Andrew J. Curreri

Background: Telehealth has provided many researchers, especially those conducting psychosocial research, with the tools necessary to transition from in-person to remote clinical trials 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 depression in individuals with traumatic brain injury (TBI; CBT-TBI) to a telemental health study 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 have been discussed. Feasibility, acceptability, and safety were 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 were 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 (eg, cognitive impairment). Preliminary data support the feasibility, acceptability, and safety of remotely conducting a randomized controlled trial of CBT-TBI. Trial Registration: ClinicalTrials.gov NCT03307070; https://clinicaltrials.gov/ct2/show/NCT03307070

BACKGROUND Telehealth has provided many researchers, especially those conducting psychosocial research, with the tools necessary to transition from in-person to remote clinical trials 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 depression in individuals with traumatic brain injury (TBI; CBT-TBI) to a telemental health study 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 have been discussed. Feasibility, acceptability, and safety were 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 were 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 (eg, cognitive impairment). Preliminary data support the feasibility, acceptability, and safety of remotely conducting a randomized controlled trial of CBT-TBI. CLINICALTRIAL ClinicalTrials.gov NCT03307070; https://clinicaltrials.gov/ct2/show/NCT03307070

Exposure therapy works through inhibitory learning, whereby patients are exposed to stimuli that elicit anxiety in order to establish safety associations. Mindful emotion awareness, or nonjudgmental and present-focused attention toward emotions, may facilitate engagement in exposures, which may in turn enhance therapeutic outcome. This study utilizes a single-case experimental design (n = 6) to investigate the effect of mindful emotion awareness training on the use of avoidant strategies during exposures, distress during exposures, overall mindfulness, experiential avoidance, and symptom reduction in a sample of participants with social anxiety disorder. Data were analyzed using a combination of visual inspection and quantitative effect size metrics commonly applied in single-case experimental designs. To further investigate the relationship between distress and avoidant strategy use, contemporaneous and cross-lagged correlations were run. Results highlight individual differences in responses to mindful emotion awareness training and exposure exercises. Given these individual differences, repeated assessment and monitoring over the course of treatment may help clinicians most effectively identify treatment skills that will be most helpful for individual patients.

The purpose of the current study was to investigate the unique effects of a commonly used skill incorporated into treatment packages for borderline personality disorder (BPD), countering emotion-driven behavioral urges. Individuals with BPD (N = 8) participated in a single-case experimental design, specifically a multiple baseline, in which they were randomly assigned to complete a baseline assessment-only phase of 2 or 4 weeks. Participants then received four sessions of the countering emotional behaviors module from the unified protocol, followed by a 4-week follow-up phase. Throughout the duration of the study, daily data capture was used to assess real-time changes in the frequency of emotionally avoidant behaviors in response to emotional experiences. Symptoms of BPD, depression, and anxiety were also assessed. By follow-up, the majority of patients demonstrated a meaningful reduction (per single-case experimental design guidelines for evaluating improvements) in their use of avoidant behaviors. There was also preliminary evidence that encouraging participants to act counter to avoidant urges is associated with decreases in BPD, depression, and anxiety symptoms, as well as negative affectivity. The countering emotional behaviors skill from the unified protocol indeed engages its putative target of emotionally avoidant behavioral coping, indicating it is an active ingredient in multicomponent treatment packages for BPD, with implications for downstream clinical endpoints such as BPD and depressive and anxiety symptoms.