Clinical trial NCT05095506: Evaluation of an eHealth System to Reduce Depression and Increase Resilience After SCI
Official title: Initial Evaluation of an eHealth Self-Management System to Reduce Depression and Increase Resilience After SCI (SCIRP Pilot Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: University of Delaware
Sponsor class: OTHER
Collaborators: name: Kessler Foundation
name: Department of Veterans Affairs, New Jersey
First posted: 2021-10-27
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in weekly depression symptoms as measured by the Spinal Cord Injury - Quality of Life (SCI-QOL) Depression computer adaptive test (CAT)
timeFrame: Weeks 1-6
measure: Change in weekly anxiety symptoms as measured by the Spinal Cord Injury - Quality of Life (SCI-QOL) Anxiety computer adaptive test (CAT)
timeFrame: Weeks 1-6
Secondary outcomes:
measure: Change in Current Depressive Symptoms as assessed by the Patient Health Questionnaire (PHQ)-8
timeFrame: Change from Baseline to Week 6. Also used for screening.
measure: Change in Current Symptoms of anxiety as assessed by the Generalized Anxiety Disorder (GAD-7)
timeFrame: Change from Baseline to Week 6. Also used for screening.
measure: Change in weekly resilience levels as measured by the Spinal Cord Injury - Quality of Life (SCI-QOL) resilience computer adaptive test (CAT)
timeFrame: Weeks 1-6
Other outcomes:
measure: Qualitative information on the usability of the system as measured by a System Usability Survey
timeFrame: 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.
Locations:
city: Newark
country: United States
facility: University of Delaware College of Health Sciences
state: Delaware
Study officials:
References: