Magnetic Seizure Therapy Compared to Electroconvulsive Therapy for Schizophrenia: A Randomized Controlled Trial

Background: Magnetic seizure therapy (MST) is a potential alternative to electroconvulsive therapy (ECT). However, reports on the use of MST for patients with schizophrenia, particularly in developing countries, which is a main indication for ECT, are limited.Methods: From February 2017 to July 2018, 79 inpatients who met the DSM-5 criteria for schizophrenia were randomized to receive 10 sessions of MST (43 inpatients) or ECT (36 inpatients) over the course of 4 weeks. At baseline and 4-week follow-up, the Positive and Negative Syndrome Scale (PANSS) and the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) were used to assess symptom severity and cognitive functions, respectively.Results: Seventy-one patients who completed at least half of the treatment protocol were included in the per-protocol analysis. MST generated a non-significant larger antipsychotic effect in terms of a reduction in PANSS total score [g = 0.17, 95% confidence interval (CI) = −0.30, 0.63] and response rate [relative risk (RR) = 1.41, 95% CI = 0.83–2.39]. Twenty-four participants failed to complete the cognitive assessment as a result of severe psychotic symptoms. MST showed significant less cognitive impairment over ECT in terms of immediate memory (g = 1.26, 95% CI = 0.63–1.89), language function (g =1.14, 95% CI = 0.52–1.76), delayed memory (g = 0.75, 95% CI = 0.16–1.35), and global cognitive function (g = 1.07, 95% CI = 0.45–1.68). The intention-to-treat analysis generated similar results except for the differences in delayed memory became statistically insignificant. Better baseline cognitive performance predicted MST and ECT response.Conclusions: Compared to bitemporal ECT with brief pulses and age-dose method, MST had similar antipsychotic efficacy with fewer cognitive impairments, indicating that MST is a promising alternative to ECT as an add-on treatment for schizophrenia.Clinical Trial Registration: ClinicalTrials.gov, identifier: NCT02746965.

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Preventive effect of sensorimotor exercise and resistance training on chemotherapy-induced peripheral neuropathy: a randomised-controlled trial

British Journal of Cancer ◽

10.1038/s41416-021-01471-1 ◽

2021 ◽

Author(s):

Jana Müller ◽

Markus Weiler ◽

Andreas Schneeweiss ◽

Georg Martin Haag ◽

Karen Steindorf ◽

...

Keyword(s):

Peripheral Neuropathy ◽

Resistance Training ◽

Training Stimulus ◽

Controlled Trial ◽

Dose Intensity ◽

Chemotherapeutic Agents ◽

Clinical Trial Registration ◽

Intention To Treat ◽

Eortc Qlq

Abstract Background Chemotherapy-induced peripheral neuropathy (CIPN) is a common, unpleasant and usually long-lasting side effect of neurotoxic chemotherapeutic agents. This study aimed to investigate the preventive potential of sensorimotor- (SMT) and resistance training (RT) on CIPN. Methods Patients (N = 170) were randomised to SMT, RT or usual care (UC). Both exercise groups trained 3×/week for a total of 105 min/week during neurotoxic chemotherapy (mean length: 20 weeks). Before and 3 weeks after neurotoxic chemotherapy, CIPN signs/symptoms were assessed via Total Neuropathy Score (TNSr; primary endpoint) and EORTC QLQ-CIPN15 questionnaire. In addition, balance (centre of pressure), muscle strength (isokinetic), quality of life (QoL, EORTC QLQ-C30) and relative chemotherapy dose intensity (RDI) were investigated. The follow-up period covered 6 months after the end of chemotherapy. Results Intention-to-treat analyses (N = 159) revealed no differences regarding CIPN signs/symptoms. Exploratory per-protocol analyses (minimum training attendance rate 67%; N = 89) indicated that subjectively perceived sensory symptoms in the feet increased less during chemotherapy in the adherent exercisers (pooled group: SMT+RT) than in the UC group (−8.3 points (−16.1 to −0.4); P = 0.039, ES = 1.27). Furthermore, adherent exercisers received a higher RDI (96.6 ± 4.8 vs. 92.2 ± 9.4; P = 0.045), showed a better course of muscular strength (+20.8 Nm (11.2–30.4); P < 0.001, ES = 0.57) and QoL (+12.9 points (3.9–21.8); P = 0.005, ES = 0.64). During follow-up, CIPN signs/symptoms persisted in all groups. Conclusions This study demonstrates that SMT and/or RT alleviate subjectively perceived sensory CIPN symptoms in the feet and other clinically relevant cancer therapy-related outcomes, if an appropriate training stimulus is achieved. Clinical trial registration NCT02871284.

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Preliminary Outcomes of a Digital Therapeutic Intervention for Smoking Cessation in Adult Smokers: Randomized Controlled Trial (Preprint)

10.2196/preprints.22833 ◽

2020 ◽

Author(s):

Jamie Webb ◽

Sarrah Peerbux ◽

Peter Smittenaar ◽

Sarim Siddiqui ◽

Yusuf Sherwani ◽

...

Keyword(s):

Carbon Monoxide ◽

Randomized Controlled Trial ◽

Smoking Cessation ◽

Therapeutic Intervention ◽

Primary Outcome ◽

Controlled Trial ◽

Promising Alternative ◽

Intention To Treat ◽

Randomized Controlled ◽

Brief Advice

BACKGROUND Tobacco smoking remains the leading cause of preventable death and disease worldwide. Digital interventions delivered through smartphones offer a promising alternative to traditional methods, but little is known about their effectiveness. OBJECTIVE Our objective was to test the preliminary effectiveness of Quit Genius, a novel digital therapeutic intervention for smoking cessation. METHODS A 2-arm, single-blinded, parallel-group randomized controlled trial design was used. Participants were recruited via referrals from primary care practices and social media advertisements in the United Kingdom. A total of 556 adult smokers (aged 18 years or older) smoking at least 5 cigarettes a day for the past year were recruited. Of these, 530 were included for the final analysis. Participants were randomized to one of 2 interventions. Treatment consisted of a digital therapeutic intervention for smoking cessation consisting of a smartphone app delivering cognitive behavioral therapy content, one-to-one coaching, craving tools, and tracking capabilities. The control intervention was very brief advice along the Ask, Advise, Act model. All participants were offered nicotine replacement therapy for 3 months. Participants in a random half of each arm were pseudorandomly assigned a carbon monoxide device for biochemical verification. Outcomes were self-reported via phone or online. The primary outcome was self-reported 7-day point prevalence abstinence at 4 weeks post quit date. RESULTS A total of 556 participants were randomized (treatment: n=277; control: n=279). The intention-to-treat analysis included 530 participants (n=265 in each arm; 11 excluded for randomization before trial registration and 15 for protocol violations at baseline visit). By the quit date (an average of 16 days after randomization), 89.1% (236/265) of those in the treatment arm were still actively engaged. At the time of the primary outcome, 74.0% (196/265) of participants were still engaging with the app. At 4 weeks post quit date, 44.5% (118/265) of participants in the treatment arm had not smoked in the preceding 7 days compared with 28.7% (76/265) in the control group (risk ratio 1.55, 95% CI 1.23-1.96; <i>P</i><.001; intention-to-treat, n=530). Self-reported 7-day abstinence agreed with carbon monoxide measurement (carbon monoxide <10 ppm) in 96% of cases (80/83) where carbon monoxide readings were available. No harmful effects of the intervention were observed. CONCLUSIONS The Quit Genius digital therapeutic intervention is a superior treatment in achieving smoking cessation 4 weeks post quit date compared with very brief advice. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN) 65853476; https://www.isrctn.com/ISRCTN65853476

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A prospective multicenter assessor-blinded randomized controlled study to compare the efficacy of short versus long protocols of electroconvulsive therapy as an augmentation strategy to clozapine in patients with ultra-resistant schizophrenia (SURECT study)

Trials ◽

10.1186/s13063-021-05227-3 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Virginie Moulier ◽

◽

Mohamed Wassim Krir ◽

Marine Dalmont ◽

Olivier Guillin ◽

...

Keyword(s):

Electroconvulsive Therapy ◽

Negative Symptoms ◽

Controlled Trial ◽

Optimal Number ◽

Controlled Study ◽

Psychotic Symptoms ◽

Clozapine Treatment ◽

Randomized Controlled ◽

Augmentation Strategy ◽

Long Protocol

Abstract Background Although clozapine is the most effective antipsychotic drug for treatment-resistant schizophrenia, it leads to a poor or partial response in 40 to 70% of patients. Augmentation of clozapine with electroconvulsive therapy (ECT) is a highly effective and relatively safe treatment for these clozapine-resistant patients. However, parameters are not yet well specified, such as the optimal number of sessions, their frequency, and the relevance of maintenance ECT. Our objective is to compare the efficacy and tolerance between two protocols of combined ECT and clozapine treatment in patients with ultra-resistant schizophrenia (URS): a 6-month protocol (short protocol with 20 ECT sessions) and a 12-month protocol (long protocol with 40 ECT sessions). Methods Sixty-four patients with schizophrenia with persistent psychotic symptoms despite clozapine treatment will be enrolled in a prospective multicentric assessor-blinded randomized controlled trial. Patients will be randomly assigned to the short or the long protocol. The main outcome is the response rate assessed by the Positive and Negative Symptoms Scale (PANSS) 3 months after the end of the treatment in patients following the long protocol compared to those following the short protocol. The response was defined as a 30% reduction on the PANSS baseline. Clinical assessments (PANSS, BPRS, HAMD-21, YMRS, CGI, GAF, Modified Overt Aggression Scale (MOAS), and Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS)) and plasma clozapine concentration will be performed at baseline and at 2, 4, 6, 9, 12, and 15 months. Neuropsychological measures (MMSE, RL/RI-16, Doors test, D2 Test of Attention, Copy of the Rey-Osterrieth complex figure) will be performed at baseline and at 6 and 15 months. Discussion The aims of this research are to optimize protocols of combined ECT with clozapine in patients with URS and to offer specific recommendations for these patients’ care. Trial registration ClinicalTrials.gov NCT03542903. Registered on May 31, 2018. Id RCB: 2017-A02657-46

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Music Therapy vs. Music Listening for Negative Symptoms in Schizophrenia: Randomized, Controlled, Assessor- and Patient-Blinded Trial

Frontiers in Psychiatry ◽

10.3389/fpsyt.2021.738810 ◽

2021 ◽

Vol 12 ◽

Author(s):

Inge Nygaard Pedersen ◽

Lars Ole Bonde ◽

Niels Jørgensen Hannibal ◽

Jimmi Nielsen ◽

Jørgen Aagaard ◽

...

Keyword(s):

Music Therapy ◽

Negative Symptoms ◽

Primary Outcome ◽

Controlled Trial ◽

Mixed Effects ◽

Music Listening ◽

Clinical Trial Registration ◽

Intention To Treat ◽

First Choice ◽

Significant Difference

Objective: To investigate the efficacy of music therapy for negative symptoms in patients with schizophrenia.Methods: Randomized, participant- and assessor-blinded, multicenter, controlled trial including patients diagnosed with schizophrenia according to ICD-10 with predominantly negative symptoms, between 18 and 65 years. Participants were randomized to 25 successive weekly individual sessions (excluding holidays, including cancellation by the participant) of either music therapy conducted by trained music therapists, or music listening together with a social care worker. The primary outcome was reduction in negative symptoms as measured by The Positive and negative Syndrome Scale (PANSS) negative subscale total score, assessed by a blinded rater, utilizing mixed-effects model analysis.Results: In total, 57 participants were randomized; 39 completed the study's initial 15 weeks, and 30 completed follow-up at 25 weeks. On the primary outcome of PANSS negative subscale, no significant difference was observed between groups with a coefficient of −0.24 (95% CI −1.76 to 1.27, P = 0.754) in the intention to treat analysis, and −0.98 (95% CI −5.06 to 3.09, P = 0.625) when only analyzing completers. Both interventions showed significant reduction from baseline to 25 weeks on PANSS negative subscale. On secondary outcomes, no between group differences were observed in The Brief Negative Symptom Scale, WHOQOL-Bref (Quality of Life), The Helping Alliance Questionnaire and The Global Assessment of Functioning in the intention to treat or completers populations utilizing Mixed Effects Models.Conclusion: No difference between groups randomized to music therapy vs. musical listening was observed resulting in no clear recommendation for which intervention to use as the first choice for treatment of patients diagnosed with schizophrenia and predominantly having negative symptoms.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT02942459.

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Magnetic Non-invasive Auricular Acupuncture During Eye-Exam for Retinopathy of Prematurity in Preterm Infants: A Multicentre Randomized Controlled Trial

Frontiers in Pediatrics ◽

10.3389/fped.2020.615008 ◽

2020 ◽

Vol 8 ◽

Author(s):

Kimberly M. L. Gan ◽

Ju-Lee Oei ◽

Im Quah-Smith ◽

Azanna A. Kamar ◽

Alexis A. D. Lordudass ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Preterm Infants ◽

Retinopathy Of Prematurity ◽

Controlled Trial ◽

Mean Difference ◽

Auricular Acupuncture ◽

Long Term Effects ◽

Clinical Trial Registration ◽

Intention To Treat ◽

Randomized Controlled

Background: Eye exam for Retinopathy of prematurity (ROP) is a painful procedure and pharmacological analgesia might be ineffective. We hypothesized that magnetic auricular acupuncture (MAA) compared to placebo will decrease pain during ROP exam in preterm infants.Methods: Multicentre randomized controlled trial conducted in three hospitals (Australia, Canada, and Malaysia). Eligibility: >32 weeks, ROP exam, not sedated, and parental consent. A total of 100 infants were randomized (1:1) to MAA (n = 50) or placebo (n = 50). MAA stickers or placebo were placed on both ears by an unblinded investigator. Pain was assessed using the Premature Infant Pain Profile. Primary analyses were by intention-to-treat. ClinicalTrials.gov:NCT03650621.Findings: The mean (standard deviation, SD) gestation, birthweight, and postnatal age were (MAA 28(3) vs. placebo 28(2) weeks; MAA 1,057(455) vs. placebo 952(273) g; MAA 7(3) vs. placebo 7(3) weeks. Placebo infants had significantly higher PIPP scores during [mean difference 1.6 points (95%CI 0.1–3.1)] and 1 h mean difference 1.5 points (95%CI 0.7–2.2) after the procedure (p < 0.03). Heart rate was lower (173(22) vs. 184(18)/min) and oxygen saturations were higher (93.8(6.2) vs. 91.7(6.1)%, p = 0.05) in MAA infants. No adverse effects.Interpretation: MAA may reduce physiological pain responses during and after ROP exam in preterm infants. Assessment of long-term effects are warranted.Clinical trial registration: www.ClinicalTrials.gov, identifier: NCT03650621.

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Contrasting approaches for addressing non-adherence in randomized controlled trials: An illustration from the REFLUX trial

Clinical Trials ◽

10.1177/17407745211056881 ◽

2021 ◽

pp. 174077452110568

Author(s):

Luke Keele ◽

Richard Grieve

Keyword(s):

Randomized Controlled Trials ◽

Causal Effect ◽

Controlled Trial ◽

Treatment Protocol ◽

Analytical Framework ◽

Controlled Trials ◽

Intention To Treat ◽

Randomized Controlled ◽

Average Causal Effect ◽

Study Context

Background: In many randomized controlled trials, a substantial proportion of patients do not comply with the treatment protocol to which they have been randomly assigned. Randomized controlled trials are required to report results according to the intention-to-treat estimand, but recent methodological guidance recognizes the importance of estimating other causal quantities. Methods: This article outlines an analytical framework for randomized controlled trials with non-compliance. We apply the ICH E9 (R1) addendum and combine it with the potential outcomes framework to define key estimands, outline the major assumptions for identification of each estimand, and highlight the assumptions that cannot be verified from the randomized controlled trial data. We contrast the assumptions and estimates in a re-analysis of the REFLUX trial. We report alternative estimates for the effectiveness of receipt of laparoscopic surgery versus medical management for patients with gastro-intestinal reflux disease. Results: The article finds that adjusted as-treated and per-protocol estimates were similar in magnitude to those based intention-to-treat methods. Instrumental variable estimates of the complier average causal effect were larger, with wider confidence intervals. Conclusion: We recommend that in randomized controlled trials with non-compliance, studies should outline which estimand is most relevant to the study context, evaluate key assumptions, and present estimates from a range of methods as a sensitivity analysis.

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The effect of a mindfulness-based intervention on executive, behavioural and socio-emotional competencies in very preterm young adolescents

Scientific Reports ◽

10.1038/s41598-021-98608-2 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Vanessa Siffredi ◽

Maria Chiara Liverani ◽

Petra Susan Hüppi ◽

Lorena G. A. Freitas ◽

Jiske De Albuquerque ◽

...

Keyword(s):

Controlled Trial ◽

Neuropsychological Testing ◽

Emotional Difficulties ◽

Young Adolescents ◽

Emotional Competencies ◽

Clinical Trial Registration ◽

Intention To Treat ◽

Very Preterm ◽

Executive Competencies ◽

Randomised Controlled

AbstractVery preterm (VPT) children and adolescents show executive, behavioural and socio-emotional difficulties that persists into adulthood. This study aims to assess the effectiveness of a mindfulness-based intervention (MBI) in improving these competencies in VPT young adolescents using a randomised controlled trial design. 56 young adolescents aged 10–14 years, born before 32 gestational weeks, were randomly assigned to an “intervention” or a “waiting” group and completed an 8-week MBI in a cross-over design. Executive, behavioural and socio-emotional competencies were assessed at three different time points via parent and self-reported questionnaires, neuropsychological testing and computerised tasks. The data were analysed using an intention-to-treat approach with linear regression modelling. Our findings show a beneficial effect of MBI on executive, behavioural and socio-emotional competencies in VPT young adolescents measured by parent questionnaires. Increased executive competencies were also observed on computerised task with enhanced speed of processing after MBI. Two subgroups of participants were created based on measures of prematurity, which revealed increased long-term benefits in the moderate-risk that were not observed in the high-risk subgroups of VPT young adolescents. MBI seems a valuable tool for reducing detrimental consequences of prematurity in young adolescents, especially regarding executive, behavioural and socio-emotional difficulties.Clinical Trial Registration ClinicalTrials, NCT04638101. Registered 20 November 2020—Retrospectively registered, https://clinicaltrials.gov/show/NCT04638101.

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An Enhanced High-Volume Preparation for Colonoscopy Is Not Better Than a Conventional Low-Volume One in Patients at Risk of Poor Bowel Cleansing: A Randomized Controlled Trial

Frontiers in Medicine ◽

10.3389/fmed.2021.654847 ◽

2021 ◽

Vol 8 ◽

Author(s):

Antonio Z. Gimeno-García ◽

Goretti Hernández ◽

José Luis Baute Dorta ◽

Cristina Reygosa ◽

Raquel de la Barreda ◽

...

Keyword(s):

Clinical Trial ◽

Bowel Preparation ◽

Controlled Trial ◽

High Volume ◽

Risk Difference ◽

Predictive Score ◽

Clinical Trial Registration ◽

Intention To Treat ◽

Bowel Cleansing ◽

Low Volume

Objective: We tested the hypothesis that an enhanced bowel preparation strategy (EBS) improves colonic cleansing in patients at high risk for inadequate bowel cleansing (HRI).Methods: This prospective randomized clinical trial included consecutive HRI patients referred for outpatient colonoscopy between February and October 2019. HRI was considered if patients scored >1.225 according to a previously validated bowel-cleansing predictive score. HRI patients were randomized (1:1) to a low-volume conventional bowel cleansing strategy (CBS) (1-day low residue diet (LRD) plus 2 L of polyethylene glycol (PEG) plus ascorbic acid) or to an EBS (3-day LRD plus 10 mg oral bisacodyl plus 4 L PEG). The Boston Bowel Preparation Scale (BBPS) was used to assess the quality of cleanliness. Intention-to-treat (ITT) and per protocol (PP) analyses were performed. A sample size of 130 patients per group was estimated to reach a 15% difference in favor of EBP.Results: A total of 253 HRI patients were included (mean age 69.8 ± 9.5 years, 51.8% women). No statistically significant differences were found in the BBPS scale between the two groups in the ITT analysis (CBS 76.8% vs. EBS 79.7%, P = 0.58) or PP analysis (CBS 78% vs. EBS 84.3%, P = 0.21), risk difference 2.9% (95% CI−7.26 to 39.16) in the ITT analysis, or risk difference 6.3% (95% CI−3.48 to 16.08) in PP analysis. No differences in preparation tolerance, compliance, adverse effects, or colonoscopy findings were found.Conclusion: EBS is not superior to CBS in hard-to-prepare patients. (EUDRACT: 2017-000787-15, NCT03830489).Clinical Trial Registration:www.ClinicalTrials.gov, identifier NCT03830489.

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A Randomized Controlled Trial of a Digital Therapeutic Intervention for Smoking Cessation

10.1101/2020.06.25.20139741 ◽

2020 ◽

Author(s):

Jamie Webb ◽

Sarrah Peerbux ◽

Peter Smittenaar ◽

Sarim Siddiqui ◽

Yusuf Sherwani ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Smoking Cessation ◽

Therapeutic Intervention ◽

Behavioral Therapy ◽

Controlled Trial ◽

Smartphone Application ◽

Promising Alternative ◽

Intention To Treat ◽

Randomized Controlled ◽

Brief Advice

AbstractBackground and AimsTobacco smoking remains the leading cause of preventable death and disease worldwide. Digital interventions delivered through smartphones offer a promising alternative to traditional methods, but little is known about their effectiveness. Our aim was to determine the effectiveness of Quit Genius, a novel digital therapeutic intervention for smoking cessation.DesignTwo-arm, single-blinded, parallel-group randomized controlled trialSettingReferrals from primary care practicesParticipants556 Adult smokers (aged ≥ 18 years), smoking at least five cigarettes a day for the past year. 530 were included for the final analysis.Intervention and comparatorDigital therapeutic intervention for smoking cessation consisting of a smartphone application delivering cognitive behavioral therapy content, one-to-one coaching, craving tools and tracking capabilities. The control intervention was Very Brief Advice along the Ask, Advise, Act model. All participants were offered nicotine replacement therapy for three months. A random half of each arm was assigned a carbon monoxide (CO) device for biochemical verification.MeasurementsThe primary outcome was self-reported seven-day point prevalence abstinence at four-weeks post quit date.Findings556 participants were randomized (treatment n=277, control n=279). The intention-to-treat analysis included 530 participants (n=265 in each arm; 11 excluded for randomization before trial registration, and 15 for protocol violations at baseline visit).At four weeks post-quit date, 45% of participants in the treatment arm had not smoked in the preceding seven days, compared to 29% in control (risk ratio 1.55 [1.23, 1.96], p = 0.0002; intention-to-treat, n=530). Self-reported seven-day abstinence agreed with CO measurement (CO <10 ppm) in 96% of cases (80/83) where CO readings were available. No harmful effects of the intervention were observed.ConclusionsThe Quit Genius digital therapeutic intervention is a superior treatment in achieving smoking cessation four weeks post quit date compared to very brief advice.

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Treatment Fidelity Procedures for an Aphasia Intervention Within a Randomized Controlled Trial: Design, Feasibility, and Results

American Journal of Speech-Language Pathology ◽

10.1044/2019_ajslp-cac48-18-0227 ◽

2020 ◽

Vol 29 (1S) ◽

pp. 412-424

Author(s):

Elissa L. Conlon ◽

Emily J. Braun ◽

Edna M. Babbitt ◽

Leora R. Cherney

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Treatment Protocol ◽

Treatment Fidelity ◽

Protocol Adherence ◽

Study Condition ◽

Randomized Controlled ◽

Aphasia Therapy ◽

Percent Accuracy ◽

Over Time

Purpose This study reports on the treatment fidelity procedures implemented during a 5-year randomized controlled trial comparing intensive and distributed comprehensive aphasia therapy. Specifically, the results of 1 treatment, verb network strengthening treatment (VNeST), are examined. Method Eight participants were recruited for each of 7 consecutive cohorts for a total of 56 participants. Participants completed 60 hr of aphasia therapy, including 15 hr of VNeST. Two experienced speech-language pathologists delivered the treatment. To promote treatment fidelity, the study team developed a detailed manual of procedures and fidelity checklists, completed role plays to standardize treatment administration, and video-recorded all treatment sessions for review. To assess protocol adherence during treatment delivery, trained research assistants not involved in the treatment reviewed video recordings of a subset of randomly selected VNeST treatment sessions and completed the fidelity checklists. This process was completed for 32 participants representing 2 early cohorts and 2 later cohorts, which allowed for measurement of protocol adherence over time. Percent accuracy of protocol adherence was calculated across clinicians, cohorts, and study condition (intensive vs. distributed therapy). Results The fidelity procedures were sufficient to promote and verify a high level of adherence to the treatment protocol across clinicians, cohorts, and study condition. Conclusion Treatment fidelity strategies and monitoring are feasible when incorporated into the study design. Treatment fidelity monitoring should be completed at regular intervals during the course of a study to ensure that high levels of protocol adherence are maintained over time and across conditions.

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