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Completed

NCT Number: NCT03543111

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Montana, Missoula, Montana, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Baylor College of Medicine
  • National Institute on Disability, Independent Living, and Rehabilitation Research
  • TIRR Memorial Hermann
  • University of Montana

Registry information

Acronym: Zest

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 1, 2018
Registry last updated
May 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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