Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
Status: | Recruiting |
---|---|
Conditions: | Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/23/2019 |
Start Date: | February 16, 2018 |
End Date: | September 30, 2022 |
Contact: | Jennifer H Marwitz, MA |
Email: | jennifer.marwitz@vcuhealth.org |
Phone: | 804-828-3704 |
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
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
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).
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).
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.
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