ICBT Program for Caregivers of Persons With SCI
Primary Purpose
Internet-Delivered Cognitive Behavioural Therapy, Depression, Anxiety
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Internet-delivered Cognitive Behavioural Therapy(ICBT)
Sponsored by
About this trial
This is an interventional treatment trial for Internet-Delivered Cognitive Behavioural Therapy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Caregivers of Persons with Spinal Cord Injury (mTBI)
Arm Description
Outcomes
Primary Outcome Measures
Change in Depression
Patient Health Questionnaire - 9 Item (PHQ-9). Higher total scores indicate greater severity of depression. Scores range from 0 to 27.
Change in Caregiver Burden
Craig Caregiver Assessment of Reward and Effort. Higher scores indicate greater caregiver. Scores range from 0 to 96.
Secondary Outcome Measures
Change in Anxiety
Generalize Anxiety Disorder - 7 Item (GAD7). Higher total scores indicate greater severity of anxiety. Scores range from 0 to 21.
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
Full Information
NCT ID
NCT05346913
First Posted
April 21, 2022
Last Updated
March 15, 2023
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT05346913
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Internet-Delivered Cognitive Behavioural Therapy, Depression, Anxiety, Spinal Cord Injuries, Caregiver Burnout
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Caregivers of Persons with Spinal Cord Injury (mTBI)
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Internet-delivered Cognitive Behavioural Therapy(ICBT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Depression
Description
Patient Health Questionnaire - 9 Item (PHQ-9). Higher total scores indicate greater severity of depression. Scores range from 0 to 27.
Time Frame
Time Frame: Baseline to 3 months
Title
Change in Caregiver Burden
Description
Craig Caregiver Assessment of Reward and Effort. Higher scores indicate greater caregiver. Scores range from 0 to 96.
Time Frame
Time Frame: Baseline to 3 months
Secondary Outcome Measure Information:
Title
Change in Anxiety
Description
Generalize Anxiety Disorder - 7 Item (GAD7). Higher total scores indicate greater severity of anxiety. Scores range from 0 to 21.
Time Frame
Time Frame: Baseline to 3 months
Title
Change in quality of life
Description
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
Time Frame: Baseline to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Swati Mehta, PhD
Phone
519-685-8500
Ext
42359
Email
swati.mehta@sjhc.london.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Swati Mehta, PhD
Organizational Affiliation
Lawson Health Research Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
ICBT Program for Caregivers of Persons With SCI
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