Spinal Cord InjuriesNCT03963843
Internet-delivered Cognitive Behavioural Therapy for Persons With Spinal Cord Injury
A study testing Guided ICBT and SCI rehabilitation mental health education in people with Spinal Cord Injuries and Anxiety, run by University of Regina at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Anxiety, Depression
- What is being tested?
- Guided ICBT and SCI rehabilitation mental health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 2 sitesCanada
- Study dates
- 18 Oct 2019to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Lawson Health Research Institute
London, Ontario, N6C 2A1
Online Therapy Unit, University of Regina
Regina, Saskatchewan, S4S 0A2
About this study
Official title: Internet-delivered Cognitive Behavioural Therapy for Persons With Spinal Cord Injury: Randomized Controlled Trial
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.
- Conditions
- Spinal Cord Injuries, Anxiety, Depression
- Being tested
- Guided ICBT, SCI rehabilitation mental health education
- Keywords
- spinal cord injuries, anxiety, depression, internet-delivered cognitive behaviour therapy
- Medical subject headings
- Spinal Cord Injuries, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided ICBTBehavioural
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.
SCI rehabilitation mental health educationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| SCI internet delivered cognitive behavioural therapy | Experimental | 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. Receives: Behavioral: Guided ICBT |
| SCI rehabilitation mental health education | Active comparator | 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. Receives: Other: SCI rehabilitation mental health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, 8 weeks, 3 months, 6 months
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
Measured: baseline, 8 weeks, 3 months, 6 months
Secondary outcomes (6)
Change in psychological distress
Measured by Kessler 10-Item Scale, higher scores indicate greater level of distress, scores range 10-50
Measured: baseline, 8 weeks, 3 months, 6 months
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.
Measured: baseline, 8 weeks, 3 months, 6 months
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.
Measured: baseline, 8 weeks, 3 months, 6 months
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.
Measured: baseline, 8 weeks, 3 months, 6 months
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.
Measured: baseline and 8 weeks
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.
Measured: baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start18 Oct 2019
- Primary completion1 Nov 2021
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Regina
- Sponsor type
- University, hospital or other
- Collaborators
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Responsible party
- Sponsor
- Investigators
- Heather Hadjistavropoulos, PhD, Principal investigator, University of ReginaSwati Mehta, PhD, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963843
- Sponsor's protocol ID
- 2019-020
- Status last verified
- Oct 2022
- First submitted
- 22 May 2019
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Cognitive Behavioural Therapy for Persons With Spinal Cord Injury: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03963843
- Acronym / sponsor ID
- 2019-020
- Conditions
- Spinal Cord Injuries, Anxiety, Depression
- Keywords
- spinal cord injuries, anxiety, depression, internet-delivered cognitive behaviour therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University of ReginaUniversity, hospital or other
- Collaborators
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Study start
- 18 Oct 2019 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 28 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCI internet delivered cognitive behavioural therapy | Experimental | Behavioral: Guided ICBTAn 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. |
| SCI rehabilitation mental health education | Active comparator | Other: SCI rehabilitation mental health educationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided ICBTAn 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. | Behavioural | SCI internet delivered cognitive behavioural therapy |
| SCI rehabilitation mental health educationParticipants 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. | Other | SCI rehabilitation mental health education |
Primary outcome
Change in depression
Time frame: baseline, 8 weeks, 3 months, 6 months
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
Time frame: baseline, 8 weeks, 3 months, 6 months
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
6 secondary outcomes
Change in psychological distress
Time frame: baseline, 8 weeks, 3 months, 6 months
Change in disability
Time frame: baseline, 8 weeks, 3 months, 6 months
Change in quality of life symptoms: SCI-QoL-SF
Time frame: baseline, 8 weeks, 3 months, 6 months
Change in pain: Brief Pain Inventory-Short Form
Time frame: baseline, 8 weeks, 3 months, 6 months
Treatment credibility
Time frame: baseline and 8 weeks
Treatment satisfaction: Internet-CBT Treatment Satisfaction Measure
Time frame: baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Spinal Cord Injuries
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Brief Prolonged Exposure Therapy Versus Clinical Standard to Reduce Posttraumatic Stress Post Spinal Cord Injury
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Transcutaneous Tibial Nerve Stimulation in Acute Spinal Cord Injury
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Hadjistavropoulos, PhD principal investigator
University of Regina
Swati Mehta, PhD principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided ICBT and SCI rehabilitation mental health education in people with Spinal Cord Injuries and Anxiety, run by University of Regina at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression (time frame: baseline, 8 weeks, 3 months, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.