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Completed

NCT Number: NCT05095506

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Delaware College of Health Sciences

Newark, Delaware, 19716, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

eHealth intervention

Other

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

Other

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Collaborators

  • Department of Veterans Affairs, New Jersey
  • Kessler Foundation

Registry information

Official study title

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

Acronym: SCIRP

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 27, 2021
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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