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Clinical Trials/NCT03543111
NCT03543111
Completed
Not Applicable

Promoting the Psychological Health of Women With SCI: A Virtual World Intervention

The University of Texas Health Science Center, Houston4 sites in 1 country175 target enrollmentAugust 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Cord Injuries
Sponsor
The University of Texas Health Science Center, Houston
Enrollment
175
Locations
4
Primary Endpoint
Self-esteem as assessed by the Rosenberg Self-Esteem Scale
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The purpose of this project is to test the efficacy of an internet-based psychological health enhancement program for women with spinal cord injury. The intervention will occur in Second Life (SL), which is an online virtual word simulator with a group of women with spinal cord injury.

Registry
clinicaltrials.gov
Start Date
August 1, 2018
End Date
May 15, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Susan Robinson-Whelen

Assistant Professor

The University of Texas Health Science Center, Houston

Eligibility Criteria

Inclusion Criteria

  • have a traumatic spinal cord injury
  • be at least one year post injury
  • be able to speak and read English (to participate in the group intervention and complete study questionnaires in English).
  • have access to a phone, an email account, and a computer and high-speed Internet connection that meets minimum SL computing requirements.

Exclusion Criteria

  • have a cognitive impairment that significantly limits their ability to give informed consent, participate in the intervention, or complete study assessments as determined by an inability to correctly answer questions on a comprehension of consent questionnaire
  • have a significant visual or hearing impairment that would prohibit their ability to participate in the virtual intervention
  • report active suicidality
  • live in institutions. Individuals living in community-based group and adult foster homes will be invited to participate.

Outcomes

Primary Outcomes

Self-esteem as assessed by the Rosenberg Self-Esteem Scale

Time Frame: 6 months

The effect of the Zest intervention on self-esteem as assessed by the Rosenberg Self-Esteem Scale. This is a 10-item scale with scores ranging from 10-40 with higher scores indicating higher self-esteem.

Depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)

Time Frame: 6 months

The effect of the Zest intervention on depression as assessed by the Patient Health Questionnaire-9 (PHQ-9). This is a 9-item scale with scores ranging from 0-27 with higher scores indicating more severe depression.

Life satisfaction as assessed by the Satisfaction with Life Scale

Time Frame: 6 months

The effect of the Zest intervention on life satisfaction as assessed by the Satisfaction with Life Scale. This is a 5-item scale with scores ranging from 5-35 with higher scores indicating greater satisfaction with life.

Secondary Outcomes

  • Self-efficacy as assessed by the Generalized Self-Efficacy Scale(6 months)
  • Social connectedness as assessed by the Medical Outcomes Study Social Support Scale, Emotional/Informational Support subscale.(6 months)
  • Perceived stress as assessed the by Perceived Stress Scale(6 months)

Study Sites (4)

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