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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
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Internet-Delivered Cognitive Behavioural Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

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

    First Posted
    April 21, 2022
    Last Updated
    March 15, 2023
    Sponsor
    Lawson Health Research Institute
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    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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