Clinical trial NCT04561011: 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
Overall status: COMPLETED
Phase: NA
Conditions: Mild Traumatic Brain Injury
Internet-Delivered Cognitive Behavioural Therapy
Depression
Anxiety
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants in will receive a guided online cognitive behaviour therapy program
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. adults ≥ 18 years
2. diagnosed with mild traumatic brain injury (a neurological condition)
3. resident of Canada
4. access to a computer and the internet
5. cognitive capacity to read and understand the content of the program.

Exclusion Criteria:

1. High risk of suicide
2. Serious cognitive impairment or dementia (\<21 on the Telephone Interview of Cognitive Status (TICS)
3. primary problems with psychosis, alcohol or drug problems, mania
4. Currently receiving active psychological treatment for anxiety or depression
5. Not present in Canada during treatment; 6) Concerns about online therapy
6. Physically unable to perform the tasks.

Primary outcomes:
measure: Change in depression
timeFrame: Baseline to 3 months.
Secondary outcomes:
measure: Change in anxiety
timeFrame: Baseline to 3 months.
measure: Change in quality of life
timeFrame: Baseline to 3 months.
Other outcomes:
Locations:
city: London
country: Canada
facility: St. Josephs Parkwood Institute
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Swati Mehta, PhD
role: PRINCIPAL_INVESTIGATOR
References: