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

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zest
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Montana
  • The University of Texas Health Science Center at Houston
  • Baylor College of Medicine
  • TIRR Memorial Hermann

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Zest

Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
May 14, 2018
Last Updated
May 2, 2022
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research, TIRR Memorial Hermann, University of Montana, Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03543111
Brief Title
Promoting the Psychological Health of Women With SCI: A Virtual World Intervention
Acronym
Zest
Official Title
Promoting the Psychological Health of Women With SCI: A Virtual World Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
May 15, 2021 (Actual)
Study Completion Date
May 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research, TIRR Memorial Hermann, University of Montana, Baylor College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
175 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zest
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention - Control participants are provided intervention materials at the end of the study.
Intervention Type
Behavioral
Intervention Name(s)
Zest
Intervention Description
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 Measure Information:
Title
Self-esteem as assessed by the Rosenberg Self-Esteem Scale
Description
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.
Time Frame
Baseline
Title
Self-esteem as assessed by the Rosenberg Self-Esteem Scale
Description
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.
Time Frame
10 weeks
Title
Self-esteem as assessed by the Rosenberg Self-Esteem Scale
Description
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.
Time Frame
6 months
Title
Depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
Description
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.
Time Frame
Baseline
Title
Depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
Description
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.
Time Frame
10 weeks
Title
Depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
Description
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.
Time Frame
6 months
Title
Life satisfaction as assessed by the Satisfaction with Life Scale
Description
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.
Time Frame
Baseline
Title
Life satisfaction as assessed by the Satisfaction with Life Scale
Description
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.
Time Frame
10 weeks
Title
Life satisfaction as assessed by the Satisfaction with Life Scale
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Self-efficacy as assessed by the Generalized Self-Efficacy Scale
Description
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.
Time Frame
Baseline
Title
Self-efficacy as assessed by the Generalized Self-Efficacy Scale
Description
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.
Time Frame
10 weeks
Title
Self-efficacy as assessed by the Generalized Self-Efficacy Scale
Description
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.
Time Frame
6 months
Title
Social connectedness as assessed by the Medical Outcomes Study Social Support Scale, Emotional/Informational Support subscale.
Description
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.
Time Frame
Baseline
Title
Social connectedness as assessed by the Medical Outcomes Study Social Support Scale, Emotional/Informational Support subscale.
Description
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.
Time Frame
10 weeks
Title
Social connectedness as assessed by the Medical Outcomes Study Social Support Scale, Emotional/Informational Support subscale.
Description
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.
Time Frame
6 months
Title
Perceived stress as assessed the by Perceived Stress Scale
Description
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.
Time Frame
Baseline
Title
Perceived stress as assessed the by Perceived Stress Scale
Description
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.
Time Frame
10 weeks
Title
Perceived stress as assessed the by Perceived Stress Scale
Description
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.
Time Frame
6 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Participants must self-identify as a woman during the screening interview.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Robinson-Whelen, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Montana
City
Missoula
State/Province
Montana
ZIP/Postal Code
59812
Country
United States
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77006
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
TIRR Memorial Hermann
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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

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