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

• ClinicalTrials.gov Identifier: NCT05095506
• Recruitment Status: Not yet recruiting
• First Posted: October 27, 2021
• Last Update Posted: October 27, 2021
• Sponsor: University of Delaware
• Collaborators: Kessler Foundation; Department of Veterans Affairs, New Jersey
• Information provided by (Responsible Party): David Tulsky, University of Delaware

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Spinal Cord Injuries	Other: eHealth Intervention; Other: Active Control Condition	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Initial Evaluation of an eHealth Self-Management System to Reduce Depression and Increase Resilience After SCI (SCIRP Pilot Clinical Trial)
• Estimated Study Start Date: April 2023
• Estimated Primary Completion Date: March 2024
• Estimated Study Completion Date: June 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: eHeatlh Intervention Arm; The intervention platform is an interactive, web-based self-management program comprised of computer-adaptive tests (CATs) to assess depression, anxiety, and resilience and multimedia-assisted components. Participants will access the system once a week for 6 weeks, complete the symptom monitoring CATs, receive score reports, and watch a system-assigned self-management strategy video (which is selected by the system based on the participant's current level of depression/anxiety symptoms).	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 Comparator: Active Control Arm; The active control condition is a static web-based program which also includes computer-adaptive tests (CATs) to assess depression, anxiety, and resilience, but does not provide score reports and plays a predetermined educational video (related to health promotion after SCI) each week. Participants will access the system once a week for 6 weeks, complete the symptom monitoring CATs and watch the educational video.	Other: 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.

Outcome Measures

Primary Outcome Measures :

1. Change in weekly depression symptoms as measured by the Spinal Cord Injury - Quality of Life (SCI-QOL) Depression computer adaptive test (CAT) [ Time Frame: Weeks 1-6 ]
   Patient-reported outcome measure of current depressive symptoms which is included in the intervention and control conditions each week.
2. Change in weekly anxiety symptoms as measured by the Spinal Cord Injury - Quality of Life (SCI-QOL) Anxiety computer adaptive test (CAT) [ Time Frame: Weeks 1-6 ]
   Patient-reported outcome measure of current anxiety symptoms which is included in the intervention and control conditions each week.

Secondary Outcome Measures :

1. Change in Current Depressive Symptoms as assessed by the Patient Health Questionnaire (PHQ)-8 [ Time Frame: Change from Baseline to Week 6. Also used for screening. ]
   Patient-reported measure of depression
2. Change in Current Symptoms of anxiety as assessed by the Generalized Anxiety Disorder (GAD-7) [ Time Frame: Change from Baseline to Week 6. Also used for screening. ]
   Patient-reported measure of depression
3. Change in weekly resilience levels as measured by the Spinal Cord Injury - Quality of Life (SCI-QOL) resilience computer adaptive test (CAT) [ Time Frame: Weeks 1-6 ]
   Patient-reported outcome measure of current resilience which is included in the intervention and control conditions each week.

Other Outcome Measures:

1. Qualitative information on the usability of the system as measured by a System Usability Survey [ Time Frame: 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. ]
   Participants will complete a usability survey following the final session to provide information on the usability of the system.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: David S Tulsky, PhD; 3028314606; dtulsky@udel.edu

Contact: Pamela A Kisala, MA; 9192373166; pkisala@udel.edu

Sponsors and Collaborators

University of Delaware

Kessler Foundation

Department of Veterans Affairs, New Jersey

More Information

• Responsible Party: David Tulsky, Professor and Director, Center for Health Assessment Research and Translation, University of Delaware
• ClinicalTrials.gov Identifier: NCT05095506
• Other Study ID Numbers: 1564112; W81XWH-20-1-0786 ( Other Grant/Funding Number: Department of Defense )
• First Posted: October 27, 2021
• Last Update Posted: October 27, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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