Randomized Controlled Trial of the Focus Parent Training for Toddlers with Autism: 1-Year Outcome

This randomized controlled trial compared results obtained after 12 months of nonintensive parent training plus care-as-usual and care-as-usual alone. The training focused on stimulating joint attention and language skills and was based on the intervention described by Drew et al. (Eur Child Adolesc Psychiatr 11:266–272, 2002). Seventy-five toddlers with autism spectrum disorder (65 autism, 10 PDD-NOS, mean age = 34.4 months, SD = 6.2) were enrolled. Analyses were conducted on a final sample of 67 children (lost to follow-up = 8). No significant intervention effects were found for any of the primary (language), secondary (global clinical improvement), or mediating (child engagement, early precursors of social communication, or parental skills) outcome variables, suggesting that the ‘Focus parent training’ was not of additional value to the more general care-as-usual.     

Antibiotic-Impregnated Versus Silver-Bearing External Ventricular Drainage Catheters: Preliminary Results in a Randomized Controlled Trial

Background

Evaluation of antibiotic-impregnated (AI) and ionized silver particle coated external ventricular drainage catheters (EVD) in patients with subarachnoid (SAH) or intracranial hemorrhage (ICH).

Methods

Between February 2011 and June 2012, 40 patients with acute hydrocephalus due to SAH, ICH or intraventricular hemorrhage were enrolled in a prospective, randomized, mono-center pilot study. Primary endpoints were defined as: number of events of cerebrospinal fluid (CSF) infections. Secondary endpoints were defined as: neurosurgical complications following the placement of the EVD, number of revisions of EVD catheters, and cost effectiveness.

Results

Sixty-one EVD placements in 40 patients, 32 antibiotic-coated (Bactiseal^®), 29 silver-bearing catheters (VentriGuard^®), have been performed. Confirmed or high suspicion of CSF infections occurred in 11 out of 61 events (confirmed infection: p = 0.71, probable infection: p = 0.90). Revisions of EVD were needed in 13 cases (22 %) due to CSF infection, dysfunction, impaired healing, or malplacement (p = 0.37).

Conclusion

Regarding CSF infection rate and dysfunction, no statistical significant differences between the two EVD catheters Bactiseal^® versus VentriGuard^® were found. The silver-bearing catheter might offer a safe and cost-conscious alternative to the AI catheter.     

An Online Mindfulness Intervention Targeting Socioemotional Regulation in Fibromyalgia: Results of a Randomized Controlled Trial

Background

Patients with fibromyalgia (FM) experience pain as well as deficits in positive affect and social relations that are not explicitly addressed in most behavioral treatments.

Purpose

The purpose of this study is to compare the effects of a 12-module online intervention targeting socioemotional regulation via mindful awareness/acceptance (MSER) with those of an attention-control treatment, healthy lifestyle tips (HT).

Methods

Seventy-nine FM patients were randomly assigned to MSER or HT, with outcomes assessed via online diary reports of pain, coping efficacy, affect, and social relations. Multilevel analyses revealed greater improvements in social functioning, positive affect, and coping efficacy for pain and stress (all ps?<?.05) in MSER versus HT across the 6-week trial.

Conclusions

FM patients experience increases in self-efficacy for coping with pain and positive engagement in relationships, marginal increases in positive affect, and decreases in relationship stress from an automated online intervention that targets socioemotional regulation skills. Findings highlight the potential utility of widely accessible, low-cost intervention methods for fibromyalgia (Clinicaltrials.gov number NCT01748786).     

Incongruent Expression of Brain-Derived Neurotrophic Factor and Cortisol in Schizophrenia: Results from a Randomized Controlled Trial of Laughter Intervention

ObjectiveSchizophrenia has been associated with dysfunction of the hypothalamic-pituitary-adrenal axis. Furthermore, alterations in neurotrophic factors might contribute to the pathogenesis of schizophrenia. We aimed to evaluate the effects of a simulated laughter intervention on the levels of cortisol and BDNF and to determine whether the effects associated with simulated laughter could be sustained after discontinuation of the intervention.MethodsIn this randomized controlled study, patients with schizophrenia according to DSM-IV clinical criteria were randomly assigned to receive either 8-week-long simulated laughter intervention (n=32) or treatment-as-usual group (control group, n=27). The serum levels of BDNF and cortisol were measured at baseline, week 8, and four weeks after discontinuation (week 12) of the intervention program. ResultsAfter an 8-week simulated laughter intervention, the laughter group had significantly higher levels of BDNF; however, four weeks after discontinuation of the intervention, the levels of BDNF significantly dropped. Interestingly, the levels of cortisol did not change significantly at week 8, but they were significantly elevated at week 12. The levels of BDNF and cortisol in the control group did not change significantly between week 0 and week 8. ConclusionThese findings suggest that the simulated laughter intervention has an early effect on neurogenesis with a significant delayed effect on stress regulation in subjects with schizophrenia.     

Randomized Controlled Trial of a Video Gaming-Based Social Skills Program for Children on the Autism Spectrum

Journal of Autism and Developmental Disorders - Families often face financial and geographical barriers to services for children with autism. The current study explored the effectiveness of a...     

Improving Propensity for Patient Self-Advocacy Through Wellness Recovery Action Planning: Results of a Randomized Controlled Trial

A fundamental aspect of successful illness self-management for people with serious mental illnesses is the ability to advocate for themselves in health and rehabilitation settings. This study reports findings from a randomized controlled trial comparing propensity for patient self-advocacy among those who received a peer-led mental illness self-management intervention called Wellness Recovery Action Planning (WRAP) and those who received usual care. Outcomes were self-reported engagement in self-advocacy with service providers, and the relationship between patient self-advocacy and other key recovery outcomes. In a multivariable analysis, at immediate post-intervention and 6-month follow-up, WRAP participants were significantly more likely than controls to report engaging in self-advocacy with their service providers. Higher self-advocacy also was associated with greater hopefulness, better environmental quality of life, and fewer psychiatric symptoms among the intervention group. These findings provide additional support for the positive impact of peer-led illness self-management on mental health recovery.     

Enhancing and Promoting Recovery in Attentionally Impaired People Diagnosed with Schizophrenia: Results From a Randomized Controlled Trial of Attention Shaping in a Partial Hospital Program

The attentional impairments associated with schizophrenia are well documented and profound. Psychopharmacological and most psychosocial interventions have been shown to have limited effect in improving attentional capacity. That said, one form of psychosocial treatment, attention shaping procedures (ASP), has been repeatedly demonstrated to produce significant and meaningful change in various aspects of participant attentiveness behaviors. To date, studies of ASP have been limited in that they have been conducted primarily with inpatients, have not assessed the generalizability of ASP's effects, and have not explored whether reinforcement is required to be contingent on performance of attentive behaviors. To address these limitations, we conducted the first randomized clinical trial of ASP with people diagnosed with schizophrenia who were being treated in a partial hospital program. Our results indicate that ASP is effective in improving attention in people with schizophrenia in these types of programs, the effects of ASP generalize outside the immediate treatment context to both other treatment groups and real-world functioning, and contingent reinforcement is a critical ingredient of ASP. This project provides further evidence for the benefits of use of ASP in the recovery-oriented treatment of people diagnosed with schizophrenia who have significant attentional impairments.     

Randomized Controlled Trial of an Interactive Internet Smoking Cessation Program with Long-Term Follow-up

Background  

Internet programs for smoking cessation are widely available but few controlled studies demonstrate long-term efficacy.     

Effects of a Home-based Exercise Intervention on Fatigue in Postpartum Depressed Women: Results of a Randomized Controlled Trial

Background Fatigue is prevalent during the postpartum period and may be heightened in postpartum depressed women. Purpose To evaluate the efficacy of a home-based exercise intervention in reducing physical and mental fatigue scores in postpartum depressed women. Methods Eighty-eight women in the postpartum (4–38 weeks) obtaining a score ≥10 on the Edinburgh Postnatal Depression Scale (EPDS) were randomly assigned to a 12-week individualized home-based intervention (n = 46) or a control group (n = 42). All participants completed a cardiovascular fitness test at baseline. Outcomes were physical and mental fatigue scores and were measured at baseline, posttreatment and 3 months posttreatment. Results On the basis of intent-to-treat analyses, compared to the control group, women in the exercise group showed significantly greater reduction in physical fatigue at posttreatment [mean change =  −4.07, (95% CI, (−5.15, −2.98)] and 3 months posttreatment [mean change = −4.24, (95% CI, (−5.36, −3.12)]. Significant reductions in mental fatigue with exercise were observed at posttreatment for women reporting lower physical fatigue at baseline. Conclusions Fatigue is a common symptom experienced in the postpartum that can be heightened by depression. The findings show that home-based exercise can reduce physical and mental fatigue in postpartum depressed women. This study was funded by an operating grant from the Fonds de recherche en santé du Québec (#024018).     

Therapeutic Misestimation in Patients with Degenerative Ataxia: Lessons from a Randomized Controlled Trial

Background

The absence of effective treatments may render patients with degenerative cerebellar ataxias susceptible to a placebo response, which could affect the outcome of clinical trials.

Objective

To retrospectively examine expectations of benefit in participants of an ataxia trial and identify determinants of possible therapeutic misestimation.

Methods

Individuals with spinocerebellar ataxia type 3 who participated in a randomized, double-blind, sham-controlled trial received a custom-designed questionnaire about short-term and long-term treatment expectations, allocation preferences, and interpretation of treatment arm assignment based on the presence or absence of clinical improvement. To evaluate whether expectations were specifically related to the application of cerebellar transcranial direct current stimulation (tDCS) or more generally reflect an overly positive attitude of patients with ataxia toward trial participation and results, the last questions involved a hypothetical scenario in which an oral drug was tested against placebo with an aim identical to that of our tDCS study.

Results

All 20 trial participants completed the questionnaire. If allocated to the active treatment arm, 75% of patients expected short-term health benefits and 55% thought they would still have less severe ataxia at 1-year follow-up compared with baseline. After 2 weeks, an average reduction in ataxia severity of 31.5% (standard deviation, 22.2%) was anticipated. Conversely, 65% associated a lack of improvement with probable or definite allocation to the placebo group. High expectations of benefit were neither related to the type of intervention nor to clinical or demographic characteristics.

Conclusion

Therapeutic misestimation is common in patients with degenerative ataxia and requires special attention in future trials. © 2022 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.     

A Randomized Controlled Trial of a Mindfulness-Based Smoking Cessation Program for Individuals with Mild Intellectual Disability

Smoking is a risk factor for death and dying for individuals who smoke and for those who inhale second hand smoke. Smokers struggle to quit smoking because of the negative affect associated with nicotine withdrawal. We assessed the efficacy of a mindfulness-based intervention for smoking cessation in individuals with mild intellectual disabilities. In addition to the basic concentration meditation, the mindfulness-based smoking cessation program included daily intention, mindful observation of thoughts, and Meditation on the Soles of the Feet. In a two-group randomized controlled trial, 51 protocol-eligible participants were randomly assigned to either the experimental group (mindfulness-based intervention) or the control group (treatment as usual). Results showed a statistically significant reduction in smoking commensurate with mindfulness-based training when compared to the treatment as usual condition. This finding was evident regardless of whether the analysis included only those who completed the study or the total sample in an intent-to-treat analysis. Furthermore, those receiving the mindfulness-based intervention were significantly more successful in abstaining from smoking during a 1-year follow-up than the treatment as usual group. These results suggest mindfulness-based interventions may be effective treatments for smoking cessation in individuals with mild intellectual disabilities.     

Sibling Configuration as a Moderator of the Effectiveness of a Theory of Mind Training in Children with Autism: a Randomized Controlled Trial

This RCT investigated whether participants’ sibling configuration moderated the effect of a Theory of Mind (ToM) intervention for children with autism. Children with autism aged 8–13 years (n?=?141) were randomized over a waitlist control or treatment condition. Both having more siblings, as well as having an older sibling were related to better outcomes on measures of ToM-related behavior and social cognition, but not ToM knowledge or autistic features in general. The finding that these associations were limited to practical skills addressed in the intervention, seems to indicate that having more siblings and having an older sibling provides enhanced opportunities for children with autism to practice taught skills in the home environment.

     

Long-Term Effects of Self-Administered Transcranial Direct Current Stimulation in Episodic Migraine Prevention: Results of a Randomized Controlled Trial

BackgroundMigraine is a multifactorial neurovascular disorder, which affects about 12% of the general population. In episodic migraine, the visual cortex revealed abnormal processing, most likely due to decreased preactivation level. Transcranial direct current stimulation (tDCS) is able to modify cortical excitability and might result in an alleviation of migraine occurrence if used repetitively.ObjectiveTo test the hypothesis that self-administered anodal tDCS over the visual cortex significantly decreases the number of monthly migraine days in episodic migraine.Materials and MethodsThe study was single-blind, randomized, and sham-controlled. Inclusion criteria were age 18–80 years and an ICHD-3 diagnosis of episodic migraine. Exclusion criteria were pregnancy, presence of a neurodegenerative disorder, a contraindication against MRI examinations, and less than two migraine days during the 28-day baseline period. Patients in whom the baseline period suggested chronic migraine were excluded. After baseline, participants applied daily either verum (anodal-1 mA to 20 min) or sham tDCS (anodal-1 mA to 30 sec) at Oz (reference Cz electrode) for 28 days. Headache diaries were used to record the number of migraine days at baseline, during the stimulation period, and during four subsequent 28-day periods.ResultsTwenty-eight patients were included; two were excluded after the baseline period because less than two migraine days occurred; three were excluded because their headache diaries suggested the diagnosis of chronic migraine. Twenty-three datasets were taken for further analysis. Compared to sham tDCS (n = 12), verum tDCS (n = 11) resulted in a lower number of migraine days (p = 0.010) across all follow-up periods. We found no significant change in total headache days (p = 0.165), anxiety (p = 0.884), or depression scores (p = 0.535). No serious adverse events occurred; minor side effects were similar in both groups.ConclusionsThis study provides Class II evidence that self-administered anodal tDCS over the visual cortex in episodic migraine results in a significantly lower number of monthly migraine days. However, it has neither an immediate nor a long-term effect.