Clinical trial NCT03543111: Promoting the Psychological Health of Women With SCI: A Virtual World Intervention
Official title: Promoting the Psychological Health of Women With SCI: A Virtual World Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
name: TIRR Memorial Hermann
name: University of Montana
name: Baylor College of Medicine
First posted: 2018-06-01
Enrollment: 175
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Self-esteem as assessed by the Rosenberg Self-Esteem Scale
timeFrame: Baseline
measure: Self-esteem as assessed by the Rosenberg Self-Esteem Scale
timeFrame: 10 weeks
measure: Self-esteem as assessed by the Rosenberg Self-Esteem Scale
timeFrame: 6 months
measure: Depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline
measure: Depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 10 weeks
measure: Depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 6 months
measure: Life satisfaction as assessed by the Satisfaction with Life Scale
timeFrame: Baseline
measure: Life satisfaction as assessed by the Satisfaction with Life Scale
timeFrame: 10 weeks
measure: Life satisfaction as assessed by the Satisfaction with Life Scale
timeFrame: 6 months
Secondary outcomes:
measure: Self-efficacy as assessed by the Generalized Self-Efficacy Scale
timeFrame: Baseline
measure: Self-efficacy as assessed by the Generalized Self-Efficacy Scale
timeFrame: 10 weeks
measure: Self-efficacy as assessed by the Generalized Self-Efficacy Scale
timeFrame: 6 months
measure: Social connectedness as assessed by the Medical Outcomes Study Social Support Scale, Emotional/Informational Support subscale.
timeFrame: Baseline
measure: Social connectedness as assessed by the Medical Outcomes Study Social Support Scale, Emotional/Informational Support subscale.
timeFrame: 10 weeks
measure: Social connectedness as assessed by the Medical Outcomes Study Social Support Scale, Emotional/Informational Support subscale.
timeFrame: 6 months
measure: Perceived stress as assessed the by Perceived Stress Scale
timeFrame: Baseline
measure: Perceived stress as assessed the by Perceived Stress Scale
timeFrame: 10 weeks
measure: Perceived stress as assessed the by Perceived Stress Scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Missoula
country: United States
facility: University of Montana
state: Montana
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: TIRR Memorial Hermann
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Susan Robinson-Whelen, PhD
role: PRINCIPAL_INVESTIGATOR
References: