Internet Delivered Cognitive Behavioural Therapy for Persons With Mild Traumatic Brain Injury
Primary Purpose
Mild Traumatic Brain Injury, Internet-Delivered Cognitive Behavioural Therapy, Depression
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Internet-delivered Cognitive Behavioural Therapy(ICBT)
Sponsored by
About this trial
This is an interventional treatment trial for Mild Traumatic Brain Injury
Eligibility Criteria
Inclusion Criteria:
- adults ≥ 18 years
- diagnosed with mild traumatic brain injury (a neurological condition)
- resident of Canada
- access to a computer and the internet
- cognitive capacity to read and understand the content of the program.
Exclusion Criteria:
- High risk of suicide
- Serious cognitive impairment or dementia (<21 on the Telephone Interview of Cognitive Status (TICS)
- primary problems with psychosis, alcohol or drug problems, mania
- Currently receiving active psychological treatment for anxiety or depression
- Not present in Canada during treatment; 6) Concerns about online therapy
- Physically unable to perform the tasks.
Sites / Locations
- St. Josephs Parkwood Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Persons with Mild Traumatic Brain 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.
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
EuroQol five-dimension (EQ-5D) questionnaire. Every dimension of the EQ-5D-5L includes five answer levels, covering no problems (1) to extreme problems (5). Higher numbers indicates poorer quality of life.
Full Information
NCT ID
NCT04561011
First Posted
September 1, 2020
Last Updated
March 7, 2023
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04561011
Brief Title
Internet Delivered Cognitive Behavioural Therapy for Persons With Mild Traumatic Brain Injury
Official Title
Internet Delivered Cognitive Behavioural Therapy for Persons With Mild Traumatic Brain Injury: Pilot Phase 2
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
April 13, 2021 (Actual)
Primary Completion Date
March 21, 2022 (Actual)
Study Completion Date
March 21, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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
5. Study Description
Brief Summary
Background: Individuals with neurological conditions (stemming from brain injury or stroke) can experience high levels of emotional distress leading to decreased quality of life and increased health care costs. Though mental health problems are prevalent and disabling, they often go untreated for various reasons, such as access to specialized care, rural and remote location, lack of time, or concerns about stigma related to seeking care. Internet delivered cognitive behaviour therapy (ICBT) overcomes barriers to face-to-face therapy by often reaching a much wider group of patients who experience unequal access to health care. The internet based program is based on cognitive behaviour therapy, which is an evidenced-based treatment that helps patients identify and modify thoughts and behaviours that contribute to their mental health concerns. ICBT has been shown to be effective in improving psychosocial outcomes such as depression and anxiety, along with disability and quality of life among persons with chronic health conditions.
Rationale: Despite evidence for ICBT among those with other chronic conditions, its efficacy has yet to be evaluated among those with neurological conditions such as brain injury and stroke.
Objective: The aim of the current study is to pilot an ICBT program developed through a patient oriented approach to improve overall wellbeing among those with mild traumatic brain injury.
Methods: In this project, an ICBT program for those with mild traumatic brain injury developed through an patient oriented approach (Phase 1) will be piloted amongst a small group of participants (n=20) to examine acceptability, feasibility, and limited efficacy. At the end of the program, participants will be asked to complete a brief semi-structured interview examining barriers and facilitators to the ICBT program. Participant feedback from the interviews will be used to further improve the ICBT program to meet the needs of the population. The results from the study will be used to guide larger studies to evaluate effectiveness of the program in a community setting.
Anticipated Impact: Ultimately, the proposed project aims to improve overall wellbeing and access to health care service for those who have mild traumatic brain injury and mental health concerns.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Traumatic Brain Injury, Internet-Delivered Cognitive Behavioural Therapy, Depression, Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants in will receive a guided online cognitive behaviour therapy program
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Persons with Mild Traumatic Brain 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
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
Baseline to 3 months.
Title
Change in quality of life
Description
EuroQol five-dimension (EQ-5D) questionnaire. Every dimension of the EQ-5D-5L includes five answer levels, covering no problems (1) to extreme problems (5). Higher numbers indicates poorer quality of life.
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
diagnosed with mild traumatic brain injury (a neurological condition)
resident of Canada
access to a computer and the internet
cognitive capacity to read and understand the content of the program.
Exclusion Criteria:
High risk of suicide
Serious cognitive impairment or dementia (<21 on the Telephone Interview of Cognitive Status (TICS)
primary problems with psychosis, alcohol or drug problems, mania
Currently receiving active psychological treatment for anxiety or depression
Not present in Canada during treatment; 6) Concerns about online therapy
Physically unable to perform the tasks.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Swati Mehta, PhD
Organizational Affiliation
Lawson Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Josephs Parkwood Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 5J1
Country
Canada
12. IPD Sharing Statement
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Internet Delivered Cognitive Behavioural Therapy for Persons With Mild Traumatic Brain Injury
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