Clinical trial NCT03963843: 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
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Anxiety
Depression
Keywords: spinal cord injuries
anxiety
depression
internet-delivered cognitive behaviour therapy
Lead sponsor: University of Regina
Sponsor class: OTHER
Collaborators: name: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
First posted: 2019-05-28
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in depression
timeFrame: baseline, 8 weeks, 3 months, 6 months
measure: Change in anxiety
timeFrame: baseline, 8 weeks, 3 months, 6 months
Secondary outcomes:
measure: Change in psychological distress
timeFrame: baseline, 8 weeks, 3 months, 6 months
measure: Change in disability
timeFrame: baseline, 8 weeks, 3 months, 6 months
measure: Change in quality of life symptoms: SCI-QoL-SF
timeFrame: baseline, 8 weeks, 3 months, 6 months
measure: Change in pain: Brief Pain Inventory-Short Form
timeFrame: baseline, 8 weeks, 3 months, 6 months
measure: Treatment credibility
timeFrame: baseline and 8 weeks
measure: Treatment satisfaction: Internet-CBT Treatment Satisfaction Measure
timeFrame: baseline and 8 weeks
Other outcomes:
Locations:
city: London
country: Canada
facility: Lawson Health Research Institute
state: Ontario
city: Regina
country: Canada
facility: Online Therapy Unit, University of Regina
state: Saskatchewan
Study officials:
affiliation: University of Regina
name: Heather Hadjistavropoulos, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Swati Mehta, PhD
role: PRINCIPAL_INVESTIGATOR
References: