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Telepsychology in Spinal Cord Injury

Primary Purpose

Spinal Cord Injuries, Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
telepsychology
Sponsored by
Santa Clara Valley Health & Hospital System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring telepsychology, spinal cord injuries, depression, cognitive behavioral therapy

Eligibility Criteria

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

Inclusion Criteria:

Pre-screening 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

Tele-psychology (full study) Inclusion Criteria:

  • 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:

Pre-screening 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)

Tele-psychology (full study) Exclusion Criteria:

  • Endorsement of suicidality on the PHQ-9

Sites / Locations

  • Santa Clara Valley Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention

usual care

Arm Description

telepsychology treatment

standard of care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Generalized Anxiety Disorder-7
The Generalized Anxiety Disorder Instrument is a 7-item tool for assessment of anxiety severity. It has a total scoring range of 0 to 21, and a higher score signifies more severe anxiety.
Change in Satisfaction with Life Scale
The Satisfaction with Life Scale is a 5-item tool for assessing life satisfaction and subjective quality of life. It has a total scoring range of 7-35, and a higher score signifies better satisfaction with life.

Full Information

First Posted
October 10, 2018
Last Updated
February 15, 2023
Sponsor
Santa Clara Valley Health & Hospital System
Collaborators
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT03711760
Brief Title
Telepsychology in Spinal Cord Injury
Official Title
Telepsychology Intervention for Individuals With Spinal Cord Injury and Depression
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santa Clara Valley Health & Hospital System
Collaborators
University of California, San Francisco

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Depression
Keywords
telepsychology, spinal cord injuries, depression, cognitive behavioral therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
single center, blinded assessor, controlled, randomized, intention to treat.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention
Arm Type
Experimental
Arm Description
telepsychology treatment
Arm Title
usual care
Arm Type
No Intervention
Arm Description
standard of care
Intervention Type
Behavioral
Intervention Name(s)
telepsychology
Intervention Description
CBT delivered by telepsychology
Primary Outcome Measure Information:
Title
Change in Patient Health Questionnaire-9
Description
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.
Time Frame
Baseline, 12 weeks, 24 weeks
Secondary Outcome Measure Information:
Title
Change in Generalized Anxiety Disorder-7
Description
The Generalized Anxiety Disorder Instrument is a 7-item tool for assessment of anxiety severity. It has a total scoring range of 0 to 21, and a higher score signifies more severe anxiety.
Time Frame
Baseline, 12 weeks, 24 weeks
Title
Change in Satisfaction with Life Scale
Description
The Satisfaction with Life Scale is a 5-item tool for assessing life satisfaction and subjective quality of life. It has a total scoring range of 7-35, and a higher score signifies better satisfaction with life.
Time Frame
Baseline, 12 weeks, 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pre-screening 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 Tele-psychology (full study) Inclusion Criteria: 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: Pre-screening 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) Tele-psychology (full study) Exclusion Criteria: Endorsement of suicidality on the PHQ-9
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kazuko Shem, MD
Phone
4088852100
Email
kazuko.shem@hhs.sccgov.org
First Name & Middle Initial & Last Name or Official Title & Degree
Ben Dirlikov, MA
Phone
4087818175
Email
ben.dirlikov@hhs.sccgov.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kazuko Shem, MD
Organizational Affiliation
Santa Clara Valley Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Santa Clara Valley Medical Center
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kazuko Shem, MD
Phone
408-885-2100
Email
Kazuko.Shem@hhs.sccgov.org
First Name & Middle Initial & Last Name & Degree
Ben Dirlikov, MA
Phone
4087818175
Email
Ben.Dirlikov@hhs.sccgov.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Telepsychology in Spinal Cord Injury

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