Clinical trial NCT03457714: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injuries
Depression
Anxiety
Keywords: spinal cord injuries
anxiety
depression
internet-delivered cognitive behaviour therapy
pilot study
Lead sponsor: University of Regina
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Change in depression
timeFrame: baseline, start of each Lesson 2-5, 8 weeks, 3 months
measure: Change in anxiety
timeFrame: baseline, start of each Lesson 2-5, 8 weeks, 3 months
measure: Change in Caregiver Burden from baseline to 8 weeks (Caregivers of persons with SCI only)
timeFrame: baseline, 8 weeks
Secondary outcomes:
measure: Pain (Persons with SCI only)
timeFrame: baseline, 8 weeks, 3 months
measure: Pain interference (Persons with SCI only)
timeFrame: baseline, 8 weeks, 3 months
measure: Quality of life (Persons with SCI only)
timeFrame: baseline, 8 weeks, 3 months
measure: Service usage (Persons with SCI only)
timeFrame: baseline, 8 weeks, 3 months
measure: Quality of Life (Caregivers of persons with SCI only)
timeFrame: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
Other outcomes:
Locations:
city: Regina
country: Canada
facility: Online Therapy Unit, University of Regina
state: Saskatchewan
Study officials:
affiliation: University of Regina
name: Swati Mehta, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Regina
name: Heather D Hadjistavropoulos, PhD
role: STUDY_DIRECTOR
References:
citation: 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 Aug;64(3):351-359. doi: 10.1037/rep0000276. Epub 2019 Apr 8.