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

University of Delaware

Status: Completed

Conditions: Spinal Cord Injuries

Treatments: Other: Active Control Condition; Other: eHealth Intervention

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05095506

W81XWH-20-1-0786 (Other Grant/Funding Number)

1564112

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups

eHeatlh Intervention Arm

Experimental group

Description:

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).

Treatment:

Other: eHealth Intervention

Active Control Arm

Active Comparator group

Description:

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.

Treatment:

Other: Active Control Condition