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Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability

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ClinicalTrials.gov Identifier: NCT03421964
Recruitment Status : Recruiting
First Posted : February 5, 2018
Last Update Posted : February 21, 2019
Sponsor:
Collaborator:
The National Institute on Disability, Independent Living, and Rehabilitation Research
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief 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. to evaluate the short and long-term impact of intervention on emotional well-being and postinjury adjustment with the RAI vs. the RAI+
  3. to evaluate the short and long-term impact of the RAI and the RAI+ on abilities including problem solving, communication, and stress management
  4. to determine if demographic, lifestyle, injury, or treatment response information can predict maintenance of gains

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Behavioral: Resilience/Adjustment Counseling Behavioral: Resilience/Adjustment Counseling with Booster Sessions Not Applicable

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). During the first session, participants will receive 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 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 in-person, unless the participant requests to complete 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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
Actual Study Start Date : February 16, 2018
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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, in-person sessions.
Behavioral: Resilience/Adjustment Counseling
The Resilience and Adjustment Intervention (RAI) consists of seven 60-minute sessions scheduled over seven weeks. During the first session, participants will receive 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.
Other Name: RAI

Experimental: Resilience/Adjustment Counseling with Booster Sessions
Intervention to promote resilience and adjustment (RAI) is implemented in seven, 60-minute, in-person sessions; however individuals within this study arm will receive three additional 60-minute, in-person 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.
Behavioral: Resilience/Adjustment Counseling with Booster Sessions

The Resilience and Adjustment Intervention (RAI) consists of seven 60-minute sessions scheduled over seven weeks. During the first session, participants will receive 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.

Other Name: RAI+




Primary Outcome Measures :
  1. Connor-Davidson Resilience Scale-10 (CD-RISC-10) [ Time Frame: Change from Baseline to Follow-Up (11 months after Baseline) ]
    During the past decade, researchers have developed resilience measurement scales, and a recent review suggested that Connor and Davidson have been most successful. The authors first developed a 25 item scale (CD-RISC) reflecting resilience characteristics identified by Kobasa and Rutter. Normative studies including factor analyses indicated that the CD-RISC is reliable, valid, and sensitive to treatment effects. More recently, a 10-item version was developed using exploratory and confirmatory factors analyses. Respondents are presented with a series of descriptors (e.g., "I am able to adapt and change," "Coping with stress can strengthen me") and rate themselves on a 0 - 4 scale ranging from rarely true (0) to true nearly all the time (4). Campbell-Sills and colleagues have characterized the 10-item version, used in the present study, as demonstrating excellent psychometric properties, namely reliability, internal consistency, and construct validity.


Secondary Outcome Measures :
  1. Mayo Portland Adaptability Inventory-4 (MPAI-4) [ Time Frame: Change from Baseline to Follow-Up (11 months after Baseline) ]
    The MPAI-4 is comprised of 30 items rated from 0 - 4 with higher scores indicating greater problem severity. Items are subdivided into three subscales reflecting emotional and behavioral self-regulation (Adjustment Index), cognitive and physical abilities (Ability Index), and community integration (Participation Index). T-scores are obtained based on norms derived from a brain injury sample. The present investigation focuses on the former two subscales. Adjustment Index items relate to anxiety, depression, irritability, anger, social interaction, and self-awareness. The Ability Index includes items relating to verbal and nonverbal communication and problem solving ability. Research has provided evidence of good concurrent, construct, and predictive validity as well as satisfactory internal consistency. Sensitivity to treatment-related change has also been substantiated.

  2. Brief Symptom Inventory-18 (BSI-18) [ Time Frame: Change from Baseline to Follow-Up (11 months after Baseline) ]
    This 18-item self-report instrument was developed to quantify psychological distress in the general population. A number of investigators have used the measure to quantify distress after TBI. In particular, researchers have used the BSI to monitor change in psychological status in response to treatment and general change in status over time. The BSI-18 is often used because of its sound psychometric properties, brevity, ease of administration, 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). T-scores are calculated based on community norms. The GSI score reflects the overall distress level and is the focus of the present investigation.

  3. 13 Item Stress Test [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03421964


Contacts
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Contact: Jennifer H Marwitz, MA 804-828-3704 jennifer.marwitz@vcuhealth.org
Contact: Abigail M Welch, BS,BA 804-828-3703 abigail.welch@vcuhealth.org

Locations
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United States, Virginia
Jennifer H Marwitz Recruiting
Midlothian, Virginia, United States, 23113
Contact: Jennifer H Marwitz, MA    804-828-3704    jennifer.marwitz@vcuhealth.org   
Contact: Abigail M Welch, BS,BA    804-828-3703    abigail.welch@vcuhealth.org   
Sponsors and Collaborators
Virginia Commonwealth University
The National Institute on Disability, Independent Living, and Rehabilitation Research
Investigators
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Principal Investigator: Jeffrey S Kreutzer, PhD Virginia Commonwealth University

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03421964     History of Changes
Other Study ID Numbers: HM20011840
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries