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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03963843
• Other study ID #: 2019-020
• Status: Completed
• Phase: N/A
• Start date: October 18, 2019
• Est. completion date: July 1, 2022

Study information

• Verified date: October 2022
• Source: University of Regina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: July 1, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Behavioral:
• Guided ICBT
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.

Other:
• SCI rehabilitation mental health education
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.

Locations

Country	Name	City	State
Canada	Lawson Health Research Institute	London	Ontario
Canada	Online Therapy Unit, University of Regina	Regina	Saskatchewan

Sponsors (2)

Lead Sponsor	Collaborator
University of Regina	Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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