search
Back to results

Internet-delivered Cognitive Behavioural Therapy for Persons With Spinal Cord Injury

Primary Purpose

Spinal Cord Injuries, Anxiety, Depression

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Guided ICBT
SCI rehabilitation mental health education
Sponsored by
University of Regina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring spinal cord injuries, anxiety, depression, internet-delivered cognitive behaviour therapy

Eligibility Criteria

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

Inclusion Criteria:

  • 18 years of age or older
  • residing in Canada
  • endorsing symptoms of anxiety or depression
  • diagnosed with a spinal cord injury
  • condition does not impact ability to complete treatment (ex.cognitive impairment)
  • able to access a computer and internet service
  • willing to provide a physician as emergency contact

Exclusion Criteria:

  • high suicide risk
  • suicide attempt or hospitalization in the last year
  • primary problems with psychosis, alcohol or drug problems, mania
  • currently receiving active psychological treatment for anxiety or depression
  • not present in country during treatment
  • concerns about online therapy

Sites / Locations

  • Lawson Health Research Institute
  • Online Therapy Unit, University of Regina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SCI internet delivered cognitive behavioural therapy

SCI rehabilitation mental health education

Arm Description

An 8-week internet- delivered cognitive behavioural therapy (ICBT) will be delivered to participants who have sustained a spinal cord injury. In addition to the online program, a health educator with experience delivering ICBT will provide support by email once a week. The health educator will spend approximately 15 minutes per week/per client.

Participants will receive information provided to SCI patients in usual care at specialized SCI rehabilitation units (the Spinal Cord Injury Rehabilitation Evidence (SCIRE) Community handouts available at: https://scireproject.com/community/handouts/). The lessons will include information on spinal cord injury rehabilitation: 1)spinal cord injury basics, 2)mental health after SCI, 3)pain after SCI, 4)understanding rehabilitation 5)summary of lessons through an online platform over 8 weeks. A health educator will check in with participants once a week to answer any content related questions. The health educator will spend approximately 15 minutes per week/per client.

Outcomes

Primary Outcome Measures

Change in depression
Measured by Patient Health Questionnaire - 9 Item (PHQ-9), Higher scores indicate greater levels of depression. 0-4 No Depression, 5-9 Mild, 10-14 Moderate, 15-19 Moderately Severe, >19 Severe
Change in anxiety
Measured by Generalize Anxiety Disorder - 7 Item (GAD7), higher scores indicate greater level of anxiety. 0-4 Minimal, 5-9 Mild, 10-14 Moderate, 15-21 Severe

Secondary Outcome Measures

Change in psychological distress
Measured by Kessler 10-Item Scale, higher scores indicate greater level of distress, scores range 10-50
Change in disability
Measured by World Health Organization Disability Assessment Schedule - 12 Item, higher scores indicate greater level of disability. Scores range from 0-48.
Change in quality of life symptoms: SCI-QoL-SF
Spinal Cord Injury Quality of Life Short Form; SCI-QoL-SF, subscales of positive affect, resilience, self esteem higher scores indicate better function; subscale of grief/loss higher scores indicate severe symptoms.
Change in pain: Brief Pain Inventory-Short Form
Measured by Brief Pain Inventory-Short Form, the measure includes 4 items regarding pain intensity with scores ranging from 0-10 with higher scores indicating greater level of pain intensity; 7 items assess pain interference, scores ranging from 0-10 with higher scores indicating greater pain interference.
Treatment credibility
Measured by Treatment Credibility Questionnaire (TCQ) which contains 4 items. The first three items range from 0-9 with higher scores indicating better outcome, and the fourth item ranges from 0-100%, with higher scores indicating greater improvement in functioning.
Treatment satisfaction: Internet-CBT Treatment Satisfaction Measure
Measured by Internet-CBT Treatment Satisfaction Measure, each item is measured on a 0-4 scale, with higher scores indicating greater level of satisfaction.

Full Information

First Posted
May 22, 2019
Last Updated
October 31, 2022
Sponsor
University of Regina
Collaborators
Lawson Health Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT03963843
Brief Title
Internet-delivered Cognitive Behavioural Therapy for Persons With Spinal Cord Injury
Official Title
Internet-delivered Cognitive Behavioural Therapy for Persons With Spinal Cord Injury: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 18, 2019 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Regina
Collaborators
Lawson Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In Canada the prevalence of spinal cord injury (SCI) is approximately 85,556, with incidence rates of traumatic and non-traumatic SCI at 1,785 and 2,286 cases per year, respectively. Common secondary health conditions experienced by individuals with SCI include psychological distress and pain. Appropriate management of these secondary conditions, through a multidisciplinary approach, is imperative as they have been shown to contribute to slower recovery, increased negative outcomes, and greater rates of rehospitalizations and health care utilization. However, resource limitations can restrict the ability of service providers to deliver these integrative biopsychosocial approaches in the community. Guided internet delivered cognitive behavioural therapy (ICBT) program offers an alternative approach for psychosocial service delivery in the community. The program provides online structured self-help modules based on the principles of cognitive behavioural therapy (CBT) in combination with guidance from a coach through weekly emails and telephone calls. ICBT was shown to have similar effects to face-to-face CBT. Results from the investigator's pilot pre-post study (ClinicalTrials.gov: NCT03457714), found significant effects of guided ICBT on primary outcome of depression (d=1.20, p=.02) post-intervention and gains were maintained at 3-month follow-up among persons with SCI. Significant improvements in secondary outcomes including pain interference, resilience, positive affect, self-efficacy, ability to participate, and grief were also found.These studies demonstrate that guided ICBT is a safe and effective alternative to face-to-face interventions and it may be beneficial for underserviced populations. In the proposed trial, the investigators will examine the efficacy of the Guided ICBT Chronic Conditions Course for persons with SCI versus an online SCI Rehabilitation Education program. All participants will complete questionnaires prior to the start of the program, before each lesson of the program, once they have completed the program, and 3 months after completing the program. The primary outcome measures include anxiety and depression. As part of the battery of questionnaires administered after the completion of the program, clients will be asked to rate the program content, the overall service, and their satisfaction with the program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Anxiety, Depression
Keywords
spinal cord injuries, anxiety, depression, internet-delivered cognitive behaviour therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
122 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SCI internet delivered cognitive behavioural therapy
Arm Type
Experimental
Arm Description
An 8-week internet- delivered cognitive behavioural therapy (ICBT) will be delivered to participants who have sustained a spinal cord injury. In addition to the online program, a health educator with experience delivering ICBT will provide support by email once a week. The health educator will spend approximately 15 minutes per week/per client.
Arm Title
SCI rehabilitation mental health education
Arm Type
Active Comparator
Arm Description
Participants will receive information provided to SCI patients in usual care at specialized SCI rehabilitation units (the Spinal Cord Injury Rehabilitation Evidence (SCIRE) Community handouts available at: https://scireproject.com/community/handouts/). The lessons will include information on spinal cord injury rehabilitation: 1)spinal cord injury basics, 2)mental health after SCI, 3)pain after SCI, 4)understanding rehabilitation 5)summary of lessons through an online platform over 8 weeks. A health educator will check in with participants once a week to answer any content related questions. The health educator will spend approximately 15 minutes per week/per client.
Intervention Type
Behavioral
Intervention Name(s)
Guided ICBT
Intervention Description
An 8-week internet- delivered cognitive behavioural therapy (ICBT) will be delivered to participants who have sustained a spinal cord injury. In addition to the online program, a health educator with experience delivering ICBT will provide support by email once a week. The health educator will spend approximately 15 minutes per week/per client.
Intervention Type
Other
Intervention Name(s)
SCI rehabilitation mental health education
Intervention Description
Participants will receive information provided to SCI patients in usual care at specialized SCI rehabilitation units (the Spinal Cord Injury Rehabilitation Evidence (SCIRE) Community handouts available at: https://scireproject.com/community/handouts/). The lessons will include information on spinal cord injury rehabilitation: 1)spinal cord injury basics, 2)mental health after SCI, 3)pain after SCI, 4)understanding rehabilitation 5)summary of lessons through an online platform over 8 weeks. A health educator will check in with participants once a week to answer any content related questions. The health educator will spend approximately 15 minutes per week/per client.
Primary Outcome Measure Information:
Title
Change in depression
Description
Measured by Patient Health Questionnaire - 9 Item (PHQ-9), Higher scores indicate greater levels of depression. 0-4 No Depression, 5-9 Mild, 10-14 Moderate, 15-19 Moderately Severe, >19 Severe
Time Frame
baseline, 8 weeks, 3 months, 6 months
Title
Change in anxiety
Description
Measured by Generalize Anxiety Disorder - 7 Item (GAD7), higher scores indicate greater level of anxiety. 0-4 Minimal, 5-9 Mild, 10-14 Moderate, 15-21 Severe
Time Frame
baseline, 8 weeks, 3 months, 6 months
Secondary Outcome Measure Information:
Title
Change in psychological distress
Description
Measured by Kessler 10-Item Scale, higher scores indicate greater level of distress, scores range 10-50
Time Frame
baseline, 8 weeks, 3 months, 6 months
Title
Change in disability
Description
Measured by World Health Organization Disability Assessment Schedule - 12 Item, higher scores indicate greater level of disability. Scores range from 0-48.
Time Frame
baseline, 8 weeks, 3 months, 6 months
Title
Change in quality of life symptoms: SCI-QoL-SF
Description
Spinal Cord Injury Quality of Life Short Form; SCI-QoL-SF, subscales of positive affect, resilience, self esteem higher scores indicate better function; subscale of grief/loss higher scores indicate severe symptoms.
Time Frame
baseline, 8 weeks, 3 months, 6 months
Title
Change in pain: Brief Pain Inventory-Short Form
Description
Measured by Brief Pain Inventory-Short Form, the measure includes 4 items regarding pain intensity with scores ranging from 0-10 with higher scores indicating greater level of pain intensity; 7 items assess pain interference, scores ranging from 0-10 with higher scores indicating greater pain interference.
Time Frame
baseline, 8 weeks, 3 months, 6 months
Title
Treatment credibility
Description
Measured by Treatment Credibility Questionnaire (TCQ) which contains 4 items. The first three items range from 0-9 with higher scores indicating better outcome, and the fourth item ranges from 0-100%, with higher scores indicating greater improvement in functioning.
Time Frame
baseline and 8 weeks
Title
Treatment satisfaction: Internet-CBT Treatment Satisfaction Measure
Description
Measured by Internet-CBT Treatment Satisfaction Measure, each item is measured on a 0-4 scale, with higher scores indicating greater level of satisfaction.
Time Frame
baseline and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or older residing in Canada endorsing symptoms of anxiety or depression diagnosed with a spinal cord injury condition does not impact ability to complete treatment (ex.cognitive impairment) able to access a computer and internet service willing to provide a physician as emergency contact Exclusion Criteria: high suicide risk suicide attempt or hospitalization in the last year primary problems with psychosis, alcohol or drug problems, mania currently receiving active psychological treatment for anxiety or depression not present in country during treatment concerns about online therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Hadjistavropoulos, PhD
Organizational Affiliation
University of Regina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Swati Mehta, PhD
Organizational Affiliation
Lawson Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lawson Health Research Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 2A1
Country
Canada
Facility Name
Online Therapy Unit, University of Regina
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4S 0A2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Internet-delivered Cognitive Behavioural Therapy for Persons With Spinal Cord Injury

We'll reach out to this number within 24 hrs