Bridge Reinvention

NCT ID: NCT03554733

Last Updated: 2018-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-01
• Study Completion Date: 2018-04-30

Brief Summary

The goal of this randomized controlled trial is to determine the efficacy of a treatment to improve resilience to stress for individuals with SCI who are transitioning from inpatient rehabilitation to home. The overarching hypothesis is that individuals who participate in an intervention that presents positive psychotherapy topics in an interactive, structured, cognitive-behaviorally-based group intervention that stresses restructuring maladaptive thought processes and provides experiential opportunities to reinforce behavioral change will demonstrate increased self-efficacy.

Detailed Description

The goal of this randomized controlled trial is to determine the efficacy of a treatment to improve resilience to stress for individuals with SCI who are transitioning from inpatient rehabilitation to home. The overarching hypothesis is that individuals who participate in an intervention that presents positive psychotherapy topics in an interactive, structured, cognitive-behaviorally-based group intervention that stresses restructuring maladaptive thought processes and provides experiential opportunities to reinforce behavioral change will demonstrate increased self-efficacy. There were three aims of this study: AIM 1: Self-Efficacy - To examine the ability of a six-week, manualized, cognitive-behaviorally based group educational intervention (Re-Inventing Yourself after SCI-Bridge) to improve both SCI-specific and general self-efficacy for people who are early in the process of community reintegration; AIM 2: Psychosocial Adjustment - To assess the ability of the Re-Inventing Yourself after SCI-Bridge intervention to improve psychosocial adjustment of people with SCI who are early in the community reintegration process; and, Aim 3: Participation - To determine the ability of the Re-Inventing Yourself after SCI-Bridge intervention to improve societal participation for people with SCI who are early in the community reintegration process.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment

Re-Inventing Yourself after SCI protocol - 6-week educational sessions

Group Type: EXPERIMENTAL

ReInventing Yourself after SCI

Intervention Type: BEHAVIORAL

6-week, manualized, cognitive-behaviorally based group educational intervention

Control

No intervention during course of study; participants offered the option of receiving the study intervention after completion of study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ReInventing Yourself after SCI

6-week, manualized, cognitive-behaviorally based group educational intervention

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. History of SCI at any level;

2. completed initial inpatient rehabilitation but are no more than 6 months post-discharge;

3. 18 years of age or older at the time of study enrollment;

4. English speaking in order to complete study measures and participate in group interactions; and

5. able to provide informed consent to participate.

Exclusion Criteria

1. History of moderate or severe traumatic brain injury;

2. current participation in another RCT;

3. live beyond a reasonable commuting distance from Craig Hospital;

4. unable to verbally communicate;

5. unable to attend group sessions;

6. active participation in another formal clinical group or psychological therapy;

7. are currently experiencing severe depression which would require more intense treatment than is provided in this intervention, as evidenced by a score of 20 or higher on the Personal Health Questionnaire-9;

8. report any current suicidal ideation on the Personal Health Questionnaire-9; or

9. have any condition that, in the judgment of the investigators, precludes successful participation in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Craig H. Neilsen Foundation

OTHER

Sponsor Role: collaborator

Craig Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Coker

Research Associate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Coker, MPH

Role: PRINCIPAL_INVESTIGATOR

Craig Hospital

Locations

Craig Hospital

Englewood, Colorado, United States

Countries

United States

Other Identifiers

2959

Identifier Type: -

Identifier Source: org_study_id