Spinal Cord InjuriesNCT03457714
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
An observational study of Spinal Cord Injuries and Depression, run by University of Regina at 1 site 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, Depression, Anxiety
- What is being tested?
- Guided ICBT for persons with Spinal Cord Injury and Survey
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 7 Sep 2017to 31 Dec 2018
- Phase
- Observational
- 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
Study population: Any individual with a spinal cord injury will be recruited through primary care physicians, rehabilitation facilities, and community peer groups.
Who may be able to join
- 18 years of age or older
- residing in Canada
- diagnosed with spinal cord injury
- 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 Canada during treatment
- concerns about online therapy
Trial locations and contacts
1 site in 1 country.
Canada1 site
Online Therapy Unit, University of Regina
Regina, Saskatchewan, S4S 0A2
About this study
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. In Canada over 37% of individuals with SCI expressed a need for emotional counselling; of these, only 43% felt that these needs were met. Transportation can also be a significant issue for persons with SCI, with 87% and 73% respectively expressing a need for short- and long-distance transportation. 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 has shown to have a greater reduction in levels of anxiety and depression post treatment compared to a waitlist control group, and these levels were maintained at both 3 and 12 month follow-ups. ICBT was shown to have similar effects to face-to-face CBT. These studies demonstrate that guided ICBT is a safe and effective alternative to face-to-face interventions and it may be beneficial for under serviced populations. Hence, examination of its effectiveness is warranted in the SCI population which faces various psychological and somatic secondary issues. Participants with SCI will receive a 8 week guided ICBT program called the Chronic Conditions Course for persons with SCI. The program is completed over 8 weeks with once a week guidance from a coach. The guided course consists of five lessons, "Do It Yourself" activities, and case vignettes adapted from persons with SCI. The course also provides guidance and resources on other essential skills for persons with SCI, including communicating with health care professional, managing chronic pain, and sleep hygiene. Psychosocial outcomes will be assessed at baseline, 8 weeks, and at 3 months. Data on intervention usage and satisfaction measures will also be examined through a qualitative interview. Caregivers of participants will be asked to complete self-report measures and a qualitative interview regarding their caregiver burden.
- Conditions
- Spinal Cord Injuries, Depression, Anxiety
- Being tested
- Guided ICBT for persons with Spinal Cord Injury, Survey
- Keywords
- spinal cord injuries, anxiety, depression, internet-delivered cognitive behaviour therapy, pilot study
- Medical subject headings
- Spinal Cord Injuries, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided ICBT for persons with Spinal Cord InjuryBehavioural
An 8-week guided 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 guide with experience delivering ICBT will provide support by email or telephone once a week. The guide will spend approximately 15 minutes per week/per client.
SurveyOther
Caregiver burden and mental health will be assessed through online questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Guided I-CBT for persons with SCI | Persons with spinal cord injury Receives: Behavioral: Guided ICBT for persons with Spinal Cord Injury; Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression
Patient Health Questionnaire - 9 Item (PHQ-9). Higher total scores indicate greater severity of depression. Scores range from 0 to 27.
Measured: baseline, start of each Lesson 2-5, 8 weeks, 3 months
Change in anxiety
Generalize Anxiety Disorder - 7 Item (GAD7). Higher total scores indicate greater severity of anxiety. Scores range from 0 to 21
Measured: baseline, start of each Lesson 2-5, 8 weeks, 3 months
Change in Caregiver Burden from baseline to 8 weeks (Caregivers of persons with SCI only)
Caregiver burden questionnaire. The tool has 12 items. Total scores ranging from 0 to 18. Higher scores indicate greater burden
Measured: baseline, 8 weeks
Secondary outcomes (5)
Pain (Persons with SCI only)
International Spinal Cord Injury Pain Basic Data Set v2.0 ISCIPBDS
Measured: baseline, 8 weeks, 3 months
Pain interference (Persons with SCI only)
Brief Pain Inventory Short Form; BPI-SF
Measured: baseline, 8 weeks, 3 months
Quality of life (Persons with SCI only)
Spinal Cord Injury Quality of Life Short Form; SCI-QoL-SF
Measured: baseline, 8 weeks, 3 months
Service usage (Persons with SCI only)
Measured: baseline, 8 weeks, 3 months
Quality of Life (Caregivers of persons with SCI only)
EQ5D
Measured: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start7 Sep 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Regina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Swati Mehta, PhD, Principal investigator, University of ReginaHeather D Hadjistavropoulos, PhD, Study director, University of Regina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03457714
- Sponsor's protocol ID
- 2017-104
- Status last verified
- Apr 2019
- First submitted
- 7 Dec 2017
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mehta S, Hadjistavropoulos HD, Earis D, Titov N, Dear BF. Patient perspectives of Internet-delivered cognitive behavior therapy for psychosocial issues post spinal cord injury. Rehabil Psychol. 2019 Aug;64(3):351-359. doi: 10.1037/rep0000276. Epub 2019 Apr 8.
PubMed 30958020
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
- ClinicalTrials.gov ID
- NCT03457714
- Acronym / sponsor ID
- 2017-104
- Conditions
- Spinal Cord Injuries, Depression, Anxiety
- Keywords
- spinal cord injuries, anxiety, depression, internet-delivered cognitive behaviour therapy, pilot study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ReginaUniversity, hospital or other
- Study start
- 7 Sep 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 7 Mar 2018 (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. In Canada over 37% of individuals with SCI expressed a need for emotional counselling; of these, only 43% felt that these needs were met. Transportation can also be a significant issue for persons with SCI, with 87% and 73% respectively expressing a need for short- and long-distance transportation. 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 has shown to have a greater reduction in levels of anxiety and depression post treatment compared to a waitlist control group, and these levels were maintained at both 3 and 12 month follow-ups. ICBT was shown to have similar effects to face-to-face CBT. These studies demonstrate that guided ICBT is a safe and effective alternative to face-to-face interventions and it may be beneficial for under serviced populations. Hence, examination of its effectiveness is warranted in the SCI population which faces various psychological and somatic secondary issues. Participants with SCI will receive a 8 week guided ICBT program called the Chronic Conditions Course for persons with SCI. The program is completed over 8 weeks with once a week guidance from a coach. The guided course consists of five lessons, "Do It Yourself" activities, and case vignettes adapted from persons with SCI. The course also provides guidance and resources on other essential skills for persons with SCI, including communicating with health care professional, managing chronic pain, and sleep hygiene. Psychosocial outcomes will be assessed at baseline, 8 weeks, and at 3 months. Data on intervention usage and satisfaction measures will also be examined through a qualitative interview. Caregivers of participants will be asked to complete self-report measures and a qualitative interview regarding their caregiver burden.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Guided I-CBT for persons with SCI | – | Behavioral: Guided ICBT for persons with Spinal Cord Injury, Other: SurveyPersons with spinal cord injury |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any individual with a spinal cord injury will be recruited through primary care physicians, rehabilitation facilities, and community peer groups.
Key inclusion criteria (5 listed)
- 18 years of age or older
- residing in Canada
- diagnosed with spinal cord injury
- able to access a computer and internet service
- willing to provide a physician as emergency contact
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 Canada 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 ICBT for persons with Spinal Cord InjuryAn 8-week guided 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 guide with experience delivering ICBT will provide support by email or telephone once a week. The guide will spend approximately 15 minutes per week/per client. | Behavioural | Guided I-CBT for persons with SCI |
| SurveyCaregiver burden and mental health will be assessed through online questionnaires. | Other | Guided I-CBT for persons with SCI |
Primary outcome
Change in depression
Time frame: baseline, start of each Lesson 2-5, 8 weeks, 3 months
Patient Health Questionnaire - 9 Item (PHQ-9). Higher total scores indicate greater severity of depression. Scores range from 0 to 27.
Change in anxiety
Time frame: baseline, start of each Lesson 2-5, 8 weeks, 3 months
Generalize Anxiety Disorder - 7 Item (GAD7). Higher total scores indicate greater severity of anxiety. Scores range from 0 to 21
Change in Caregiver Burden from baseline to 8 weeks (Caregivers of persons with SCI only)
Time frame: baseline, 8 weeks
Caregiver burden questionnaire. The tool has 12 items. Total scores ranging from 0 to 18. Higher scores indicate greater burden
5 secondary outcomes
Pain (Persons with SCI only)
Time frame: baseline, 8 weeks, 3 months
Pain interference (Persons with SCI only)
Time frame: baseline, 8 weeks, 3 months
Quality of life (Persons with SCI only)
Time frame: baseline, 8 weeks, 3 months
Service usage (Persons with SCI only)
Time frame: baseline, 8 weeks, 3 months
Quality of Life (Caregivers of persons with SCI only)
Time frame: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
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 19 Apr 2019.
- Derived from this study: PubMed 30958020Mehta S, Hadjistavropoulos HD, Earis D, Titov N, Dear BF. Patient perspectives of Internet-delivered cognitive behavior therapy for psychosocial issues post spinal cord injury. Rehabil Psychol. 2019 Aug;64(3):351-359. doi: 10.1037/rep0000276. Epub 2019 Apr 8.
- Individual participant dataSharing planned: No
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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.
Swati Mehta, PhD principal investigator
University of Regina
Heather D Hadjistavropoulos, PhD study director
University of Regina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries and Depression, run by University of Regina at 1 site 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 5 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 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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, start of each Lesson 2-5, 8 weeks, 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03457714, which also lists 1 linked publication.
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 19 Apr 2019.