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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Depression; Anxiety; Spinal Cord Injuries; Caregiver Burnout; Internet-Delivered Cognitive Behavioural Therapy
• Intervention / Treatment: Behavioral: Internet-delivered Cognitive Behavioural Therapy(ICBT)

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Swati Mehta, PhD; Phone Number: 42359 519-685-8500; Email: swati.mehta@sjhc.london.on.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Caregivers of Persons with Spinal Cord Injury (mTBI)

Behavioral: Internet-delivered Cognitive Behavioural Therapy(ICBT); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Anxiety	Generalize Anxiety Disorder - 7 Item (GAD7). Higher total scores indicate greater severity of anxiety. Scores range from 0 to 21.	Time Frame: Baseline to 3 months
Change in quality of life	The 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	Time Frame: Baseline to 3 months

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Swati Mehta, PhD, Lawson Health Research Institute

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 26, 2022

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Stress, Psychological; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries; Caregiver Burden
• Other Study ID Numbers: 118285P2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No