Uncontrolled Open Trial Research Articles

Smartphone-based behaviour analysis for challenging behaviour in intellectual and developmental disabilities and autism spectrum disorder - Study protocol for the ProVIA trial.

BackgroundChallenging behaviour (CB) comprises various forms of aggressive and problematic behaviours frequently occurring in children with intellectual and developmental disability (IDD) or autism spectrum disorder (ASD). CB often arises from impaired communication or problem solving skills. It is often met with coercive measure due to a lack of alternative strategies on the part of the caregiver, while it also impacts on the caregivers due to the exposure to physical harm and high levels of stress. Within the ProVIA project we developed a smartphone-based tool for caregivers of children with IDD and/or ASD to prevent and modify CB. The ProVIA app systematically helps caregivers to identify specific causes of CB and provides individualised practical guidance to prevent CB and consecutive coercive measures, thus aiming to improve the health and well-being of the children and caregivers.MethodsIn this uncontrolled open trial we will enrol N = 25 caregivers of children aged 3–11 years with a diagnosis of IDD and/or ASD. Participants will use the ProVIA-Kids app for 8 weeks. During the intervention phase, participants will conduct behaviour analyses after each instance of CB. The app will summarise the identified putative causes for the CB in each situation, and provide recommendations regarding the handling and prevention of CB. Furthermore, the app will aggregate data from all available behaviour analyses and identify the most relevant (i.e., most frequently reported) risk factors. Measurement points are at baseline (T0), after the intervention (T1) and 12 weeks after the end of the intervention (follow-up; T2). The primary outcome is the absolute change in parental stress (EBI total scale) between T0 and T1. Further aspects of interest are changes in CB severity and frequency, caregiver mood, satisfaction with the parenting role (EFB-K total scale) and experienced parenting competence (FKE total scale). Pre-post comparisons will be analysed with paired sample t-tests.DiscussionProVIA is pioneering structured behaviour analysis via smartphone, assessing predefined causes of CB and providing feedback and recommendations. If this approach proves successful, the ProVIA-Kids app will be a valuable tool for caregivers to prevent CB and improve their own as well as the children’s quality of life.Trial registrationThe study is registered at https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_IDDRKS00029039 (registered May 31, 2022).

"The effects of web-prolonged exposure among military personnel and veterans with posttraumatic stress disorder": Correction.

Web-based treatments address many of the logistical and stigma-related barriers to in-person behavioral health care. Prior studies of web-based treatments for posttraumatic stress disorder (PTSD) did not employ gold-standard treatments and have not compared to in-person therapy. We compared a web version of Prolonged Exposure Therapy, "Web-PE," to in-person Present-Centered Therapy (PCT) in a randomized controlled trial (RCT) with 40 military personnel with PTSD seeking treatment at Fort Hood, Texas. Due to recruitment challenges, we terminated the RCT and subsequently examined the effects of Web-PE in an uncontrolled open trial with 34 service members and veterans recruited nationwide. Both studies assessed PTSD, depressive symptoms, and health functioning at baseline and 1 and 3 months posttreatment; the RCT also included a 6-month assessment. Results of the RCT showed no differential impact for Web-PE and PCT, although more PCT participants achieved clinically significant change at one of the follow-up assessments. Both treatment conditions significantly reduced self-reported and blind independent interviewer-assessed symptoms of PTSD. Results of the open trial showed that Web-PE was associated with significant reductions in self-reported PTSD symptoms, with a much larger effect size than in the RCT. Web-PE significantly reduced PTSD symptoms in both studies, although the reductions in PTSD symptoms were greater among open trial participants, who were specifically seeking a web-based treatment. Future research should evaluate Web-PE relative to another web-based treatment. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

The effects of web-prolonged exposure among military personnel and veterans with posttraumatic stress disorder.

We compared a web version of Prolonged Exposure Therapy, "Web-PE," to in-person Present-Centered Therapy (PCT) in a randomized controlled trial (RCT) with 40 military personnel with PTSD seeking treatment at Fort Hood, Texas. Due to recruitment challenges, we terminated the RCT and subsequently examined the effects of Web-PE in an uncontrolled open trial with 34 service members and veterans recruited nationwide. Both studies assessed PTSD, depressive symptoms, and health functioning at baseline and 1 and 3 months posttreatment; the RCT also included a 6-month assessment. Results of the RCT showed no differential impact for Web-PE and PCT, although more PCT participants achieved clinically significant change at one of the follow-up assessments. Both treatment conditions significantly reduced self-reported and blind independent interviewer-assessed symptoms of PTSD. Results of the open trial showed that Web-PE was associated with significant reductions in self-reported PTSD symptoms, with a much larger effect size than in the RCT. Web-PE significantly reduced PTSD symptoms in both studies, although the reductions in PTSD symptoms were greater among open trial participants, who were specifically seeking a web-based treatment. Future research should evaluate Web-PE relative to another web-based treatment. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

PTSD treatment in times of COVID-19: A systematic review of the effects of online EMDR

COVID-19 affects many societies by measures as “social distancing”, forcing mental health care professionals to deliver treatments online or via telephone. In this context, online Eye Movement Desensitization and Reprocessing (EMDR) is an emerging treatment for patients with Posttraumatic Stress Disorder (PTSD). We performed a systematic review of studies investigating online EMDR for PTSD. Only one trial was identified. That uncontrolled open trial showed promising results. There is an urgent need to further examine the effects of online EMDR for PTSD, before its wider dissemination is warranted. Remotely delivered cognitive behavioural therapy seems the preferred PTSD-treatment in times of COVID-19.

An intensive form of trauma focused cognitive behaviour therapy in an acute adolescent inpatient unit: An uncontrolled open trial.

Post-traumatic stress disorder (PTSD) rates among hospitalised adolescents are between 21% and 32%, and there is a lack of evidence-based interventions for this population. Trauma-focused cognitive behaviour therapy (TF-CBT) is an evidence-based intervention for children and adolescents with PTSD; however, it has not been implemented in an acute adolescent inpatient unit. This study examines the implementation of an intensive form of TF-CBT in an adolescent inpatient unit. An uncontrolled open trail study was conducted where 15 adolescents diagnosed with PTSD were treated with an intensive form of TF-CBT. Measures used were the University of California, Los Angeles' (UCLA) PTSD Reaction Index for Diagnostic and Statistical Manual of Mental Disorders (4th ed., Adolescent Version; DSM-IV-Adolescent Version), the National Stressful Events Survey PTSD Short Scale (NSESSS) and the Children's Global Assessment Scale (CGAS). Adolescents received an average of nine sessions of TF-CBT over a period of 28 days. The average NSESSS on admission was 23.73 and 8.27 at discharge; the CGAS average on admission was 19 and on discharge was 48.7; both were statistically significant changes. Preliminary findings support the use of an intensive form of TF-CBT to treat adolescents with PTSD admitted to acute adolescent inpatient units indicating the need for further research in this area.

An Uncontrolled Open Trial of a Brief Behavioural Activation Treatment for Depression in Patients with Chronic Spontaneous Urticaria

AbstractChronic spontaneous urticaria (CSU) has been associated with depression and can have an impact on quality of life. Therefore, researchers have suggested the potential utility of psychological interventions for targeting depression among CSU patients. Psychological interventions that may hold the most promise are those that are brief and easily transportable, such as brief behavioural activation treatment for depression. We report results of a preliminary investigation of an uncontrolled open trial of a one-session behavioural activation treatment for depression designed for patients with CSU (BATD-CSU) at a university-based allergy and immunology clinic. Participants were 11 females with chronic, poorly controlled urticaria and symptoms of depression. Following the completion of pretreatment questionnaires, participants were administered BATD-CSU primarily by non-mental health professionals trained and supervised in its delivery. One month post-BATD-CSU, participants completed follow-up questionnaires. Participants exhibited significant reductions in depression severity, avoidance/rumination, and work/school impairment. BATD-CSU was also associated with improvements in urticaria control one month post-treatment. Moreover, five of nine patients reported reliable and clinically significant improvement on at least one outcome. Results demonstrate that BATD-CSU may have benefits for CSU patients even when consisting of one session and delivered by professionals with limited background in psychological interventions, thus speaking to its feasibility and transportability.

Extending research on Emotion Regulation Individual Therapy for Adolescents (ERITA) with nonsuicidal self-injury disorder: open pilot trial and mediation analysis of a novel online version

BackgroundNonsuicidal self-injury (NSSI) is common among adolescents and associated with negative outcomes. However, treatments developed specifically for NSSI and the proposed NSSI disorder (NSSID) are scarce, and access to empirically supported treatments for NSSI in many areas is limited. Online treatments carry the potential to increase the availability of evidence-based treatments. Emotion regulation individual therapy for adolescents (ERITA) has shown promise in the treatment of adolescents with NSSID.MethodThe present study examined the feasibility, acceptability, and utility of an online version of ERITA. Twenty-five adolescents (aged 13–17) with NSSID and their parents were included in an uncontrolled open trial. Self-report and clinician-rated assessments of outcomes such as NSSI, self-destructive behaviors, emotion dysregulation, and global functioning were administered at pre-treatment, post-treatment, 3- and 6- month follow-up. Measures of NSSI, self-destructive behaviors, and emotion dysregulation were also assessed weekly during treatment.ResultsRatings of treatment credibility, expectancy, and satisfaction were acceptable, and the therapeutic alliance and treatment completion rate (96%) were high. Adolescent participation in the treatment was associated with a statistically significant increase in past-month NSSI abstinence (p = .007), large-sized improvements in past-month NSSI frequency (55% reduction, 95% confidence interval [CI]: 29, 72; Cohen’s d = 0.88, 95% CI: 0.73, 1.06) and global functioning (d = 1.01, 95% CI: 0.77, 1.32), and medium-sized improvements in emotion dysregulation (d = 0.75, 95% CI: 0.59, 0.90) and NSSI versatility (d = 0.63, 95% CI: 0.54, 0.77) from pre- to post-treatment. These improvements were further strengthened at 3-month follow-up and maintained at 6-month follow-up. The online therapist-guided parent program was associated with small- to large-sized (ds = 0.47–1.22) improvements in adaptive parent behaviors, and these improvements were maintained or further improved upon at 6-month follow-up. Moreover, in line with the theoretical model underlying ERITA, change in emotion dysregulation mediated changes in both NSSI frequency and self-destructive behaviors over the course of treatment.ConclusionsTogether, results suggest that online ERITA is an acceptable, feasible, and promising low-intensity treatment for adolescents with NSSID. The results of this open trial must be replicated in controlled studies.Trial registrationClinicalTrials.gov (NCT02697019). Registered 2 March 2016

Emotion regulation individual therapy for adolescents with nonsuicidal self-injury disorder: a feasibility study

BackgroundNonsuicidal self-injury (NSSI) is a serious health risk behavior that forms the basis of a tentative diagnosis in DSM-5, NSSI Disorder (NSSID). To date, established treatments specific to NSSI or NSSID are scarce. As a first step in evaluating the feasibility, acceptability, and utility of a novel treatment for adolescents with NSSID, we conducted an open trial of emotion regulation individual therapy for adolescents (ERITA): a 12-week, behavioral treatment aimed at directly targeting both NSSI and its proposed underlying mechanism of emotion regulation difficulties.MethodsSeventeen girls (aged 13–17; mean = 15.31) with NSSID were enrolled in a study adopting an uncontrolled open trial design with self-report and clinician-rated assessments of NSSI and other self-destructive behaviors, emotion regulation difficulties, borderline personality features, and global functioning administered at pre-treatment, post-treatment, and 6-month follow-up. Measures of NSSI and emotion regulation difficulties were also administered weekly during treatment.ResultsRatings of treatment credibility and expectancy and the treatment completion rate (88%) were satisfactory, and both therapeutic alliance and treatment attendance were strong. Intent-to-treat analyses revealed significant improvements associated with large effect sizes in past-month NSSI frequency, emotion regulation difficulties, self-destructive behaviors, and global functioning, as well as a medium effect size in past-month NSSI versatility, from pre- to post-treatment. Further, all of these improvements were either maintained or further improved upon at 6-month follow-up. Finally, change in emotion regulation difficulties mediated improvements in NSSI over the course of treatment.ConclusionsResults suggest the acceptability, feasibility, and utility of this treatment for adolescents with NSSID.Trial registrationClinicalTrials.gov (NCT02326012, December 22, 2014, retrospectively registered).

Emotion regulation group therapy for deliberate self-harm: a multi-site evaluation in routine care using an uncontrolled open trial design

ObjectiveEmotion regulation group therapy (ERGT) has shown promising results in several efficacy trials. However, it has not been evaluated outside a research setting. In order to increase the availability of...

An Initial Open Trial of a Brief Behavioral Activation Treatment for Depression and Medication Adherence in HIV-Infected Patients.

Advances in HIV treatment through highly active antiretroviral therapy (HAART) have led to a steady decline in HIV-related mortality rates. However, HAART requires adherence to strict and often complicated medication regimens, and nonadherence to HAART can significantly decrease its effectiveness. Depression has consistently shown a robust association with medication nonadherence; consequently, numerous psychological interventions have been developed to target depression and increase medication adherence among HIV-infected individuals. The length of these interventions, however, may be prohibitive for certain HIV-infected populations, such as patients in rural areas. Therefore, this study provides an initial investigation of a one-session behavioral activation treatment for depression designed specifically for HIV-infected patients (BATD-HIV) at a community infectious disease clinic serving a largely rural population. In this initial uncontrolled open trial, BATD-HIV was administered to 10 HIV-infected patients with elevated symptoms of depression following their clinic appointment. Depression, anxiety, and stress symptom severity; behavioral activation processes; medication adherence; and CD4 T-cell count were assessed pre- and 1 month postintervention. Participants exhibited significant reductions in anxiety symptom severity and avoidance of negative aversive states and rumination from pre- to 1 month posttreatment. Although nonsignificant, participants also showed medium effect size reductions in depression and stress symptoms and work/school and social impairment, and medium effect size improvements in medication adherence and CD4 T-cell counts. Despite the preliminary nature of this study, results suggest that BATD-HIV may have utility as a brief treatment for HIV-infected patients with depression and warrants further investigation in larger scale randomized controlled trials.

Systematic review of large neutral amino acids for treatment of phenylketonuria

Individuals with phenylketonuria (PKU) have defective enzyme activity, leading to toxic accumulation of phenylalanine (Phe) in blood and tissues. Adherence to a Phe-restricted diet can mitigate poor outcomes; however, dietary restriction is difficult. Large neutral amino acids (LNAAs), which putatively decrease brain Phe concentration, have been suggested as a potential supplementary treatment in addition to a Phe-restricted diet. To systematically review evidence regarding LNAA usage in individuals with PKU, we searched 5 databases including Medline up to August 2011 and the reference lists of included articles. Two reviewers independently assessed studies against predetermined inclusion/exclusion criteria. Two reviewers independently extracted data regarding participant and intervention characteristics and outcomes; using their extracted data, they assigned overall quality and strength of evidence ratings based on predetermined criteria. Three small studies (two randomized controlled trials and one uncontrolled open label trial) of fair to poor quality investigated LNAAs. The studies included a total of 47 participants with severe PKU between 11 and 45 years of age receiving LNAAs for 1 to 8 weeks. In all three studies, blood Phe decreased after one week of treatment, but remained above clinically acceptable levels. The one trial measuring correlation between blood and brain Phe found no association. Research on adjuvant therapy in PKU to complement dietary restriction is early in its development and substantially more work is needed. The three very small studies of LNAAs to date cannot be considered as more than proof of concept.

Mindfulness-based stress reduction for Tourette syndrome and chronic tic disorder: A pilot study

ObjectiveIn this pilot study we sought to develop and test a modified form of mindfulness-based stress reduction (MBSR-tics) for the treatment of Tourette Syndrome (TS) and Chronic Tic Disorder (CTD). Our specific aims were: 1) To determine the feasibility and acceptability of an 8-week trial of MBSR-tics in individuals 16 and older with TS or CTD and 2) To determine the efficacy of an 8-week trial of MBSR-tics in individuals 16 and older with TS or CTD. MethodsEighteen individuals age 16–67 completed an uncontrolled open trial of MBSR-tics. The intervention consisted of 8 weekly 2-hour classes and one 4hour retreat in the fifth or sixth week of the program. Symptomatic assessments were performed at baseline, post-treatment, and one-month follow-up. ResultsMBSR-tics proved to be a feasible and acceptable intervention. It resulted in significant improvement in tic severity and tic-related impairment. 58.8% of subjects were deemed treatment responders. Therapeutic gains were maintained at 1-month follow-up. Improvements in tic severity were correlated with increases in self-reported levels of mindfulness. ConclusionsThis small open pilot study provides preliminary support for the feasibility, acceptability, and efficacy of MBSR-tics for individuals 16 or older with TS or CTD. A larger randomized controlled trial with blind assessment is necessary to confirm these initial, promising findings.Trial Registration Partners Clinical Trials Registry Number 2011P000606 (clinicaltrials.partners.org).

24-hour Intraocular Pressure Fluctuation Monitoring Using an Ocular Telemetry Sensor

To evaluate the tolerability, comfort, and reliability of the signal transmission of an ocular Sensor used for 24-hour intraocular pressure fluctuation monitoring in humans. In this uncontrolled open trial involving 10 healthy volunteers, an 8.7-mm radius prototype ocular telemetry Sensor (SENSIMED Triggerfish, Lausanne, Switzerland) and an orbital bandage containing a loop antenna were applied and connected to a portable recorder after full eye examination. Best-corrected visual acuity and position, surface wetting ability, and mobility of the Sensor were assessed after 5 and 30 minutes, 4, 12, and 24 hours. Subjective wearing comfort was scored and activities documented in a logbook. After Sensor removal, a full eye examination was repeated and the recorded signal analyzed. The comfort score was high and did not fluctuate significantly over time. The mobility of the Sensor was limited across follow-up visits and its surface wetting ability remained good. Best-corrected visual acuity was significantly reduced during Sensor wear and immediately after its removal (from 1.07 before, to 0.85 after, P value 0.008). Three subjects developed a mild, transient corneal abrasion. In all but 1 participant, we obtained usable data of a telemetric signal recording with sufficient sensitivity to depict ocular pulsation. This 24-hour trial has encouraging results on the tolerability and functionality of the ocular telemetric Sensor for intraocular pressure fluctuation monitoring. Further studies with different Sensor radii conducted on a larger study population are needed to improve comfort, precision, and interpretation of the telemetric signal.

Approach to Antihypertensive Adherence: A Feasibility Study on the Use of Student Health Coaches for Uninsured Hypertensive Adults

Despite pharmacologic advances, medication non-adherence continues to challenge primary care providers in blood pressure (BP) management. Medical, nursing and pharmacy students (n = 11) were recruited and trained as health coaches for uninsured, hypertensive patients (n = 25) of a free clinic in an uncontrolled open trial. Pre–post analysis was conducted on BP, medication adherence, frequency of home BP monitoring, and health behavior (eg, diet, exercise). Patient satisfaction and feasibility of a student coach model was qualitatively evaluated. In the 12 patients who completed the intervention, an increase in medication adherence as measured by the Brief Medication Questionnaire was observed (P < .01), with a 11mmHg reduction in systolic BP (P = .03). Qualitative data showed patient satisfaction with the intervention and other health behavior change. This feasibility study shows use of student health coaches to combat medication non-adherence in uninsured, hypertensive adults is promising.

Intravenous cyclophosphamide in refractory polyneuropathy associated with IgM monoclonal gammopathy: An uncontrolled open trial

Intravenous cyclophosphamide in refractory polyneuropathy associated with IgM monoclonal gammopathy: An uncontrolled open trial

A large open trial of proglumetacin in the treatment of soft-tissue rheumatisms

In an uncontrolled open trial, 317 outpatients suffering from soft-tissue rheumatisms (ie, 148 patients with painful shoulder, 92 with tendinitis, 42 with epicondylitis, and 35 with minor traumas) received 450 mg/day of proglumetacin, a prodrug of indomethacin. After 7 days of treatment, a highly significant reduction in pain and an improvement of function were observed in all groups of patients ( P < 0.001). The incidence of side effects (13.8%), mainly gastrointestinal (10.1%), was low, especially compared with that classically described for indomethacin. More than 50% of the patients who developed side effects were able to continue proglumetacin treatment, and only one fifth of them (ie, 2.8% of all patients in the study) had to discontinue the treatment. For the short-term treatment of soft-tissue rheumatisms, proglumetacin appears to be a safe nonsteroidal anti-inflammatory compound that is associated with a reduction in pain and an improvement in function in treated patients.

Treatment of tumor-induced osteolysis by APD.

Bisphosphonates, associated with rehydration, became the treatment of choice of malignant hypercalcemia when it became apparent that these compounds normalized plasma calcium in most cases within a few days and with almost no side effects, and that their effect was prolonged. Dichloromethylene bisphosphonate and aminobisphosphonate, especially APD, were shown to inhibit bone resorption with no noticeable inhibition of bone formation, and were highly effective in the long-term treatment of Paget's disease. APD was used in almost 300 patients with malignant hypercalcemia published in the literature and has been used in the medical clinic at Lausanne for several years. When given to 14 patients with malignant hypercalcemia at the dose of 25 mg/day until plasma calcium became normal for two consecutive days, APD had to be given for 4-11 days, severe hypercalcemia needing longer treatment than mild hypercalcemia (Adami et al. 1982). When given for a fixed period of 6 days, again plasma calcium normalized in all patients, whether APD was given i.v. (30 mg/day, ten patients) or orally (1200 mg/day, ten patients) (Adami et al. 1985). Further shortening of the treatment to one single infusion given over 24 h did not decrease the efficacy, as long as high enough doses were given (Blomqvist 1986). For severe hypercalcemia of above 3.5 mmol/liter 60-90 mg had to be given, while 30-45 mg was sufficient in milder cases (Body 1984). Otherwise, mild, transient, and asymptomatic hypocalcemia could occur. Normalization of plasma calcium went along with clinical improvement, sometimes even with correction of coma. Renal function was improved, even when the initial plasma creatinine levels were up to twice normal. Hypercalcemia could reoccur, but the duration of the effect of APD (1 week to several months) depended among other things on the dose administered. The decrease in plasma calcium was accompanied by a decrease in urinary calcium and hydroxyproline, both showing inhibition of bone resorption. In the case of recurrency, the treatment could be repeated with almost unaltered efficacy, except in end-stage cancer disease. When given to 13 normocalcemic patients with bone metastases from breast cancer, hydroxyproline and urinary calcium again decreased. Bone pains and radiologic signs of metastatic bone resorption also showed significant improvement, although these latter effects could also be explained by the antitumoral treatment, in this uncontrolled open trial.(ABSTRACT TRUNCATED AT 400 WORDS)