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

NCT03963843 | Completed

• 1 other identifier: 2019-020
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 2

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.

Conditions

Spinal Cord Injuries; Anxiety; Depression

Keywords

spinal cord injuries; anxiety; depression; internet-delivered cognitive behaviour therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Change in psychological distress

  baseline, 8 weeks, 3 months, 6 months

• Change in disability

  baseline, 8 weeks, 3 months, 6 months

• Change in quality of life symptoms: SCI-QoL-SF

  baseline, 8 weeks, 3 months, 6 months

• Change in pain: Brief Pain Inventory-Short Form

  baseline, 8 weeks, 3 months, 6 months

• Treatment credibility

  baseline and 8 weeks

Study Arms (2)

SCI internet delivered cognitive behavioural therapy

EXPERIMENTAL

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

SCI rehabilitation mental health education

ACTIVE COMPARATOR

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

Interventions

Guided ICBT BEHAVIORAL

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.

SCI internet delivered cognitive behavioural therapy

SCI rehabilitation mental health education OTHER

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.

SCI rehabilitation mental health education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Regina: lead
• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: collaborator

Study Sites (2)

Lawson Health Research Institute

London, Ontario, N6C 2A1, Canada

Location

Online Therapy Unit, University of Regina

Regina, Saskatchewan, S4S 0A2, Canada

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Heather Hadjistavropoulos, PhD

  University of Regina

  PRINCIPAL INVESTIGATOR

• Swati Mehta, PhD

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 28, 2019
• Study Start: October 18, 2019
• Primary Completion: November 1, 2021
• Study Completion: July 1, 2022
• Last Updated: December 4, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)