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

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ClinicalTrials.gov Identifier: NCT03457714
Recruitment Status : Completed
First Posted : March 7, 2018
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
University of Regina

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. 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.

Condition or disease Intervention/treatment
Spinal Cord Injuries Depression Anxiety Behavioral: Guided ICBT for persons with Spinal Cord Injury Other: Survey

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Actual Study Start Date : September 7, 2017
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Guided I-CBT for persons with SCI
Persons with spinal cord injury
Behavioral: Guided 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.

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




Primary Outcome Measures :
  1. Change in depression [ Time Frame: baseline, start of each Lesson 2-5, 8 weeks, 3 months ]
    Patient Health Questionnaire - 9 Item (PHQ-9). Higher total scores indicate greater severity of depression. Scores range from 0 to 27.

  2. Change in anxiety [ Time Frame: baseline, start of each Lesson 2-5, 8 weeks, 3 months ]
    Generalize Anxiety Disorder - 7 Item (GAD7). Higher total scores indicate greater severity of anxiety. Scores range from 0 to 21

  3. Change in Caregiver Burden from baseline to 8 weeks (Caregivers of persons with SCI only) [ Time Frame: baseline, 8 weeks ]
    Caregiver burden questionnaire. The tool has 12 items. Total scores ranging from 0 to 18. Higher scores indicate greater burden


Secondary Outcome Measures :
  1. Pain (Persons with SCI only) [ Time Frame: baseline, 8 weeks, 3 months ]
    International Spinal Cord Injury Pain Basic Data Set v2.0 ISCIPBDS

  2. Pain interference (Persons with SCI only) [ Time Frame: baseline, 8 weeks, 3 months ]
    Brief Pain Inventory Short Form; BPI-SF

  3. Quality of life (Persons with SCI only) [ Time Frame: baseline, 8 weeks, 3 months ]
    Spinal Cord Injury Quality of Life Short Form; SCI-QoL-SF

  4. Service usage (Persons with SCI only) [ Time Frame: baseline, 8 weeks, 3 months ]
  5. Quality of Life (Caregivers of persons with SCI only) [ Time Frame: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up ]
    EQ5D



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03457714


Locations
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Canada, Saskatchewan
Online Therapy Unit, University of Regina
Regina, Saskatchewan, Canada, S4S 0A2
Sponsors and Collaborators
University of Regina
Investigators
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Principal Investigator: Swati Mehta, PhD University of Regina
Study Director: Heather D Hadjistavropoulos, PhD University of Regina

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Regina
ClinicalTrials.gov Identifier: NCT03457714     History of Changes
Other Study ID Numbers: 2017‐104
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Regina:
spinal cord injuries
anxiety
depression
internet-delivered cognitive behaviour therapy
pilot study

Additional relevant MeSH terms:
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Wounds and Injuries
Depression
Spinal Cord Injuries
Behavioral Symptoms
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System