Active Control Intervention Research Articles

Effects of Multicomponent Home-Based Intervention on Muscle Composition, Fitness, and Bone Density After Hip Fracture.

Mechanistic factors on the pathway to improving independent ambulatory ability among hip fracture patients by a multicomponent home-based physical therapy intervention that emphasized aerobic, strength, balance, and functional training are unknown. The aim of this study was to determine the effects of 2 different home-based physical therapy programs on muscle area and attenuation (reflects muscle density) of the lower extremities, bone mineral density (BMD), and aerobic capacity. Randomized controlled trial of home-based 16 weeks of strength, endurance, balance, and function exercises (PUSH, n = 19) compared to seated active range-of-motion exercises and transcutaneous electrical neurostimulation (PULSE, n = 18) in community-dwelling adults >60 years of age within 26 weeks of hip fracture. In PUSH and PULSE groups combined, the fractured leg had lower muscle area and muscle attenuation and higher subcutaneous fat than the nonfractured leg (p < .001) at baseline. At 16 weeks, mean muscle area of the fractured leg was higher in the PUSH than PULSE group (p = .04). Changes in muscle area were not significantly different when compared to the comparative PULSE group. There was a clinically relevant difference in change in femoral neck BMD between groups (p = .05) that showed an increase after PULSE and decrease after PUSH. There were generally no between-group differences in mean VO2peak tests at 16-week follow-up, except the PUSH group reached a higher max incline (p = .04). The treatment effects of a multicomponent home-based physical therapy intervention on muscle composition, BMD, and aerobic capacity were not significantly different than an active control intervention in older adults recovering from hip fracture. ClinicalTrials.gov Identifier: NCT01783704.

Short-term effectiveness of the national German quitline for smoking cessation: results of a randomized controlled trial

BackgroundThe objective of the present study was to examine the short-term effectiveness of the national German quitline for smoking cessation.MethodsA parallel-group, two-arm, superiority, randomized controlled trial with data collection at baseline and post-intervention (three months from baseline) was conducted. Individuals were randomized to either the intervention group, receiving up to six telephone counselling calls, or the control group, receiving an active control intervention (self-help brochure). The primary outcome was the seven-day point prevalence abstinence at post-assessment. Secondary outcomes included changes in smoking-related cognitions and coping strategies from pre- to post-assessment, the perceived effectiveness of intervention components, and the satisfaction with the intervention.ResultsA total of n = 905 adult daily smokers were assigned to either the intervention group (n = 477) or the control group (n = 428). Intention-to-treat analyses demonstrated that individuals allocated to the telephone counselling condition were more likely to achieve seven-day point prevalence abstinence at post-assessment compared to those allocated to the self-help brochure condition (41.1% vs. 23.1%; OR = 2.3, 95% CI [1.7, 3.1]). Participants who received the allocated intervention in both study groups displayed significant improvements in smoking-related cognitions and coping strategies with the intervention group showing greater enhancements than the control group. This pattern was also found regarding the perceived effectiveness of intervention components and the satisfaction with the intervention.ConclusionThe present study provides first empirical evidence on the short-term effectiveness of the national German quitline for smoking cessation, highlighting its potential as an effective public health intervention to reduce the burden of disease associated with smoking.Trial registrationThis study is registered in the German Clinical Trials Register (DRKS00025343). Date of registration: 2021/06/07.

Is blinding in studies of manual soft tissue mobilisation of the back possible? A feasibility randomised controlled trial with Swiss graduate students

Study designSingle-centre, two-parallel group, methodological randomised controlled trial to assess blinding feasibility.BackgroundTrials of manual therapy interventions of the back face methodological challenges regarding blinding feasibility and success. We assessed the feasibility of blinding an active manual soft tissue mobilisation and control intervention of the back. We also assessed whether blinding is feasible among outcome assessors and explored factors influencing perceptions about intervention assignment.MethodsOn 7–8 November 2022, 24 participants were randomly allocated (1:1 ratio) to active or control manual interventions of the back. The active group (n = 11) received soft tissue mobilisation of the lumbar spine. The control group (n = 13) received light touch over the thoracic region with deep breathing exercises. The primary outcome was blinding of participants immediately after a one-time intervention session, as measured by the Bang blinding index (Bang BI). Bang BI ranges from –1 (complete opposite perceptions of intervention received) to 1 (complete correct perceptions), with 0 indicating ‘random guessing’—balanced ‘active’ and ‘control’ perceptions within an intervention arm. Secondary outcomes included blinding of outcome assessors and factors influencing perceptions about intervention assignment among both participants and outcome assessors, explored via thematic analysis.Results24 participants were analysed following an intention-to-treat approach. 55% of participants in the active manual soft tissue mobilisation group correctly perceived their group assignment beyond chance immediately after intervention (Bang BI: 0.55 [95% confidence interval (CI), 0.25 to 0.84]), and 8% did so in the control group (0.08 [95% CI, −0.37 to 0.53]). Bang BIs in outcome assessors were 0.09 (−0.12 to 0.30) and −0.10 (−0.29 to 0.08) for active and control participants, respectively. Participants and outcome assessors reported varying factors related to their perceptions about intervention assignment.ConclusionsBlinding of participants allocated to an active soft tissue mobilisation of the back was not feasible in this methodological trial, whereas blinding of participants allocated to the control intervention and outcome assessors was adequate. Findings are limited due to imprecision and suboptimal generalisability to clinical settings. Careful thinking and consideration of blinding in manual therapy trials is warranted and needed.Trial registrationClinicalTrials.gov: NCT05822947 (retrospectively registered)

A generalized phase 1-2-3 design integrating dose optimization with confirmatory treatment comparison.

A generalized phase 1-2-3 design, Gen 1-2-3, that includes all phases of clinical treatment evaluation is proposed. The design extends and modifies the design of Chapple and Thall (2019), denoted by CT. Both designs begin with a phase 1-2 trial including dose acceptability and optimality criteria, and both select an optimal dose for phase 3. The Gen 1-2-3 design has the following key differences. In stage 1, it uses phase 1-2 criteria to identify a set of candidate doses rather than 1 dose. In stage 2, which is intermediate between phase 1-2 and phase 3, it randomizes additional patients fairly among the candidate doses and an active control treatment arm and uses survival time data from both stage 1 and stage 2 patients to select an optimal dose. It then makes a Go/No Go decision of whether or not to conduct phase 3 based on the predictive probability that the selected optimal dose will provide a specified substantive improvement in survival time over the control. A simulation study shows that the Gen 1-2-3 design has desirable operating characteristics compared to the CT design and 2 conventional designs.

Pilot randomized controlled trial of biofeedback on reducing psychological and physiological stress among persons experiencing homelessness.

People experiencing homelessness report increased exposure to traumatic life events and higher rates of depression, anxiety, and post-traumatic stress disorder as compared with the general population. Heart rate variability-biofeedback (HRV-BF) has been shown to decrease symptoms of stress, anxiety, depression, and PTSD. However, HRV-BF has not been tested with the most vulnerable of populations, homeless adults. The purpose of this randomized controlled trial was to compare the effectiveness of an HRV-BF intervention versus a Health Promotion (HP) active control intervention focused on improving mental health symptoms among homeless adults. Guided by a community advisory board, homeless adults residing in Skid Row, Los Angeles (n=40) were randomized to either the HRV-BF or an active HP control group and received eight weekly, 30-min sessions over two months, delivered by a nurse-led community health worker team. Dependent variables of HRV, mental health, anxiety, depression, and PTSD were measured at baseline, the 8-week session, and/or 2-month follow-up. All intervention sessions were completed by 90% (36/40) of participants. Both the HRV-BF and HP interventions showed significant increases in HRV from baseline to 2-month follow-up, with no significant difference between the intervention groups. The HRV-BF programme revealed a somewhat greater, although non-significant, improvement in anxiety, depression, and PTSD symptoms than the HP programme. The usefulness of both interventions, focused on emotional and physical health, warrants future studies to examine the value of a combined HRV-BF and HP intervention.

Internet-delivered therapist-assisted cognitive behavioral therapy for gambling disorder: a randomized controlled trial.

Cognitive behavioral therapy (CBT) is the most promising treatment for gambling disorder (GD) but only 21% of those with problematic gambling seek treatment. CBT over the Internet might be one way to reach a larger population. The aim of this study was to assess the effectiveness of Internet-delivered CBT with therapist guidance compared to an active control treatment. Using a single-blinded design, 71 treatment-seeking gamblers (18-75 years) diagnosed with GD were randomized to 8 weeks of Internet-delivered CBT guided by telephone support, or 8 weeks of Internet-delivered motivational enhancement paired with motivational interviewing via telephone (IMI). The primary outcome was gambling symptoms measured at a first face-to-face assessment, baseline (treatment start), every 2 weeks, post-treatment, and 6-month follow-up. Gambling expenditures, time spent gambling, depression, anxiety, cognitive distortions, and quality of life were assessed as secondary outcomes. Analysis was performed on the full analysis sample (n = 60), with intention-to-treat sensitivity analyses (n = 69). In the CBT group, 80% stayed in treatment until the final week, compared to 67% in IMI. Post-treatment and at 6-month follow-up, no differences were found between CBT and IMI for any outcome measure. An exploratory analysis of the total sample (n = 60) showed a significant effect of time during treatment on gambling symptoms (d, [95% CI] 0.52, [-1.15, 2.02]) and all secondary outcomes except the gambling diary (depression (0.89, [-1.07-2.65]); anxiety (0.69, [-1.20-2.38])); cognitive distortions (0.84, [-0.73-2.29]); quality of life (0.60, [-0.61-1.70])). Post-treatment, there were no clinical gambling symptoms in either group. Some deterioration was seen between post-treatment and 6-month follow-up on gambling symptoms (0.42, [-1.74-2.43]), depression (0.59, [-0.82-1.86]), and anxiety (0.30, [-0.99-1.48]). Additionally, it was observed that the largest reduction in gambling symptoms was between the first assessment and baseline. Both treatments offered in this study were effective at reducing gambling symptoms. It is also possible that the process of change started before treatment, which gives promise to low-intensity interventions for GD. Additional research is needed as this approach could be both cost-effective and has the potential to reach more patients in need of treatment than is currently possible. https://www.isrctn.com/, identifier ISRCTN38692394.

Reducing fear and avoidance of memory loss improves mood and social engagement in community-based older adults: a randomized trial

BackgroundAlzheimer’s disease and related dementias (ADRD) are among the most feared age-related conditions. The aim of this study was to evaluate a brief psychological intervention to promote adaptive coping in older adults experiencing heightened fear of ADRD and investigate positive downstream effects on health-related secondary outcomes, including frequency of reported memory failures, psychosocial functioning, and quality of life.MethodsEighty-one older adults were recruited and randomized into REFRAME or active control intervention arms. Both groups received psycho-education and training in mindful monitoring of fears related to ADRD. The REFRAME group received an additional behavioral activation component intended to disrupt maladaptive avoidant coping (i.e., avoidance) strategies. Both groups completed 3-weeks of intervention exercises with accompanying questionnaires (baseline, mid- and post-intervention and 4-week follow-up).ResultsAdherence was strong (> 75%). We observed a significant reduction in ADRD-related fear and avoidance in both groups. Significant reductions were also observed for frequency of self-reported memory failures, anxiety, and depression. Depression was significantly reduced in the REFRAME group compared to the control group. Significant increases in participants’ ability to participate in social activities and well-being were also observed.ConclusionsFindings suggest that a brief psychological intervention can mitigate ADRD-related fears and avoidant coping in older adults, and that benefits extend to broader health-related outcomes including anxiety, depression, social functioning, and well-being. Addressing ADRD-related fear has implications for healthy aging and risk reduction, as individuals may be more likely to engage in activities that are protective against ADRD but were previously avoided.Trial registration: https://clinicaltrials.gov/ct2/show/NCT04821960.

Efficacy and safety of perioperative ketamine for the prevention of chronic postsurgical pain: A meta-analysis.

Assessment of the efficacy and safety of perioperative intravenous ketamine in reducing incidence and severity of chronic postsurgical pain. A systematic review and meta-analysis of randomized controlled trials (RCTs). The following data sources were systematically searched: MEDLINE, CENTRAL, and EMBASE (till 02/2021). Adult patients undergoing any surgery. Perioperative use of intravenous ketamine as an additive analgesic drug compared to placebo, no active control treatment, and other additive drugs. Primary outcomes were number of patients with chronic postsurgical pain after 6 months and ketamine related adverse effects. Secondary outcomes were chronic postsurgical pain incidence after 3 and 12 months, chronic postsurgical neuropathic pain incidence, chronic postsurgical moderate to severe pain incidence, intensity of chronic postsurgical pain at rest, and during movement, oral morphine consumption after 3, 6, and 12 months and incidence of opioid-related adverse effects. Thirty-six RCTs were included with a total of 3572 patients. Ketamine compared to placebo may result in no difference in the number of patients with chronic postsurgical pain after 6 months (risk ratio (RR) 0.86, 95% confidence interval (CI) 0.71-1.05; I2 = 34%; 16 studies; low-certainty evidence). Ketamine may reduce the incidence of chronic postsurgical neuropathic pain after 3 months in comparison to placebo (RR 0.78, 95% CI 0.62-0.99, I2 = 31%, seven trials, low-certainty evidence). Ketamine compared to placebo may increase the risk for postoperative nystagmus (RR 9.04, 95% CI 1.15-70.90, I2 30%, two trials, low-certainty evidence) and postoperative visual disturbances (RR 2.29, 95% CI 1.05-4.99, I2 10%, seven trials, low-certainty evidence). There is low-certainty evidence that perioperative ketamine has no effect on chronic postsurgical pain in adult patients. Low-certainty evidence suggests that ketamine compared to placebo may reduce incidence of chronic postsurgical neuropathic pain after 3 months. Questions like ideal dosing, treatment duration and more patient-related outcome measures remain unanswered, which warrants further studies. Prospero CRD42021223625, 07.01.2021.

Mindfulness-based therapy improves brain functional network reconfiguration efficiency

Mindfulness-based interventions are showing increasing promise as a treatment for psychological disorders, with improvements in cognition and emotion regulation after intervention. Understanding the changes in functional brain activity and neural plasticity that underlie these benefits from mindfulness interventions is thus of interest in current neuroimaging research. Previous studies have found functional brain changes during resting and task states to be associated with mindfulness both cross-sectionally and longitudinally, particularly in the executive control, default mode and salience networks. However, limited research has combined information from rest and task to study mindfulness-related functional changes in the brain, particularly in the context of intervention studies with active controls. Recent work has found that the reconfiguration efficiency of brain activity patterns between rest and task states is behaviorally relevant in healthy young adults. Thus, we applied this measure to investigate how mindfulness intervention changed functional reconfiguration between rest and a breath-counting task in elderly participants with self-reported sleep difficulties. Improving on previous longitudinal designs, we compared the intervention effects of a mindfulness-based therapy to an active control (sleep hygiene) intervention. We found that mindfulness intervention improved self-reported mindfulness measures and brain functional reconfiguration efficiency in the executive control, default mode and salience networks, though the brain and behavioral changes were not associated with each other. Our findings suggest that neuroplasticity may be induced through regular mindfulness practice, thus bringing the intrinsic functional configuration in participants’ brains closer to a state required for mindful awareness.

Evaluating the feasibility and exploring the efficacy of an emotion-based approach-avoidance modification training (eAAMT) in the context of perceived stress in an adult sample — protocol of a parallel randomized controlled pilot study

BackgroundStress levels and thus the risk of developing related physical and mental health conditions are rising worldwide. Dysfunctional beliefs contribute to the development of stress. Potentially, such beliefs can be modified with approach-avoidance modification trainings (AAMT). As previous research indicates that effects of AAMTs are small, there is a need for innovative ways of increasing the efficacy of these interventions. For this purpose, we aim to evaluate the feasibility of the intervention and study design and explore the efficacy of an innovative emotion-based AAMT version (eAAMT) that uses the display of emotions to move stress-inducing beliefs away from and draw stress-reducing beliefs towards oneself.MethodsWe will conduct a parallel randomized controlled pilot study at the Friedrich-Alexander-Universität Erlangen-Nürnberg, Germany. Individuals with elevated stress levels will be randomized to one of eight study conditions (n = 10 per condition) — one of six variants of the eAAMT, an active control intervention (swipe-based AAMT), or an inactive control condition. Participants in the intervention groups will engage in four sessions of 20–30 min (e)AAMT training on consecutive days. Participants in the inactive control condition will complete the assessments via an online tool. Non-blinded assessments will be taken directly before and after the training and 1 week after training completion. The primary outcome will be perceived stress. Secondary outcomes will be dysfunctional beliefs, symptoms of depression, emotion regulation skills, and physiological stress measures. We will compute effect sizes and conduct mixed ANOVAs to explore differences in change in outcomes between the eAAMT and control conditions.DiscussionThe study will provide valuable information to improve the intervention and study design. Moreover, if shown to be effective, the approach can be used as an automated smartphone-based intervention. Future research needs to identify target groups benefitting from this intervention utilized either as stand-alone treatment or an add-on intervention that is combined with other evidence-based treatments.Trial registrationThe trial has been registered in the German Clinical Trials Register (Deutsches Register Klinischer Studien; DRKS00023007; September 7, 2020).

Biomechanical effect of neurologic dance training (NDT) for breast cancer survivors with chemotherapy-induced neuropathy: study protocol for a randomized controlled trial and preliminary baseline data

BackgroundBreast cancer (BC) is among the most common forms of cancer experienced by women. Up to 80% of BC survivors treated with chemotherapy experience chemotherapy-induced neuropathy (CIN), which degrades motor control, sensory function, and quality of life. CIN symptoms include numbness, tingling, and/or burning sensations in the extremities; deficits in neuromotor control; and increased fall risk. Physical activity (PA) and music-based medicine (MBM) are promising avenues to address sensorimotor symptoms. Therefore, we propose that we can combine the effects of music- and PA-based medicine through neurologic dance training (NDT) through partnered Adapted Tango (NDT-Tango). We will assess the intervention effect of NDT-Tango v. home exercise (HEX) intervention on biomechanically-measured variables. We hypothesize that 8 weeks of NDT-Tango practice will improve the dynamics of posture and gait more than 8 weeks of HEX.MethodsIn a single-center, prospective, two-arm randomized controlled clinical trial, participants are randomly assigned (1:1 ratio) to the NDT-Tango experimental or the HEX active control intervention group. Primary endpoints are change from baseline to after intervention in posture and gait. Outcomes are collected at baseline, midpoint, post, 1-month follow-up, and 6-month follow-up. Secondary and tertiary outcomes include clinical and biomechanical tests of function and questionnaires used to compliment primary outcome measures. Linear mixed models will be used to model changes in postural, biomechanical, and PROs. The primary estimand will be the contrast representing the difference in mean change in outcome measure from baseline to week 8 between treatment groups.DiscussionThe scientific premise of this study is that NDT-Tango stands to achieve more gains than PA practice alone through combining PA with MBM and social engagement. Our findings may lead to a safe non-pharmacologic intervention that improves CIN-related deficits.Trial registrationThis trial was first posted on 11/09/21 at ClinicalTrials.gov under the identifier NCT05114005.

Özgül Fobilerin Tedavisinde Tek Seans Sanal Gerçeklikle Maruz Bırakmanın Etkinliği

The present study endeavors to evaluate the therapeutic efficacy of a singular session of virtual reality (VR) exposure therapy for treating specific phobias. A total of 33 individuals with clinically diagnosed specific phobias were allocated into either a treatment group (N=16) or a waiting list control group (N=17). Measurement instruments included the Demographic Information Form, the DSM-5 Severity Measure for Specific Phobia Scale, and the Self-Reported Anxiety Measure. In terms of statistical analyses, a mixed-design analysis of variance (ANOVA) was utilized to examine both within-group and between-group differences over time, effectively allowing for a more comprehensive understanding of the treatment's impact. Results demonstrated a statistically significant reduction in the severity of phobia symptoms in the treatment group compared to the control group (p &lt; .05). The therapeutic gains were maintained during a three-month follow-up assessment, with associated levels of anxiety and panic also showing a significant reduction in the treatment group (p &lt; .01). This study corroborates the clinical efficacy of a single VR exposure session for the amelioration of specific phobias. The gains were not only immediate but also durable over a follow-up period, substantiating the longer-term effectiveness of this treatment modality. Despite certain limitations, such as the absence of active control treatments and a somewhat homogeneous sample demographic, the findings make a significant contribution to the extant literature. The study serves as an important foundation for future research that aims to broaden the applicability and understanding of VR-based therapeutic interventions for specific phobias.

Clinic-based interventions to increase preexposure prophylaxis awareness and uptake among United States patients attending an obstetrics and gynecology clinic in Baltimore, Maryland

Cisgender women account for one of every five new U.S. HIV diagnoses, with the majority (86%) attributed to heterosexual contact. HIV pre-exposure prophylaxis (PrEP) is an effective prevention strategy; however, PrEP awareness and prescriptions among women are low. Our objective was to increase PrEP counseling and uptake among cisgender women attending obstetrics/gynecology (OB/GYN) clinics. The study included three OB/GYN clinics within a single health system in a high HIV prevalence region. There were three phases: baseline (three-month period before the clinical trial that included provider education and training of a registered nurse about PrEP [PrEP-RN]), clinical trial (three-month period during which eligible patients were randomized to an active control or PrEP-RN intervention), and maintenance (three-month period after the trial ended). Electronic medical record (EMR) clinical decision support tools (CSTs) were available to both arms during the clinical trial, which included best practice alerts (BPAs), order sets, progress note templates, and written and video PrEP educational materials for patients. In the intervention arm, a PrEP-nurse contacted and counseled patients, and was equipped to prescribe PrEP. We evaluated the phases through the RE-AIM framework (Reach-Effectiveness-Adoption-Implementation-Maintenance). The primary outcome of the study was effectiveness (e.g., percentage of eligible patients with documented HIV prevention counseling in the EMR or PrEP prescriptions). Secondary outcomes included reach (e.g., percentage of BPAs that providers acted upon or the percentage of eligible patients who spoke with the PrEP-RN), adoption (e.g., percentage of eligible patients with a BPA that triggered or the percentage of eligible patients the PrEP-RN attempted to contact), and maintenance (e.g., percentage of patients with documented HIV prevention counseling or PrEP prescriptions during the maintenance phase). There were 904 unique patients in all phases with a mean age of 28.8+/-7.7 years, and 46% were pregnant; 436 patients were randomized in the clinical trial phase. Reach/Adoption: BPAs were triggered for 100% of eligible encounters; however, providers acted on 52% of them. The PrEP nurse attempted to contact every patient and successfully spoke with 81.2% of them in the PrEP-RN arm. Compared to the active control, there were significantly more patients counseled about PrEP in the PrEP-RN group (66.5% vs. 12.3%, p<0.001), while PrEP prescriptions were equivalent (p=1.0). Among the subgroup of patients who were counseled about PrEP, 18.5% of patients in the active control and 3.4% in the PrEP-RN arm were prescribed PrEP (p=0.02). Maintenance: CSTs alone resulted in PrEP counseling of 1.0% of patients during the maintenance phase versus 0.6% during baseline and 11.2% during the clinical trial (p<0.001). PrEP prescriptions were not statistically different between the three phases (p=0.096). A PrEP nurse effectively increased HIV prevention discussions but did not lead to more PrEP prescriptions than the PrEP-focused CSTs used by providers. The decrease in PrEP counseling following the trial phase suggests that persistent interventions are needed to maintain effects.

Effectiveness of an app-based intervention to improve well-being through cultivating positive thinking and positive emotions in an adult sample: study protocol for a randomized controlled trial.

Interventions to promote health and well-being based on the construction of psychological resources can positively impact the daily life of users and foster human flourishing. Nowadays, mobile health represents a safe way to support health research and implement evidence-based psychological interventions. The present study aims to evaluate the effectiveness of a mobile app-based intervention program (OneUS) designed to cultivate positive emotions and positive thinking to improve overall well-being. The study is designed as a randomized controlled trial. Two hundred participants will be randomly assigned to either a mobile health intervention condition (OneUS App) or an active control condition. The intervention consists of a program to cultivate positive emotions and positive thoughts. The active control intervention will comprise a set of mental imagery exercises and daily routine recording. The primary outcome comprises optimal well-being assessed using the multidimensional PERMA-Profiler scale. The sample will include adult people from the general population, who will be assessed at 8 time points: baseline (t1), intervention (t2, t3, t4, t5, t6) post-intervention (t7) and 3-month follow-up (t8). Mobile apps seem to be promising tools to promote health and well-being. This study will evaluate the effectiveness of a mobile app (OneUS) aiming to cultivate positive emotions and positive thinking to improve well-being. The main strength of this study is the development of an evidence-based mobile health app, based on intentional mental training, to promote well-being. The limitations of this study relate to potential participant drop-out and the non-generalizability of the results to clinical populations. https://ensaiosclinicos.gov.br/rg/RBR-43hpwqk, Identifier RBR-43hpwqk.

Internet delivered cognitive behavioral therapy for adults with ADHD - A randomized controlled trial

Evidence-based psychological interventions for adults with attention deficit hyperactivity disorder (ADHD) are seldom available in clinical settings. Medication is often offered as the sole treatment, with non-optimal effects for a majority of patients. The objective was to compare internet-based cognitive behavioral therapy (iCBT) to an active control treatment of internet-based applied relaxation training (iART), and to treatment as usual only (TAU) in adult outpatients with ADHD.One hundred and four patients, of which 67 % used ADHD medication, were randomized to 12 weeks of iCBT (n = 36), iART (n = 37), or TAU (n = 31). Primary outcome was change in the Adult ADHD Self Report Scale (ASRS) up to 3 (FU3) and 12 months (FU12) after treatment.ASRS improved more for iCBT (p < .01; Cohen's d = 0.42 at post-treatment and 0.67 at FU3) and iART (p < .01; Cohen's d = 0.57 at post-treatment and 0.66 at FU3) than for TAU. The effects sustained over 12 months for iCBT (p < .001) and iART (p < .001). No significant difference was found when comparing iCBT to iART (p = .53).Treatment responders reached 25 % for both treatments, which was superior to the 3 % responders in TAU (p < .05).iCBT and iART could both be promising add-ons to medication and increase availability to psychological treatment with sustained symptom reductions after one year.

0347 CBT-I Leads to Changes in Actigraphy and Sleep Diary-Assessed Sleep Parameters in Veterans with Psychosis and Insomnia

Abstract Introduction Up to 80% of people with psychosis have insomnia. While insomnia worsens psychotic symptoms and functioning, treating insomnia may improve functioning and recovery. Cognitive Behavioral Therapy for Insomnia (CBT-I) is an effective treatment, but there is limited research on CBT-I in people living with psychosis. We developed guidelines and materials for conducting CBT-I with people with psychosis and evaluated actigraphy and sleep diary-measured outcomes in Veterans who participated in an RCT of CBT-I for psychosis. Methods Forty-seven Veterans with insomnia and psychosis were randomized to either CBT-I using novel psychosis-specific guidelines and materials (n=26) or to an active treatment control, the Health and Wellness (HW) intervention (n=21). Participants completed both actigraphy and daily sleep logs for two weeks at baseline, post-treatment, and 3-month follow-up. Results Using a mixed effects model for repeated measures, mean change from baseline at post and follow-up was compared for CBT-I for psychosis and HW. For actigraphy-measured total sleep time (TST) and time in bed (TIB), and diary-measured TIB, there was a significant decrease in these parameters for the CBT-I group relative to an increase for HW at post (t(1082)=-2.41, p=.016, d=-.38; t(1082)=-2.19, p=.029, d=-.44; t(1318)=-3.19, p=.002, d =-.70, respectively) and in diary-measured TIB at follow-up (t(1318)=-1.97, p=.049, d=-.37. Sleep diary-measured sleep efficiency (SE) increased significantly more in CBT-I than in HW (t(1266)=1.99, p=.047, d=.54) at post. There were no group differences in actigraphy-measured SE, sleep onset latency (SOL), or WASO, or sleep diary-measured TST, SOL, WASO, or number of awakenings at post. There were no other group differences for actigraphy- or diary-measured sleep variables at follow-up, though underpowered due to sample size at the follow-up timepoint. Conclusion Results indicate that CBT-I tailored to the needs of people with psychosis can change several actigraphy- and diary-assessed common sleep variables of interest--TST, TIB, and SE. CBT-I for psychosis should be further investigated with a larger randomized controlled trial over a longer time period. Support (if any) Time supported by U.S. Department of Veterans Affairs, RR&amp;D-1IK2RX001836, PI: Elizabeth A. Klingaman.

0711 Health-Economic Implications of Tonic Motor Activation (TOMAC) therapy for RLS: An Exploratory Analysis based on the RESTFUL study

Abstract Introduction Restless legs syndrome (RLS) is a debilitating condition associated with reduced health-related quality of life (HRQoL) and increased resource utilization. Recently, the RESTFUL study demonstrated significant improvement in RLS severity following treatment with a novel non-invasive neuromodulation treatment (Tonic Motor Activation; TOMAC). Our objective was to provide model-based estimates of quality-adjusted life year (QALY) gain and reduction in healthcare utilization that might be expected for the observed changes in symptom severity. Methods The RESTFUL study randomized n=133 subjects 1:1 to active TOMAC treatment and sham control, with change in International Restless Legs Scale (IRLS) scores reported at four weeks at the end of the randomization period. Functional relationships between IRLS and HRQoL and resource utilization were derived from two prior health-economic studies (Happe et al. 2009 and Durgin et al. 2015). Model-projected quality-adjusted life year (QALY) gain and events avoided at a five-year analysis horizon were calculated based on assumption of maintained treatment effect. Results From baseline of 25.2, change in IRLS at four weeks was -7.2 for the active and -3.8 for the sham group (between group difference -3.4, p&amp;lt; 0.01). Based on this effect size, TOMAC was projected to add 0.16 QALYs over 5 years (0.39 when considering reduction from baseline). Based on lower symptom severity, TOMAC was projected to avoid 3.80 (8.05) health care provider visits, 0.29 (0.62) ER visits, and 0.12 (0.26) hospitalizations over 5 years, resulting in a relative risk (RR) of composite healthcare utilization of 0.94 (0.88). Conclusion The findings of this exploratory analysis suggest TOMAC-associated improvements in RLS severity as observed in the RESTFUL study may lead to meaningful improvements in patient quality-of-life and concurrent reductions in healthcare utilization. Further investigation is warranted. Support (if any) Wing Tech Inc. (AMR, KNC, JBP) received consulting fees from Noctrix Health. AR is an investigator in the RESTFUL study.

Mindfulness meditation and bimanual coordination control: study of acute effects and the mediating role of cognition.

Mindfulness meditation (MM) involves and benefits cognitive functioning, especially attention and inhibition processes, which are also implicated in the control of complex motor skills, such as bimanual coordination. Thus, MM practice could potentially enhance bimanual coordination control through its cognitive benefits. Accordingly, in this study, we investigated the acute effects of a brief MM session on bimanual coordination dynamics, attention, and inhibition abilities, as well as the mediation link between MM's cognitive and motor improvements. Healthy meditation-naïve (novices, n = 29) and meditation-experienced participants (meditators, n = 26) were randomly assigned to either an active control intervention (attentive listening to a documentary podcast) or a MM intervention (breathing and open monitoring exercise), both lasting 15 min. In the motor domain, pre- and post-tests assessed participants' ability to intentionally maintain the anti-phase coordination pattern at maximal movement frequency and resist the spontaneous transition to the in-phase pattern. In the cognitive domain, the participants' attentional, perceptual inhibition and motor inhibition abilities were assessed. Following both interventions, meditators and novices improved the stability of their anti-phase coordination pattern (p = 0.034, ηp2 = 0.10) and their attentional performance (p's < 0.001, ηp2 > 0.40). Only following the MM intervention, meditators and novices improved their ability to intentionally maintain the anti-phase pattern by delaying or even suppressing the spontaneous transition to in-phase (p's < 0.05, ηp2 ≥ 0.11), and improved concomitantly their motor inhibition scores (p = 0.011, ηp2 = 0.13). No effects were found on perceptual inhibition. The increase in motor inhibition capacities did not however statistically mediate the observed acute effects of MM on bimanual coordination control. We showed that a single MM session may have acute benefits in the motor domain regardless of the familiarity with MM practice. Although these benefits were concomitant to enhanced attentional and motor inhibition abilities, no formal mediation link could be established between the observed motor and cognitive benefits. This study paves the way for the investigation of the mechanisms underlying MM effects on motor control, as well as longer-term benefits.

Transdiagnostic Cognitive Behavioral Group Interventions: A Systematic Review

BackgroundTransdiagnostic cognitive behavioral therapy (tCBT) has presented itself as an intervention proposal that aims to integrate the common processes of human functioning with the therapeutic strategies of conventional cognitive-behavioral therapy, considered the gold standard for treating numerous disorders.ObjectiveAs far as we know, this review is the first to specifically evaluate transdiagnostic cognitive-behavioral interventions in groups. This review aimed to systematically examine the evidence regarding the efficacy of cognitive-behavioral transdiagnostic interventions in groups for the adult population compared to the general interventions or no intervention (control/waiting list).MethodThe report of the systematic review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. PsycINFO, PubMed, and Web of Science databases were searched, obtaining a total of 1,058 records. After applying the inclusion and exclusion criteria, 32 articles, published between 2005 and 2022, were selected. Eligible studies were submitted to the assessment of the potential risk of bias through Cochrane's tool for risk assessment of bias (RoB 2).ResultsThe results suggest that transdiagnostic treatments are superior to waiting list conditions and the common treatments, and are at least as effective as active control interventions and specific cognitive-behavioral treatments for diagnosis.

Autonomic function and inflammation in pregnant women participating in a randomized controlled study of Mindfulness Based Childbirth and Parenting

BackgroundPregnancy and childbirth are significant events in many women’s lives, and the prevalence of depressive symptoms increases during this vulnerable period. Apart from well documented cognitive, affective, and somatic symptoms, stress and depression are associated with physiological changes, such as reduced heart-rate variability (HRV) and activation of the inflammatory response system. Mindfulness Based Interventions may potentially have an effect on both HRV, inflammatory biomarkers, and self-assessed mental health. Therefore, the aim of this study was to assess the effects of a Mindfulness Childbirth and Parenting (MBCP) intervention on HRV, serum inflammatory marker levels, through an RCT study design with an active control group.MethodsThis study is a sub-study of a larger RCT, where significant intervention effects were found on perinatal depression (PND) and perceived stress. Participants were recruited through eight maternity health clinics in Stockholm, Sweden. In this sub-study, we included altogether 80 women with increased risk for PND, and blood samples and HRV measures were available from 60 of the participants (26 in the intervention and 34 in the control group).ResultsParticipants who received MBCP reported a significantly larger reduction in perceived stress and a significantly larger increase in mindfulness, compared to participants who received the active control treatment. However, in this sub-study, the intervention had no significant effect on PND, inflammatory serum markers or measures of HRV.ConclusionsNo significant differences were found regarding changes in HRV measures and biomarkers of inflammation, larger studies may be needed in the future.Trial registrationClinicalTrials.gov ID: NCT02441595. Registered 12 May 2015 - Retrospectively registered.