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

NCT ID: NCT03457714

Last Updated: 2019-04-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-07
• Study Completion Date: 2018-12-31

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.

Conditions

Spinal Cord Injuries; Depression; Anxiety

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Guided I-CBT for persons with SCI

Persons with spinal cord injury

Guided ICBT for persons with Spinal Cord Injury

Intervention Type: BEHAVIORAL

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.

Survey

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: BEHAVIORAL

Survey

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Regina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Swati Mehta, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Regina

Heather D Hadjistavropoulos, PhD

Role: STUDY_DIRECTOR

University of Regina

Locations

Online Therapy Unit, University of Regina

Regina, Saskatchewan, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 30958020 (View on PubMed)

Other Identifiers

2017-104

Identifier Type: -

Identifier Source: org_study_id