Clinical trial NCT05346913: ICBT Program for Caregivers of Persons With SCI
Official title: Internet-Delivered Cognitive Behaviour Therapy Program for Caregivers of Persons With Spinal Cord Injury: A Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Internet-Delivered Cognitive Behavioural Therapy
Depression
Anxiety
Spinal Cord Injuries
Caregiver Burnout
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Spinal cord injuries have a devastating effect on individuals incurring the life changing event; however, the injury can also affect those who are integrally involved in their care. Assisting individuals after an SCI frequently falls on unpaid, family caregivers. Studies have reported that caregivers experienced significantly greater negative outcomes than positives. The most common negative outcome factors were high levels of burden, poor adjustment to role, decreased QOL, emotional distress, and strain on relationships. Burden of care was also associated with lower levels of functioning of the care recipient, demonstrating the integral relationship between those who provide care and those who receive it. Considering their importance in maintaining their care recipient's wellbeing post-injury, caregivers require ongoing support as a central part of the wider healthcare system. Numerous caregivers are unprepared to handle the responsibilities of their role and lack specialized training to efficiently cope with the burden. Guided internet-delivered CBT (ICBT) offers an accessible and flexible approach for psychosocial service delivery in the community. Evidence for the effectiveness of ICBT has been reported in various populations. The results from our study provide evidence for the potential of guided ICBT to improve psychosocial outcomes among those with SCI. Enhancing the overall wellbeing of the caregiver has previously been shown to improve outcomes of those with SCI. However, evidence for the acceptability and effectiveness of an ICBT approach among caregivers is lacking; as a first step, we plan to conduct a feasibility study of ICBT for SCI caregivers.


Eligibility criteria: Inclusion Criteria:

1. adults ≥ 18 years
2. have provided care to a person with SCI in the community for a period of over six months post injury
3. report elevated symptoms of anxiety and/or depression
4. access to a computer and the internet
5. cognitive capacity to read and understand the content of the intervention.

Exclusion Criteria:

1. high risk of suicide
2. primary problems with psychosis, alcohol or drug problems, mania
3. currently receiving active psychological treatment for anxiety or depression
4. concerns about online therapy.

Primary outcomes:
measure: Change in Depression
timeFrame: Time Frame: Baseline to 3 months
measure: Change in Caregiver Burden
timeFrame: Time Frame: Baseline to 3 months
Secondary outcomes:
measure: Change in Anxiety
timeFrame: Time Frame: Baseline to 3 months
measure: Change in quality of life
timeFrame: Time Frame: Baseline to 3 months
Other outcomes:
Locations:
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Swati Mehta, PhD
role: PRINCIPAL_INVESTIGATOR
References: