Web-Based Therapist-Guided Mindfulness-Based Cognitive Behavioral Therapy for Body Dysmorphic Disorder: Pilot Randomized Controlled Trial.

BACKGROUND: Internet-based cognitive behavioral therapy (CBT) and stand-alone mindfulness meditation interventions are gaining empirical support for a wide variety of mental health conditions. In this study, we test the efficacy of web-based therapist-guided mindfulness-based cognitive behavioral therapy (CBT-M) for body dysmorphic disorder (BDD), a psychiatric disorder characterized by preoccupations with perceived defects in appearance. OBJECTIVE: This study aims to determine whether CBT-M for BDD delivered on the web is feasible and acceptable and whether mindfulness meditation adds to CBT treatment effects for BDD. METHODS: In this 8-week, 2-arm, parallel pilot randomized controlled trial, n=28 adults (aged between 18 and 55 years) were randomly allocated to an experimental group (web-based therapist-guided CBT-M) or a control group (web-based therapist-guided CBT). Study retention, accrual, and intervention adherence were assessed, along with self-report measures for BDD, depression, anxiety, and pain intensity taken at baseline and postintervention. RESULTS: This study was feasible to implement and deemed acceptable by participants. After 8 weeks, significant improvements were found on all outcome measures for both treatment groups, and large between-group effect sizes favoring CBT-M were found for BDD symptom severity (d=-0.96), depression (d=-1.06), pain severity (d=-1.12), and pain interference (d=-1.28). However, linear mixed models demonstrated no significant differences between the groups over 8 weeks. CONCLUSIONS: The results suggest that mindfulness meditation may add to beneficial web-based CBT treatment effects for BDD. An adequately powered randomized control trial of web-based CBT-M is warranted. TRIAL REGISTRATION: ClinicalTrials.gov NCT05402475, http://clinicaltrials.gov/ct2/show/NCT05402475.

The Use of Text Messaging as an Adjunct to Internet-Based Cognitive Behavioral Therapy for Major Depressive Disorder in Youth: Secondary Analysis.

BACKGROUND: As an established treatment for major depressive disorder (MDD), cognitive behavioral therapy (CBT) is now implemented and assessed in internet-based formats that, when combined with smartphone apps, enable secure text messaging. As an adjunct to such internet-based CBT (ICBT) approaches, text messaging has been associated with increased adherence and therapeutic alliance. OBJECTIVE: This study analyzed data from the intervention arm of a randomized control trial evaluating 24-week ICBT for MDD (intervention arm) against standard-care psychiatry (waitlist control). The aim of this secondary analysis was to assess MDD symptom improvement in relation to the frequency and content of text messages sent by ICBT participants to Navigator-Coaches during randomized control trial participation. Higher text frequency in general and in 3 conceptual categories (appreciating alliance, alliance building disclosures, and agreement confirmation) was hypothesized to predict larger MDD symptom improvement. METHODS: Participants were young adults (18-30 years) from the Centre for Addiction and Mental Health. The frequencies of categorized texts from 20 ICBT completers were analyzed with respect to MDD symptom improvement using linear regression models. Texts were coded by 2 independent coders and categorized using content analysis. MDD symptoms were measured using the Beck Depression Inventory-II (BDI-II). RESULTS: Participants sent an average of 136 text messages. Analyses indicated that BDI-II improvement was negatively associated with text messaging frequency in general (ß=-0.029, 95% CI -0.11 to 0.048) and in each of the 3 categories: appreciating alliance (ß=-0.096, 95% CI -0.80 to 0.61), alliance building disclosures (ß=-0.098, 95% CI -0.28 to 0.084), and agreement confirmation (ß=-0.076, 95% CI -0.40 to 0.25). Altogether, the effect of text messaging on BDI-II improvement was uniformly negative across statistical models. More text messaging appeared associated with less MDD symptom improvement. CONCLUSIONS: The hypothesized positive associations between conceptually categorized text messages and MDD symptom improvement were not supported in this study. Instead, more text messaging appeared to indicate less treatment benefit. Future studies with larger samples are needed to discern the optimal use of text messaging in ICBT approaches using adjunctive modes of communication. TRIAL REGISTRATION: Clinical Trials.gov NCT03406052; https://www.clinicaltrials.gov/ct2/show/NCT03406052.

Predicting the Effectiveness of a Mindfulness Virtual Community Intervention for University Students: Machine Learning Model.

BACKGROUND: Students' mental health crisis was recognized before the COVID-19 pandemic. Mindfulness virtual community (MVC), an 8-week web-based mindfulness and cognitive behavioral therapy program, has proven to be an effective web-based program to reduce symptoms of depression, anxiety, and stress. Predicting the success of MVC before a student enrolls in the program is essential to advise students accordingly. OBJECTIVE: The objectives of this study were to investigate (1) whether we can predict MVC's effectiveness using sociodemographic and self-reported features and (2) whether exposure to mindfulness videos is highly predictive of the intervention's success. METHODS: Machine learning models were developed to predict MVC's effectiveness, defined as success in reducing symptoms of depression, anxiety, and stress as measured using the Patient Health Questionnaire-9 (PHQ-9), the Beck Anxiety Inventory (BAI), and the Perceived Stress Scale (PSS), to at least the minimal clinically important difference. A data set representing a sample of undergraduate students (N=209) who took the MVC intervention between fall 2017 and fall 2018 was used for this secondary analysis. Random forest was used to measure the features' importance. RESULTS: Gradient boosting achieved the best performance both in terms of area under the curve (AUC) and accuracy for predicting PHQ-9 (AUC=0.85 and accuracy=0.83) and PSS (AUC=1 and accuracy=1), and random forest had the best performance for predicting BAI (AUC=0.93 and accuracy=0.93). Exposure to online mindfulness videos was the most important predictor for the intervention's effectiveness for PHQ-9, BAI, and PSS, followed by the number of working hours per week. CONCLUSIONS: The performance of the models to predict MVC intervention effectiveness for depression, anxiety, and stress is high. These models might be helpful for professionals to advise students early enough on taking the intervention or choosing other alternatives. The students' exposure to online mindfulness videos is the most important predictor for the effectiveness of the MVC intervention. TRIAL REGISTRATION: ISRCTN Registry ISRCTN12249616; https://www.isrctn.com/ISRCTN12249616.

Psychotherapy for Ketamine's Enhanced Durability in Chronic Neuropathic Pain: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: Chronic pain affects approximately 8 million Canadians (~20%), impacting their physical and mental health while burdening the health care system with costs of upwards of US $60 billion a year. Indeed, patients are often trialed on numerous medications over several years without reductions to their symptoms. Therefore, there is an urgent need to identify new therapies for chronic pain to improve patients' quality of life, increase the availability of treatment options, and reduce the burden on the health care system. OBJECTIVE: The primary objective of this study is to examine the feasibility of a parallel 3-arm pilot randomized controlled trial whereby patients are randomized to either intravenous ketamine alone, cognitive behavioral therapy (CBT) and mindfulness meditation (MM) training (CBT/MM), or the combination of intravenous ketamine and CBT/MM. The secondary outcome is to assess the durability and efficacy of combination intravenous ketamine and CBT/MM for treatment of chronic pain as compared to CBT/MM or intravenous ketamine alone (assessed at week 20 of the study). METHODS: This is a single-center, 16-week, 3-arm pilot study that will take place at the Chronic Pain Clinic at St. Michael's Hospital, Toronto, Ontario, which receives 1000 referrals per year. Patients will be enrolled in the study for a total of 20 weeks. Participants who are allocated CBT/MM therapy will receive remote weekly psychotherapy from week 1 to week 16, inclusive of health coaching administered through the NexJ Health Inc (NexJ Health) platform. Patients who are allocated ketamine-infusion therapy will receive monthly ketamine infusion treatments on weeks 2, 7, and 12. Patients who are allocated ketamine+CBT/MM will receive weekly psychotherapy from weeks 1 to 16, inclusive, as well as ketamine infusion treatments on weeks 2, 7, and 12. We will be assessing recruitment rates, consent rates, withdrawal rates, adherence, missing data, and adverse events as pilot outcome measures. Secondary clinical outcomes include changes relative to baseline in pain intensity and pain interference. RESULTS: As of November 1, 2023, the recruitment process has not been initiated. Given the recruitment, consent, and intervention target of 30 participants for this feasibility study, with each patient undergoing monitoring and treatments for a course of 20 weeks, we expect to complete the study by December 2025. CONCLUSIONS: This study assesses the feasibility of conducting a 3-arm randomized controlled trial to examine the effects of ketamine administration with the concurrent use of CBT/MM in a population with chronic neuropathic pain. The results of this pilot randomized controlled trial will inform the development of a larger-scale randomized controlled trial. Future studies will be aimed at including a sufficiently powered sample that will inform decisions about optimal treatment calibration and treatment effect duration. TRIAL REGISTRATION: ClinicalTrials.gov NCT05639322; https://classic.clinicaltrials.gov/ct2/show/NCT05639322. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/54406.

Phenotyping coronary plaque by computed tomography in premature coronary artery disease.

AIMS: Premature coronary artery disease (CAD) is an aggressive disease with multiple recurrences mostly related to new coronary lesions. This study aimed to compare coronary plaque characteristics of individuals with premature CAD with those of incidental plaques found in matched individuals free of overt cardiovascular disease, using coronary computed tomography angiography (CCTA). METHODS AND RESULTS: Of 1552 consecutive individuals who underwent CCTA, 106 individuals with history of acute or stable obstructive CAD ≤45 years were matched by age, sex, smoking status, cardiovascular heredity, and dyslipidaemia with 106 controls. CCTA were analysed for Coronary Artery Disease Reporting and Data System score, plaque composition, and high-risk plaque (HRP) features, including spotty calcification, positive remodelling, low attenuation, and napkin-ring sign. The characteristics of 348 premature CAD plaques were compared with those of 167 incidental coronary plaques of matched controls. The prevalence of non-calcified plaques was higher among individuals with premature CAD (65.1 vs. 30.2%, P < 0.001), as well as spotty calcification (42.5 vs. 17.9%, P < 0.001), positive remodelling (41.5 vs. 9.4%, P < 0.001), low attenuation (24.5 vs. 3.8%, P < 0.001), and napkin-ring sign (1.9 vs. 0.0%). They exhibited an average of 2.2 (2.7) HRP, while the control group displayed 0.4 (0.8) HRP (P < 0.001). Within a median follow-up of 24 (16, 34) months, individuals with premature CAD and ischaemic recurrence (n = 24) had more HRP [4.3 (3.9)] than those without ischaemic recurrence [1.5 (1.9)], mostly non-calcified with low attenuation and positive remodelling. CONCLUSION: Coronary atherosclerosis in individuals with premature CAD is characterized by a high and predominant burden of non-calcified plaque and unusual high prevalence of HRP, contributing to disease progression with multiple recurrences. A comprehensive qualitative CCTA assessment of plaque characteristics may further risk stratify our patients, beyond cardiovascular risk factors.

Home-based versus supervised group exercise in men with prostate cancer on androgen deprivation therapy: A randomized controlled trial and economic analysis.

INTRODUCTION: Differences between health outcomes, participation/adoption, and cost-effectiveness of home-based (HOME) interventions and supervised group-based training (GROUP) in men with prostate cancer (PC) on androgen deprivation therapy (ADT) are currently unknown. The objective of this study was to assess the clinical efficacy, adherence, and cost-effectiveness of HOME versus GROUP in men on ADT for PC. MATERIALS AND METHODS: This was a multicentre, 2-arm non-inferiority randomized controlled trial and companion cost-effectiveness analysis. Men with PC on ADT were recruited from August 2016 to March 2020 from four Canadian centres and randomized 1:1 to GROUP or HOME. All study participants engaged in aerobic and resistance training four to five days weekly for six months. Fatigue [Functional Assessment of Cancer Therapy-Fatigue (FACT-F)] and functional endurance [6-min walk test (6MWT)] at six months were the co-primary outcomes. Secondary outcomes included quality of life, physical fitness, body composition, blood markers, sedentary behaviour, and adherence. Between-group differences in primary outcomes were compared to margins of 3 points for FACT-F and 40 m for 6MWT using a Bayesian analysis of covariance (ANCOVA). Secondary outcomes were compared with ANCOVA, Costs included Ministry of Health costs, program costs, patient out-of-pocket, and time costs. TRIAL REGISTRATION: #NCT02834416. RESULTS: Thirty-eight participants (mean [standard deviation (SD)] age, 70 [9.0] years) were enrolled (GROUP n = 20; HOME n = 18). There was an 89.8% probability that HOME was non-inferior to GROUP for both fatigue and functional endurance and a 9.5% probability that HOME reduced fatigue compared to GROUP (mean [SD] change, 12.1 [8.1] vs 3.6 [6.1]; p = 0.040) at six months. Adherence was similar among study arms. HOME was cost-saving (mean difference: -$4122) relative to GROUP. DISCUSSION: A HOME exercise intervention appears non-inferior to GROUP for fatigue and functional endurance and requires fewer resources to implement. HOME appears to ameliorate fatigue more than GROUP, but has comparable effects on other clinically relevant outcomes. Although limited by sample size and attrition, these results support further assessment of home-based programs.

The Role of Daily Steps in the Treatment of Major Depressive Disorder: Secondary Analysis of a Randomized Controlled Trial of a 6-Month Internet-Based, Mindfulness-Based Cognitive Behavioral Therapy Intervention for Youth.

BACKGROUND: Current evidence supports physical activity (PA) as an adjunctive treatment for major depressive disorder (MDD). Few studies, however, have examined the relationship between objectively measured PA and MDD treatment outcomes using prospective data. OBJECTIVE: This study is a secondary analysis of data from a 24-week internet-based, mindfulness-based cognitive behavioral therapy program for MDD. The purpose of this analysis was twofold: (1) to examine average daily step counts in relation to MDD symptom improvement, and whether pain moderated this relationship; and (2) to examine whether changes in step activity (ie, step trajectories) during treatment were associated with baseline symptoms and symptom improvement. METHODS: Patients from the Centre for Addiction and Mental Health were part of a randomized controlled trial evaluating the effects of internet-based, mindfulness-based cognitive behavioral therapy for young adults (aged 18-30 years old) with MDD. Data from 20 participants who had completed the intervention were analyzed. PA, in the form of objectively measured steps, was measured using the Fitbit-HR Charge 2 (Fitbit Inc), and self-reported depression severity was measured with the Beck Depression Inventory-II (BDI-II). Linear regression analysis was used to test PA's relationship with depression improvement and the moderating effect of pain severity and pain interference. Growth curve and multivariable regression models were used to test longitudinal associations. RESULTS: Participants walked an average of 8269 steps per day, and each additional +1000-step difference between participants was significantly associated with a 2.66-point greater improvement (reduction) in BDI-II, controlling for anxiety, pain interference, and adherence to Fitbit monitoring (P=.02). Pain severity appeared to moderate (reduce) the positive effect of average daily steps on BDI-II improvement (P=.03). Higher baseline depression and anxiety symptoms predicted less positive step trajectories throughout treatment (Ps≤.001), and more positive step trajectories early in the trial predicted greater MDD improvement at the end of the trial (Ps<.04). However, step trajectories across the full duration of the trial did not significantly predict MDD improvement (Ps=.40). CONCLUSIONS: This study used objective measurements to demonstrate positive associations between PA and depression improvement in the context of cognitive behavioral treatment. Pain appeared to moderate this relationship, and baseline symptoms of anxiety and depression predicted PA trajectories. The findings inform future interventions for major depression. Future research with larger samples should consider additional moderators of PA-related treatment success and the extent to which outcomes are related to PA change in multimodal interventions. TRIAL REGISTRATION: Clinical Trials.gov NCT03406052; https://www.clinicaltrials.gov/ct2/show/NCT03406052. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/11591.

A culturally tailored personaliseD nutrition intErvention in South ASIan women at risk of Gestational Diabetes Mellitus (DESI-GDM): a randomised controlled trial protocol.

INTRODUCTION: South Asians are more likely to develop gestational diabetes mellitus (GDM) than white Europeans. Diet and lifestyle modifications may prevent GDM and reduce undesirable outcomes in both the mother and offspring. Our study seeks to evaluate the effectiveness and participant acceptability of a culturally tailored, personalised nutrition intervention on the glucose area under the curve (AUC) after a 2-hour 75 g oral glucose tolerance test (OGTT) in pregnant women of South Asian ancestry with GDM risk factors. METHODS AND ANALYSIS: A total of 190 South Asian pregnant women with at least 2 of the following GDM risk factors-prepregnancy body mass index>23, age>29, poor-quality diet, family history of type 2 diabetes in a first-degree relative or GDM in a previous pregnancy will be enrolled during gestational weeks 12-18, and randomly assigned in a 1:1 ratio to: (1) usual care, plus weekly text messages to encourage walking and paper handouts or (2) a personalised nutrition plan developed and delivered by a culturally congruent dietitian and health coach; and FitBit to track steps. The intervention lasts 6-16 weeks, depending on week of recruitment. The primary outcome is the glucose AUC from a three-sample 75 g OGTT 24-28 weeks' gestation. The secondary outcome is GDM diagnosis, based on Born-in-Bradford criteria (fasting glucose>5.2 mmol/L or 2 hours post load>7.2 mmol/L). ETHICS AND DISSEMINATION: The study has been approved by the Hamilton Integrated Research Ethics Board (HiREB #10942). Findings will be disseminated among academics and policy-makers through scientific publications along with community-orientated strategies. TRIAL REGISTRATION NUMBER: NCT03607799.

Clinical Assessment of Eye Movement Desensitization and Reprocessing in Memory Distress: Protocol for a Double-Blinded Randomized Controlled Trial.

BACKGROUND: Exposures to "traumatic" events are widespread and can cause posttraumatic stress disorder (PTSD). Cognitive behavioral therapy and eye movement desensitization and reprocessing (EMDR) are frequently used and validated behavioral PTSD treatments. Despite demonstrated effectiveness, highly upsetting memory reactions can be evoked, resulting in extensive distress and, sometimes, treatment dropout. In recent years, multiple treatment approaches have aimed at reducing such upsetting memory reactions to traumatic memories while therapeutic progress proceeds. One of these methods, the flash technique (FT), a modification of standard EMDR (S-EMDR), appears effective in distressing memory reduction. This study will examine FT-EMDR and S-EMDR efficacies when both methods are delivered via web-based video. OBJECTIVE: This study aims to assess the relative efficacy of (web-based) FT-EMDR versus S-EMDR in reducing the PTSD symptoms, anxieties, and depression associated with traumatic memories at postintervention and 1-month follow-up. METHODS: This double-blinded, web-based, 2-arm randomized controlled trial will employ self-report outcomes. A total of 90 participants will be identified from the web-based CloudResearch platform and randomly allocated to the experimental or comparison group. Inclusion criteria are as follows: (1) approved for engagement by the CloudResearch platform; (2) 25-60 years of age; (3) residing in Canada or the United States; (4) a recalled disturbing memory of an event >2 years ago that has not repeated and was moderately or more upsetting during occurrence; (5) memory moderately or more upsetting at baseline and not linked to an earlier memory that is equally or more than equally disturbing. Exclusion criteria are bipolar disorder, borderline personality disorder, obsessive-compulsive disorder, schizophrenia, substance abuse or addiction in the past 3 months, suicidal ideation, and suicide attempt in the past 6 months. Interventions include guided video instruction of full FT or guided video of EMDR. Outcome measures are as follows: Primary outcome is PTSD symptoms that are measured by the PTSD Checklist for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) at 1-month follow-up. Secondary outcomes are State Anxiety subscale of State-Trait Anxiety Inventory at baseline, postintervention, and 1-month follow-up; Trait Anxiety subscale of State-Trait Anxiety Inventory; depression (Patient Health Questionnaire-9); and Positive and Negative Affect Schedule measured at 1-month follow-up. RESULTS: If, at 1-month follow-up, the web-based FT-EMDR intervention is more effective in reducing PTSD symptoms (as measured by the PTSD Checklist for DSM-5) than EMDR, it may help reduce traumatic memory distress in multiple contexts. CONCLUSIONS: This randomized controlled trial will advance current understandings of PTSD symptoms and interventions that target traumatic memory-related distress. TRIAL REGISTRATION: ClinicalTrials.gov NCT05262127; https://clinicaltrials.gov/ct2/show/NCT05262127.

Preference-based versus randomized controlled trial in prostate cancer survivors: Comparison of recruitment, adherence, attrition, and clinical outcomes.

Introduction: Patients' unwillingness to be randomized to a mode of exercise may partly explain their poor recruitment, adherence, and attrition in randomized controlled trials (RCTs) of exercise in oncology. It is unknown whether a preference-based trial can improve recruitment, adherence, retention, and clinical outcomes compared to a RCT of the same exercise interventions. Objective: We assessed the effects of a 2-arm exercise preference trial on adherence and clinical outcomes compared to a similar 2-arm RCT in men with prostate cancer (PC). Methods: This was a two-arm preference-based trial of group-based training (GROUP) or home-based training (HOME). PC survivors on androgen deprivation therapy (ADT) who declined randomization to the RCT but chose to participate in a preference trial were recruited in four Canadian centers. All study participants engaged in aerobic and resistance training, 4-5 days weekly for 6 months, aiming for 150 minutes/week of moderate-to-vigorous physical activity. The primary outcomes were changes from baseline to 6 months in fatigue and functional endurance. Secondary outcomes were quality of life, physical fitness, body composition, blood markers, and adherence. Linear mixed models were used to assess the effects of HOME versus GROUP on primary outcomes. In pooled preference and RCT data, the selection effect (i.e., difference between those who were and were not willing to be randomized) and treatment effect (i.e., difference between GROUP and HOME) were estimated using linear regression. Results and conclusion: Fifty-four participants (mean [SD] age, 70.2 [8.6] years) were enrolled (GROUP n=17; HOME n=37). Comparable effects on primary and secondary outcomes were observed following GROUP or HOME in the preference-based trial. Adherence was similar between preference and RCT participants. However, attrition was higher in the RCT (50.0% vs. 27.8%, p= 0.04). Compared to GROUP, HOME was more effective in ameliorating fatigue (mean difference: +5.2, 95%CI=1.3 to 9.3 p=0.01) in pooled preference and RCT data. A preference-based trial results in comparable observed effects on clinical outcomes and adherence and lower attrition compared with a RCT of the same exercise interventions in PC survivors on ADT. Given the appeals of preference-based trials to study participants, additional studies are warranted. Clinical trial registration: clinicaltrials.gov, identifier (NCT03335631).

Barriers and facilitators to healthy active living in South Asian families in Canada: a thematic analysis.

OBJECTIVES: The study objective was to understand the barriers and facilitators to healthy active living in South Asian families living in Canada. DESIGN: Semi-structured interviews of 30-60-minute duration with South Asian women with young families, and analysed using a thematic analytical approach. SETTING: Community-dwelling South Asian women interviewed in the home environment or by phone. PARTICIPANTS: Fifteen married South Asian women (mean age=34.2 years) living in the Peel region of Ontario, Canada, with at least 1 child under the age of 5 years. The majority of women had immigrated to Canada (13/15), during a 5-10-year interval preceding interviews. RESULTS: 57 different codes were derived from 18 interview hours, and further evaluated through member checking. The top three barriers to healthy eating were: (1) not having enough time for healthy food preparation, (2) lack of knowledge about what is healthy eating and (3) viewing healthy eating as a matter of engaging in time limited dieting. These barriers were addressed with: (1) knowledge and awareness of healthy eating, (2) clear goal setting, (3) access to fresh vegetables and fruits and (4) better arrangements and more time for food preparation. The top five barriers to physical activity were: (1) not enough time and energy, (2) competing priorities, (3) lack of childcare, (4) lack of family-engaging exercise and (5) limited access to interesting exercise programming. These barriers were addressed by: (1) experiencing exercise as enjoyable and stress releasing, (2) commitments to walking exercise, (3) use of an electronic exercise-tracking device, (4) offspring exercise supported by spouse and family and (5) success stories about exercise from others. CONCLUSIONS: Barriers to healthy active living in South Asian women with young families can be addressed with facilitators that stimulate clear goal setting and healthy food preparation skills, and exercise formats that engage mothers and offspring, with or without exercise tracking.

Promoting the use of the PRECISE score for prostate MRI during active surveillance: results from the ESOR Nicholas Gourtsoyiannis teaching fellowship.

OBJECTIVES: The PRECISE criteria for serial multiparametric magnetic resonance imaging (MRI) of the prostate during active surveillance recommend the use of a dedicated scoring system (PRECISE score) to assess the likelihood of clinically significant radiological change. This pilot study assesses the effect of an interactive teaching course on prostate MRI during active surveillance in assessing radiological change in serial imaging. METHODS: Eleven radiology fellows and registrars with different experience in prostate MRI reading participated in a dedicated teaching course where they initially evaluated radiological change (based on their previous training in prostate MRI reading) independently in fifteen patients on active surveillance (baseline and follow-up scan), and then attended a lecture on the PRECISE score. The initial scans were reviewed for teaching purposes and afterwards the participants re-assessed the degree of radiological change in a new set of images (from fifteen different patients) applying the PRECISE score. Receiver operating characteristic analysis was performed. Confirmatory biopsies and PRECISE scores given in consensus by two radiologists (involved in the original draft of the PRECISE score) were the reference standard. RESULTS: There was a significant improvement in the average area under the curve (AUC) for the assessment of radiological change from baseline (AUC: 0.60 [Confidence Intervals: 0.51-0.69] to post-teaching (AUC: 0.77 [0.70-0.84]). This was an improvement of 0.17 [0.016-0.28] (p = 0.004). CONCLUSIONS: A dedicated teaching course on the use of the PRECISE score improves the accuracy in the assessment of radiological change in serial MRI of the prostate.

Ketamine Assisted Psychotherapy: A Systematic Narrative Review of the Literature.

Currently, ketamine is used in treating multiple pain, mental health, and substance abuse disorders due to rapid-acting analgesic and antidepressant effects. Its limited short-term durability has motivated research into the potential synergistic actions between ketamine and psychotherapy to sustain benefits. This systematic review on ketamine-assisted psychotherapy (KAP) summarizes existing evidence regarding present-day practices. Through rigorous review, seventeen articles that included 603 participants were identified. From available KAP publications, it is apparent that combined treatments can, in specific circumstances, initiate and prolong clinically significant reductions in pain, anxiety, and depressive symptoms, while encouraging rapport and treatment engagement, and promoting abstinence in patients addicted to other substances. Despite much variance in how KAP is applied (route of ketamine administration, ketamine dosage/frequency, psychotherapy modality, overall treatment length), these findings suggest psychotherapy, provided before, during, and following ketamine sessions, can maximize and prolong benefits. Additional large-scale randomized control trials are warranted to understand better the mutually influential relationships between psychotherapy and ketamine in optimizing responsiveness and sustaining long-term benefits in patients with chronic pain. Such investigations will assist in developing standardized practices and maintenance programs.

Correction: Comparing Online and On-Site Cognitive Behavior Therapy in Major Depressive Disorder: Protocol for a Noninferiority Randomized Controlled Trial.

[This corrects the article DOI: 10.2196/29726.].

Comparing Online and On-Site Cognitive Behavior Therapy in Major Depressive Disorder: Protocol for a Noninferiority Randomized Controlled Trial.

BACKGROUND: The incidence of mental health disorders in Canada is increasing with costs of CAD $51 billion (US $40 billion) per year. Depression is the most prevalent cause of disability while cognitive behavioral therapy (CBT) is the best validated behavioral depression treatment. CBT, when combined with mindfulness meditation (CBT-M), has strong evidence for increased efficacy. While randomized controlled trials (RCTs) have demonstrated online CBT-M efficacy, comparisons with in-office delivery are lacking. OBJECTIVE: The aim of this research is to assess whether online group CBT-M (with standard psychiatric care) is non-inferior in efficacy and more cost-effective than office-based, on-site group CBT-M at post-intervention and 6-months follow-up in major depressive disorder. The study will also assess whether digitally recorded data (ie, online workbooks completed, Fitbit step count, and online text messages) predict depression symptom reduction in online participants. METHODS: This single-center, two-arm, noninferiority RCT employs assessor-blinded and self-report outcomes and economic evaluation. The research site is the Centre for Addiction and Mental Health (Toronto), a research-based psychiatry institution where participants will be identified from service wait lists and through contacts with other Toronto clinics. Inclusion criteria are as follows: (1) aged 18-60 years, any ethnicity; (2) Beck Depression Inventory-II (BDI-II) of mild severity (score ≥14) with no upper severity limit; (3) Mini-International Neuropsychiatric Interview-confirmed, psychiatric major depressive disorder diagnosis; (4) fluent in English. All patients are diagnosed by staff psychiatrists. Exclusion criteria are as follows: (1) receipt of weekly structured psychotherapy; (2) observation of Diagnostic and Statistical Manual of Mental Disorders (5th Edition) criteria for severe alcohol or substance use disorder (in past 3 months), borderline personality disorder, schizophrenia (or other primary psychotic disorder), bipolar disorder, or obsessive-compulsive disorder; (3) clinically significant suicidal ideation (imminent intent or attempted suicide in the past 6 months); and (4) treatment-resistant depression. All participants receive standard psychiatric care, experimental participants receive online group CBT-M, and controls receive standard care in-office group CBT-M. The online group program (in collaboration with NexJ Health, Inc) combines smartphone and computer-accessed workbooks with mental health phone counselling (16 hours in 16 weeks) that coordinates software interactions (eg, secure text messaging and Fitbit-tracked walking). The primary outcome is BDI-II, and secondary outcomes are anxiety (Beck Anxiety Inventory), depression (ie, Quick Inventory of Depressive Symptomatology and 17-item Hamilton Depression Rating Scale), mindfulness (Five-Facet Mindfulness Questionnaire), quality of life (European Quality of Life Five Dimension), and pain (Brief Pain Inventory). RESULTS: Based on prior studies with the BDI-II and 80% power to reject an inferiority hypothesis with a 1-sided type I error rate of 5%, a sample of 78 per group is adequate to detect small-to-medium-effect sizes. CONCLUSIONS: This study assesses online CBT-M efficacy and noninferiority in relation to in-person CBT, and the cost-effectiveness of both interventions. TRIAL REGISTRATION: ClinicalTrials.gov NCT04825535; https://www.clinicaltrials.gov/ct2/show/NCT04825535. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/29726.

A Web-Based Cognitive Behavioral Therapy, Mindfulness Meditation, and Yoga Intervention for Posttraumatic Stress Disorder: Single-Arm Experimental Clinical Trial.

BACKGROUND: Posttraumatic stress disorder (PTSD) is a debilitating, undertreated condition. The web-based delivery of cognitive behavioral therapy supplemented with mindfulness meditation and yoga is a viable treatment that emphasizes self-directed daily practice. OBJECTIVE: This study aims to examine the effectiveness of a web-based cognitive behavioral therapy, mindfulness, and yoga (CBT-MY) program designed for daily use. METHODS: We conducted an 8-week, single-arm, experimental, registered clinical trial on adults reporting PTSD symptoms (n=22; aged 18-35 years). Each participant received web-based CBT-MY content and an hour of web-based counseling each week. Pre-post outcomes included self-reported PTSD symptom severity, depression, anxiety, chronic pain, and mindfulness. Pre-post psychophysiological outcomes included peak pupil dilation (PPD) and heart rate variability (HRV). HRV and PPD were also compared with cross-sectional data from a non-PTSD comparison group without a history of clinical mental health diagnoses and CBT-MY exposure (n=46). RESULTS: Pre-post intention-to-treat analyses revealed substantial improvements in PTSD severity (d=1.60), depression (d=0.83), anxiety (d=0.99), and mindfulness (d=0.88). Linear multilevel mixed models demonstrated a significant pre-post reduction in PPD (B=-0.06; SE=0.01; P<.001; d=0.90) but no significant pre-post change in HRV (P=.87). Overall, participants spent an average of 11.53 (SD 22.76) min/day on self-directed mindfulness practice. CONCLUSIONS: Web-based CBT-MY was associated with clinically significant symptom reductions and significant PPD changes, suggesting healthier autonomic functioning. Future randomized controlled trials are needed to further examine the gains apparent in this single-arm study. TRIAL REGISTRATION: ClinicalTrials.gov NCT03684473; https://clinicaltrials.gov/ct2/show/NCT03684473.

Studies to Improve Perinatal Health through Diet and Lifestyle among South Asian Women Living in Canada: A Brief History and Future Research Directions.

South Asians (i.e., people who originate from India, Pakistan, Sri Lanka, Nepal, and Bangladesh) have higher cardiovascular disease rates than other populations, and these differences persist in their offspring. Nutrition is a critical lifestyle-related factor that influences fetal development, and infant and child health in early life. In high-income countries such as Canada, nutrition-related health risks arise primarily from overnutrition, most strikingly for obesity and associated non-communicable diseases. Evidence for developmental programming during fetal life underscores the critical influence of maternal diet on fetal growth and development, backed by several birth cohort studies including the Pune Maternal Nutrition Study, the South Asian Birth Cohort Study, and the Born in Bradford Study. Gestational diabetes mellitus is a strong risk factor for type 2 diabetes, future atherosclerosis and cardiovascular disease in the mother and increases the risk of type 2 diabetes in her offspring. Non-pharmacological trials to prevent gestational diabetes are few, often not randomized, and are heterogeneous with respect to design, and outcomes have not converged upon a single optimal prevention strategy. The aim of this review is to provide an understanding of the current knowledge around perinatal nutrition and gestational diabetes among the high-risk South Asian population as well as summarize our research activities investigating the role of culturally-tailored nutrition advice to South Asian women living in high-income settings such as Canada. In this paper, we describe these qualitative and quantitative studies, both completed and underway. We conclude with a description of the design of a randomized trial of a culturally tailored personalized nutrition intervention to reduce gestational glycaemia in South Asian women living in Canada and its implications.

Meaning in life and vagally-mediated heart rate variability: Evidence of a quadratic relationship at baseline and vagal reactivity differences.

Higher meaning in life (MIL) consistently predicts better health, but the physiological processes underlying this relationship are not well understood. This study examined the relationship between MIL and vagally-mediated heart rate variability (VmHRV) under resting (N = 77), stressor (n = 73), and mindfulness intervention (n = 72) conditions. Regression was used for MIL-VmHRV analyses at baseline, and longitudinal mixed models were used to examine phasic changes in VmHRV as a function of MIL. Regression revealed a quadratic MIL-VmHRV relationship, and mixed models linked higher MIL to greater stress-reactivity but not enhanced stress-attenuation. MIL and mindfulness did not interact to influence VmHRV recovery after experimental stress. Findings suggest that cardiac vagal tone and cardiac vagal reactivity are linked to MIL, shedding light on the physiology underlying MIL and its health associations.

Online Mindfulness-Based Cognitive Behavioral Therapy Intervention for Youth With Major Depressive Disorders: Randomized Controlled Trial.

BACKGROUND: Approximately 70% of mental health disorders appear prior to 25 years of age and can become chronic when ineffectively treated. Individuals between 18 and 25 years old are significantly more likely to experience mental health disorders, substance dependencies, and suicidality. Treatment progress, capitalizing on the tendencies of youth to communicate online, can strategically address depressive disorders. OBJECTIVE: We performed a randomized controlled trial (RCT) that compared online mindfulness-based cognitive behavioral therapy (CBT-M) combined with standard psychiatric care to standard psychiatric care alone in youth (18-30 years old) diagnosed with major depressive disorder. METHODS: Forty-five participants were randomly assigned to CBT-M and standard care (n=22) or to standard psychiatric care alone (n=23). All participants were provided standard psychiatric care (ie, 1 session per month), while participants in the experimental group received an additional intervention consisting of the CBT-M online software program. Interaction with online workbooks was combined with navigation coaching delivered by phone and secure text messaging. RESULTS: In a two-level linear mixed-effects model intention-to-treat analysis, significant between-group differences were found for the Beck Depression Inventory-II score (difference -8.54, P=.01), Quick Inventory of Depressive Symptoms score (difference -4.94, P=.001), Beck Anxiety Inventory score (difference -11.29, P<.001), and Brief Pain Inventory score (difference -1.99, P=.03), while marginal differences were found for the Five Facet Mindfulness Questionnaire-Nonjudging subscale (difference -2.68, P=.05). CONCLUSIONS: These results confirm that youth depression can be effectively treated with online CBT-M that can be delivered with less geographic restriction. TRIAL REGISTRATION: Clinical Trials.gov NCT03406052; https://www.clinicaltrials.gov/ct2/show/NCT03406052.