Evaluation of an eHealth System to Reduce Depression and Increase Resilience After SCI

Spinal Cord Injuries Clinical Trial

— SCIRP  

Official title:

Initial Evaluation of an eHealth Self-Management System to Reduce Depression and Increase Resilience After SCI (SCIRP Pilot Clinical Trial)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05095506
• Other study ID #: 1564112
• Secondary ID: W81XWH-20-1-0786
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: September 2025

Study information

• Verified date: August 2023
• Source: University of Delaware
• Contact: David S Tulsky, PhD
• Phone: 3028314606
• Email: dtulsky[@]udel.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The availability of symptom monitoring and self-management (SMSM) interventions is especially important for civilians and military populations with spinal cord injuries (SCI). High rates of depressive disorders (20-40%) and anxiety disorders (20-25%) have been found in both civilian and military populations and are significant contributors to both quality of life and well-being after SCI. Previous self-management interventions targeting physical activity and self-reliance in individuals with SCI have demonstrated significant health and lifestyle benefits. However, it has been shown that the injured individual's psychological outlook and mood can either enable or hinder self-management efforts and that currently available SCI-specific self-management programs may be inadequate. Developing interventions to reduce mental health symptoms following SCI is therefore critical to improve the lives of individuals, alleviate resource strain on military and civilian health care systems, and potentially reduce the rate of mortality by suicide in Veterans and civilians living with SCI. The current study will build on prior work developing an intervention platform to assess the effectiveness of this eHealth SMSM system and will test the feasibility and effectiveness of the intervention platform.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: September 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Access to the internet and an internet-enabled device

• Diagnosis of a sudden-onset (i.e. not due to a degenerative disease such as ALS or MS) SCI (either traumatic or non-traumatic)

• Discharged from initial inpatient rehabilitation and living in the community for at least 3 months

• Age 18 or older at the time of enrollment

• Age at least 16 years at the time of their spinal cord injury

• Current symptoms (no more than two weeks from the time of consent) of at least mild depression and/or anxiety, as determined by a score of =5 on the eight-item Patient Health Questionnaire depression scale (PHQ-8) and/or seven-item Generalized Anxiety Disorder measure (GAD-7).

Exclusion Criteria:

• Male and female participants younger than 18 years old

• A lack of English proficiency needed to comprehend and complete study measures and review online study content.

• Current cognitive impairment that would limit comprehension of informed consent or study procedures, as determined by the member of the study team conducting informed consent.

• Lack of access to the internet and an internet-enabled computer or smart device.

• A spinal cord injury that is due to a degenerative disease (e.g. ALS, MS) and not sudden onset.

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Other:
• eHealth Intervention
The intervention platform is interactive, and uses multimedia-assisted components. The system uses three SCI-QOL computer-adaptive tests (CATs) to assess depression, anxiety, and resilience; cut scores are used to tailor multi-media content that specifically addresses users' emotional health concerns.
• Active Control Condition
The active control condition is a static site that displays symptom assessments followed by one educational video each week. These videos, which play in a predetermined order, provide education about managing physical health in individuals with SCI.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Delaware	Department of Veterans Affairs, New Jersey, Kessler Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Qualitative information on the usability of the system as measured by a System Usability Survey	Participants will complete a usability survey following the final session to provide information on the usability of the system.	At the end of the final (6th) system session. Each system session is open for 4 days or until the participant completes the session, whichever comes first.
Primary	Change in weekly depression symptoms as measured by the Spinal Cord Injury - Quality of Life (SCI-QOL) Depression computer adaptive test (CAT)	Patient-reported outcome measure of current depressive symptoms which is included in the intervention and control conditions each week.	Weeks 1-6
Primary	Change in weekly anxiety symptoms as measured by the Spinal Cord Injury - Quality of Life (SCI-QOL) Anxiety computer adaptive test (CAT)	Patient-reported outcome measure of current anxiety symptoms which is included in the intervention and control conditions each week.	Weeks 1-6
Secondary	Change in Current Depressive Symptoms as assessed by the Patient Health Questionnaire (PHQ)-8	Patient-reported measure of depression	Change from Baseline to Week 6. Also used for screening.
Secondary	Change in Current Symptoms of anxiety as assessed by the Generalized Anxiety Disorder (GAD-7)	Patient-reported measure of depression	Change from Baseline to Week 6. Also used for screening.
Secondary	Change in weekly resilience levels as measured by the Spinal Cord Injury - Quality of Life (SCI-QOL) resilience computer adaptive test (CAT)	Patient-reported outcome measure of current resilience which is included in the intervention and control conditions each week.	Weeks 1-6