Brain Concussion, Concussion, Mild Traumatic Brain Injury
Conditions
Keywords
concussion, mild traumatic brain injury, mindfulness-based intervention, digital health, persisting symptoms after concussion
Brief summary
Concussion or mild traumatic brain injury (mTBI) is a major public health concern. Most adolescents will recover from mTBI without complication; however, a sizeable minority experience symptoms that last more than one most post-injury (i.e., persisting symptoms after concussion). Few evidence-based treatments exist for adolescents with persisting symptoms after concussion. Mindfulness-based interventions (MBIs) are effective for treating a wide range of mental and physical health conditions that overlap with post-concussion symptoms. Participants will participate in an 8-week smartphone app-based MBI or a health education program as a control. The study will determine the practicality of doing a larger study to evaluate the effectiveness of the MBI by assessing participants' level of interest, view of intervention helpfulness, and their completion of all the components of the study.
Interventions
BEHAVIORALMindfulness-based intervention
The mindfulness-based intervention (MBI) is delivered via a smartphone application called Dawn. The MBI consists of 8-week MBI program developed to meet the needs of adolescents post-concussion/mTBI. The intervention includes audio-recorded psychoeducation and guided mindfulness exercises. The goal of this intervention is to support better coping with symptoms.
BEHAVIORALHealth Education
The health education program is delivered via a smartphone application called Dawn. It is an 8-week program designed to deliver information about health behaviors (e.g., sleep, exercise, nutrition, social support) that is inline with clinical practice guidelines for adolescents post-concussion/mTBI. The intervention includes audio-recorded psychoeducation and health behavior tracking exercises. The goal of this intervention is to provide a credible, time- and attention-matched control group.
Sponsors
Molly Cairncross
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Age 12-18 2. Structured interview confirming a concussion/mTBI or suspected concussion/mTBI diagnosis according to the American Congress of Rehabilitation Medicine definition 3. Concussion/mTBI occurred 1-12 months prior to randomization 4. Persisting symptoms after concussion as demonstrated by a score \>75th percentile on the Health and Behaviour Inventory compared to orthopedic injury normative group 5. English proficiency
Exclusion criteria
1. Parent- or self-reported psychiatric hospitalization in past year or prior diagnosis of a psychiatric disorders or psychiatric symptoms that may be contraindicated for mindfulness-based interventions (e.g., psychosis) 2. Participation in a clinical trial using the Dawn intervention app in acute concussion (e.g., \<2 weeks post-injury).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eligibility | pre-enrollment | % screened that are eligible |
| Recruitment rate | at randomization | % eligible participants randomized |
| Treatment Adherence | post-intervention questionnaires (Week 8) | % participants who complete 70% of the intervention |
| Retention | post-intervention questionnaires (Week 8) | % participants who complete follow-up assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment credibility and expectancy | 7-14 days post-enrollment | Proportion of participants who view the treatment as logical (credibility) and expect that it will help (expectancy) will be measured by the Credibility Expectancy Questionnaire. Scores range from 6-64 with higher scores reflecting higher treatment credibility and expectancy. A score above the midpoint will be considered acceptable. |
| Treatment Satisfaction | Post-intervention questionnaires (Week 8) | This Client Satisfaction Questionnaire is a validated, reliable, 8-item questionnaire used to measure client satisfaction with a particular program or services (range 8-32). Higher scores reflect better treatment satisfaction. A score above the scale midpoint on the Client Satisfaction Questionnaire will be considered acceptable. |
Countries
Canada
Contacts
CONTACTMolly Cairncross, PhD
CONTACTNina Andres
Outcome results
None listed