NCT03711760

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 18, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2024

Completed
Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

5.4 years

First QC Date

October 10, 2018

Last Update Submit

November 19, 2025

Conditions

Spinal Cord InjuriesDepression

Keywords

telepsychologyspinal cord injuriesdepressioncognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

  • Change in Patient Health Questionnaire-9

    The Patient Health Questionnaire - 9 is a 9-item tool for assessment of depression severity. It has a total scoring range of 0 to 27, and a higher score signifies more severe depression.

    Baseline, 12 weeks, 24 weeks

Secondary Outcomes (2)

  • Change in Generalized Anxiety Disorder-7

    Baseline, 12 weeks, 24 weeks

  • Change in Satisfaction with Life Scale

    Baseline, 12 weeks, 24 weeks

Study Arms (2)

intervention

EXPERIMENTAL

telepsychology treatment

Behavioral: telepsychology

usual care

NO INTERVENTION

standard of care

Interventions

telepsychologyBEHAVIORAL

CBT delivered by telepsychology

intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santa Clara Valley Medical Center

San Jose, California, 95128, United States

Location

Related Links

MeSH Terms

Conditions

Spinal Cord InjuriesDepression

Interventions

Mental Health Teletherapy

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Kazuko Shem, MD

    Santa Clara Valley Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: single center, blinded assessor, controlled, randomized, intention to treat.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2018

First Posted

October 18, 2018

Study Start

April 1, 2019

Primary Completion

August 21, 2024

Study Completion

August 21, 2024

Last Updated

November 25, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)