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

NCT03543111 | Completed

• 2 other identifiers: HSC-MS-17-0474H133G080042-10
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 4

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (9)

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

  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.

  Baseline

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

  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.

  10 weeks

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

  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.

  6 months

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

  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.

  Baseline

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

  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.

  10 weeks

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

  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.

  6 months

• Life satisfaction as assessed by the Satisfaction with Life Scale

  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.

  Baseline

• Life satisfaction as assessed by the Satisfaction with Life Scale

  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.

  10 weeks

• Life satisfaction as assessed by the Satisfaction with Life Scale

  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.

  6 months

Secondary Outcomes (9)

• Self-efficacy as assessed by the Generalized Self-Efficacy Scale

  Baseline

• Self-efficacy as assessed by the Generalized Self-Efficacy Scale

  10 weeks

• 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.

  Baseline

• Social connectedness as assessed by the Medical Outcomes Study Social Support Scale, Emotional/Informational Support subscale.

  10 weeks

Study Arms (2)

Zest

EXPERIMENTAL

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.

Behavioral: Zest

Control

NO INTERVENTION

No intervention - Control participants are provided intervention materials at the end of the study.

Interventions

Zest BEHAVIORAL

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.

Zest

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants must self-identify as a woman during the screening interview.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator
• TIRR Memorial Hermann: collaborator
• University of Montana: collaborator
• Baylor College of Medicine: collaborator

Study Sites (4)

University of Montana

Missoula, Montana, 59812, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77006, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

TIRR Memorial Hermann

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Robinson-Whelen S, Hughes RB, Gonzalez D, Norah-Davis L, Leon-Novelo LG, Ngan E, Whelen ML, Wenzel L, Taylor HB. Promoting psychological health in women with spinal cord injury: A randomized trial. Rehabil Psychol. 2025 Nov;70(4):426-436. doi: 10.1037/rep0000602. Epub 2025 Feb 6.

  PMID: 39913478 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Susan Robinson-Whelen, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: June 1, 2018
• Study Start: August 1, 2018
• Primary Completion: May 15, 2021
• Study Completion: May 15, 2021
• Last Updated: May 6, 2022

Record last verified: 2022-05

Locations

US (4)