Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03972579 |
| Other study ID # |
H18-02344 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 15, 2019 |
| Est. completion date |
July 1, 2021 |
Study information
| Verified date |
November 2021 |
| Source |
University of British Columbia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
At least 1 in 5 people who sustain a concussion will have persistent symptoms and
difficulties with daily activities. The researchers have identified two unhelpful coping
styles following a concussion - avoidance and endurance. Individuals who engage in avoidance
behavior may benefit from a different type of treatment than those who engage in endurance
behavior. The researchers will evaluate whether assigning individuals to a specific
psychologically-informed treatment tailored to their coping style is practical, acceptable,
and beneficial for their recovery.
Description:
Psychosocial factors are known to affect recovery from concussion, but are not sufficiently
taken into account by current treatment approaches. Distinct behavioral profiles after
concussion have emerged in our research: (1) avoidance, where individuals perceive activity
as overly dangerous and take care to avoid overexertion, and (2) endurance, where individuals
persist with high levels of activity despite worse symptoms until they "crash," requiring
recuperative rest. The researchers hypothesize that patients with these behavioral profiles
likely benefit from different treatment approaches. The next step in our research program is
to evaluate the feasibility and potential impact of tailoring therapies based on an
Avoidance-Endurance Model adapted from the chronic pain literature.
The proposed project aims to evaluate whether matching patients with concussion to tailored
therapies based on their behavioral profile (avoidance vs endurance) is feasible. A secondary
aim is to test our hypothesis that participants receiving the intervention matched to their
behavioral profile will have less post-treatment disability than mismatched participants.
In a pilot double-blind (patient, assessor) RCT with 1:1 allocation stratified by behavioral
profile (avoidance vs. endurance), 64 adults with persistent symptoms after concussion will
complete an initial evaluation, an activity diary over the following week, and then be
randomized to receive an interdisciplinary treatment package tailored to avoidance or
endurance profiles.
In brief, the program designed for avoidance will involve graded exposure to cognitively
demanding activity (e.g., mental math exercises), physical exertion (e.g., treadmill
jogging), and sensory stimulation (e.g., scenes with visual motion). The focus of the
endurance program will be pacing, i.e., shifting from symptom-contingent to time-contingent
behavior. A blinded assessor will administer outcome measures 12 weeks after enrollment.
Feasibility criteria include acceptability of randomization and treatment tolerability,
fidelity, and adherence.
Proposed changes to "profile matching" study due to COVID-19 pandemic (March 30, 2020)
Due to the COVID-19 pandemic, there will be no new enrollments as of March 30, 2020. The
study will continue to be advertised at concussion clinic group education sessions, which are
now being held virtually, but inform prospective participants that enrollment will be
postponed by at least one month. Interested patients will be added to a waitlist for
screening when the study resumes enrollment (once COVID-19 social distancing restrictions are
lifted and non-essential business/services are resumed).
For participants who have expressed interest in the study and/or have already been screened,
but have not completed their baseline assessment: Defer baseline assessment. Inform the
participant that the study will resume enrolling when COVID-19 restrictions have been lifted.
They will keep their place on a study waitlist. Patients who have been screened will need to
be re-screened when enrollment resumes.
For participants who have completed their baseline assessment or are already active in
treatment: Continue treatment per protocol. However, participants who have completed no more
than 25% of treatment (4 of 16 sessions) should be offered the option of a temporary stoppage
for at least one month (i.e., the target of completing all 16 sessions within 10 weeks can be
dropped). If the therapists believe that treatment progress is being significantly impeded by
COVID-19 restrictions, they may suggest a stoppage. The final decision about stoppage should
be made by the participant. If they prefer a stoppage, the therapists should contact the
participant in one month to decide whether to resume treatment or delay by another month. Any
stoppages should be communicated to the study coordinator.
For participants who completed treatment, or at least 75% of their treatment (12 of 16
sessions), by March 13, 2020 but did not complete their outcome assessment until after that
date: Complete the outcome assessment per protocol, but add one question immediately
following the WHODAS. Introduce the question as follows:
"These questions were about how much difficulty you had with various activities due to your
health conditions over the past month. In other words, I asked you focus on difficulties
caused by your concussion and/or other health conditions. However, the investigators
recognize that it might be hard to ignore circumstances other than your health conditions
when answering these questions." Ask: "To what extent were your answers to these questions
affected by the COVID-19 pandemic?" If they ask what "affected by the COVID-19 pandemic"
means, the research assistant may provide examples: "Such as all of sudden being laid off or
asked to work overtime, or not being able to go out because of social distancing policies."
Provide responses: 0=minimally or not at all, 1=somewhat, 2=quite a bit, 3=very much or
entirely.
Confirm their response by asking "So, were it not for the COVID-19 pandemic, would you have
answered these questions ___________ differently?" Please also record (free text) notes if
participants provide explanations or reasons. Note that this additional question is being
asked only for the primary study outcome (WHODAS). This question will be removed from the
protocol one month after COVID-19 social distancing restrictions are lifted and non-essential
business/services are resumed.
Changes to the statistical analysis plan:
Participants whose treatment progress and/or outcome assessment was likely substantially
impacted by COVID-19 will be excluded from the primary analysis. Participants who treatment
progress and/or outcome assessment was possibly mildly impacted, but not likely substantially
impacted, by COVID-19 will be included in the primary analysis. This will be operationalized
according to the Table 1 below.
Participants who are eligible (completed no more than 4 therapy sessions by March 30, 2020)
and choose to temporarily stop treatment during the COVID-19 disruption period will not be
counted in the numerator or denominator for calculating the retention rate as a feasibility
outcome.
Coding the COVID_status variable: 0
Operational definition:
0a. Participants who completed their outcome assessment by March 13, 2020. 0b. Participants
who completed at least 75% of their treatment (12 of 16 sessions) by March 13, 2020 and the
outcome assessment between March 14 and on April 30*, and answered 0 or 1 to the WHODAS COVID
question.
0c. Participants who completed no more than 25% of their treatment (0-4 therapy sessions) by
March 30, 2020 and agreed to temporarily stop treatment (before their 5th therapy session)
until after April 30, 2020*.
0d. Participants who enrolled after April 30, 2020*. 0e. Participants who meet criteria 1b or
1c (below) but both of their therapists agreed with the statement "therapy goals and progress
were not affected by COVID-19" and the participant answered 0 or 1 to the WHODAS COVID
question.
-Represents participants whose therapy progress and outcome assessment were minimally or not
affected by COVID-19 disruptions. It captures participants who did most or all of their
therapy outside of the COVID-19 disruption period, as well as the few who continued therapy
unimpeded by COVID-19 disruptions. These participants will be included the primary analysis.
Coding the COVID_status variable: 1
Operational definition:
1a. Participants who completed at least 75% of their treatment (12 of 16 sessions) by March
13, 2020 and their outcome assessment between March 14-April 30, 2020*, and answered 2 or 3
to the WHODAS COVID-19 question.
1b. Participants who completed more than 25% but less than 75% of their treatment (i.e., 5-11
sessions) by March 30, 2020, and do not meet criterion 0e.
1c. Participants who completed no more than 25% of their treatment (0-4) by March 30, 2020
and chose to continue treatment during the period in which COVID-19 social distancing
restrictions, and do not meet criterion 0e.
-Represents participants whose therapy progress and/or outcome assessment were likely
affected by COVID-19 disruptions. These participants will be excluded from primary analysis.
*Note: March 14, 2020 is the start of the COVID-19 disruption period in British Columbia,
when the first social distancing policies were introduced. April 30, 2020 is a placeholder
date for when COVID-19 social distancing restrictions are lifted and non-essential
business/services are resumed. The actual date will be updated.
