Re-Inventing Yourself After Spinal Cord Injury
30 janvier 2018 mis à jour par: Craig Hospital
Re-Inventing Yourself After SCI: A Site-Specific Randomized Clinical Trial
The purpose of this study is to evaluate the efficacy of a replicable, psychologically-based group education intervention, Re-Inventing Yourself after Spinal Cord Injury (SCI), which aims to enhance personal self-efficacy.
A structured six-week, manualized, group therapy intervention that delivers positive psychology concepts within a cognitive-behavioral therapy-based model has been created for the purpose of developing a resilient and optimistic sense of efficacy for people with SCI.
Concepts covered within this intervention include: reframing and restructuring a person's method of looking at events, building confidence by focusing on personal strengths, developing methods of recognizing and appreciating the good in one's life and expressing gratitude for positive attributes.
The goals of this intervention are to increase personal self-efficacy, enhance emotional well-being and improve participation in society for people with SCI living in the community.
The investigators hypothesize that persons receiving the intervention will demonstrate improved SCI-specific and overall self-efficacy as compared to waitlist controls.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
81
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Colorado
-
Englewood, Colorado, États-Unis, 80113
- Craig Hospital
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 100 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- History of traumatic SCI at any level;
- at least 4 weeks post-discharge from initial inpatient rehabilitation;
- 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
Exclusion Criteria:
- 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 moderately severe or greater levels of depression which would require more intense treatment than is provided in this intervention, as evidenced by a score of 15 or higher on the Personal Health Questionnaire-9;37
- are currently of high self efficacy, as determined by a score of 90 or higher on the MSES,32 which has a range of 16 to 112, with higher scores representing higher SCI-specific self-efficacy; or
- have any condition that, in the judgment of the investigators, precludes successful participation in the study.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: SCI Reinvention Protocol Participants
This group will receive 6 instructor-led 2 hour long didactic presentations regarding 8 key principles of self-efficacy and experiential exercises, including goal setting and problem solving with extensive group discussion.
At the end of each session, tasks are assigned to participants to be completed outside the group during the week between sessions.
Experiences from these activities and practice implementing the intervention principles will be shared and discussed each week, providing additional opportunities for problem solving and positive feedback.
|
The intervention involves participation in a six week psychologically-based educational intervention.
During the course, 8 specific skills are reviewed in order to specifically address reframing a person's method of looking at events, build confidence by focusing on personal strengths, develop methods of recognizing and appreciating the good in one's life and express gratitude for positive attributes.
These skills are presented in a specific sequence so that participants can gain mastery of introductory concepts before undertaking those that are both more difficult and complex.
|
|
Autre: Waitlist Group
This group will include individuals randomized to receive no treatment for the 30 weeks during which the interventional group will receive the active treatment and have their progress tracked.
|
Wait list arm will begin study intervention after 4 1/2 months.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Moorong Self-Efficacy Scale (MSES) score over a 30 week time period
Délai: Baseline, 6 weeks, 14 weeks, 22 weeks, 30 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.
|
Baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in General Self-Efficacy Scale scores over a 30 week time period
Délai: Baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
|
The General Self-Efficacy Scale (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).
|
Baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 avril 2012
Achèvement primaire (Réel)
1 septembre 2017
Achèvement de l'étude (Réel)
1 septembre 2017
Dates d'inscription aux études
Première soumission
26 juin 2012
Première soumission répondant aux critères de contrôle qualité
29 juin 2012
Première publication (Estimation)
4 juillet 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
1 février 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
30 janvier 2018
Dernière vérification
1 janvier 2018
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- H133N110006
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .