Spinal Cord InjuriesZestNCT03543111
Promoting the Psychological Health of Women With SCI: A Virtual World Intervention
A study testing Zest in people with Spinal Cord Injuries, run by The University of Texas Health Science Center, Houston at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Zest
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Aug 2018to 15 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The University of Texas Health Science Center at Houston
Houston, Texas, 77006
Baylor College of Medicine
Houston, Texas, 77030
TIRR Memorial Hermann
Houston, Texas, 77030
University of Montana
Missoula, Montana, 59812
About this study
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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Zest
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZestBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Zest | Experimental | 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. Receives: Behavioral: Zest |
| Control | No intervention | No intervention - Control participants are provided intervention materials at the end of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start1 Aug 2018
- Primary completion15 May 2021
- Study completion15 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research, TIRR Memorial Hermann, University of Montana, Baylor College of Medicine
- Responsible party
- Principal investigator, Susan Robinson-Whelen, The University of Texas Health Science Center, Houston
- Investigators
- Susan Robinson-Whelen, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543111
- Sponsor's protocol ID
- HSC-MS-17-0474
- Other IDs
- H133G080042-10
- Acronym
- Zest
- Status last verified
- May 2022
- First submitted
- 14 May 2018
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Robinson-Whelen S, Hughes RB, Gonzalez D, Norah-Davis L, Leon-Novelo LG, Ngan E, Whelen ML, Wenzel L, Taylor HB. Promoting psychological health in women with spinal cord injury: A randomized trial. Rehabil Psychol. 2025 Nov;70(4):426-436. doi: 10.1037/rep0000602. Epub 2025 Feb 6.
PubMed 39913478
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting the Psychological Health of Women With SCI: A Virtual World Intervention
- ClinicalTrials.gov ID
- NCT03543111
- Acronym / sponsor ID
- Zest / HSC-MS-17-0474
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research, TIRR Memorial Hermann, University of Montana, Baylor College of Medicine
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 15 May 2021 (actual)
- First posted
- 1 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zest | Experimental | Behavioral: ZestZest 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. |
| Control | No intervention | –No intervention - Control participants are provided intervention materials at the end of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZestZest 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. | Behavioural | Zest |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
9 secondary outcomes
Self-efficacy as assessed by the Generalized Self-Efficacy Scale
Time frame: Baseline
Self-efficacy as assessed by the Generalized Self-Efficacy Scale
Time frame: 10 weeks
Self-efficacy as assessed by the Generalized Self-Efficacy Scale
Time frame: 6 months
Social connectedness as assessed by the Medical Outcomes Study Social Support Scale, Emotional/Informational Support subscale.
Time frame: Baseline
Social connectedness as assessed by the Medical Outcomes Study Social Support Scale, Emotional/Informational Support subscale.
Time frame: 10 weeks
Social connectedness as assessed by the Medical Outcomes Study Social Support Scale, Emotional/Informational Support subscale.
Time frame: 6 months
Perceived stress as assessed the by Perceived Stress Scale
Time frame: Baseline
Perceived stress as assessed the by Perceived Stress Scale
Time frame: 10 weeks
Perceived stress as assessed the by Perceived Stress Scale
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- Derived from this study: PubMed 39913478Robinson-Whelen S, Hughes RB, Gonzalez D, Norah-Davis L, Leon-Novelo LG, Ngan E, Whelen ML, Wenzel L, Taylor HB. Promoting psychological health in women with spinal cord injury: A randomized trial. Rehabil Psychol. 2025 Nov;70(4):426-436. doi: 10.1037/rep0000602. Epub 2025 Feb 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Robinson-Whelen, PhD principal investigator
The University of Texas Health Science Center, Houston
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zest in people with Spinal Cord Injuries, run by The University of Texas Health Science Center, Houston at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-esteem as assessed by the Rosenberg Self-Esteem Scale (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03543111, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2022.