Effect of a 12-week nutritional intervention in the food intake of patients on the waiting list for liver transplantation: A secondary analysis of a randomized controlled trial.

BACKGROUND: Inadequate food intake contributes to malnutrition in patients with cirrhosis on the waiting list for liver transplantation (LTx). OBJECTIVE: To evaluate food intake during 12 weeks of nutritional follow-up and assess factors independently associated with the difference between energy and protein intake in LTx patients. METHODS: A secondary analysis of data from a randomized controlled trial that evaluated the effects of Beta-Hydroxy-Beta-Methylbutyrate (HMB) supplementation and nutritional intervention in patients on a liver transplant waiting list. Dietary guidelines for patients with cirrhosis were used to prescribe the nutritional plan (35 kcal/kg; 1.5 g/kg dry weight for protein) and to evaluate the nutritional goals (30 kcal/kg; 1.2 g/kg dry weight for protein; late evening snack) and nutritional counseling dietary follow-ups were performed in each evaluation. Food intake was assessed in six moments: Baseline, week 0 (W0), week 2 (W2), week 4 (W4), week 8 (W8), and week 12 (W12). RESULTS: Forty-seven patients (55.0 ± 10.6y; 72.3% male) were evaluated. Only 25.5% (n = 12) of patients achieved nutritional goals at the end of the study. The mean energy intake at Baseline was 1782 ± 784 kcal (27.6 ± 13.2 kcal/kg) without difference between moments. The protein intake increased between W0 [63.4 ± 29.8g; 0.8(0.2-2.2 g/kg)] and W8 [72.0 ± 28.0g; 1.0(0.4-2.6 g/kg); p = 0.03; p = 0.03, respectively]. The consumption of cholesterol, calcium, phosphorus, magnesium, iron, and niacin increased (p < 0.05), as well as the consumption of legumes; roots and tubers; dairy; and meat, poultry and fish groups through time (p < 0.05). The percentage of patients that consumed a late evening snack rised from 40.4% (Baseline) to 76.6% (W8) (p < 0.001). The presence of ascites, nourished patients, frailty index classification, short physical performance battery score, systemic symptoms, and emotional function in the Quality of Life Test were independently associated with the energy intake difference between W12 and Baseline (p < 0.05). Diabetes mellitus, patients with moderately malnourishment, poor performance, fatigue, systemic symptoms, and emotional function in the Quality of Life Test were independently associated with the difference in protein intake between W12 and Baseline (p < 0.05). CONCLUSION: Patients on the liver transplant waiting list showed slight food intake improvement during the follow-up, but few met nutritional guidelines. Various clinical and nutritional factors independently affected energy and protein intake from W12 to Baseline.

Improving psychological well-being among healthcare workers during the COVID-19 pandemic with an online mindfulness intervention: A randomised waitlist-controlled trial.

The high prevalence of psychological problems observed among healthcare workers (HCWs) during the COVID-19 pandemic called for interventions to safeguard their mental health. We assessed the effectiveness of a 6-week online mindfulness-based intervention in improving well-being and reducing stress among HCWs in Sri Lanka. Eighty HCWs were recruited and randomised into two groups: waitlist-control (WLC) and intervention groups. In the intervention, 1-hour online sessions were conducted at weekly intervals and participants were encouraged to do daily home practice. Stress and well-being were measured pre- and post-intervention using the Perceived Stress Scale and WHO-5 Well-being Index, respectively. One-way analysis of covariance was used to evaluate the effectiveness, in both intention-to-treat (ITT) and complete-case (CC) analyses. A significantly greater improvement in well-being occurred in the intervention arm compared to WLC on both ITT (p = .002) and CC analyses (p < .001), with medium-to-large effect sizes (partial η2 = .117-.278). However, the reduction in stress following the intervention was not significant compared to the WLC group on both ITT (p = .636) and CC analyses (p = .262). In the intervention arm, the median number of sessions attended by participants was 3. Low adherence to the intervention may have contributed to the apparent non-significant effect on stress.

Effectiveness of behavioral activation and mindfulness in increasing reward sensitivity and reducing depressive symptoms - A randomized controlled trial.

Reward insensitivity is a potential key mechanism regarding the maintenance of depression. However, there is a lack of research examining and comparing the effectiveness of different psychological interventions in modifying reward insensitivity. This four-arm randomized controlled trial (RCT) investigated a two-week online intervention. After screening for eligibility, a total of 336 participants were randomized, and 224 participated per-protocol. Participants were assigned to either a) behavioral activation, b) mindfulness and gratitude, c) a combination of both, or d) a waitlist control condition. They received videos and implemented daily exercises. Reward sensitivity and depressive symptoms served as primary outcomes. Behavioral activation and mindfulness significantly improved depressive symptoms and reward sensitivity. However, the effects of behavioral activation were not superior. The combination treatment versus the waiting group was insignificant regarding reward insensitivity. Explorative analyses revealed that all intervention groups reduced anhedonia substantially. Our findings imply that brief online interventions with behavioral activation and mindfulness-based approaches can impact reward insensitivity, while effects for a combination were less clear. Nonetheless, our results do not allow us to infer the differential effectiveness of the interventions. There is a clear need for treatments better targeting maintaining factors of depression, such as reward insensitivity. Clinical trial registration number: NCT05402150.

Effects of Introvision, a self-regulation method with a mindfulness-based perception technique in migraine prevention: a monocentric randomized waiting-list controlled study (IntroMig Study).

BACKGROUND: Migraine is a brain disorder with recurrent headache attacks and altered sensory processing. Introvision is a self-regulation method based on mindfulness-like perception techniques, developed at the University of Hamburg. Here, we examined the effect of Introvision in migraine prevention. METHODS: Migraineurs with at least five headache days per month were block-randomized to the experimental group (EG) or waiting list group (WL), the latter starting Introvision training six weeks after the EG. Participants learned Introvision in six weekly on-site group sessions with video-conference support followed by three individual video-conference sessions. Headache diaries and questionnaires were obtained before Introvision training and three months after the last individual Introvision session. RESULTS: Fifty-one patients completed the study. The primary outcome, headache days of the EG after Introvision training compared to those of the WL before the training, showed no significant effect (10.6 ± 7.7, n = 22; vs. 10.9 ± 6.3, n = 29, p = 0.63; Mann-Whitney-U-Test). The secondary outcome, comparing pooled EG and WL data before and after Introvision training, revealed a significant reduction of headache days (from 11.7 ± 6.5 to 9.8 ± 7.0; p = 0.003; Wilcoxon-paired-Test) as well as of acute medication intake and Headache-Impact-Test 6 (HIT-6) scores and increased self-efficacy as quantified by increased FKMS-scores (FKMS: german short form of the Headache Management Self-Efficacy Scale (HMSE)). CONCLUSION: Although the study did not reach its primary endpoint, several secondary outcome parameters in the pooled (non-controlled) pre-post analysis showed an improvement with a decrease in monthly headache days by 1.9 days/ month. A larger randomized controlled trial has to corroborate these preliminary findings. TRIAL REGISTRATION: NCT03507400, Registration date 09.03.2018.

EMDR versus waiting list in individuals at clinical high risk for psychosis with post-traumatic stress symptoms: A randomized controlled trial.

BACKGROUND: Post-traumatic stress disorder (PTSD) is highly prevalent in the individuals at clinical-high risk for psychosis (CHR). The aim of this study was to examine the efficacy and safety of Eye Movement Desensitization and Reprocessing (EMDR) in individuals at CHR with comorbid PTSD or subthreshold PTSD in a randomized controlled trial. METHODS: Fifty-seven individuals at CHR with PTSD or subthreshold PTSD formed the study sample. The eligible participants were randomly assigned to a 12 weeks EMDR treatment (N = 28) or a waiting list condition (WL, N = 29). The structured interview for psychosis risk syndrome (SIPS), the clinician administered post-traumatic stress disorder scale (CAPS) and a battery of self-rating inventories covering depressive, anxiety and suicidal symptoms were administered. RESULTS: Twenty-six participants in the EMDR group and all the participants in the WL group completed the study. The analyses of covariance revealed greater reduction of the mean scores on CAPS (F = 23.2, Partial η2 = 0.3, P < 0.001), SIPS positive scales (F = 17.8, Partial η2 = 0.25, P < 0.001) and all the self-rating inventories in the EMDR group than in the WL group. Participants in the EMDR group were more likely to achieve remission of CHR compared to those in the WL group at endpoint (60.7 % vs. 31 %, P = 0.025). CONCLUSIONS: EMDR treatment not only effectively improved traumatic symptoms, but also significantly reduced the attenuated psychotic symptoms and resulted in a higher remission rate of CHR. This study highlighted the necessity of adding a trauma-focused component to the present approach of early intervention in psychosis.

The effect of ß-hydroxy ß-methylbutyrate (HMB) with nutritional counselling on anthropometric muscle mass markers, strength, functionality, and quality of life in patients on the waiting list for liver transplantation: A double-blind study.

OBJECTIVE: Patients on the waiting list for liver transplantation (LTx) usually lose muscle mass. Supplementation with ß-hydroxy ß-methylbutyrate (HMB) may have a promising effect on this clinical condition. This study aimed to evaluate the effects of HMB on muscle mass, strength, functionality, and quality of life in patients on the LTx waiting list. METHODS: A double-blind, randomized study was conducted of 3g supplementation of HMB or 3g supplementation of maltodextrin (active control) with nutritional counselling for 12 wk in patients >18 y, evaluated at five points or timepoints. Body composition and anthropometric data (resistance, reactance, phase angle, weight, body mass index, arm circumference [AC], arm muscle area, and adductor pollicis muscle thickness) were collected, and muscle strength was assessed through dynamometry and muscle function by the frailty index (FI). Quality of life was assessed. RESULTS: A total of 47 patients were enrolled (HMB: 23 and active control: 24). There was a significant difference in both groups for AC (P = 0.03), dynamometry (P = 0.02), and FI (P = 0.01). There was an increase in dynamometry between weeks 0 and 12 in both groups (HMB [Δdynamometry: 10.1% ± 16.4%; P < 0.05] and active control [Δdynamometry: 23.0% ± 70.3%; P < 0.05]). The AC increased in both groups between weeks 0 and 4 (HMB [ΔAC: 0.9% ± 2.8%; P < 0.05] and active control [ΔAC: 1.6% ± 3.6%; P < 0.05]) and between weeks 0 and 12 (HMB [ΔAC: 3.2% ± 6.7%; P < 0.05] and active control [ΔAC: 2.1% ± 6.6%; P < 0.05]). The FI decreased in both groups, between weeks 0 and 4 (HMB [ΔFI: -4.2% ± 6.9%; P < 0.05) and active control [ΔFI: -3.2% ± 9.6%; P < 0.05]) and between weeks 0 and 12 (HMB ΔFI: -4.4% ± 11.2%; P < 0.05] and active control [ΔFI: -5.5% ± 11.3%; P < 0.05]). The other variables did not change (P > 0.05). CONCLUSIONS: Nutritional counselling with supplementation with HMB or active control in patients on the LTx waiting list improved AC, dynamometry, and the FI in both groups.

Effects of a online brief modified mindfulness-based stress reduction therapy for anxiety among Chinese adults: A randomized clinical trial.

The COVID-19 pandemic has exacerbated anxiety and related symptoms among the general population. In order to cope with the mental health burden, we developed an online brief modified mindfulness-based stress reduction (mMBSR) therapy. We performed a parallel-group randomized controlled trial to evaluate the efficacy of the mMBSR for adult anxiety with cognitive-behavioral therapy (CBT) as an active control. Participants were randomized to mMBSR, CBT or waitlist group. Those in the intervention arms performed each therapy for 6 sections in 3 weeks. Measurements were conducted at baseline, post-treatment and 6 months post-treatment by Generalized Anxiety Disorder-7, Patient Health Questionnaire-9, Patient Health Questionnaire-15, reverse scored Cohen Perceived Stress scale, Insomnia Severity Index, and Snaith-Hamilton Pleasure Scale. 150 participants with anxiety symptoms were randomized to mMBSR, CBT or waitlist group. Post intervention assessments showed that mMBSR improved the scores of all the six mental problem dimensions (anxiety, depression, somatization, stress, insomnia, and the experience of pleasure) significantly compared to the waitlist group. During 6-month post treatment assessment, the scores of all six mental problem dimensions in the mMBSR group still showed improvement compared to baseline and showed no significant difference with the CBT group. Our results provide positive evidence for the efficacy and feasibility of an online brief modified MBSR program to alleviate anxiety and related symptoms of individuals from the general population, and the therapeutic benefits of mMBSR persisted for up to six months. This low resource-consuming intervention could facilitate the challenges of supplying psychological health therapy to large scale of population.

Attention Bias Modification Treatment Versus a Selective Serotonin Reuptake Inhibitor Or Waiting List Control for Social Anxiety Disorder: A Randomized Clinical Trial.

OBJECTIVE: Social anxiety disorder is common and impairing. The efficacy of pharmacotherapy is moderate, highlighting the need for alternative therapies. This study compared the efficacy of gaze-contingent music reward therapy (GC-MRT), an eye-tracking-based attention bias modification treatment, with a selective serotonin reuptake inhibitor (SSRI) treatment or a waiting list control condition in reducing social anxiety disorder symptoms. Superior clinical effects of similar magnitude were expected for the active treatments relative to the control condition. METHODS: Participants were 105 treatment-seeking adults with social anxiety disorder, randomly allocated to 12 weeks of GC-MRT, SSRI, or waiting list control. Mean changes in clinician-rated and self-reported social anxiety symptoms from baseline to mid- and posttreatment assessments were compared between groups using generalized estimating equations. Changes in attentional dwell time on threat were also examined. RESULTS: Analysis indicated a significant differential reduction in symptoms between groups. Patients in the GC-MRT and SSRI groups had lower social anxiety scores at the mid- and posttreatment assessments compared with patients in the waiting list group. The efficacy of the active treatments did not differ. Only patients in the GC-MRT group showed reduction in dwell time on threat from baseline to posttreatment assessment. CONCLUSIONS: Eye-tracking-based attention bias modification is an acceptable and effective treatment option for social anxiety disorder.

The effect of local anaesthetic biopsy in head and neck cancer on cancer pathway waiting times.

INTRODUCTION: The 31-day target in urgent suspicion of cancer (USOC) referrals fast-tracks patients through the cancer pathway. Local anaesthetic (LA) biopsy can be performed during an outpatient clinic and may improve pathway times. The aim of this study was to compare LA biopsy in head and neck USOC referrals with the traditional general anaesthetic (GA) pathway. METHODS: This was a retrospective cohort study of USOC referrals to the NHS Greater Glasgow and Clyde head and neck multidisciplinary team between 1 June 2018 and 28 December 2020, and compared pathway times in LA and GA biopsies. RESULTS: The mean number of days from clinic to biopsy was 4.4 in the LA group and 28.0 in the GA group. This was significantly faster in the LA biopsy group (p < 0.05). The overall pathway time in the LA and GA biopsy groups was 35.7 and 61.5 days, respectively, and was significantly faster in LA biopsy group (p < 0.05). CONCLUSIONS: The LA cohort had significantly faster pathway times compared with GA biopsy. LA biopsy requires careful patient selection, but is an effective alternative to GA biopsy in the appropriate patient group.

Comparison of Acupuncture vs Sham Acupuncture or Waiting List Control in the Treatment of Aromatase Inhibitor-Related Joint Pain: A Randomized Clinical Trial.

Importance: Aromatase inhibitors (AIs) have proven efficacy for the treatment of hormone-sensitive breast cancer; however, arthralgias (pain and stiffness) contribute to nonadherence with therapy for more than 50% of patients. Objective: To examine the effect of acupuncture in reducing AI-related joint pain through 52 weeks. Design, Setting, and Participants: A randomized clinical trial was conducted at 11 sites in the US from May 1, 2012, to February 29, 2016, with a scheduled final date of follow-up of September 5, 2017, to compare true acupuncture (TA) with sham acupuncture (SA) or waiting list control (WC). Women with early-stage breast cancer were eligible if they were taking an AI and scored 3 or higher on the Brief Pain Inventory Worst Pain (BPI-WP) item (score range, 0-10; higher scores indicate greater pain). Analysis was conducted for data received through May 3, 2021. Interventions: Participants were randomized 2:1:1 to the TA (n = 110), SA (n = 59), or WC (n = 57) group. The TA and SA protocols were composed of 6 weeks of intervention at 2 sessions per week (12 sessions overall), followed by 6 additional weeks of intervention with 1 session per week. Participants randomized to WC received no intervention. All participants were offered 10 acupuncture sessions to be used between weeks 24 and 52. Main Outcomes and Measures: In this long-term evaluation, the primary end point was the 52-week BPI-WP score, compared by study group using linear regression, adjusted for baseline pain and stratification factors. Results: Among 226 randomized women (mean [SD] age, 60.7 [8.6] years; 87.7% White; mean [SD] baseline BPI-WP score, 6.7 [1.5]), 191 (84.5%) completed the trial. In a linear regression, 52-week mean BPI-WP scores were 1.08 (95% CI, 0.24-1.91) points lower in the TA compared with the SA group (P = .01) and were 0.99 (95% CI, 0.12-1.86) points lower in the TA compared with the WC group (P = .03). In addition, 52-week BPI pain interference scores were statistically significantly lower in the TA compared with the SA group (difference, 0.58; 95% CI, 0.00-1.16; P = .05). Between 24 and 52 weeks, 12 (13.2%) of TA, 6 (11.3%) of SA, and 5 (10.6%) of WC patients reported receipt of acupuncture. Conclusions and Relevance: In this randomized clinical trial, women with AI-related joint pain receiving 12 weeks of TA had reduced pain at 52 weeks compared with controls, suggesting long-term benefits of this therapy. Trial Registration: ClinicalTrials.gov Identifier: NCT01535066.

Risk factors for prolonged preoperative waiting time of intertrochanteric fracture patients undergoing operative treatment.

PURPOSE: Intertrochanteric fracture is a common fracture in older adults. We observed the case characteristics of intertrochanteric fracture and analyzed the risk factors for prolonged preoperative waiting time based on patient data from a 6 year period. Investigate the post-admission treatment of intertrochanteric fracture. METHODS: We retrospectively reviewed the medical records from July 2015 to July 2021 of patients hospitalized for intertrochanteric fracture who had undergone internal fixation surgery in the orthopedic ward of the Affiliated Hospital of Shandong University of Traditional Chinese Medicine. Data regarding gender, age, AO/OTA classification, preoperative waiting time, preoperative medical comorbidities, and complicated deep venous thrombosis (DVT) of lower limbs were collected. Statistical tests were used to evaluate the factors influencing preoperative preparation time and DVT. RESULTS: A total of 1812 cases were retrospectively analyzed, 1258 patients (69.43%) had three or more medical comorbidities. The average preoperative waiting time was 5.09 ± 3.27 days. Advanced age, more preoperative medical comorbidities and DVT led to longer preoperative waiting times, and preoperative medical comorbidities were an independent risk factor. Patients with advanced age and preoperative medical comorbidities were more likely to have DVT. CONCLUSION: Age and preoperative medical comorbidities are risk factors for DVT and prolonged preoperative preparation time in intertrochanteric fracture patients. Preoperative medical comorbidities are an independent risk factors affecting the preoperative waiting time, and a combination of multiple comorbidities almost predicts the delay of the operation time.

Effectiveness of time-limited eye movement desensitization reprocessing therapy for parents of children with a rare life-limiting illness: a randomized clinical trial.

BACKGROUND: Parents of children with a rare progressive life-limiting illness are at risk for parental posttraumatic stress disorder (PTSD). Studies on the treatment of parental PTSD with eye movement and desensitization reprocessing (EMDR) therapy in pediatric practice are lacking. Therefore this study aims to evaluate the feasibility and effectiveness of time-limited EMDR therapy in reducing PTSD symptoms, comorbid psychological symptoms, distress, and parental stress. METHODS: Mono-center randomized clinical trial conducted between February 2020 and April 2021. Fourteen parents (N = 7 mothers, N = 7 fathers) of mucopolysaccharidosis type III patients reporting PTSD symptoms on a (sub)clinical level were assigned to EMDR or a wait-list control condition followed by EMDR. Four sessions of EMDR (each 90 min) divided over two half-days were offered. Measurements were conducted at baseline, post-treatment/post-waitlist, and 3-months post-treatment. The primary outcome was PTSD symptom severity (PTSD Check List for DSM-5). Secondary outcomes included comorbid psychological symptoms (Brief Symptom Inventory), distress (Distress Thermometer for Parents) and parenting stress (Parenting Stress Questionnaire). Between-group comparisons pre-to-post treatment (N = 7 EMDR vs. N = 7 wait-list) and within-group comparisons (EMDR, N = 14) from pre-to-post treatment and from pre-treatment to 3-months follow-up were carried out per intent-to-treat linear mixed model analyses. RESULTS: Compared to wait-list, EMDR resulted in a significant reduction on total PTSD symptom severity (d = 1.78) and on comorbid psychological symptoms, distress and parenting stress (d = .63-1.83). Within-group comparisons showed a significant effect on all outcomes at post-treatment (d = 1.04-2.21) and at 3-months follow-up (d = .96-2.30) compared to baseline. EMDR was well-tolerated, associated with a low drop-out rate, a high therapy adherence and no adverse events. CONCLUSION: Time-limited EMDR reduces PTSD symptoms, psychological comorbidity, distress and parenting stress in parents of children with a rare progressive life-limiting illness. This treatment was feasible for these overburdened parents. Recurrent monitoring of PTSD symptoms, and, if needed, offering this time-limited type of trauma treatment should be introduced in everyday pediatric practice. Trial registration Netherlands Trial Register, NL8496. Registered 01-04-2020, https://trialsearch.who.int/Trial2.aspx?TrialID=NL8496 .

Longer wait time after identification of peripartum depression symptoms is associated with increased symptom burden at psychiatric assessment.

Untreated peripartum depression (PD) affects one in seven women and is associated with negative maternal outcomes. This retrospective observational study used health record data from an integrated health system in Texas to assess the extent to which time to access reproductive psychiatry influences the mental health of peripartum women. Women with at least one screening for depression symptoms conducted in obstetric or pediatric settings between May 2014 and October 2019 and subsequently seen by the reproductive psychiatry clinic (n=490) were included. Descriptive and inferential statistics were used to assess timing and factors related to psychiatry follow-up. Findings from this study demonstrated that the average time between a positive screen and a psychiatry assessment was 5 weeks. At psychiatry referral appointments, 85% of women continued to screen positive for PD symptoms. Depression symptom scores at the psychiatry appointment were significantly higher than scores precipitating the referral (p = 0.002). Wait time between initial positive screen and referral appointment was positively correlated with clinically meaningful increases in depression symptom scores (p < 0.001). Each week spent waiting for an appointment produced a 13% increase in odds of clinically meaningful worsening of PD scores and 9% increase in odds of developing new self-harm ideation. Given the findings that a longer period between primary care referral and subspecialty appointment has a negative impact on the mental health of women, this study supports the need for earlier psychiatric assessment to minimize decompensation. Expansion of reproductive psychiatry services are needed to support peripartum women and improve maternal outcomes.

Universal process-based CBT for positive mental health in early adolescence: A cluster randomized controlled trial.

Early adolescence is a key developmental phase for promoting positive mental health and preventing psychological difficulties. Despite calls to develop the evidence base for universal interventions in early adolescence and the promise of process-based CBT, the literature is devoid of empirical investigations of the efficacy of universal process-based CBT in this cohort. This cluster randomized controlled trial aimed to extend the empirical literature by evaluating the efficacy of a six-session universal process-based CBT intervention in elementary schools. Twenty-nine schools were randomly allocated to intervention or waiting list control groups. Six hundred four participants completed measures of positive mental health, resilience, emotional literacy, and mindfulness at baseline, post-intervention, and six-week follow-up. Although participants reported that the intervention was satisfactory, it did not yield significantly superior growth rates on the outcome measures than the control condition at post-intervention or follow-up. Implications of the findings and directions for future research are discussed.

Therapist perceptions of treating posttraumatic stress disorder in pregnancy: The VIP Study.

There is no consensus on the treatment of posttraumatic stress disorder (PTSD) during pregnancy, and therapists' views on the matter are largely unknown. This cross-sectional study aimed to explore therapist beliefs and experiences regarding PTSD treatment during pregnancy. Participants were therapists (N = 301) with experience treating PTSD who completed an online survey. The primary outcome measure was the percentage of therapists who were experienced in treating PTSD symptoms during pregnancy; secondary outcome measures assessed preferred treatments for the general and pregnant populations, perceived reluctance to treat PTSD in pregnancy, and perceived effects and adverse events attributed to treatment for pregnant women and fetuses. The majority of participants (n = 246, 81.7%) had experience with treating PTSD during pregnancy. Eye movement desensitization and reprocessing was the preferred treatment for both the general and the pregnant populations. Almost half of the sample (48.8%) reported hearing that PTSD treatment in pregnancy could be harmful; 30.5% of therapists were reluctant to treat pregnant women with PTSD. Most therapists observed a clinically relevant posttreatment reduction of PTSD symptoms in pregnant women. Perceived adverse maternal and fetal events attributed to treatment were reported by 8.4% and 1.4% of therapists, respectively. Despite reluctance, most therapists reported treating PTSD during pregnancy. The results show that although therapists often reported hearing that treating PTSD during pregnancy was harmful, only a small percentage reported perceived adverse events, and treatment was often viewed as effective. These findings implicate a more positive view on the treatment of PTSD in pregnancy.

Comparing a mindfulness- and CBT-based guided self-help Internet- and mobile-based intervention against a waiting list control condition as treatment for adults with frequent cannabis use: a randomized controlled trial of CANreduce 3.0.

BACKGROUND: Though Internet- and mobile-based interventions (IMIs) and mindfulness-based interventions (generally delivered in-situ) appear effective for people with substance use disorders, IMIs incorporating mindfulness are largely missing, including those targeting frequent cannabis use. METHODS: This paper details the protocol for a three-arm randomized controlled trial comparing a mindfulness-based self-help IMI (arm 1) and cognitive-behavioral therapy (CBT)-based self-help IMI (arm 2) versus being on a waiting list (arm 3) in their effectiveness reducing cannabis use in frequent cannabis users. Predictors of retention, adherence and treatment outcomes will be identified and similarities between the two active intervention arms explored. Both active interventions last six weeks and consist of eight modules designed to reduce cannabis use and common mental health symptoms. With a targeted sample size of n = 210 per treatment arm, data will be collected at baseline immediately before program use is initiated; at six weeks, immediately after program completion; and at three and six months post baseline assessment to assess the retention of any gains achieved during treatment. The primary outcome will be number of days of cannabis use over the preceding 30 days. Secondary outcomes will include further measures of cannabis use and use of other substances, changes in mental health symptoms and mindfulness, client satisfaction, intervention retention and adherence, and adverse effects. Data analysis will follow ITT principles and primarily employ (generalized) linear mixed models. DISCUSSION: This RCT will provide important insights into the effectiveness of an IMI integrating mindfulness to reduce cannabis use in frequent cannabis users. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number Registry: ISRCTN14971662 ; date of registration: 09/09/2021.

Compliance with recommended cancer patient pathway timeframes and choice of treatment differed by cancer type and place of residence among cancer patients in Norway in 2015-2016.

BACKGROUND: Cancer patient pathways (CPPs) were implemented in Norway to reduce unnecessary waiting times, regional variations, and to increase the predictability of cancer care for the patients. This study aimed to determine if 70% of cancer patients started treatment within the recommended time frames, and to identify potential delays. METHODS: Patients registered with a colorectal, lung, breast, or prostate cancer diagnosis at the Cancer Registry of Norway in 2015-2016 were linked with the Norwegian Patient Registry and Statistics Norway. Adjusting for sociodemographic variables, multivariable quantile (median) regressions were used to examine the association between place of residence and median time to start of examination, treatment decision, and start of treatment. RESULTS: The study included 20 668 patients. The proportions of patients who went through the CPP within the recommended time frames were highest among colon (84%) and breast (76%) cancer patients who underwent surgery and lung cancer patients who started systemic anticancer treatment (76%), and lowest for prostate cancer patients who underwent surgery (43%). The time from treatment decision to start of treatment was the main source of delay for all cancers. Travelling outside the resident health trust prolonged waiting time and was associated with a reduced odds of receiving surgery and radiotherapy for lung and rectal cancer patients, respectively. CONCLUSIONS: Achievement of national recommendations of the CCP times differed by cancer type and treatment. Identified bottlenecks in the pathway should be targeted to decrease waiting times. Further, CPP guidelines should be re-examined to determine their ongoing relevance.

The effectiveness of mindfulness-based stress reduction for school teachers: a cluster-randomized controlled trial.

BACKGROUND: Teaching has been found to be one of the most stressful occupations. Hence, current interest in reducing stress and enhancing the well-being of teachers is strong. Mindfulness-based stress reduction (MBSR) is documented to be effective in reducing stress and increasing well-being. This study investigated the effectiveness of delivering MBSR to lower secondary school teachers as a part of a teacher-training programme. METHODS: This study was a nested trial within the parallel cluster-randomized controlled trial, Stress-free Everyday LiFe for Children and Adolescents REsearch (SELFCARE). Schools were recruited from all five geographical regions in Denmark between May 2018 and May 2019. One to three teachers from each school were allowed to participate. At baseline, 110 schools, representing 191 lower secondary school teachers, were cluster-randomized to intervention or a wait-list control group. The intervention group received MBSR during 2019 and the wait-list control group during 2020. Data were collected at baseline and after 3 and 6 months. The primary outcome was measured by Cohen's Perceived Stress Scale (PSS). Data were analyzed using a mixed-effect linear regression model and bootstrapped for cluster effects. RESULTS: At 3 months, the intervention group statistically significantly reduced their PSS score 1.7 [95% confidence interval (CI) 0.04-3.3] points more than did the wait-list control group. At 6 months, the intervention group had statistically significantly reduced their mean PSS score 2.1 (95% CI: 0.5-3.8) points more than the wait-list control group. CONCLUSION: It is possible to reduce perceived stress among lower secondary school teachers by delivering MBSR as part of a teacher-training programme.

The Selah study protocol of three interventions to manage stress among clergy: a preference-based randomized waitlist control trial.

INTRODUCTION: Like many helping professionals in emotional labor occupations, clergy experience high rates of mental and physical comorbidities. Regular stress management practices may reduce stress-related symptoms and morbidity, but more research is needed into what practices can be reliably included in busy lifestyles and practiced at a high enough level to meaningfully reduce stress symptoms. METHODS AND ANALYSIS: The overall design is a preference-based randomized waitlist control trial. United Methodist clergy in North Carolina will be eligible to participate. The intervention and waitlist control groups will be recruited by email. The interventions offered are specifically targeted to clergy preference and include mindfulness-based stress reduction, Daily Examen, and stress inoculation training. Surveys will be conducted at 0, 12, and 24 weeks with heart rate data collected at 0 and 12 weeks. The primary outcomes for this study are self-reported symptoms of stress and heart rate at week 12 for each intervention compared to waitlist control; the secondary outcome is symptoms of anxiety comparing each intervention vs waitlist control. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Duke University Campus IRB (2019-0238). The results will be made available to researchers, funders, and members of the clergy community. STRENGTHS AND LIMITATIONS OF THIS STUDY: While evidence-based stress reduction practices such as mindfulness-based stress reduction (MBSR) exist, a wider variety of practices should be tested to appeal to different individuals. Clergy in particular may prefer, and consequently enact, spiritual practices like the Daily Examen, and individuals such as clergy who spend most of their time thinking and feeling may prefer experiential-based practices like stress inoculation training. If efficacious, the Daily Examen and stress inoculation training practices have high feasibility in that they require few minutes per day. This study is limited by the inclusion of Christian clergy of only one denomination. TRIAL REGISTRATION: ClinicalTrials.gov NCT04625777 . November 12, 2020.

Predictors and moderators of treatment outcome for single incident paediatric PTSD: a multi-centre randomized clinical trial.

Background: With few RCTs having compared active treatments for paediatric PTSD, little is known about whether or which baseline (i.e. pre-randomization) variables predict or moderate outcomes in the evaluated treatments. Objective: To identify predictors and moderators of paediatric PTSD outcomes for Eye Movement Desensitization and Reprocessing Therapy (EMDR) and Cognitive Behavioural Writing Therapy (CBWT). Method: Data were obtained as part of a multi-centre, randomized controlled trial of up to six sessions (up to 45 minutes each) of either EMDR therapy, CBWT, or wait-list, involving 101 youth (aged 8-18 years) with a PTSD diagnosis (full/subthreshold) tied to a single event. The predictive and moderating effects of the child's baseline sociodemographic and clinical characteristics, and parent's psychopathology were evaluated using linear mixed models (LMM) from pre- to post-treatment and from pre- to 3- and 12-month follow-ups. Results: At post-treatment and 3-month follow-up, youth with an index trauma of sexual abuse, severe symptoms of PTSD, anxiety, depression, more comorbid disorders, negative posttraumatic beliefs, and with a parent with more severe psychopathology fared worse in both treatments. For children with more severe self-reported PTSD symptoms at baseline, the (exploratory) moderator analysis showed that the EMDR group improved more than the CBWT group, with the opposite being true for children and parents with a less severe clinical profile. Conclusions: The most consistent finding from the predictor analyses was that parental symptomatology predicted poorer outcomes, suggesting that parents should be assessed, supported and referred for their own treatment where indicated. The effect of the significant moderator variables was time-limited, and given the large response rate (>90%) and brevity (<4 hours) of both treatments, the present findings suggest a focus on implementation and dissemination, rather than tailoring, of evidence-based trauma-focused treatments for paediatric PTSD tied to a single event.

Antecedentes: Dado que pocos ECA (ensayos controlados aleatorizados) han comparado tratamientos activos para el TEPT pediátrico, se sabe poco acerca de si las variables basales (es decir, pre-aleatorización) predicen o moderan los resultados en los tratamientos evaluados.Objetivo: Identificar predictores y moderadores de los resultados del TEPT pediátrico para la Terapia de Reprocesamiento y Desensibilización por Movimientos Oculares (EMDR) y la Terapia de Escritura Cognitiva Conductual (CBWT en sus siglas en ingles).Método: Los datos se obtuvieron como parte de un ensayo controlado aleatorizado multicéntrico de hasta seis sesiones (de hasta 45 minutos cada una) de terapia EMDR, CBWT o lista de espera, que incluyó a 101 jóvenes (de 8 a 18 años de edad) con un diagnóstico de TEPT (total/subumbral) vinculado a un solo evento. Los efectos predictivos y moderadores de las características sociodemográficas y clínicas basales del niño y la psicopatología de los padres se evaluaron mediante modelos lineales mixtos (MLM) desde antes y después del tratamiento y desde antes hasta los 3 y 12 meses de seguimiento.Resultados: En el post-tratamiento y en el seguimiento a los 3 meses, los jóvenes con un trauma índice de abuso sexual, síntomas severos de TEPT, ansiedad, depresión, más trastornos comórbidos, creencias postraumáticas negativas y con un padre con psicopatología más severa obtuvieron los peores resultados en ambos tratamientos. Para los niños con síntomas de TEPT auto-informados más graves al inicio del estudio, el análisis del moderador (exploratorio) mostró que el grupo EMDR mejoró más que el grupo CBWT, siendo lo opuesto para los niños y los padres con un perfil clínico menos grave.Conclusiones: El hallazgo más consistente de los análisis de predictores fue que la sintomatología de los padres predijo peores resultados, lo que sugiere que los padres deben ser evaluados, apoyados y referidos para su propio tratamiento cuando esté indicado. El efecto de las variables moderadoras significativas fue limitado en el tiempo, y dada la gran tasa de respuesta (> 90%) y la brevedad (<4 horas) de ambos tratamientos, los presentes hallazgos sugieren un enfoque en la implementación y diseminación, en lugar de la adaptación, de tratamientos centrados en el trauma basados en la evidencia para el TEPT pediátrico vinculados a un solo evento.