Viewing Study NCT03711760


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Study NCT ID: NCT03711760
Status: COMPLETED
Last Update Posted: 2025-11-25
First Post: 2018-10-10
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Telepsychology in Spinal Cord Injury
Sponsor: Santa Clara Valley Health & Hospital System
Organization:

Study Overview

Official Title: Telepsychology Intervention for Individuals With Spinal Cord Injury and Depression
Status: COMPLETED
Status Verified Date: 2025-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study will determine the effectiveness of tele-psychology in treating persons with spinal cord injury (SCI) with depressed mood in the early period post-rehabilitation discharge. Depression among individuals with SCI is the most common psychological condition following an injury; 22% of civilians with SCI and 28% of veterans with SCI experience depression after injury, which is higher than the able-bodied population (Williams 2015; Ullrich 2014). Individuals with SCI face many barriers in receiving psychotherapy, such as lack of accessible transportation, unfamiliarity with community resources, or stigma associated with seeking treatment for depression, which this project aims to address. Cognitive behavior therapy (CBT), which helps people develop different ways of thinking and behaving to reduce their psychological distress, will be provided via iPad FaceTime by a psychologist with expertise in working with persons with SCI.

The objectives of the proposed project are to reduce depressive symptoms, decrease associated symptoms of anxiety, and to improve satisfaction with life with CBT provided via tele-psychology. The secondary objective is to show intermediate efficacy of tele-psychology in persons with SCI with depressed mood.
Detailed Description: I. Rationale / Objectives This study will determine the effectiveness of tele-psychology in treating persons with spinal cord injury (SCI) with depressed mood in the early period post-rehabilitation discharge. Depression among individuals with SCI is the most common psychological condition following an injury; 22% of civilians with SCI and 28% of veterans with SCI experience depression after injury, which is higher than the able-bodied population (Williams 2015; Ullrich 2014). Individuals with SCI face many barriers in receiving psychotherapy, such as lack of accessible transportation, unfamiliarity with community resources, or stigma associated with seeking treatment for depression, which this project aims to address. Cognitive behavior therapy (CBT), which helps people develop different ways of thinking and behaving to reduce their psychological distress, will be provided via iPad FaceTime by a psychologist with expertise in working with persons with SCI.

The objectives of the proposed project are to reduce depressive symptoms, decrease associated symptoms of anxiety, and to improve satisfaction with life with CBT provided via tele-psychology. The secondary objective is to show intermediate efficacy of tele-psychology in persons with SCI with depressed mood.

II. Impact CBT via iPad FaceTime is expected to be a convenient and effective treatment for depression after SCI with short-term (14-week post-discharge) and intermediate (26-week post-discharge) benefits. This project would impact individuals with SCI, post-discharge from rehabilitation, through the provision of an innovative treatment for depression, easing the transition back to their home and community. Furthermore, CBT treatment will be provided in the comfort and privacy of the participant's home, therefore combating stigma, as well as physical and transportation-associated barriers. CBT via FaceTime does pose a potential confidentiality risk, but the study team will stress that both parties choose a location (i.e. private office for the psychologist and a private room at home for the participant) that will minimize this risk. Prior studies have shown a beneficial effect of CBT provided with tele-psychology among other populations. Telemedicine is rapidly advancing within the field of medicine; however, its impact on persons with SCI and the use of tele-psychology are not yet widespread. This proposed study aims to close this gap and can determine whether CBT via iPad improves mood and quality of life (as measured by satisfaction with life) and can assess if tele-psychology is an effective and replicable method for providing psychological care. With evidence from this study elucidating the effectiveness of tele-psychology utilizing rapidly advancing technology, tele-psychology for individuals with SCI may become as usual and routine as in-person psychological treatment within several years.

III. Contribution This project provides an innovative approach to treating depression and an exciting opportunity to understand the treatment effects of our proposed tele-psychological intervention for individuals with SCI. CBT treatment provided via iPad FaceTime tele-psychology for depression is a novel approach that can easily be disseminated to other SCI centers and community hospitals. Hence, medical teams will have an alternative option to consider during the discharge planning stages of rehabilitation and during their transition to home.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?:

Secondary ID Infos

Secondary ID Type Domain Link View
SC170243 OTHER_GRANT CDMRP-eBRAP Log Number View