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Re-Inventing Yourself After Spinal Cord Injury

30 januari 2018 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

81

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Colorado
      • Englewood, Colorado, Förenta staterna, 80113
        • Craig Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 100 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  1. History of traumatic SCI at any level;
  2. at least 4 weeks post-discharge from initial inpatient rehabilitation;
  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 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
  8. 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
  9. have any condition that, in the judgment of the investigators, precludes successful participation in the study.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Beteende: SCI Reinvention Protocol Participants
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.
Övrig: 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.
Övrig: Waitlist Group
Wait list arm will begin study intervention after 4 1/2 months.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Moorong Self-Efficacy Scale (MSES) score over a 30 week time period
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in General Self-Efficacy Scale scores over a 30 week time period
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Craig Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2012

Primärt slutförande (Faktisk)

1 september 2017

Avslutad studie (Faktisk)

1 september 2017

Studieregistreringsdatum

Först inskickad

26 juni 2012

Först inskickad som uppfyllde QC-kriterierna

29 juni 2012

Första postat (Uppskatta)

4 juli 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 februari 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 januari 2018

Senast verifierad

1 januari 2018

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • H133N110006

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