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

Not Applicable

Completed

• Conditions: Spinal Cord Injuries
• Interventions: Behavioral: Zest

• Registration Number: NCT03543111
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-14
• Study First Submitted QC: 2018-05-30
• Study First Posted: 2018-06-01
• Study Start: 2018-08-01
• Primary Completion: 2021-05-15
• Study Completion: 2021-05-15
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-02
• Last Update Posted: 2022-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 175

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zest	Zest	Zest is 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.The Zest program will consist of 10 weekly 2-hour group sessions with approximately 8 women using avatars to represent themselves.

Primary Outcome Measures

Name	Time	Method
Self-esteem as assessed by the Rosenberg Self-Esteem Scale	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)	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	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 Outcome Measures

Name	Time	Method
Self-efficacy as assessed by the Generalized Self-Efficacy Scale	6 months	The effect of the Zest intervention on self-efficacy as assessed by the Generalized Self-Efficacy Scale. This is a 10-item scale with scores ranging from 10-40 with higher scores indicating higher self-efficacy.
Social connectedness as assessed by the Medical Outcomes Study Social Support Scale, Emotional/Informational Support subscale.	6 months	The effect of the Zest intervention on social connectedness as assessed by the Medical Outcomes Study Social Support Scale, Emotional/Informational subscale. This is an 8-item scale in which scores for each item are averaged. Scores are converted to a 0-100 scale with higher scores indicating more support and, therefore, social connectedness.
Perceived stress as assessed the by Perceived Stress Scale	6 months	The effect of the Zest intervention on perceived stress as assessed by the Perceived Stress Scale. This is a 10-item scale with scores ranging from 0-40 with higher scores indicating more perceived stress.

Trial Locations

Locations (4)

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

TIRR Memorial Hermann; 🇺🇸 Houston, Texas, United States

University of Montana; 🇺🇸 Missoula, Montana, United States

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States