Clinical trial NCT03554733: Bridge Reinvention
Official title: A Bridge From Rehabilitation to Real-World: Re-Inventing Yourself After SCI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: self efficacy
participation
satisfaction with life
Lead sponsor: Craig Hospital
Sponsor class: OTHER
Collaborators: name: The Craig H. Neilsen Foundation
First posted: 2018-06-13
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind, waitlist-control
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Moorong Self-Efficacy Scale (MSES)
timeFrame: Baseline, 6 weeks, 12 weeks, 18 weeks
Secondary outcomes:
measure: Change in Generalized Self-Efficacy Scale (GSES)
timeFrame: Baseline, 6 weeks, 12 weeks, 18 weeks
measure: Change in Satisfaction with Life Scale (SWLS)
timeFrame: Baseline, 6 weeks, 12 weeks, 18 weeks
measure: Change in Participation Assessment with Recombined Tools - Objective (PART-O)
timeFrame: Baseline, 6 weeks, 12 weeks, 18 weeks
measure: Patient Health Questionnaire - 9 (PHQ-9)
timeFrame: Baseline, 6 weeks, 12 weeks, 18 weeks
measure: Change in General Anxiety Disorder 7-item (GAD-7)
timeFrame: Baseline, 6 weeks, 12 weeks, 18 weeks
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Craig Hospital
state: Colorado
Study officials:
affiliation: Craig Hospital
name: Jennifer Coker, MPH
role: PRINCIPAL_INVESTIGATOR
References: