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

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ClinicalTrials.gov Identifier: NCT03543111
Recruitment Status : Recruiting
First Posted : June 1, 2018
Last Update Posted : August 3, 2018
Sponsor:
Collaborators:
National Institute on Disability, Independent Living, and Rehabilitation Research
TIRR Memorial Hermann
University of Montana
Baylor College of Medicine
Information provided by (Responsible Party):
Susan Robinson-Whelen, 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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Behavioral: Zest Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 212 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 : August 1, 2018
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Self-esteem as assessed by the Rosenberg Self-Esteem Scale [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03543111


Contacts
Contact: Rachel L Markley, MPH 713-797-7570 Zest@memorialhermann.org

Locations
United States, Montana
University of Montana Recruiting
Missoula, Montana, United States, 59812
Contact: Rosemary Hughes, Ph.D.    406-243-2898    rosemary.hughes@mso.umt.edu   
Principal Investigator: Rosemary Hughes, Ph.D         
United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77006
Contact: Rachel Markley, MPH    713-797-7570    Zest@memorialhermann.org   
Principal Investigator: Heather Taylor, Ph.D.         
Principal Investigator: Susan Robinson-Whelen, Ph.D.         
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Rachel Markley, MPH    713-797-7570    Zest@memorialhermann.org   
Sub-Investigator: Margaret Nosek, Ph.D.         
Sub-Investigator: Lisa Wenzel, MD         
Principal Investigator: Susan Robinson-Whelen, Ph.D.         
Principal Investigator: Heather Taylor, Ph.D.         
TIRR Memorial Hermann Recruiting
Houston, Texas, United States, 77030
Contact: Rachel Markley, MPH    713-797-7570    Zest@memorialhermann.org   
Principal Investigator: Heather Taylor, Ph.D.         
Principal Investigator: Susan Robinson-Whelen, Ph.D.         
Sub-Investigator: Lisa Wenzel, MD         
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

Responsible Party: Susan Robinson-Whelen, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03543111     History of Changes
Other Study ID Numbers: HSC-MS-17-0474
H133G080042-10 ( Other Grant/Funding Number: National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR) )
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries