Transitioning From In-Person to Remote Clinical Research on Depression and Traumatic Brain Injury During the COVID-19...

Area of Science:

• Psychiatry
• Neurology
• Digital Health

Background:

• Telehealth facilitated remote clinical trials during the COVID-19 pandemic, particularly for psychosocial research.
• Effectiveness of telemental health is established for psychiatric conditions, but less is known about its use in comorbid medical diagnoses.
• Remote implementation of clinical trials for telemental health interventions requires further investigation.

Purpose of the Study:

• To outline procedural modifications for converting an in-person randomized controlled trial (RCT) of cognitive behavioral therapy (CBT) for depression in individuals with traumatic brain injury (TBI) to a remote telemental health study.
• To address challenges specific to remote delivery and TBI populations in clinical trials.

Main Methods:

• Modified an in-person RCT of CBT for depression in TBI (CBT-TBI) for remote telemental health administration.
• Considered adaptations for treatment delivery, remote consent, data management, neuropsychological assessment, safety monitoring, and supportive material distribution.
• Evaluated feasibility, acceptability, and safety through attendance rates and participant self-report measures of satisfaction and suicidal behavior.

Main Results:

• Participants completing at least one telemental health CBT-TBI session reported high treatment attendance and assessment completion rates.
• High study retention and participant satisfaction with both the intervention and the remote modality were observed.
• Preliminary data indicate successful remote implementation of the CBT-TBI trial.

Conclusions:

• Remote clinical trials necessitate study modifications, especially for populations with comorbidities and specific challenges like cognitive impairment.
• The preliminary findings support the feasibility, acceptability, and safety of conducting RCTs of CBT-TBI remotely via telemental health.
• Adapting clinical trials to telehealth requires careful consideration of population-specific needs and remote delivery logistics.