Internet Delivered Cognitive Behavioural Therapy for Persons With Mild Traumatic Brain Injury

Not Applicable

Completed

• Conditions: Mild Traumatic Brain Injury; Internet-Delivered Cognitive Behavioural Therapy; Depression; Anxiety
• Interventions: Behavioral: Internet-delivered Cognitive Behavioural Therapy(ICBT)

• Registration Number: NCT04561011
• Lead Sponsor: Lawson Health Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-17
• Study First Posted: 2020-09-23
• Study Start: 2021-04-13
• Status Verified: 2022-01
• Primary Completion: 2022-03-21
• Study Completion: 2022-03-21
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Persons with Mild Traumatic Brain Injury (mTBI)	Internet-delivered Cognitive Behavioural Therapy(ICBT)	-

Primary Outcome Measures

Name	Time	Method
Change in depression	Baseline to 3 months.	Patient Health Questionnaire - 9 Item (PHQ-9). Higher total scores indicate greater severity of depression. Scores range from 0 to 27.

Secondary Outcome Measures

Name	Time	Method
Change in anxiety	Baseline to 3 months.	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	Baseline to 3 months.	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.

Trial Locations

Locations (1)

St. Josephs Parkwood Institute; 🇨🇦 London, Ontario, Canada