Abstract Background Despite 40 years of evidence supporting psychosocial interventions as a component of comprehensive cancer care, patients continue to report vast unmet psychosocial needs and distress. Cognitive behavioral therapies for cancer distress (CBT-C) are the most rigorously tested class of psychosocial interventions for cancer care. Purpose To report clinical effectiveness outcomes of cancer-related distress and self-efficacy following implementation of best-evidence CBT-C, adapted for a real-world, billable practice setting. Methods Patients who completed group-delivered, CBT-C (10 intervention hours, 5 sessions) in the practice setting were invited to enroll in a research study to document cancer distress across the year following CBT-C. Participants (n = 65) were primarily middle-aged (mean 50.5 years, 17% were young adults ≤40 years), female, and White. Analyses utilized mixed linear models with intent-to-treat procedures. Given group delivery and social skills training content within CBT-C, social self-efficacy was assessed as a potential treatment mechanism. Results Distress decreased across the year following CBT-C (mean score change of 20 points for YAs, 6 points for non-YAs), with statistically significant age x time effects. Within-person improvements in social self-efficacy scores were related to reductions in cancer distress, including distress subscales of intrusive thoughts, avoidant coping, and hyperarousal. The model explained 76.6% of the total variance in cancer distress. Conclusions This study demonstrates the effective translation of CBT-C from controlled research trials to the practice setting. CBT-C effectiveness within a mixed-cancer population and relatively rural region of the US is also supported. CBT-C can be effectively translated to the practice settings for which it is intended.
Rizatriptan vs Placebo for Attacks of Vestibular Migraine
ImportanceVestibular migraine has no established treatments.ObjectiveTo test the efficacy of rizatriptan for treating vestibular migraine attacks.Design, Setting, and ParticipantsThis double-blind, randomized clinical trial of rizatriptan vs placebo was conducted from December 2014 through July 2020 (data analyses in 2021 and sensitivity analyses in 2022 and 2024) at 2 tertiary neurotologic centers. Adults with vestibular migraine were included.InterventionAll participants underwent prospective observation to confirm diagnosis and illness activity and were then randomized in a 2:1 ratio to receive rizatriptan 10 mg or placebo to treat up to 3 vestibular migraine attacks per participant.Main Outcomes and MeasuresParticipants rated symptoms as absent, mild, moderate, or severe at scheduled intervals. Primary outcomes were the percentage of attacks with reductions in vertigo and unsteadiness/dizziness from moderate or severe to absent or mild at 1 hour. Secondary outcomes were the percentage of attacks with complete resolution of vestibular symptoms at 1 hour; reductions in headache and associated symptoms at 1 hour; use of rescue medications after 1 hour; reductions in vestibular, headache, and associated symptoms at 24 hours without rescue medications; treatment satisfaction and quality of life at 48 hours; and rates of serious adverse effects and discontinuation due to adverse effects.ResultsOf 222 total participants (mean [SD] age, 42.3 [11.7] years; 70.7% were women), 134 (60.4%) with active illness treated 307 attacks. Efficacy was tested using 240 attacks with vestibular symptoms rated as moderate or severe when participants took study drug. At 1 hour, rizatriptan did not differ from placebo for reducing vertigo (73/151 [48.3%] vs 50/88 [56.8%] attacks; odds ratio [OR], 0.71 [95% CI, 0.42-1.21]), unsteadiness/dizziness (29/151 [19.2%] vs 11/89 [12.4%] attacks; OR, 1.69 [95% CI, 0.80-3.57]), or any secondary outcomes. Similar percentages of participants in rizatriptan and placebo groups (26.4% for both groups) added rescue remedies after 1 hour. At 24 hours, rizatriptan had medium effects over placebo for unsteadiness/dizziness (OR, 2.65) and motion sensitivity (OR, 3.58). Post hoc analyses of all treated attacks found a medium effect favoring rizatriptan for headache and photophobia or phonophobia at 24 hours. Treatment satisfaction was equivocal. Quality of life was mixed. No participants experienced serious adverse effects or discontinued treatment for adverse effects.Conclusions and RelevanceIn this study, rizatriptan was ineffective at 1 hour for treating vestibular migraine attacks and had limited benefit on symptoms at 24 hours. Findings do not support using rizatriptan for vestibular migraine attacks.Trial RegistrationClinicalTrials.gov Identifier: NCT02447991
Using session recordings to understand the content of community‐based treatment for childhood anxiety disorders and response to technology‐based training
AbstractObjectiveThe goal of the current study is to advance efforts to increase the quality of care for childhood anxiety disorder (CADs) through (1) detailing the content of community‐based treatment sessions, (2) exploring the validity of therapist surveys, (3) examining the influence of setting differences, and (4) testing the effects of a technology‐based training on use of nonexposure strategies.MethodsThirteen therapists were randomly assigned to technology‐based training in the use of exposure therapy or treatment as usual (TAU) for CADs. Therapeutic techniques were coded from 125 community‐based treatment sessions.ResultsConsistent with survey responses community therapists spent the majority of session time reviewing symptoms (34% of session time), implementing nonexposure cognitive behavioral therapy (CBT; 36%), and rarely engaged in exposure (3%). An integrated behavioral health setting was associated with greater endorsement of exposure on survey, p < 0.05, although this difference was not significant in session recordings, p = 0.14. Multilevel models indicated that technology‐based training that has been shown to increase exposure, also decreased use of nonexposure CBT techniques (2% vs. 29%, p < 0.001).ConclusionThe study supports the validity of survey‐based findings that community‐based care for CADs consists of non‐exposure CBT techniques. Efforts should be invested in dissemination of within‐session exposure.
Translation of a family-based behavioral intervention for adolescent obesity using the RE-AIM framework and common steps from adaptation frameworks
Abstract Interventions for adolescent weight management that are ready to use in clinical settings are needed to address the obesity epidemic and improve the health and wellbeing of affected adolescents. This report describes the systematic process our team followed to adapt an evidence-based intervention (EBI) for adolescent weight management from its randomized control trial protocol to a package for delivery in a group-based telehealth format within a medical center. The EBI adaptation was clinician initiated, prompted by identified practice needs, and involved collaboration of the clinical team with the EBI developer. The process was guided by the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework and followed key steps for adapting EBIs to new contexts. RE-AIM-aligned adaptations included telehealth delivery and broader inclusion criteria, separate clinical and research evaluation batteries, adaptations to fit the clinical practice, practical fidelity checklists to guide and record session delivery, and continuous quality improvement processes aimed to facilitate program longevity and family engagement. The process culminated in a package of adapted intervention materials deemed by stakeholders as appropriate to the practice and congruent with the EBI model. This report provides a much-needed practical demonstration of the translation of an EBI for adolescent weight management from research protocol to group telehealth delivery in a medical center. Key lessons include the value of clinician-researcher collaboration, the breadth of resources needed to adapt EBIs for real-world delivery, and the importance of considering delivery context in implementation and evaluation decisions, including defining inclusion criteria, staffing, and outcomes assessments.
Acceptability of a Brief, Intensive Adolescent Obesity Intervention With Wellness Coaching
Objective: This report describes data regarding the acceptability of delivering a family-based behavioral lifestyle intervention for adolescent obesity in a brief, intensive onsite program (initial 3 sequential days + 1 follow-up day) combined with telephonic wellness coaching (WC). Methods: Four cohorts consisting of 7 adolescents aged 15–17 years (self-identifying as 4 male, 2 female, 1 transgender male; 6 White, 1 African American and White) and thirteen parents participated in a new clinical intervention consisting of 3 days onsite programming, 3-months telephonic wellness coaching, and 1 day onsite follow up. Enrollment, attendance, and retention were recorded. Participants provided quantitative and qualitative feedback regarding acceptability of the program during postintervention interviews. Results: Of 11 families invited, 8 enrolled. Seven families participated, with 1 family lost to follow up. Adolescents completed an average 5.6/9 planned WC sessions. Adolescents rated the program positively overall and liked experiential sessions best. However, participants reported the onsite program was too long, they encountered barriers to sustained engagement during wellness coaching follow up, and parents desired greater guidance and structure for their involvement. Conclusions: Combining in-person sessions with telephonic wellness coaching was acceptable to participants, but intervention refinement is needed. Future program development and research investigating hybrid models should consist of briefer in-person sessions, emphasize skill practice, and include ongoing guidance to parents to provide developmentally appropriate support. Implications for Impact Statement This new clinical program evaluation found that extending onsite family-based behavioral lifestyle intervention for adolescent obesity with telephonic wellness coaching was acceptable to participants, but that program refinement is needed. Feedback highlighted the importance of keeping onsite sessions brief, engaging adolescents with hands-on skill practice, and providing ongoing guidance to parents to support sustained adolescent engagement in behavior change.
Physical Symptoms, Distress, and Functional Disability in Youth With Chronic Orthostatic Intolerance
AbstractObjectiveYouth with chronic orthostatic intolerance (OI) can experience significant physical, social, and academic functional debilitation. Previous studies have indicated associations among symptom severity, psychosocial factors, and functional disability. However, empirically tested models explaining how different medical and psychosocial factors may contribute to functional disability are lacking. The current cross-sectional study aimed to evaluate mediation, moderation, and additive models of the effect of physical symptoms and psychological distress on functional disability.MethodsOne hundred and sixty-five youth (13–22 years old) undergoing medical evaluation of chronic OI symptoms completed measures of autonomic dysfunction symptom severity, depressive and anxiety symptoms, and functional disability. Models were evaluated using tests of indirect effects and linear and logistic regression analyses.ResultsResults supported the mediation and additive effects models for depressive symptoms. Mediation, moderation, and additive models for hypothesized effects of anxiety symptoms were not supported.ConclusionsResults provide preliminary support for models in which OI symptoms affect functional debility via their effects on mood and in which depressive symptoms have unique and additive effects on functioning. Findings lay the foundation for longitudinal and experimental evaluation of biopsychosocial models of functional disability in youth with chronic OI and related conditions. Implications include the importance of a biopsychosocial conceptualization of OI symptoms and debility as a complex interplay of factors rather than as a purely physiological or psychological process.
Excessive Postural Tachycardia and Postural Orthostatic Tachycardia Syndrome in Youth: Associations With Distress, Impairment, Health Behaviors, and Medication Recommendations
Among adolescents with fatigue and postural dizziness, it is unclear how health behaviors and emotional distress relate to the presence of excessive postural tachycardia. We prospectively evaluated adolescents aged 13-22 years presenting with symptoms suggestive of autonomic dysfunction between September 2017 and December 2018. Patients underwent standard 10-minute, 70-degree head-up tilt testing. Clinician diagnoses and recommendations were recorded from the medical record. Patients completed validated self-report measures of lifestyle factors, autonomic symptoms, depression, anxiety, and functional disability. Of 179 patients, 58 were diagnosed with postural orthostatic tachycardia syndrome and 59 had excessive postural tachycardia, with 90.5% concordance between the 2 groups. Presence of excessive postural tachycardia was associated with greater baseline fluid intake and likelihood of medication prescription in their treatment plan. Medication findings were replicated for postural orthostatic tachycardia syndrome diagnosis. Presence of excessive postural tachycardia or postural orthostatic tachycardia syndrome did not differentiate patients on perceived symptom severity, emotional distress, disability, or health behaviors but did appear to determine treatment recommendations.
Quantifying Session Content in the Delivery of Parent Coached Exposure Therapy
Despite the efficacy of exposure for childhood anxiety disorders (CADs), dissemination has been unsuccessful. The current study examined community-therapist response to a brief (90-minutes) training in technology-assisted exposure therapy for CADs. The results indicated that therapists found the training in the therapy approach and technology acceptable, despite endorsing mainly non-exposure-based practice prior to the training. Training also increased positive beliefs about exposure, t (23) = 4.32, p < .000, that persisted 6 months later, t (23) = 4.56, p < .000. In addition, the number of therapists reporting an intention to implement exposure increased substantially from baseline (41.7%) to post-training (83.3%), with many therapists (70.8%) reporting use of exposure within the 6 months following training. However, automatically recorded data indicated little use of the technology. Results suggest that a dissemination message focusing on exposure is acceptable and has the potential to increase the use of this central treatment component.
Technology to Facilitate Treatment for Childhood Anxiety Disorders and Obsessive-Compulsive Disorder: Proof of Concept