. | Behavioural | Resilience/Adjustment Counseling with Booster Sessions |
Primary outcome
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
Time frame: Data collection will be after the 7th treatment session and at 3,4 and 9 months post-treatment
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.
3 secondary outcomes
Mayo Portland Adaptability Inventory-4 (MPAI-4)
Time frame: 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
Time frame: Change from Baseline to Follow-Up (11 months after Baseline)
13 Item Stress Test
Time frame: Change from Baseline to Follow-Up (11 months after Baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy HSU principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resilience/Adjustment Counseling and Resilience/Adjustment Counseling with Booster Sessions in people with Traumatic Brain Injury, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Data collection will be after the 7th treatment session and at 3,4 and 9 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.