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

NCT ID: NCT05095506

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-08

Study Completion Date

2024-11-24

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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).

Group Type EXPERIMENTAL

eHealth Intervention

Intervention Type 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 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.

Group Type ACTIVE_COMPARATOR

Active Control Condition

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kessler Foundation

OTHER

Sponsor Role collaborator

Department of Veterans Affairs, New Jersey

FED

Sponsor Role collaborator

University of Delaware

OTHER

Sponsor Role lead

Responsible Party

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David Tulsky

Professor and Director, Center for Health Assessment Research and Translation

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Delaware College of Health Sciences

Newark, Delaware, United States

Site Status

Countries

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United States

Other Identifiers

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W81XWH-20-1-0786

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1564112

Identifier Type: -

Identifier Source: org_study_id