Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03543111
Other study ID # HSC-MS-17-0474
Secondary ID H133G080042-10
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2018
Est. completion date May 15, 2021

Study information

Verified date May 2022
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 175
Est. completion date May 15, 2021
Est. primary completion date May 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Baylor College of Medicine Houston Texas
United States The University of Texas Health Science Center at Houston Houston Texas
United States TIRR Memorial Hermann Houston Texas
United States University of Montana Missoula Montana

Sponsors (5)

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

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06321172 - Muscle and Bone Changes After 6 Months of FES Cycling N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05484557 - Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury N/A
Suspended NCT05542238 - The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury N/A
Recruiting NCT05503316 - The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System N/A
Not yet recruiting NCT05506657 - Early Intervention to Promote Return to Work for People With Spinal Cord Injury N/A
Recruiting NCT03680872 - Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System N/A
Recruiting NCT04105114 - Transformation of Paralysis to Stepping Early Phase 1
Completed NCT04221373 - Exoskeletal-Assisted Walking in SCI Acute Inpatient Rehabilitation N/A
Completed NCT00116337 - Spinal Cord Stimulation to Restore Cough N/A
Completed NCT03898700 - Coaching for Caregivers of Children With Spinal Cord Injury N/A
Recruiting NCT04883463 - Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury N/A
Active, not recruiting NCT04881565 - Losing Balance to Prevent Falls After Spinal Cord Injury (RBT+FES) N/A
Completed NCT04864262 - Photovoice for Spinal Cord Injury to Prevent Falls N/A
Recruiting NCT04007380 - Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI N/A
Active, not recruiting NCT04544761 - Resilience in Persons Following Spinal Cord Injury
Completed NCT03220451 - Use of Adhesive Elastic Taping for the Therapy of Medium/Severe Pressure Ulcers in Spinal Cord Injured Patients N/A
Terminated NCT03170557 - Randomized Comparative Trial for Persistent Pain in Spinal Cord Injury: Acupuncture vs Aspecific Needle Skin Stimulation N/A
Recruiting NCT04811235 - Optical Monitoring With Near-Infrared Spectroscopy for Spinal Cord Injury Trial N/A
Recruiting NCT04736849 - Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury N/A