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

Primary Purpose

Spinal Cord Injuries

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
eHealth Intervention
Active Control Condition
Sponsored by
University of Delaware
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    eHeatlh Intervention Arm

    Active Control Arm

    Arm 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).

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Change in Current Depressive Symptoms as assessed by the Patient Health Questionnaire (PHQ)-8
    Patient-reported measure of depression
    Change in Current Symptoms of anxiety as assessed by the Generalized Anxiety Disorder (GAD-7)
    Patient-reported measure of depression
    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.

    Full Information

    First Posted
    October 22, 2021
    Last Updated
    August 2, 2023
    Sponsor
    University of Delaware
    Collaborators
    Kessler Foundation, Department of Veterans Affairs, New Jersey
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05095506
    Brief Title
    Evaluation of an eHealth System to Reduce Depression and Increase Resilience After SCI
    Acronym
    SCIRP
    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

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    September 2024 (Anticipated)
    Study Completion Date
    September 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Delaware
    Collaborators
    Kessler Foundation, Department of Veterans Affairs, New Jersey

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Cord Injuries

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    eHeatlh Intervention Arm
    Arm Type
    Experimental
    Arm 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).
    Arm Title
    Active Control Arm
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Other
    Intervention Name(s)
    eHealth Intervention
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Active Control Condition
    Intervention Description
    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 Outcome Measure Information:
    Title
    Change in weekly depression symptoms as measured by the Spinal Cord Injury - Quality of Life (SCI-QOL) Depression computer adaptive test (CAT)
    Description
    Patient-reported outcome measure of current depressive symptoms which is included in the intervention and control conditions each week.
    Time Frame
    Weeks 1-6
    Title
    Change in weekly anxiety symptoms as measured by the Spinal Cord Injury - Quality of Life (SCI-QOL) Anxiety computer adaptive test (CAT)
    Description
    Patient-reported outcome measure of current anxiety symptoms which is included in the intervention and control conditions each week.
    Time Frame
    Weeks 1-6
    Secondary Outcome Measure Information:
    Title
    Change in Current Depressive Symptoms as assessed by the Patient Health Questionnaire (PHQ)-8
    Description
    Patient-reported measure of depression
    Time Frame
    Change from Baseline to Week 6. Also used for screening.
    Title
    Change in Current Symptoms of anxiety as assessed by the Generalized Anxiety Disorder (GAD-7)
    Description
    Patient-reported measure of depression
    Time Frame
    Change from Baseline to Week 6. Also used for screening.
    Title
    Change in weekly resilience levels as measured by the Spinal Cord Injury - Quality of Life (SCI-QOL) resilience computer adaptive test (CAT)
    Description
    Patient-reported outcome measure of current resilience which is included in the intervention and control conditions each week.
    Time Frame
    Weeks 1-6
    Other Pre-specified Outcome Measures:
    Title
    Qualitative information on the usability of the system as measured by a System Usability Survey
    Description
    Participants will complete a usability survey following the final session to provide information on the usability of the system.
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    David S Tulsky, PhD
    Phone
    3028314606
    Email
    dtulsky@udel.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Pamela A Kisala, MA
    Phone
    9192373166
    Email
    pkisala@udel.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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