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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03457714
• Other study ID #: 2017-104
• Status: Completed
• Start date: September 7, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2019
• Source: University of Regina
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

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.

Locations

Country	Name	City	State
Canada	Online Therapy Unit, University of Regina	Regina	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Regina

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in depression	Patient Health Questionnaire - 9 Item (PHQ-9). Higher total scores indicate greater severity of depression. Scores range from 0 to 27.	baseline, start of each Lesson 2-5, 8 weeks, 3 months
Primary	Change in anxiety	Generalize Anxiety Disorder - 7 Item (GAD7). Higher total scores indicate greater severity of anxiety. Scores range from 0 to 21	baseline, start of each Lesson 2-5, 8 weeks, 3 months
Primary	Change in Caregiver Burden from baseline to 8 weeks (Caregivers of persons with SCI only)	Caregiver burden questionnaire. The tool has 12 items. Total scores ranging from 0 to 18. Higher scores indicate greater burden	baseline, 8 weeks
Secondary	Pain (Persons with SCI only)	International Spinal Cord Injury Pain Basic Data Set v2.0 ISCIPBDS	baseline, 8 weeks, 3 months
Secondary	Pain interference (Persons with SCI only)	Brief Pain Inventory Short Form; BPI-SF	baseline, 8 weeks, 3 months
Secondary	Quality of life (Persons with SCI only)	Spinal Cord Injury Quality of Life Short Form; SCI-QoL-SF	baseline, 8 weeks, 3 months
Secondary	Service usage (Persons with SCI only)		baseline, 8 weeks, 3 months
Secondary	Quality of Life (Caregivers of persons with SCI only)	EQ5D	baseline, 8 weeks, 3 months, 6 months, and 1 year follow up