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

Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Completed
CT.gov ID
NCT03543111
Collaborator
National Institute on Disability, Independent Living, and Rehabilitation Research (U.S. Fed), TIRR Memorial Hermann (Other), University of Montana (Other), Baylor College of Medicine (Other)
175
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2
33.4
43.8
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Zest
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
175 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Promoting the Psychological Health of Women With SCI: A Virtual World Intervention
Actual Study Start Date :
Aug 1, 2018
Actual Primary Completion Date :
May 15, 2021
Actual Study Completion Date :
May 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Behavioral: 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.

No Intervention: Control

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

Outcome Measures

Primary Outcome Measures

  1. Self-esteem as assessed by the Rosenberg Self-Esteem Scale [Baseline]

    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.

  2. Self-esteem as assessed by the Rosenberg Self-Esteem Scale [10 weeks]

    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.

  3. 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.

  4. Depression as assessed by the Patient Health Questionnaire-9 (PHQ-9) [Baseline]

    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.

  5. Depression as assessed by the Patient Health Questionnaire-9 (PHQ-9) [10 weeks]

    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. 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.

  7. Life satisfaction as assessed by the Satisfaction with Life Scale [Baseline]

    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.

  8. Life satisfaction as assessed by the Satisfaction with Life Scale [10 weeks]

    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.

  9. 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

  1. Self-efficacy as assessed by the Generalized Self-Efficacy Scale [Baseline]

    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.

  2. Self-efficacy as assessed by the Generalized Self-Efficacy Scale [10 weeks]

    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.

  3. 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.

  4. Social connectedness as assessed by the Medical Outcomes Study Social Support Scale, Emotional/Informational Support subscale. [Baseline]

    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.

  5. Social connectedness as assessed by the Medical Outcomes Study Social Support Scale, Emotional/Informational Support subscale. [10 weeks]

    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.

  6. 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.

  7. Perceived stress as assessed the by Perceived Stress Scale [Baseline]

    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.

  8. Perceived stress as assessed the by Perceived Stress Scale [10 weeks]

    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.

  9. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Montana Missoula Montana United States 59812
2 The University of Texas Health Science Center at Houston Houston Texas United States 77006
3 Baylor College of Medicine Houston Texas United States 77030
4 TIRR Memorial Hermann Houston Texas United States 77030

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Susan Robinson-Whelen, PhD, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Susan Robinson-Whelen, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT03543111
Other Study ID Numbers:
  • HSC-MS-17-0474
  • H133G080042-10
First Posted:
Jun 1, 2018
Last Update Posted:
May 6, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 6, 2022