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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

Tracking Information
First Submitted Date December 7, 2017
First Posted Date March 7, 2018
Last Update Posted Date April 19, 2019
Actual Study Start Date September 7, 2017
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 6, 2018)
  • 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.
  • 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
  • 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
Original Primary Outcome Measures
 (submitted: February 28, 2018)
  • 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.
  • 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
  • Change in Caregiver Burden from baseline to 8 weeks (Caregivers of persons with SCI only) [ Time Frame: baseline, 8 weeks ]
    Zarit Burden Interview-Short Form
Change History Complete list of historical versions of study NCT03457714 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 6, 2018)
  • Pain (Persons with SCI only) [ Time Frame: baseline, 8 weeks, 3 months ]
    International Spinal Cord Injury Pain Basic Data Set v2.0 ISCIPBDS
  • Pain interference (Persons with SCI only) [ Time Frame: baseline, 8 weeks, 3 months ]
    Brief Pain Inventory Short Form; BPI-SF
  • 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
  • Service usage (Persons with SCI only) [ Time Frame: baseline, 8 weeks, 3 months ]
  • Quality of Life (Caregivers of persons with SCI only) [ Time Frame: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up ]
    EQ5D
Original Secondary Outcome Measures
 (submitted: February 28, 2018)
  • Pain (Persons with SCI only) [ Time Frame: baseline, 8 weeks, 3 months ]
    International Spinal Cord Injury Pain Basic Data Set v2.0 ISCIPBDS
  • Pain interference (Persons with SCI only) [ Time Frame: baseline, 8 weeks, 3 months ]
    Brief Pain Inventory Short Form; BPI-SF
  • 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
  • Service usage (Persons with SCI only) [ Time Frame: baseline, 8 weeks, 3 months ]
  • Treatment satisfaction (Persons with SCI only) [ Time Frame: 8 weeks ]
    Treatment Satisfaction Questionnaire; TSQ
  • Quality of Life (Caregivers of persons with SCI only) [ Time Frame: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up ]
    EQ5D
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Official Title Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Spinal Cord Injuries
  • Depression
  • Anxiety
Intervention
  • 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.
Study Groups/Cohorts Guided I-CBT for persons with SCI
Persons with spinal cord injury
Interventions:
  • Behavioral: Guided ICBT for persons with Spinal Cord Injury
  • Other: Survey
Publications * Mehta S, Hadjistavropoulos HD, Earis D, Titov N, Dear BF. Patient perspectives of Internet-delivered cognitive behavior therapy for psychosocial issues post spinal cord injury. Rehabil Psychol. 2019 Apr 8. doi: 10.1037/rep0000276. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 17, 2019)
20
Original Estimated Enrollment
 (submitted: February 28, 2018)
15
Actual Study Completion Date December 31, 2018
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03457714
Other Study ID Numbers 2017‐104
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Regina
Study Sponsor University of Regina
Collaborators Not Provided
Investigators
Principal Investigator: Swati Mehta, PhD University of Regina
Study Director: Heather D Hadjistavropoulos, PhD University of Regina
PRS Account University of Regina
Verification Date April 2019