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Completed

NCT Number: NCT04561011

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

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.

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Key information

Conditions

Mild Traumatic Brain Injury Anxiety Anxiety Disorders Behavior Behavioral Symptoms Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Depression Head Injuries, Closed Internet-Delivered Cognitive Behavioural Therapy Mental Disorders Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Josephs Parkwood Institute

London, Ontario, N6C 5J1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Internet-delivered Cognitive Behavioural Therapy(ICBT)

Behavioral

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 outcomes

  1. Change in depression

    Time frame: 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 outcomes

  1. Change in anxiety

    Time frame: Baseline to 3 months.

    Generalize Anxiety Disorder - 7 Item (GAD7). Higher total scores indicate greater severity of anxiety. Scores range from 0 to 21.

  2. Change in quality of life

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Official study title

Internet Delivered Cognitive Behavioural Therapy for Persons With Mild Traumatic Brain Injury: Pilot Phase 2

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 23, 2020
Registry last updated
Mar 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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