Telepsychology in Spinal Cord Injury

NCT ID: NCT03711760

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2024-08-21

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.

Conditions

Spinal Cord Injuries; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

intervention

telepsychology treatment

Group Type: EXPERIMENTAL

telepsychology

Intervention Type: BEHAVIORAL

CBT delivered by telepsychology

usual care

standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

telepsychology

CBT delivered by telepsychology

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adults 18 years or older with traumatic or non-traumatic SCI at any level of injury
• Individuals with acute SCI being discharged to or residing in a private residence in the state of California
• Within one year of date of injury

• Mild to moderate depression (PHQ-9 total score between 5-14)
• Intact cognitive status (i.e., full scale MoCA ≥ 25). Potential subjects being screened remotely or who cannot complete the motoric components of the MoCA will be screened with the MoCA Blind (required score ≥ 17)

Exclusion Criteria

• Medically unstable as determined by the subject's treating physician or a review of medical records (e.g. pneumonia)
• Acute psychosis
• Incapable of giving informed consent
• Inability to comprehend written or oral English
• For Non-County of Santa Clara Residents: Inability to identify a treating physician to the study team. (* Please contact the study team if you are not sure who your treating physician may be)

• Endorsement of suicidality on the PHQ-9

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: collaborator

Congressionally Directed Medical Research Programs

FED

Sponsor Role: collaborator

Santa Clara Valley Health & Hospital System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kazuko Shem, MD

Role: PRINCIPAL_INVESTIGATOR

Santa Clara Valley Medical Center

Locations

Santa Clara Valley Medical Center

San Jose, California, United States

Countries

United States

Related Links

https://www.scvmc.org/health-care-services/rehabilitation/rehabilitation-research-center/research-projects

Rehabilitation Research Center

Other Identifiers

SC170243

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SC170243

Identifier Type: -

Identifier Source: org_study_id