ICBT Program for Caregivers of Persons With SCI

NCT05346913 | Not Yet Recruiting

• 1 other identifier: 118285P2
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Change in Depression

  Patient Health Questionnaire - 9 Item (PHQ-9). Higher total scores indicate greater severity of depression. Scores range from 0 to 27.

  Time Frame: Baseline to 3 months

• Change in Caregiver Burden

  Craig Caregiver Assessment of Reward and Effort. Higher scores indicate greater caregiver. Scores range from 0 to 96.

  Time Frame: Baseline to 3 months

Secondary Outcomes (2)

• Change in Anxiety

  Time Frame: Baseline to 3 months

• Change in quality of life

  Time Frame: Baseline to 3 months

Study Arms (1)

Caregivers of Persons with Spinal Cord Injury (mTBI)

EXPERIMENTAL

Behavioral: Internet-delivered Cognitive Behavioural Therapy(ICBT)

Interventions

Internet-delivered Cognitive Behavioural Therapy(ICBT) BEHAVIORAL

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.

Caregivers of Persons with Spinal Cord Injury (mTBI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

MeSH Terms

Conditions

Depression; Anxiety Disorders; Spinal Cord Injuries; Caregiver Burden

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Stress, Psychological

Study Officials

• Swati Mehta, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Swati Mehta, PhD

CONTACT

519-685-8500; swati.mehta@sjhc.london.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist, Principle Investigator

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: April 26, 2022
• Study Start: April 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03