ClinicalTrials.gg
CompletedNCT03457714Updated Apr 19, 2019

Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial

An observational study in Spinal Cord Injuries, Depression and Anxiety, sponsored by University of Regina. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-19.

Sponsored by University of Regina · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 203 studies in Spinal Cord Injuries with a site in Canada — 66 open to participants now, 73 under way, 4 of them phase 3. Spinal Cord Injuries · Canada.

Enrollment
18th of 25
20 · median 42
Started
2017
with 11 others
Observational
25 of 203
6 open now
Registered
80th of 203
by date

Among the 203 studies in Spinal Cord Injuries with a site in Canada, this one is the 18th largest by enrollment of the 25 observational ones that give a count, is one of 12 that started in 2017, is one of 25 observational ones, and was the 80th registered.

Spinal Cord Injuries

2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.

Browse Spinal Cord Injuries studies →

Open to participants now

66 of the 203 studies in Spinal Cord Injuries with a site in Canada are open now. Recruiting first, the newest first:

61 more — sign in →

All 66 open studies →

A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →

Who these studies take

Of the 375 Spinal Cord Injuries studies recruiting now, 166 (44%) set no upper age limit and 158 (42%) stop at 75 or younger; 41 take children under 18; 52 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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. 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.

03

Conditions studied

  • Spinal Cord Injuries
  • Depression
  • Anxiety

Keywords

  • spinal cord injuries
  • anxiety
  • depression
  • internet-delivered cognitive behaviour therapy
  • pilot study
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Any individual with a spinal cord injury will be recruited through primary care physicians, rehabilitation facilities, and community peer groups.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

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 Canada during treatment
  • concerns about online therapy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No

Groups and cohorts

  • Guided I-CBT for persons with SCI

    Persons with spinal cord injury

    Behavioral: Guided ICBT for persons with Spinal Cord Injury · Other: Survey

Interventions

  • BehavioralGuided ICBT for persons with Spinal Cord Injury

    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.

  • OtherSurvey

    Caregiver burden and mental health will be assessed through online questionnaires.

06

What researchers measure

Primary outcomes

  1. Change in depression

    Patient Health Questionnaire - 9 Item (PHQ-9). Higher total scores indicate greater severity of depression. Scores range from 0 to 27.

    Time frame: baseline, start of each Lesson 2-5, 8 weeks, 3 months

  2. Change in anxiety

    Generalize Anxiety Disorder - 7 Item (GAD7). Higher total scores indicate greater severity of anxiety. Scores range from 0 to 21

    Time frame: baseline, start of each Lesson 2-5, 8 weeks, 3 months

  3. 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

    Time frame: baseline, 8 weeks

Secondary outcomes

  1. Pain (Persons with SCI only)

    International Spinal Cord Injury Pain Basic Data Set v2.0 ISCIPBDS

    Time frame: baseline, 8 weeks, 3 months

  2. Pain interference (Persons with SCI only)

    Brief Pain Inventory Short Form; BPI-SF

    Time frame: baseline, 8 weeks, 3 months

  3. Quality of life (Persons with SCI only)

    Spinal Cord Injury Quality of Life Short Form; SCI-QoL-SF

    Time frame: baseline, 8 weeks, 3 months

  4. Service usage (Persons with SCI only)

    Time frame: baseline, 8 weeks, 3 months

  5. Quality of Life (Caregivers of persons with SCI only)

    EQ5D

    Time frame: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up

07

Study locations

1 site
  • Online Therapy Unit, University of Regina
    Regina, Saskatchewan S4S 0A2, Canada
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2017 to primary completion in Dec 2018, 15 months.

Of 124 non-industry observational studies under Spinal Cord Injuries, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 74. This study's 15 months is below that.

Counting every sponsor, half of 135 studies reached it within 39 months; a quarter within 16 and three quarters within 78.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 7, 2017
First posted
Mar 7, 2018
StartActual
Sep 7, 2017
Primary completionActual
Dec 31, 2018
CompletionActual
Dec 31, 2018
Last update
Apr 19, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03457714
Lead sponsor
University of Regina
Responsible party
Sponsor
First posted
Mar 7, 2018
Start date
Sep 7, 2017
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018
Last update
Apr 19, 2019

Study contacts

Swati Mehta, PhD
principal investigator · University of Regina
Heather D Hadjistavropoulos, PhD
study director · University of Regina

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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