Reduction of Sleep Medications via a Combined Digital Insomnia and Pharmacist-Led Deprescribing Intervention: Protocol for a Feasibility Trial.

BACKGROUND: Chronic insomnia is one of the most common health problems among veterans and negatively impacts their health, function, and quality of life. Although cognitive behavioral therapy for insomnia (CBT-I) is the first-line recommended treatment, sedative-hypnotic medications remain the most common. Sedative-hypnotics, however, have mixed effectiveness, are frequently prescribed longer than recommended, and are associated with numerous risks and adverse effects that negatively impact veteran function. Meeting the treatment needs of veterans impacted by insomnia requires delivering gold standard behavioral care, like CBT-I, and the reduction of sedative-hypnotics through innovative methods. OBJECTIVE: The objective of this feasibility clinical trial is to test a digital CBT-I approach combined with deprescribing to improve the success of sedative-hypnotic reduction among veterans. The intervention combines Noctem Health Clinician Operated Assistive Sleep Technology (COAST), an effective and efficient, scalable, and adaptable digital platform to deliver CBT-I, with clinical pharmacy practitioner (CPP)-led deprescribing of sedative-hypnotic medications. METHODS: In this nonrandomized single-group clinical trial, 50 veterans will be recruited and enrolled to receive CBT-I delivered via Noctem COAST and CPP-led deprescribing for up to 12 weeks. Assessments will occur at baseline, posttreatment, and 3-month follow-up. The aims are to (1) assess the feasibility of recruiting veterans with chronic sedative-hypnotic use to participate in the combined intervention, (2) evaluate veterans' acceptability and usability of the COAST platform, and (3) measure changes in veterans' sleep, sedative-hypnotic use, and function at baseline, posttreatment, and 3-month follow-up. RESULTS: The institutional review board approved the study in October 2021 and the trial was initiated in May 2022. Recruitment and data collection began in September 2022 and is anticipated to be completed in April 2024. Aim 1 will be measured by tracking the response to a mail-centric recruitment approach using electronic medical records to identify potentially eligible veterans based on sedative-hypnotic use. Aim 2 will be measured using the Post-Study System Usability Questionnaire, assessing overall usability as well as system usefulness, information quality, and interface quality. Aim 3 will use the Insomnia Severity Index and sleep diaries to measure change in insomnia outcomes, the Patient-Reported Outcome Measurement Information System Profile to measure change in physical function, anxiety, depression, fatigue, sleep disturbance, participation in social roles, pain, cognitive function, and self-reported sedative-hypnotic use to measure change in dose and frequency of use. CONCLUSIONS: Findings will inform the utility of a combined digital CBT-I and CPP-led deprescribing intervention and the development of an adequately powered clinical trial to test the effectiveness in a diverse sample of veterans. Further, findings will help inform potential new approaches to deliver care and improve access to care for veterans with insomnia, many of whom use sedative-hypnotics that may be ineffective and increase the risk for negative outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT05027438; https://classic.clinicaltrials.gov/ct2/show/NCT05027438. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47636.

Effects of a chemical imbalance causal explanation on individuals' perceptions of their depressive symptoms.

Although the chemical imbalance theory is the dominant causal explanation of depression in the United States, little is known about the effects of this explanation on depressed individuals. This experiment examined the impact of chemical imbalance test feedback on perceptions of stigma, prognosis, negative mood regulation expectancies, and treatment credibility and expectancy. Participants endorsing a past or current depressive episode received results of a bogus but credible biological test demonstrating their depressive symptoms to be caused, or not caused, by a chemical imbalance in the brain. Results showed that chemical imbalance test feedback failed to reduce self-blame, elicited worse prognostic pessimism and negative mood regulation expectancies, and led participants to view pharmacotherapy as more credible and effective than psychotherapy. The present findings add to a growing literature highlighting the unhelpful and potentially iatrogenic effects of attributing depressive symptoms to a chemical imbalance. Clinical and societal implications of these findings are discussed.

Theory-based training strategies for modifying practitioner concerns about exposure therapy.

Despite the well-established efficacy of exposure therapy in the treatment of pathological anxiety, many therapists believe this treatment carries an unacceptably high risk for harm, is intolerable for patients, and poses a number of ethical quandaries. These beliefs have been shown to account for two related problems: (a) underutilization of exposure therapy, and (b) overly cautious and suboptimal delivery the treatment, which likely attenuates treatment outcomes. At present, there is little guidance for those who train exposure therapists to address these concerns. This article reviews therapist negative beliefs about exposure therapy and discusses their modification based on findings from social and cognitive psychology pertinent to belief change, including dual-processing in reasoning, the need for cognition and affect, and attitude inoculation. A number of strategies are offered for augmenting training in exposure therapy in order to promote positive beliefs about the treatment. These strategies involve: (a) therapists engaging in simulated exposure therapy exercises and presenting arguments in defense of exposure's safety, tolerability, and ethicality, and (b) training therapists using emotion-based appeals (e.g., case examples) to supplement research findings. Directions for future research on practitioner concerns about exposure therapy are discussed.

Therapist perceptions and delivery of interoceptive exposure for panic disorder.

Interoceptive exposure (IE) is widely regarded as an essential procedure in the cognitive-behavioral treatment of panic disorder (PD). However, treatment manuals differ substantially in their prescribed delivery of IE, and little research exists to inform the optimal manner of its implementation. The present study examined therapists' perceptions and delivery of IE for PD. Results revealed substantial variability in how clinicians provide IE. In contrast to the prolonged and intense manner in which exposure techniques are traditionally applied, many therapists reported delivering a low dose of IE accompanied by controlled breathing strategies. Concerns about the potential adverse effects of IE were common despite the fact that participants reported the actual occurrence of negative outcomes of IE in their own practice to be extremely infrequent. It is possible that some therapists deliver IE in a cautious manner in an attempt to minimize the perceived risks associated with this treatment.

Breathing Retraining for Individuals Who Fear Respiratory Sensations: Examination of Safety Behavior and Coping Aid Hypotheses.

Cognitive behavioral theorists have suggested that breathing retraining may be used as a safety behavior. Safety behaviors are acts aimed at preventing or minimizing feared catastrophe and may maintain pathologic anxiety by hindering resolution of maladaptive cognitive processes. An opposing position is that breathing retraining is an effective coping aid. This study examined the safety behavior and coping aid hypotheses as they apply to breathing retraining. Individuals high in fear of respiratory sensations were randomly assigned to a psychoeducation control condition (EDU; n = 27) or a psychoeducation plus breathing retraining condition (EDU+BR; n = 30). As compared to psychoeducation alone, the addition of breathing retraining neither limited improvement of cognitive processes (e.g., anxiety sensitivity) nor added to the gains observed on measures of coping (e.g., perceived control). The findings are evaluated in light of the available literature regarding breathing retraining and the safety behavior and coping aid hypotheses.

A Comparison of Cognitive and Behavioral Approaches for Reducing Cost Bias in Social Anxiety.

Cognitive-behavioral theories suggest that anxiety is maintained in part by estimates of the probability and cost of feared negative outcomes. Social phobia may be unique among the anxiety disorders in that it is characterized by overestimates of the cost of events that are objectively noncatastrophic (e.g., committing social mishaps). As such, treatment approaches that target cost bias may be particularly effective in reducing social phobia symptoms. This study examined the efficacy of 2 cost-specific techniques in a single-session intervention for social anxiety. Individuals (n = 61) with elevated social interaction anxiety were randomly assigned to an expressive writing control condition, a cognitive restructuring condition, or a behavioral experiment condition. Results demonstrated that the cognitive restructuring condition produced significantly greater improvement in indices of social anxiety than the other conditions. Reduction in cost bias fully mediated the significantly greater improvement in social interaction anxiety in the cognitive restructuring condition relative to the behavioral experiment condition. The present findings highlight the value of techniques designed to reduce cost biases in social anxiety. Clinical implications are discussed.

Development and validation of the shy bladder scale.

Paruresis, characterized by the difficulty or inability to urinate in a variety of social contexts, is a scientifically under-studied phenomenon. One reason for this state of affairs is the paucity of reliable and valid measures for assessing this problem. The present article attempted to address this limitation by investigating the psychometric properties and validity of a new measure of paruresis: the Shy Bladder Scale (SBS). In two undergraduate samples, the SBS demonstrated excellent internal consistency and a stable factor structure assessing difficulty urinating in public, impairment and distress, and paruresis-related fear of negative evaluation. Undergraduate students evidenced very low levels of paruresis-related concerns. In contrast, SBS scores were markedly elevated among individuals recruited from an online support network who appeared to meet diagnostic criteria for paruresis-specific social phobia. Our findings highlight the SBS's potential utility as a measure of paruresis in clinical and research contexts.

Failure to replicate the deleterious effects of safety behaviors in exposure therapy.

The current study attempted to replicate the finding obtained by Powers, Smits, and Telch (2004; Journal of Consulting and Clinical Psychology, 72, 448-545) that both the availability and utilization of safety behaviors interfere with the efficacy of exposure therapy. An additional goal of the study was to evaluate which explanatory theories about the detrimental effects of safety behaviors best account for this phenomenon. Undergraduate students (N=58) with high claustrophobic fear were assigned to one of three treatment conditions: (a) exposure only, (b) exposure with safety behavior availability, and (c) exposure with safety behavior utilization. Participants in each condition improved substantially, and there were no significant between-group differences in fear reduction. Unexpectedly, exposure with safety behavior utilization led to significantly greater improvement in self-efficacy and claustrophobic cognitions than exposure only. The extent to which participants inferred danger from the presence of safety aids during treatment was associated with significantly less improvement on all outcome measures. The findings call into question the hypothesized deleterious effects of safety behaviors on the outcome of exposure therapy and highlight a possible mechanism through which the mere presence of safety cues during exposure trials might affect treatment outcomes depending on participants' perceptions of the dangerousness of exposure stimuli.

Targeting the probability versus cost of feared outcomes in public speaking anxiety.

Cognitive-behavioral theory suggests that social phobia is maintained, in part, by overestimates of the probability and cost of negative social events. Indeed, empirically supported cognitive-behavioral treatments directly target these cognitive biases through the use of in vivo exposure or behavioral experiments. While cognitive-behavioral theories and treatment protocols emphasize the importance of targeting probability and cost biases in the reduction of social anxiety, few studies have examined specific techniques for reducing probability and cost bias, and thus the relative efficacy of exposure to the probability versus cost of negative social events is unknown. In the present study, 37 undergraduates with high public speaking anxiety were randomly assigned to a single-session intervention designed to reduce either the perceived probability or the perceived cost of negative outcomes associated with public speaking. Compared to participants in the probability treatment condition, those in the cost treatment condition demonstrated significantly greater improvement on measures of public speaking anxiety and cost estimates for negative social events. The superior efficacy of the cost treatment condition was mediated by greater treatment-related changes in social cost estimates. The clinical implications of these findings are discussed.

Does the judicious use of safety behaviors improve the efficacy and acceptability of exposure therapy for claustrophobic fear?

Exposure therapy is traditionally conducted with an emphasis on the elimination of safety behaviors. However, theorists have recently suggested that the judicious use of safety behaviors may improve the tolerability of this treatment without reducing its efficacy. The present study tested this notion by randomly assigning participants with high claustrophobic fear to receive a single-session intervention with or without access to safety aids during early exposure trials. Improvement was generally equivalent between the treatment conditions, and no reliable benefits or drawbacks were associated with the judicious use of safety behaviors. The theoretical and clinical implications of these findings are discussed.