Accepted for/Published in: JMIR Formative Research
Date Submitted: Mar 12, 2021
Date Accepted: Oct 5, 2021
Date Submitted to PubMed: Dec 2, 2021
Conducting Clinical Research Remotely for Individuals with Traumatic Brain Injury (TBI) and Depression during the COVID-19 Pandemic: Transitioning from In-Person to Remote Implementation
ABSTRACT
Background:
Telehealth provided many researchers, especially those conducting psychosocial research, with the tools necessary to transition in-person clinical trials to remote implementation during the COVID-19 pandemic. A growing body of research supports the effectiveness of telemental health for a variety of psychiatric conditions, but few studies have examined telemental health for individuals with comorbid medical diagnoses. Furthermore, little is known about the remote implementation of clinical trials examining telemental health interventions.
Objective:
This paper outlines the procedural modifications used to facilitate conversion of an in-person randomized controlled trial of cognitive behavioral therapy (CBT) for individuals with depression and traumatic brain injury (TBI), CBT-TBI, to a telemental health study that is administered remotely.
Methods:
Given the nature of remote implementation and specific challenges experienced by individuals with TBI, considerations related to treatment delivery, remote consent, data management, neuropsychological assessment, safety monitoring, and delivery of supportive material are discussed. Feasibility, acceptability, and safety are evaluated by examining attendance and participant responses on self-report measures of treatment satisfaction and suicidal behavior.
Results:
High rates of treatment attendance, assessment completion, study retention, and satisfaction with the intervention and modality are reported by participants who completed at least one telemental health CBT-TBI session.
Conclusions:
Study modifications are necessary when conducting a study remotely, and special attention should be paid to comorbidities and population-specific challenges (e.g., cognitive impairment). Preliminary data supports the feasibility, acceptability, and safety of remotely conducting a randomized controlled trial of CBT for depression after TBI. Clinical Trial: NCT03307070 https://clinicaltrials.gov/ct2/show/NCT03307070?cond=Traumatic+Brain+Injury&locn=boston&age=1&draw=3&rank=11
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