Trial Outcomes & Findings for Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability (NCT NCT03421964)
NCT ID: NCT03421964
Last Updated: 2025-03-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
184 participants
Primary outcome timeframe
Data collection will be after the 7th treatment session and at 3,4 and 9 months post-treatment
Results posted on
2025-03-27
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
95
|
|
Overall Study
COMPLETED
|
66
|
69
|
|
Overall Study
NOT COMPLETED
|
23
|
26
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
21
|
|
Overall Study
Withdrawal by Subject
|
9
|
3
|
|
Overall Study
Incarcerated
|
1
|
0
|
|
Overall Study
Inpt Treatment Facility
|
1
|
1
|
|
Overall Study
Virtual Platform Issues
|
1
|
1
|
Baseline Characteristics
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
Baseline characteristics by cohort
| Measure |
Resilience/Adjustment Counseling
n=89 Participants
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.
|
Resilience/Adjustment Counseling With Booster Sessions
n=95 Participants
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.
|
Total
n=184 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.3 years
STANDARD_DEVIATION 13.66 • n=5 Participants
|
44.41 years
STANDARD_DEVIATION 13.39 • n=7 Participants
|
44.36 years
STANDARD_DEVIATION 13.48 • n=5 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
85 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
178 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
89 participants
n=5 Participants
|
95 participants
n=7 Participants
|
184 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Data collection will be after the 7th treatment session and at 3,4 and 9 months post-treatmentPopulation: Number of participants who have completed the treatment sessions for each arm
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.
Outcome measures
| Measure |
Resilience/Adjustment Counseling
n=20 Participants
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.
|
Resilience/Adjustment Counseling With Booster Sessions
n=16 Participants
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.
|
|---|---|---|
|
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
|
12 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Change from Baseline to Follow-Up (11 months after Baseline)Population: Subjects
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.
Outcome measures
| Measure |
Resilience/Adjustment Counseling
n=51 Participants
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.
|
Resilience/Adjustment Counseling With Booster Sessions
n=67 Participants
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.
|
|---|---|---|
|
Mayo Portland Adaptability Inventory-4 (MPAI-4)
|
-3.07 Change in BSI T-scores (mean=50, sd=10)
Standard Deviation 5.42
|
-4.42 Change in BSI T-scores (mean=50, sd=10)
Standard Deviation 6.00
|
SECONDARY outcome
Timeframe: Change from Baseline to Follow-Up (11 months after Baseline)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+)
Outcome measures
| Measure |
Resilience/Adjustment Counseling
n=51 Participants
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.
|
Resilience/Adjustment Counseling With Booster Sessions
n=67 Participants
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.
|
|---|---|---|
|
Brief Symptom Inventory-18 (BSI-18), 18-item Self-report Instrument Was Developed to Quantify Psychological Distress in the General Population
|
-7.6 Change in BSI T-scores (mean= 50; SD=10)
Standard Deviation 8.62
|
-7.72 Change in BSI T-scores (mean= 50; SD=10)
Standard Deviation 11.28
|
SECONDARY outcome
Timeframe: Change from Baseline to Follow-Up (11 months after Baseline)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.
Outcome measures
| Measure |
Resilience/Adjustment Counseling
n=49 Participants
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.
|
Resilience/Adjustment Counseling With Booster Sessions
n=63 Participants
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.
|
|---|---|---|
|
13 Item Stress Test
|
-1.47 units on a scale
Standard Deviation 2.36
|
-1.9 units on a scale
Standard Deviation 2.77
|
Adverse Events
Resilience/Adjustment Counseling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Resilience/Adjustment Counseling With Booster Sessions
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place