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

Study Overview
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Brief Summary
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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.

Official Title
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Internet-delivered Cognitive Behavioural Therapy for Persons With Spinal Cord Injury: Randomized Controlled Trial

Conditions
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Spinal Cord Injuries, Anxiety, Depression

Intervention / Treatment
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* Behavioral: Guided ICBT
* Other: SCI rehabilitation mental health education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCI internet delivered cognitive behavioural therapy<br>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. | Behavioral: Guided ICBT<br>* 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.<br>|
| Active Comparator: SCI rehabilitation mental health education<br>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. | Other: SCI rehabilitation mental health education<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | baseline, 8 weeks, 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in psychological distress | Measured by Kessler 10-Item Scale, higher scores indicate greater level of distress, scores range 10-50 | 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. | 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. | 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. | 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. | 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. | baseline and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal cord injuries, anxiety, depression, internet-delivered cognitive behaviour therapy