Can peripheral psychophysiological markers predict response to exposure-based cognitive behavioral therapy in youth with severely impairing irritability? A study protocol.

BACKGROUND: Irritability, an increased proneness to anger, is a primary reason youth present for psychiatric care. While initial evidence supports the efficacy of exposure-based cognitive behavioral therapy (CBT) for youth with clinically impairing irritability, treatment mechanisms remain unclear. Here, we propose to measure peripheral psychophysiological indicators of arousal-heart rate (HR)/electrodermal activity (EDA)-and regulation-heart rate variability (HRV)-during exposures to anger-inducing stimuli as potential predictors of treatment efficacy. The objective of this study is to evaluate whether in-situ biosensing data provides peripheral physiological indicators of in-session response to exposures. METHODS: Blood volume pulse (BVP; from which HR and HRV canl be derived) and EDA will be collected ambulatorily using the Empatica EmbracePlus from 40 youth (all genders; ages 8-17) undergoing six in-person exposure treatment sessions, as part of a multiple-baseline trial of exposure-based CBT for clinically impairing irritability. Clinical ratings of irritability will be conducted at baseline, weekly throughout treatment, and at 3-month and 6-month follow-ups via the Clinical Global Impressions Scale (CGI) and the Affective Reactivity Index (ARI; clinician-, parent-, and child-report). Multilevel modeling will be used to assess within- and between-person changes in physiological arousal and regulation throughout exposure-based CBT and to determine whether individual differences are predictive of treatment response. DISCUSSION: This study protocol leverages a wearable biosensor (Empatica) to continuously record HR/HRV (derived from BVP) and EDA during in-person exposure sessions for youth with clinically impairing irritability. Here, the goal is to identify changes in physiological arousal (EDA, HR) and regulation (HRV) over the course of treatment in tandem with changes in clinical symptoms. TRIAL REGISTRATION: The participants in this study come from an overarching clinical trial (trial registration numbers: NCT02531893 first registered on 8/25/2015; last updated on 8/25/2023). The research project and all related materials were submitted and approved by the appropriate Institutional Review Board of the National Institute of Mental Health (NIMH).

An Exposure-Based Cognitive-Behavioral Therapy for Youth with Severe Irritability: Feasibility and Preliminary Efficacy.

OBJECTIVE: Clinically impairing irritability and temper outbursts are among the most common psychiatric problems in youth and present transdiagnostically; however, few mechanistically informed treatments have been developed. Here, we test the acceptability, feasibility, and preliminary efficacy of a novel exposure-based treatment with integrated parent management skills for youth with severe irritability using a randomized between-subjects multiple baseline design. METHOD: N = 41 patients (Age, Mean (SD) = 11.23 years (1.85), 62.5% male, 77.5% white) characterized by severe and impairing temper outbursts and irritability were randomized to different baseline observation durations (2, 4, or 6 weeks) prior to active treatment; 40 participants completed the 12 session treatment of exposure-based cognitive-behavioral therapy for irritability with integrated parent management skills. Masked clinician ratings were acquired throughout baseline and treatment phases, as well as 3- and 6-months post-treatment. To examine acceptability and feasibility, drop-out rates and adverse events were examined. Primary clinical outcome measures included clinician-administered measures of irritability severity and improvement. Secondary clinical outcome measures included multi-informant measures of irritability, depression, anxiety, and attention-deficit/hyperactivity disorder symptoms. RESULTS: No patients dropped out once treatment began, and no adverse events were reported. Irritability symptoms improved during the active phase of treatment across all measurements (all ßs > -0.04, ps < .011, Cohen's d range: -0.33 to -0.98). Treatment gains were maintained at follow-up (all ßs(39) < -0.001, ps > .400). Sixty-five percent of patients were considered significantly improved or recovered post-treatment based on the primary clinician-rated outcome measure. CONCLUSIONS: Results support acceptability, feasibility, and preliminary efficacy of this novel treatment for youth with severe irritability. Limitations and future directions are also discussed.

Across-subjects multiple baseline trial of exposure-based cognitive-behavioral therapy for severe irritability: a study protocol.

INTRODUCTION: Irritability is defined as a tendency towards anger in response to frustration. Clinically, impairing irritability is a significant public health problem. There is a need for mechanism-based psychotherapies targeting severe irritability as it manifests in the context of disruptive mood dysregulation disorder (DMDD). This study protocol describes a randomised multiple baseline design testing the preliminary efficacy of a new treatment, exposure-based cognitive-behavioral therapy for severe irritability in youth, which also integrates components of parent management training. We will investigate associations of this intervention with primary clinical measures, as well as ecological momentary assessment measures. METHODS AND ANALYSIS: Forty youth will be enrolled. Participants, aged 8-17 years, must present at least one of two core symptoms of DMDD: abnormal mood or increased reactivity to negative emotional stimuli, with severe impairment in one domain (home, school, peers) and moderate in another, or moderate impairment in at least two domains. Each participant is randomised to a 2-week, 4-week or 6-week baseline observation period, followed by 12 active treatment sessions. Clinical ratings are conducted at baseline, biweekly (clinician), weekly (parent/child) throughout treatment, post-treatment, and 3-month and 6-month follow-up (clinician). Clinician ratings on the Affective Reactivity Index and Clinical Global Impressions-Improvement scale for DMDD are our primary outcome measures. Secondary outcome measures include parent and child reports of irritability. Post hoc additional symptom measures include clinician, parent and self-ratings of depression, anxiety and overall functional impairment. Prospective, digitally based event sampling of symptoms is acquired for a week pre-treatment, mid-treatment and post-treatment. Based on our pathophysiological model of irritability implicating frustrative non-reward, aberrant threat processing and instrumental learning, we probe these three brain-based targets using functional MRI paradigms to assess target engagement. ETHICS AND DISSEMINATION: The research project and all related materials were submitted and approved by the appropriate Institutional Review Board (IRB) of the National Institute of Mental Health (NIMH). TRIAL REGISTRATION NUMBERS: NCT02531893 and NCT00025935.

Are there any robust predictors of "sudden gainers," and how is sustained improvement in treatment outcome achieved following a gain?

OBJECTIVE: It has been widely demonstrated that the process of change many patients undergo in therapy is not linear. Some patients benefit greatly from large sudden improvements, commonly referred to as "sudden gains." It is less clear whether certain baseline characteristics make patients more prone to displaying sudden gains, as well as what mechanisms are responsible for the lasting effects of sudden gains. METHOD: In a sample of 547 patients receiving treatment in an outpatient mental health clinic, a machine learning approach was used to search for potential predictors of sudden gains. A within-patient mediation model was used to investigate whether alliance serves as a mechanism underlying the sustained effect of sudden gains. RESULTS: Twelve percent of patients showed sudden gains. Consistent with previous studies, no robust predictors of sudden gains were found, even when using an approach capable of evaluating the contributions of multiple predictors and their interactions. A significant within-patient mediation model was found, according to which sudden gains predict subsequent strengthening in alliance, which in turn predict subsequent improvement in life satisfaction and psychological dysfunction. These findings support the proposed theoretical framework whereby alliance is an important ingredient of an upward spiral that may results in sustained sudden gains. CONCLUSIONS: The findings provide first evidence of the presence of an ingredient responsible for the sustained effect of sudden gains, using a within-patient mediation model. The findings support the important role alliance may play in the consolidation and subsequent expansion of the effect of sudden gains. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Testing a Web-Based, Trained-Peer Model to Build Capacity for Evidence-Based Practices in Community Mental Health Systems.

OBJECTIVE: Use of expert-led workshops plus consultation has been established as an effective strategy for training community mental health (CMH) clinicians in evidence-based practices (EBPs). Because of high rates of staff turnover, this strategy inadequately addresses the need to maintain capacity to deliver EBPs. This study examined knowledge, competency, and retention outcomes of a two-phase model developed to build capacity for an EBP in CMH programs. METHODS: In the first phase, an initial training cohort in each CMH program participated in in-person workshops followed by expert-led consultation (in-person, expert-led [IPEL] phase) (N=214 clinicians). After this cohort completed training, new staff members participated in Web-based training (in place of in-person workshops), followed by peer-led consultation with the initial cohort (Web-based, trained-peer [WBTP] phase) (N=148). Tests of noninferiority assessed whether WBTP was not inferior to IPEL at increasing clinician cognitive-behavioral therapy (CBT) competency, as measured by the Cognitive Therapy Rating Scale. RESULTS: WBTP was not inferior to IPEL at developing clinician competency. Hierarchical linear models showed no significant differences in CBT knowledge acquisition between the two phases. Survival analyses indicated that WBTP trainees were less likely than IPEL trainees to complete training. In terms of time required from experts, WBTP required 8% of the resources of IPEL. CONCLUSIONS: After an initial investment to build in-house CBT expertise, CMH programs were able to use a WBTP model to broaden their own capacity for high-fidelity CBT. IPEL followed by WBTP offers an effective alternative to build EBP capacity in CMH programs, rather than reliance on external experts.

Implementation of transdiagnostic cognitive therapy in community behavioral health: The Beck Community Initiative.

OBJECTIVE: Progress bringing evidence-based practice (EBP) to community behavioral health (CBH) has been slow. This study investigated feasibility, acceptability, and fidelity outcomes of a program to implement transdiagnostic cognitive therapy (CT) across diverse CBH settings, in response to a policy shift toward EBP. METHOD: Clinicians (n = 348) from 30 CBH programs participated in workshops and 6 months of consultation. Clinician retention was examined to assess feasibility, and clinician feedback and attitudes were evaluated to assess implementation acceptability. Experts rated clinicians' work samples at baseline, mid-, and end-of-consultation with the Cognitive Therapy Rating Scale (CTRS) to assess fidelity. RESULTS: Feasibility was demonstrated through high program retention (i.e., only 4.9% of clinicians withdrew). Turnover of clinicians who participated was low (13.5%) compared to typical CBH turnover rates, even during the high-demand training period. Clinicians reported high acceptability of EBP and CT, and self-reported comfort using CT improved significantly over time. Most clinicians (79.6%) reached established benchmarks of CT competency by the final assessment point. Mixed-effects hierarchical linear models indicated that CTRS scores increased significantly from baseline to the competency assessment (p < .001), on average by 18.65 points. Outcomes did not vary significantly between settings (i.e., outpatient vs. other). CONCLUSIONS: Even clinicians motivated by policy-change rather than self-nomination may feasibly be trained to deliver a case-conceptualization driven EBP with high levels of competency and acceptability. (PsycINFO Database Record

It's complicated: The relation between cognitive change procedures, cognitive change, and symptom change in cognitive therapy for depression.

Many attempts have been made to discover and characterize the mechanisms of change in psychotherapies for depression, yet no clear, evidence-based account of the relationship between therapeutic procedures, psychological mechanisms, and symptom improvement has emerged. Negatively-biased thinking plays an important role in the phenomenology of depression, and most theorists acknowledge that cognitive changes occur during successful treatments. However, the causal role of cognitive change procedures in promoting cognitive change and alleviating depressive symptoms has been questioned. We describe the methodological and inferential limitations of the relevant empirical investigations and provide recommendations for addressing them. We then develop a framework within which the possible links between cognitive procedures, cognitive change, and symptom change can be considered. We conclude that cognitive procedures are effective in alleviating symptoms of depression and that cognitive change, regardless of how it is achieved, contributes to symptom change, a pattern of findings that lends support to the cognitive theory of depression.

Understanding processes of change: how some patients reveal more than others-and some groups of therapists less-about what matters in psychotherapy.

OBJECTIVE: We identify difficulties researchers encounter in psychotherapy process-outcome investigations, and we describe several limitations of the popular "variance accounted for" approach to understanding the effects of psychotherapy. METHODS & RESULTS: Using data simulations, we show how the expected correlation between an excellent measure of therapy quality and outcome would be surprisingly small (approximately .25) under conditions likely to be common in psychotherapy research. Even when we modeled conditions designed to increase the likelihood that strong process-outcome relationships would be observed, we found that the expected correlations were still only in the modest range (.38-.51). CONCLUSIONS: We discuss the implications of our analysis for the interpretation of process-outcome findings as well as for design considerations in future investigations.

Biases in affective forecasting and recall in individuals with depression and anxiety symptoms.

The authors used experience sampling to investigate biases in affective forecasting and recall in individuals with varying levels of depression and anxiety symptoms. Participants who were higher in depression symptoms demonstrated stronger (more pessimistic) negative mood prediction biases, marginally stronger negative mood recall biases, and weaker (less optimistic) positive mood prediction and recall biases. Participants who were higher in anxiety symptoms demonstrated stronger negative mood prediction biases, but positive mood prediction biases that were on par with those who were lower in anxiety. Anxiety symptoms were not associated with mood recall biases. Neither depression symptoms nor anxiety symptoms were associated with bias in event prediction. Their findings fit well with the tripartite model of depression and anxiety. Results are also consistent with the conceptualization of anxiety as a "forward-looking" disorder, and with theories that emphasize the importance of pessimism and general negative information processing in depressive functioning.

Brain activation during autobiographical relationship episode narratives: a core conflictual relationship theme approach.

The authors combined the core conflictual relationship theme (CCRT) method and functional magnetic resonance imaging (fMRI) to identify brain regions involved in recall of autobiographical relationship episodes, a key process in psychotherapy. Relationship narratives were obtained from healthy subjects and scored for CCRT relationship themes and emotion. Autobiographical personal and nonautobiographical control narratives were presented in a block-design fMRI experiment. Personal versus control narratives showed activations in anterior cingulate, precuneus, inferior and middle frontal gyri, and inferior parietal lobule. These are regions involved in autobiographical memory, theory of mind, self-referential processing, and emotion. In an exploratory analysis, higher CCRT scores correlated with increased brain activation in the left hippocampus, parahippocampal gyrus, and middle occipital gyrus. This suggests that brain systems subserving memory processes are more active when recalling relationship episodes with greater CCRT content.

Is psychotherapy good for your health?

This is a dedicated review of the evidence for the relation of having a period of psychotherapy and then comparing it with a measure of improved physical health. We aimed to make it the first intended-to-be-complete review of this type. Three inter-related types of studies were examined: Type 1: reduction in physical illnesses through psychotherapy, especially for the patient's survival time during the interval between diagnosis and an end point, Type 2: reduction in pain in relation to receiving psychotherapy, and Type 3: reduction in costs of treatment in relation to receiving psychotherapy. To find the relevant studies on these topics, we performed a literature search using both Psychinfo and Medline databases. An average of the effect sizes under each type was taken to calculate the mean effect size along with its confidence interval. Our results (1) on survival time for the combined severe patients, did not reach even the lowest significant level of effect size, although the low severity patients seemed to fit the hypothesis better, but the other two reduction topics, (2) and (3), clearly did achieve it.