Clinical trial NCT03421964: Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
Official title: Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2018-02-05
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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).

Eligibility 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.

Primary outcomes:
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
timeFrame: Data collection will be after the 7th treatment session and at 3,4 and 9 months post-treatment
Secondary outcomes:
measure: Mayo Portland Adaptability Inventory-4 (MPAI-4)
timeFrame: Change from Baseline to Follow-Up (11 months after Baseline)
measure: Brief Symptom Inventory-18 (BSI-18), 18-item Self-report Instrument Was Developed to Quantify Psychological Distress in the General Population
timeFrame: Change from Baseline to Follow-Up (11 months after Baseline)
measure: 13 Item Stress Test
timeFrame: Change from Baseline to Follow-Up (11 months after Baseline)
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Nancy HSU
role: PRINCIPAL_INVESTIGATOR
References: