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

Study Overview
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Brief Summary
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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.

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

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Behavioral: Zest


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zest<br>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<br>* 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.<br>|
| No Intervention: Control<br>No intervention - Control participants are provided intervention materials at the end of the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline | 
| 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. | 10 weeks | 
| 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. | 6 months | 
| 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. | Baseline | 
| 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. | 10 weeks | 
| 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. | 6 months | 
| 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. | Baseline | 
| 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. | 10 weeks | 
| 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. | 6 months |