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Intervention to Promote Survivor Resilience and Adjustment: Efficacy Evaluation

NCT ID: NCT01935583

Last Updated: 2017-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2017-09-30

Brief Summary

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1. To evaluate the short and longer-term efficacy of a structured outpatient intervention program (The Resilience and Adjustment Intervention, RAI) to improve survivors' resilience.
2. To evaluate the impact of treatment on emotional well-being and postinjury adjustment.
3. To evaluate the impact of the intervention on abilities including problem solving, communication, and stress management.
4. To examine the extent to which treatment benefits are sustained in the longer-term.

Detailed Description

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To design effective resilience interventions, a treatment modality which is effective for traumatic brain injury (TBI) survivors is needed. Virginia Commonwealth University (VCU) researchers have had considerable success in the past several decades developing and evaluating interventions for neurobehavioral, cognitive, and vocational challenges after TBI. Researchers have demonstrated the utility of the curriculum-based (C-B) treatment structure in various settings. Additionally, the efficacy of the C-B structure, independent of postinjury timeframe, allows the flexibility necessary to address the unique consequences of TBI.

The C-B treatment modality offers a promising strategy for the promotion of resilience postinjury. The primary purpose of the study is to evaluate the efficacy of a structured, curriculum-based intervention to promote postinjury resilience and adjustment. Objectives include:

1. to evaluate the short and longer-term efficacy of a structured outpatient intervention program (The Resilience and Adjustment Intervention, RAI) to improve survivors' resilience
2. to evaluate the impact of treatment on emotional well-being and postinjury adjustment
3. to evaluate the impact of the intervention on abilities including problem solving, communication, and stress management
4. to examine the extent to which treatment benefits are sustained in the longer-term

Conditions

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Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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 brain injury address issues related to resilience and adjustment to injury. The RAI is implemented in seven, 60-minute, in-person sessions.

Group Type EXPERIMENTAL

Resilience/Adjustment Counseling

Intervention Type BEHAVIORAL

Intervention to promote individual's resilience and adjustment (RAI) - The RAI is a structured approach to helping individuals after brain injury address issues related to resilience and adjustment. The RAI is implemented in seven sessions. Each session is in-person and lasts for 60 minutes.

Waitlist Control

Individuals are randomly assigned to the treatment group or waitlist control (WLC) group. Individuals will complete the study measures on 2 occasions, 5 weeks apart. In fairness, WLC participants will then be offered the opportunity to participate in the intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Resilience/Adjustment Counseling

Intervention to promote individual's resilience and adjustment (RAI) - The RAI is a structured approach to helping individuals after brain injury address issues related to resilience and adjustment. The RAI is implemented in seven sessions. Each session is in-person and lasts for 60 minutes.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* mild, moderate, or severe TBI
* able to understand and provide consent

Exclusion Criteria

* active substance abusers (e.g., intoxicated at arrival to intake)
* at imminent risk of psychiatric hospitalization
* in imminent danger of hurting themselves or others
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Department of Health and Human Services

FED

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey S Kreutzer, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor, Virginia Commonwealth University

Locations

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Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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H133A120031

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HM14738

Identifier Type: -

Identifier Source: org_study_id