Spinal Cord InjuriesNCT03554733
Bridge Reinvention
A study testing ReInventing Yourself after SCI in people with Spinal Cord Injuries, run by Craig Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- ReInventing Yourself after SCI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2014to 30 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- History of SCI at any level;
- completed initial inpatient rehabilitation but are no more than 6 months post-discharge;
- 18 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Bridge From Rehabilitation to Real-World: Re-Inventing Yourself After SCI
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.
Read the 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
- Being tested
- ReInventing Yourself after SCI
- Keywords
- self efficacy, participation, satisfaction with life
- Medical subject headings
- Spinal Cord Injuries, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReInventing Yourself after SCIBehavioural
6-week, manualized, cognitive-behaviorally based group educational intervention
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Re-Inventing Yourself after SCI protocol - 6-week educational sessions Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 weeks, 12 weeks, 18 weeks
Secondary outcomes (5)
Change in Generalized Self-Efficacy Scale (GSES)
The GSES is a questionnaire designed to assess a person's ability to cope with a variety of difficult demands in life, with ten items scored using a Likert rating scale, ranging from 1 (not at all true) to 4 (exactly true). This scale has acceptable internal reliability (ranging from.73 to .90) and criterion validity, as demonstrated by positive correlations with positive emotions, optimism, and work satisfaction, and negative correlations with anxiety, stress, depression, and health complaints. The GSES has been used and validated in numerous populations and cultures, including people with SCI. This self-administered scale produces a Total Score ranging from 10-40, with higher scores indicating greater general self-efficacy. Time to administer: 3 to 5 minutes.
Measured: Baseline, 6 weeks, 12 weeks, 18 weeks
Change in Satisfaction with Life Scale (SWLS)
The SWLS is a five item measure on which respondents rate their life satisfaction using a 7-point Likert scale, ranging from 1 (strongly disagree) to 7 (strongly agree). A Total Score is calculated by summing each of the items, having a range of 5 to 35, with higher scores representing greater perceived quality of life. This measure has well established psychometric properties, with high reliability (.79 to .89), good content validity, criterion validity, and has been extensively used in research regarding people with SCI. Time to administer: 1 to 3 minutes.
Measured: Baseline, 6 weeks, 12 weeks, 18 weeks
Change in Participation Assessment with Recombined Tools - Objective (PART-O)
The PART-O is a 17-item assessment of participation and has demonstrated good psychometric properties in measuring participation for people living with disabilities. The PART-O has acceptable reliability and validity for persons with SCI. An Averaged Total Score is computed by taking the mean of 17 items, with scores ranging from 0 (never participate in these types of activities) to 5 (almost always participate in these types of activities), with higher scores representing greater participation. This assessment will be utilized to measure overall participation. Time to administer: 8 to 10 minutes.
Measured: Baseline, 6 weeks, 12 weeks, 18 weeks
Patient Health Questionnaire - 9 (PHQ-9)
The PHQ-9 is a 9 item scale that will be used to assess depression. Respondents rate the frequency at which specific problems have been bothersome during the past two weeks, using a four point scale ranging from 0 (not at all) to 3 (nearly every day). A total score is calculated by summing all items, with higher scores indicating an increasing severity of depression. This scale demonstrates excellent psychometrics, with excellent internal consistency (α = 0.86 - 0.89), high test-retest reliability (0.84) and good criterion and construct validity and has been used extensively in populations with SCI. Time to administer: 1 to 3 minutes.
Measured: Baseline, 6 weeks, 12 weeks, 18 weeks
Change in General Anxiety Disorder 7-item (GAD-7)
The GAD-7 is a brief 7 item measure that will be used to assess the severity of general anxiety. Using a four point Likert scale ranging from 0 (not at all sure) to 3 (nearly every day), respondents rate how often they have been bothered by specific symptoms during the past two weeks. A total severity score, ranging from 0 to 21, is calculated by summing all items. This measure has demonstrated high internal consistency (α = .89 - .92), good test-retest reliability (icc = .83) and adequate convergent and discriminant validity. This scale has been used in previous studies involving persons with SCI. Time to administer: 1 to 3 minutes.
Measured: Baseline, 6 weeks, 12 weeks, 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start1 Apr 2014
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind, waitlist-control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Craig Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Responsible party
- Principal investigator, Jennifer Coker, Craig Hospital
- Investigators
- Jennifer Coker, MPH, Principal investigator, Craig Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03554733
- Sponsor's protocol ID
- 2959
- Status last verified
- Jun 2018
- First submitted
- 30 May 2018
- Last updated
- 13 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bridge From Rehabilitation to Real-World: Re-Inventing Yourself After SCI
- ClinicalTrials.gov ID
- NCT03554733
- Acronym / sponsor ID
- 2959
- Conditions
- Spinal Cord Injuries
- Keywords
- self efficacy, participation, satisfaction with life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Craig HospitalUniversity, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 13 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-blind, waitlist-control
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: ReInventing Yourself after SCIRe-Inventing Yourself after SCI protocol - 6-week educational sessions |
| Control | No intervention | –No intervention during course of study; participants offered the option of receiving the study intervention after completion of study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- History of SCI at any level;
- completed initial inpatient rehabilitation but are no more than 6 months post-discharge;
- 18 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReInventing Yourself after SCI6-week, manualized, cognitive-behaviorally based group educational intervention | Behavioural | Treatment |
Primary outcome
Change in Moorong Self-Efficacy Scale (MSES)
Time frame: Baseline, 6 weeks, 12 weeks, 18 weeks
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.
5 secondary outcomes
Change in Generalized Self-Efficacy Scale (GSES)
Time frame: Baseline, 6 weeks, 12 weeks, 18 weeks
Change in Satisfaction with Life Scale (SWLS)
Time frame: Baseline, 6 weeks, 12 weeks, 18 weeks
Change in Participation Assessment with Recombined Tools - Objective (PART-O)
Time frame: Baseline, 6 weeks, 12 weeks, 18 weeks
Patient Health Questionnaire - 9 (PHQ-9)
Time frame: Baseline, 6 weeks, 12 weeks, 18 weeks
Change in General Anxiety Disorder 7-item (GAD-7)
Time frame: Baseline, 6 weeks, 12 weeks, 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Coker, MPH principal investigator
Craig Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReInventing Yourself after SCI in people with Spinal Cord Injuries, run by Craig Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Moorong Self-Efficacy Scale (MSES) (time frame: Baseline, 6 weeks, 12 weeks, 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2018.