A Mobile Application Adjunct to Augment Cognitive-Behavioral Group Therapy for Adolescents with Social Anxiety: Feasibility and Acceptability Results from the Wiring Adolescents with Social Anxiety via Behavioral Interventions Pilot Trial.

Objective: Cognitive-Behavioral Group Therapy (CBGT) is an established treatment for Social Anxiety (SA). However, diagnostic recovery rate is only 20.5% in CBGT, and up to 50% of patients remain symptomatic posttreatment. Using videocalls to deliver digital CBGT (dCBGT) is feasible, cost-effective, and efficacious. Yet, the impact of dCBGT on social functioning remains limited, as dCBGT does not offer opportunities for monitoring cognition and behavior in social situations. Wiring Adolescents with Social Anxiety via Behavioral Interventions (WASABI), a clinician-assisted application that uses ecological momentary assessments (EMAs), cognitive bias tests, and clinical self-reports, was investigated as an adjunct to dCBGT. Methods: A prospective, parallel arm, double-blind randomized controlled trial was employed in 24 SA adolescents randomly assigned to dCBGT versus dCBGT plus WASABI. Results: Study completion rates (83%) and exit survey data indicated that WASABI is feasible and acceptable. Engagement with EMAs varied from four to 244 EMAs completed per person. Cognitive bias tests and clinical self-reports were completed at least weekly by 53% and 69% of participants, respectively. While standard tests did not reveal statistically significant differences between dCBGT plus WASABI and dCBGT alone, effect sizes were greater for dCBGT plus WASABI on symptom severity, social skills, and functioning. Conclusions: Despite the small sample, preliminary results suggest that WASABI is feasible, acceptable, and may be an effective augmentation tool for treating SA in teenagers.

Improving social functioning in people with schizophrenia-spectrum disorders via mobile experimental interventions: Results from the CLIMB pilot trial.

BACKGROUND: Patients with Schizophrenia Spectrum Disorders (SSD) demonstrate poor social functioning. While group-based approaches show long-term improvements, access to treatments is limited. Digital platforms hold promise to overcome barriers to treatment delivery and improve outcomes. OBJECTIVE: In a parallel arm, double-blind RCT, we tested CLIMB, a clinician-assisted, adjunct to treatment that includes computerized social cognition training (SCT), ecological momentary assessments (EMAs), group tele-therapy, and moderated messaging. CLIMB was compared to an active control that includes computerized general cognitive training (GCT), unstructured support groups, and unmoderated messaging. METHODS: The primary outcome was social functioning. Secondary outcomes were negative symptoms and quality of life (QoL). Given the sample size, Propensity Score Models were used to ensure balanced baseline covariates. Mixed-effects models examined change over time. RESULTS: 24 participants completed the study (12 per arm). No significant between-group differences emerged in engagement. CLIMB participants engaged in a median of 8 sessions (IQR = 2), 2.8 h of SCT (IQR = 7.5), and 2710 EMAs; control participants engaged in a median of 9 sessions (IQR = 3) and 2.2 h of GCT (IQR = 7.9). As a group, participants showed significant improvements in social functioning (p = .046), with no between-group differences. Intent-to-treat analyses indicated greater improvements in QoL (p = .025) for the active control. CONCLUSIONS: Delivering group-based mobile interventions to individuals with SSD is feasible. EMAs allow clinicians to maintain inter-session engagement, build participant self-awareness, and tailor treatment delivery. In this treatment model, whether SCT or GCT is more effective remains unclear. Further research will evaluate group-based mobile interventions to improve outcomes in SSD.

Alertness Training Improves Spatial Bias and Functional Ability in Spatial Neglect.

OBJECTIVE: We conducted a multisite, randomized, double-blinded, controlled trial to examine the effectiveness of a digital health intervention targeting the intrinsic regulation of goal-directed alertness in patients with chronic hemispatial neglect. METHODS: Forty-nine participants with hemispatial neglect, who demonstrated significant spatially biased attention after acquired brain injury, were randomly assigned to the experimental attention remediation treatment or the active control group. The participants engaged with the remotely administered interventions for 12 weeks. The primary outcome was spatial bias on the Posner cueing task (response time difference: left minus right target trials). Secondary outcomes included functional abilities (measured via the Catherine Bergego scale and Barthel index), spatial cognition, executive function, quality of life, and sleep. Assessments were conducted before and immediately after participation in the experimental intervention or control condition, and again after a 3-month no-contact period. RESULTS: Compared with the active control group, the intervention group exhibited a significant improvement in the primary outcome, a reduction in spatially biased attention on the Posner cueing task (p = 0.010, Cohen's d = 0.96), in addition to significant improvements in functional abilities as measured on the Catherine Bergego and Barthel indices (p = 0.027, Cohen's d = 0.24). INTERPRETATION: Our results demonstrate that our attention training program was effective in improving the debilitating attention deficits common to hemispatial neglect. This benefit generalized to improvements in real-world functional abilities. This safe, highly scalable, and self-administered treatment for hemispatial neglect might serve as a useful addition to the existing standard of care. ANN NEUROL 2020;88:747-758.

Childhood trauma and clinical high risk for psychosis.

As a risk factor for psychosis, childhood trauma rates are elevated in the clinical-high-risk (CHR) syndrome compared to the general population. However, it is unknown whether trauma is typically experienced in childhood or adolescence/young adulthood, whether it occurred prior to CHR syndrome onset, and how severe trauma relates to presenting symptoms. In this study, we examined the relationship of trauma history to symptoms and functioning in individuals diagnosed with the CHR syndrome on the Structured Interview for Psychosis-Risk Syndromes (N = 103). Trauma, defined as meeting the DSM-IV A1 criterion of actual or threatened death or injury, was assessed by semi-structured interview. A large proportion of CHR participants (61%) reported trauma exposure, including interpersonal trauma, trauma prior to CHR onset, and childhood trauma prior to age 12. Those with a trauma history (versus those without trauma) were rated as having more severe perceptual disturbances, general/affective symptoms and more impairment on the Global Assessment of Functioning Scale. The number of traumatic events correlated with more severe ratings in those three domains. Additionally, the number of interpersonal traumas was correlated with ratings of suspiciousness. Trauma was unrelated to specific measures of social and role functioning. A small proportion of CHR participants were diagnosed with formal PTSD (14%), which was unrelated to symptom severity or functioning. Thus, we demonstrate that trauma exposure is often early in life (before age 12), occurs prior to the onset of the CHR syndrome, and is related to both positive and affective symptoms.

Randomized control trial of computer-based training targeting alertness in older adults: the ALERT trial protocol.

BACKGROUND: Healthy aging is associated with a decline in multiple functional domains including perception, attention, short and long-term memory, reasoning, decision-making, as well as cognitive and motor control functions; all of which are significantly modulated by an individual's level of alertness. The control of alertness also significantly declines with age and contributes to increased lapses of attention in everyday life, ranging from minor memory slips to a lack of vigilance and increased risk of falls or motor-vehicle accidents. Several experimental behavioral therapies designed to remediate age-related cognitive decline have been developed, but differ widely in content, method and dose. Preliminary studies demonstrate that Tonic and Phasic Alertness Training (TAPAT) can improve executive functions in older adults and may be a useful adjunct treatment to enhance benefits gained in other clinically validated treatments. The purpose of the current trial (referred to as the Attention training for Learning Enhancement and Resilience Trial or ALERT) is to compare TAPAT to an active control training condition, include a larger sample of patients, and assess both cognitive and functional outcomes. METHODS/DESIGN: We will employ a multi-site, longitudinal, blinded randomized controlled trial (RCT) design with a target sample of 120 patients with age-related cognitive decline. Patients will be asked to complete 36 training sessions remotely (30 min/day, 5 days a week, over 3 months) of either the experimental TAPAT training program or an active control computer games condition. Patients will be assessed on a battery of cognitive and functional outcomes at four time points, including: a) immediately before training, b) halfway through training, c) within forty-eight hours post completion of total training, and d) after a three-month no-contact period post completion of total training, to assess the longevity of potential training effects. DISCUSSION: The strengths of this protocol are that it tests an innovative, in-home administered treatment that targets a fundamental deficit in adults with age-related cognitive decline; employs highly sensitive computer-based assessments of cognition as well as functional abilities, and incorporates a large sample size in an RCT design. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02416401.

Targeting alertness to improve cognition in older adults: A preliminary report of benefits in executive function and skill acquisition.

Efficient self-regulation of alertness declines with age exacerbating normal declines in performance across multiple cognitive domains, including learning and skill acquisition. Previous cognitive intervention studies have shown that it is possible to enhance alertness in patients with acquired brain injury and marked attention impairments, and that this benefit generalizes to improvements in more global cognitive functions. In the current preliminary studies, we sought to test whether this approach, that targets both tonic (over a period of minutes) and phasic (moment-to-moment) alertness, can improve key executive functioning declines in older adults, and enhance the rate of skill acquisition. The results of both Experiments 1 and 2 demonstrate that, compared to active control (AC) training, alertness training significantly enhanced performance in several validated executive function measures. In Experiment 2, alertness training significantly improved skill acquisition compared to AC training in a well-characterized speed of processing (SOP) task, with the largest benefits shown in the most challenging SOP blocks. The results of the current study suggest that targeting intrinsic alertness through cognitive training provides a novel approach to improve executive functions in older adults and may be a useful adjunct treatment to enhance benefits gained in other clinically validated treatments.

Randomized control trial of computer-based rehabilitation of spatial neglect syndrome: the RESPONSE trial protocol.

BACKGROUND: Spatial neglect is a frequent and debilitating consequence of acquired brain injury and currently has no widely accepted standard of care. While previous interventions for spatial neglect have targeted patients' overt spatial deficits (e.g., reduced contralesional visual scanning), far fewer have directly targeted patients' non-spatial deficits (e.g., sustained attention deficits). Considering that non-spatial deficits have shown to be highly predictive of long-term disability, we developed a novel computer based training program that targets both sustained (tonic) and moment-to-moment (phasic) aspects of non-spatial attention (Tonic and Phasic Alertness Training, TAPAT). Preliminary studies demonstrate that TAPAT is safe and effective in improving both spatial and non-spatial attention deficits in the post-acute recovery phase in neglect patients. The purpose of the current trial (referred to as the REmediation of SPatial Neglect or RESPONSE trial) is to compare TAPAT to an active control training condition, include a larger sample of patients, and assess both cognitive and functional outcomes. METHODS/DESIGN: We will employ a multi-site, longitudinal, blinded randomized controlled trial (RCT) design with a target sample of 114 patients with spatial neglect. Patients will either perform, at their home, the experimental TAPAT training program or an active control computer games condition for thirty minutes/day, five days a week, over three months. Patients will be assessed on a battery of cognitive and functional outcomes on three occasions: a) immediately before training, b) within forty-eight hours post completion of total training, and c) after a three-month no-contact period post completion of total training, to assess the longevity of potential training effects. DISCUSSION: The strengths of this protocol are that it tests an innovative, in-home administered treatment that targets a fundamental deficit in neglect, employs highly sensitive computer-based assessments of cognition as well as functional outcomes, and incorporates a large sample size (relative to other neglect treatment studies) in an RCT design. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01965951.