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ICBT Program for Caregivers of Persons With SCI

Internet-Delivered Cognitive Behaviour Therapy Program for Caregivers of Persons With Spinal Cord Injury: A Pilot Study

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05346913
Enrollment
20
Registered
2022-04-26
Start date
2024-04-30
Completion date
2024-09-30
Last updated
2024-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Caregiver Burnout, Depression, Internet-Delivered Cognitive Behavioural Therapy, Spinal Cord Injuries

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.

Interventions

ICBT provides online structured self-help modules over several months based on the principles of CBT in combination with weekly guidance through emails and telephone calls. The course comprises 6 online lessons that provide psychoeducation about: 1) symptom identification and the cognitive behavioural model; 2) thought monitoring and challenging; 3) de-arousal strategies and pleasant activity scheduling; 4) graduated exposure/pacing; 5) memory and attention; and 6) relapse prevention. Participants will also have the opportunity to ask any questions regarding the content of the program materials and will receive a response from their Guide within 48-72 hours. Guide will spend \ 15 mins. per week/per participant. All Guides have completed a university program (psychology or social work) and are registered clinicians or students working under supervision of a registered clinician.

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in DepressionTime Frame: Baseline to 3 monthsPatient Health Questionnaire - 9 Item (PHQ-9). Higher total scores indicate greater severity of depression. Scores range from 0 to 27.
Change in Caregiver BurdenTime Frame: Baseline to 3 monthsCraig Caregiver Assessment of Reward and Effort. Higher scores indicate greater caregiver. Scores range from 0 to 96.

Secondary

MeasureTime frameDescription
Change in AnxietyTime Frame: Baseline to 3 monthsGeneralize Anxiety Disorder - 7 Item (GAD7). Higher total scores indicate greater severity of anxiety. Scores range from 0 to 21.
Change in quality of lifeTime Frame: Baseline to 3 monthsThe Visual Analogue Scale of the EuroQol five-dimension (EQ-5D) questionnaire will be used. Higher numbers indicates poorer quality of life. Scores range from 0 to 100

Contacts

Primary ContactSwati Mehta, PhD
swati.mehta@sjhc.london.on.ca519-685-8500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026