Bridge Reinvention

NCT03554733 | Completed

• 1 other identifier: 2959
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

self efficacy; participation; satisfaction with life

Outcome Measures

Primary Outcomes (1)

• Change in Moorong Self-Efficacy Scale (MSES)

  The MSES is a 16 item self-report measure of self-efficacy related to everyday life activities, designed specifically for persons with SCI. Individuals use a 7-point Likert scale ranging from 1 (very uncertain) to 7 (very certain) to rate their ability to perform 16 everyday tasks, with higher scores representing greater perceived self-efficacy. A Total Score, ranging from 16 to 112 is calculated by summing all item responses. The MSES has been used in previous studies of SCI, and demonstrates excellent internal consistency (alpha = 0.91 - 0.93), high reliability, and good convergent, concurrent and divergent validity. Time to administer: 5 to 10 minutes.

  Baseline, 6 weeks, 12 weeks, 18 weeks

Secondary Outcomes (5)

• Change in Generalized Self-Efficacy Scale (GSES)

  Baseline, 6 weeks, 12 weeks, 18 weeks

• Change in Satisfaction with Life Scale (SWLS)

  Baseline, 6 weeks, 12 weeks, 18 weeks

• Change in Participation Assessment with Recombined Tools - Objective (PART-O)

  Baseline, 6 weeks, 12 weeks, 18 weeks

• Patient Health Questionnaire - 9 (PHQ-9)

  Baseline, 6 weeks, 12 weeks, 18 weeks

• Change in General Anxiety Disorder 7-item (GAD-7)

  Baseline, 6 weeks, 12 weeks, 18 weeks

Study Arms (2)

Treatment

EXPERIMENTAL

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

Behavioral: ReInventing Yourself after SCI

Control

NO INTERVENTION

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

Interventions

ReInventing Yourself after SCI BEHAVIORAL

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

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of SCI at any level;
• completed initial inpatient rehabilitation but are no more than 6 months post-discharge;
• years of age or older at the time of study enrollment;
• English speaking in order to complete study measures and participate in group interactions; and
• able to provide informed consent to participate.

You may not qualify if:

• History of moderate or severe traumatic brain injury;
• current participation in another RCT;
• live beyond a reasonable commuting distance from Craig Hospital;
• unable to verbally communicate;
• unable to attend group sessions;
• active participation in another formal clinical group or psychological therapy;
• 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;
• report any current suicidal ideation on the Personal Health Questionnaire-9; or
• have any condition that, in the judgment of the investigators, precludes successful participation in the study.

Sponsors & Collaborators

• Craig Hospital: lead
• The Craig H. Neilsen Foundation: collaborator

Study Sites (1)

Craig Hospital

Englewood, Colorado, 80113, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Personal Satisfaction

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Behavior

Study Officials

• Jennifer Coker, MPH

  Craig Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate

Model Details: Single-blind, waitlist-control

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: June 13, 2018
• Study Start: April 1, 2014
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: June 13, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)