Wait-list Control Research Articles

Evocation of positive memories as complement to trauma-focused cognitive–behavioural therapy for intimate partner violence against women

ABSTRACT Background: Focusing on positive memories as a complement to trauma-focused interventions for intimate partner violence against women (IPVAW) could contribute to enhancing the recovery from trauma with the development of a more integrated and emotionally modulated autobiographical narrative. Objective: To test the effectiveness of a trauma-focused cognitive behavioural therapy (CBT) tailored for IPVAW that incorporates the evocation of positive memories. Methods: Female survivors of IPVAW entered a randomized controlled trial comparing trauma-focused CBT for IPVAW (CBT; n = 35) to a version that incorporates the evocation of positive memories (CBT-M+; n = 44) and to a waitlist (WL; n = 12) control group. Pre and post measures were obtained for: posttraumatic stress, meaning of trauma, affect, emotional regulation, associated symptoms, self-concept and overall functioning. Results: A total of 43.04% of women who entered treatment dropped out, without significant treatment differences. Pre–post changes were not significant for the WL; both treatments resulted in significant improvements, with good effect sizes, for posttraumatic stress (g = 0.78 and g = 1.00 for CBT and CBT-M+, respectively), meaning of trauma, affect, associated symptoms, self-concept and overall functioning, but not in emotional regulation. There were no significant differences between CBT and CBT-M+ in the direct comparisons; however, the effect sizes showed better effects of CBT for centrality of the IPVAW, whereas they favoured CBT-M+ for PTSD, depression, self-esteem and impairment measures. No clinically significant change was reached for the WL, while both treatments significantly reduced the percentage of women with PTSD and self-esteem problems; additionally, the percentage of women with depression and impairment problems in the CBT-M+ group was significantly decreased. Conclusions: Although there were few differences between both treatments, CBT-M+ seemed to have a greater effect, pointing to the potential of the inclusion of the evocation of positive memories that should be further researched.

Results of a Randomized Wait-List Controlled Trial of CAYA: A Nurse Case Management HIV Prevention Intervention for Youth Experiencing Homelessness

Abstract Youth experiencing homelessness (YEH) face challenges that increase their susceptibility to HIV/STIs. Nurse case management is effective in managing the complex needs of populations experiencing homelessness and reducing HIV risk. A randomized wait-list control study conducted between September 2019 to May 2023 evaluated the CAYA “Come As You Are” intervention. This nurse-led HIV prevention for YEH aged 16–25 years focused on the uptake of HIV prevention methods: pre- and post-HIV exposure prophylaxis (PrEP, nPEP), HIV/STI testing and treatment, sober sex, and condom use. Secondarily, we examined intervention impact on housing stability. Descriptive statistics were calculated by study arm. Multiple imputation (m = 10) was used for missing values and intervention effects were estimated from Bayesian multilevel models with noninformative priors. Participants (N = 450) were 21.1 years old on average, 62% Black, 11% Hispanic, 11% White, and 10% other race and reported being homeless for an average of 3 years. An intervention effect was found for PrEP use, which showed a larger increase from baseline to first follow-up (OR = 3.27; 95% Cr.I.: 1.13 to 10.14). No intervention impact was found for nPEP use, HIV and STI cases, sober sex, or condom use. Sheltering arrangements improved from baseline to the first follow-up in both groups with increase in shelter stability (OR = 3.85; 95% Cr.I.: 1.61 to 10.30) and decreased shelter transiency (OR = 0.29; 95% Cr.I.: 0.14 to 0.60). This study demonstrates that a personalized, nurse-led HIV prevention approach increased uptake of some but not all HIV prevention strategies among YEH. Clinical Trial Registration number NCT03910218.

An online, father‐inclusive parenting intervention for reducing child conduct problems: a randomised controlled trial of family man

BackgroundParenting interventions are effective for improving child conduct problems (CPs), but online self‐directed interventions are required to improve reach and impact. Mothers are the main users of such programmes; fathers show low participation rates despite evidence of increased efficacy when they participate.MethodsThis randomised controlled trial examined the efficacy of Family Man, a brief, self‐directed online parenting intervention for fathers and mothers of children with CPs. The intervention involves several innovative design features to maximise the engagement of fathers. Families (N = 103; 102 mothers, 78 fathers) seeking help with managing their 2‐ to 8‐year‐old child's CPs were randomly assigned to either the Family Man intervention condition (n = 53) or a 4‐week waitlist control group (n = 50). Primary outcomes were frequency and severity of child CPs and secondary outcomes included dysfunctional parenting, parenting efficacy, parenting stress, parental psychological distress, household disorganisation and interparental conflict.ResultsRepeated measures ANOVAs/MANOVAs found that at 4‐week post‐assessment, parents in the intervention group reported significantly lower levels of child CPs than waitlist. Significant effects for the intervention group relative to waitlist were also found across all secondary outcomes examined. Intervention effects were maintained at 2‐month follow‐up for the intervention group. Outcomes did not significantly differ for mothers and fathers.ConclusionsResults support the efficacy of this brief, self‐directed online parenting intervention in improving child CPs and a range of parent and family outcomes, both for fathers and mothers. Implications for improving the reach and impact of parenting interventions and increasing father engagement, are discussed.

A live online exercise program for older adults improves depression and life-space mobility: A mixed-methods pilot randomized controlled trial

Background Aging is the primary risk factor for sarcopenia and mobility limitations. Exercise reduces these risks, but older adults have low levels of participation in physical activity and exercise. We investigated the preliminary effectiveness of a live, online exercise program on community-dwelling older adults’ physical activity levels. Methods A mixed-method pilot randomized controlled trial was conducted according to CONSORT 2010 statement: extension for pilot and feasibility trials. Sedentary older adults (65–80 years) were randomly assigned to the online exercise intervention (ACTIVE) or a waitlist control (CON) group. Outcomes were measured pre-randomization and following the 8-week intervention for ACTIVE and CON and two months following the end of the intervention for the ACTIVE group. Outcomes included habitual physical activity levels, depression, anxiety, loneliness, life-space mobility, nutrition risk, and feasibility. All participants were invited to participate post-intervention in individual semi-structured qualitative interviews. Reporting of the qualitative research followed the checklist for the Consolidated Criteria for Reporting research. Results Seventeen older adults (71% women) were allocated to ACTIVE group, while 15 were allocated to CON group (87% women). Following the intervention, participants in the ACTIVE group reported reduced symptoms of depression (ACTIVE: pre = 4.2 ± 2.5; post = 2.2 ± 1.9; CON: pre = 3.5 ± 2.1, post = 3.5 ± 2.1; p <0.001) and improved life-space mobility (ACTIVE: pre = 62.4 ± 14.7; post = 71.8 ± 16.0; CON: pre = 65.1 ± 19.0, post = 63.6 ± 22.0; p = 0.003) compared to waitlist control participants. The ACTIVE group had good adherence (97%) and acceptability (98%). Twenty-two participants participated in qualitative interviews. Five themes were identified, including (1) Feasibility of the online exercise program; (2) Perceived health benefits and improvements; (3) Registered Kinesiologists and Physiotherapists contributed to perceived safety; (4) Social connectivity associated with synchronous/live delivery; and (5) Growing old gracefully and preventing disability. Conclusions Our online exercise program was acceptable to older adults, had good adherence, reduced depression, and increased life space. Participants reported improved functional and mental health benefits. Further research is warranted to expand on these findings. Trial registration NCT04627493; 13/11/2020.

A Randomized Feasibility Study of Rehabilitation Targeting Upper Extremity Function and Participation Using Hippotherapy and the Equine Environment for Children with Cerebral Palsy and Autism Spectrum Disorder.

Introduction: Children with upper extremity neuromotor impairments often have decreased participation in life activities. Hippotherapy and rehabilitation in the equine environment might be effective in targeting participation, given the community context and natural activity involvement. This randomized controlled feasibility trial assessed recruitment, retention, treatment fidelity, and acceptability of rehabilitation using hippotherapy and the equine environment, targeting upper extremity function and participation for children with neuromotor impairments to inform a larger trial. Methods: This 6-month trial occurred in Ohio, June-December 2021. Participants were 6-17 years old with upper extremity neuromotor impairment (and primary diagnosis of cerebral palsy and/or autism). Participants were randomized into treatment or waitlist control using REDCap. Treatment was 16 h (4 h/week/4 weeks) of rehabilitation using hippotherapy and the equine environment. Control participants completed a 4-week waiting period, then received the treatment. Recruitment, screening, enrollment, attendance, and retention were tracked. Nonblinded assessments of body structures and functions, activity, and participation were administered pre- and postcontrol and treatment. Assessment measure completion, treatment fidelity, and acceptability were recorded. Results: Twenty-six participants were screened between July and October 2021; 77% (20/26) met inclusion criteria; 70% (14/20) enrolled and randomized: 6 control and 8 treatment. Two withdrew after randomization and one was excluded for fear of horses. In total, n = 5 control and n = 6 treatment completed initial assessment. Retention was 80% (4/5) control and 83% (5/6) treatment, just below the a priori criteria (85%). Assessment measure completion was variable (77%-100%) and replacement of some should be considered before advancing to a clinical trial. Treatment fidelity and acceptability were moderate to high. There were no adverse events from study participation. Conclusions: Results demonstrated preliminary evidence of fidelity and acceptability of rehabilitation using hippotherapy and the equine environment for children with upper extremity neuromotor impairments. Some changes should be made to improve enrollment, retention, and outcome measure completion before advancing to a definitive trial. Trial registration: ClinicalTrials.gov identifier: NCT0653068. Trial funding: Eunice Kennedy Shriver National Institute of Child Health and Human Development, Foundation for Physical Therapy Research, American Academy of Cerebral Palsy and Developmental Medicine, and Pedal With Pete Foundation.

Deliberate Practice with Motivational Interviewing: Basic Listening Skills for Undergraduates

Background Training in professional psychology is moving beyond knowledge-based education and toward competency-based education. Similarly, experiential learning, focused more on skills than facts, is emphasized in undergraduate education. Few studies, however, have investigated the use of skill-based learning for clinically relevant skills in undergraduate psychology courses. Objective This study investigated deliberate practice as a skill-based method for training undergraduates to use basic Motivational Interviewing and reflective listening skills. Method In an upper-level undergraduate clinical psychology course, students were randomly assigned to an MI workshop that included deliberate practice to learn basic reflective listening skills or a waitlist control group. Results In both between (workshop versus waitlist) and within (pre versus post) group comparisons, students’ ability to use reflective listening improved as evaluated by raters, blind to condition, and in self-report measures of MI knowledge and skill. Conclusion Deliberate practice may be effectively incorporated into undergraduate courses to prepare novice helpers with basic listening skills. Teaching Implications Competency-based training in listening skills may help undergraduate students prepare for graduate school in the helping professions or any of multiple post-graduation professions not requiring professional training and licensure.

Facilitating Thought Progression to Reduce Depressive Symptoms: Randomized Controlled Trial.

The constant rise in the prevalence of major depressive disorder calls for new, effective, and accessible interventions that can rapidly and effectively reach a wide range of audiences. Recent developments in the digital health domain suggest that dedicated online platforms may potentially address this gap. Focusing on targeting ruminative thought, a major symptomatic hallmark of depression, in this study we hypothesized that delivering a digital health-based intervention designed to systematically facilitate thought progression would substantially alleviate depression. The study aims to investigate the efficacy of a novel digital intervention on the reduction of depressive symptoms. This intervention was designed as an easy-to-use gamified app specifically aimed to facilitate thought progression through intense practicing of associative, semantically broad, fast, and creative thought patterns. A randomized clinical trial was conducted, comparing changes in depression symptoms between participants who used the app in the intervention group (n=74) and waitlist control group (n=27) over the course of 8 weeks. All participants filled out a battery of clinical questionnaires to assess the severity of depression at baseline and 4 and 8 weeks after starting the study. These primarily included the Montgomery-Åsberg Depression Rating Scale (MADRS) and the Patient Health Questionnaire-9 as well as the Positive Affect Negative Affect Scale-Negative Affect Score, Ruminative Response Scale, and Symptoms of Depression Questionnaire. Additional questionnaires were implemented to assess anxiety, positive affect, anhedonia, and quality of life. The results indicate that across multiple clinical measurements, participants in the intervention group who played the gamified app showed greater and faster improvement in depressive symptoms compared with their waitlist control counterparts. The difference between the groups in MADRS improvement was -7.01 points (95% CI -10.72 to -3.29; P<.001; Cohen d=0.67). Furthermore, the difference in improvement between groups persisted up to 4 weeks posttrial (MADRS differences at week 12: F49,2=6.62; P=.003; ηp2=0.21). At the end of the trial, participants who played the app showed high interest in continuing using the app. The results demonstrate that a gamified app designed to facilitate thought progression is associated with improvement in depressive symptoms. Given its innovative and accessibility features, this gamified method aiming to facilitate thought progression may successfully complement traditional treatments for depression in the future, providing a safe and impactful way to enhance the lives of individuals experiencing depression and anxiety. ClinicalTrials.gov NCT05685758; https://clinicaltrials.gov/study/NCT05685758.

Changes in Resting-State Functional Connectivity and Cognitive-Affective Symptoms in Patients With Post-Concussion Syndrome Treated With N-Acetyl Cysteine

Objective: Concussion accounts for more than 80% of people experiencing traumatic brain injury. Acute concussion is associated with characteristic cognitive and functional deficits that may persist for weeks to months. A subgroup of these patients (from 10% to 50%) have persistent symptoms referred to as chronic post-concussion syndrome (PCS). There are limited treatment options for these patients and the pathophysiology is poorly understood, though oxidative stress is thought to be a contributing factor. The purpose of this study was to evaluate whether an antioxidant, N-acetylcysteine (NAC), might be beneficial in patients with PCS. Setting: Outpatient medicine center. Participants: Fifty patients with chronic PCS for at least 3 months post injury. Design: The patients with PCS were enrolled in this randomized unblinded clinical trial to receive the antioxidant NAC as a combination of daily oral and weekly intravenous infusions, or assigned to a waitlist control group where they would continue to receive standard of care. Main Measures: Resting-state functional connectivity (FC) magnetic resonance imaging (rsFC-MRI) was performed pre and post either NAC or the waitlist period along with cognitive, emotional, and sensory symptom assessments. Results: The results demonstrated significant (P &lt; .05) improvements in symptoms as determined by the Rivermead Post-Concussion Symptoms Questionnaire, Spielberger State-Trait Anxiety Inventory, and Profile of Mood Scale in the PCS group receiving NAC as compared to patients receiving ongoing standard care. Importantly, there were significant (P&lt; .01) changes in FC in the NAC group, particularly in networks such as the default mode network, salience network, and executive control network. These changes in FC also correlated with improvements in symptoms. Conclusions: In patients with chronic PCS, NAC treatment was associated with significant changes in resting state FC and improvement in a variety of symptoms, particularly cognitive and affective symptoms.

The overestimation of the effect sizes of psychotherapies for depression in waitlist controlled trials: a meta-analytic comparison with usual care controlled trials.

There is considerable evidence that waiting list (WL) control groups overestimate the effect sizes of psychotherapies for depression. It is not clear, however, what are the exact causes for this overestimation. We decided to conduct a meta-analytic study to compare trials on psychotherapy for depression with a WL control group against trials with a care-as-usual (CAU) control group. We used an existing meta-analytic database of randomized trials comparing psychological treatments of adult depression with control groups and selected trials using a WL or a CAU control group. We used subgroup and meta-regression analyses to examine differences in effect sizes between WL and CAU controlled trials. We included 333 randomized controlled trials (472 comparisons; total number participants: 41,480), 141 with a WL and 195 with a CAU control group (3 included both). We found several significant differences between WL and CAU controlled trials (in type of therapy examined, treatment format, recency, target group, recruitment strategy, number of treatment arms and number of depression outcome measures). The overall effect size indicating the difference between treatment and control at post-test for all comparisons was g = 0.77 (95% confidence interval [CI]: 0.71; 0.84) with high heterogeneity (I2 = 84; 95% CI: 82; 85). A highly significant difference was observed between studies with a CAU control group (g = 0.63; 95% CI: 0.55; 0.71; I2 = 85; 95% CI: 83; 86) and studies with a WL (g = 0.95; 95% CI: 0.85; 1.04; I2 = 80; 95% CI: 78; 82; p for difference < 0.001). This difference remained significant in all sensitivity analyses, including a meta-regression analysis in which we adjusted for all differences in characteristics of studies with a WL versus CAU control group. We also found that pre-post effect sizes in WL control conditions (g = 0.37; 95% CI: 0.28; 0.46) were significantly smaller than change within CAU conditions (g = 0.64; 95% CI: 0.50; 0.78). We found few indications that pre-post effect sizes within therapy conditions differed between WL and CAU controlled trials. WL control conditions considerably overestimate the effect sizes of psychological treatments, compared to trials using CAU control conditions. This overestimation is probably caused by a smaller improvement within the WL condition compared to the improvement in the CAU condition. WL control conditions should be avoided in randomized trials examining psychological treatments of adult depression.

The Impact of Cognitive Behavioral Therapy for Insomnia on Neurofilament Light and Phosphorylated Tau in Individuals with a Concussion.

Concussions damage neurologic tissue, increasing release of intercellular proteins including phosphorylated Tau (pTau) and neurofilament light (NfL). Disrupted sleep from a concussion negatively impacts the ability of the glymphatic system to remove cellular waste from the brain. The purpose of this study was to determine if enhancing sleep using Cognitive Behavioral Therapy for Insomnia (CBT-I) impacts pTau and NFL levels following a concussion. This is pre/post intervention analysis of a larger wait-list control study. Participants had their blood sampled pre/post the CBT-I intervention which was analyzed using SIMOA analytics. Paired sampling statistics and linear regression models were used to examine how insomnia severity impacts pTau181 and NfL. Twenty-eight participants were enrolled in this study. Age and baseline protein level were significantly associated with post-intervention protein levels, but post-intervention insomnia severity was not associated with post-intervention protein levels. About 50% of participants that had clinically meaningful change in insomnia and had a reduction in their NfL and pTau181 values. Post-intervention insomnia was not associated with post-intervention NfL or pTau. Yet, on an individual level, ~50% of participants had a clinically meaningful change in insomnia and reduced level of NfL and pTau 18.1. NCT04885205 https://clinicaltrials.gov.

Digital health intervention for children with ADHD to improve mental health intervention, patient experiences, and outcomes: a study protocol

BackgroundAttention Deficit Hyperactivity Disorder (ADHD) is the most prevalent childhood psychiatric condition with profound public health, personal, and family consequences. ADHD requires comprehensive treatment; however, lack of communication and integration across multiple points of care is a substantial barrier to progress. Given the chronic and pervasive challenges associated with ADHD, innovative approaches are crucial. We developed the digital health intervention (DHI)—CoolTaCo [Cool Technology Assisting Co-regulation] to address these critical barriers. CoolTaCo uses Patient-Centered Digital Healthcare Technologies (PC-DHT) to promote co-regulation (child/parent), capture patient data, support efficient healthcare delivery, enhance patient engagement, and facilitate shared decision-making, thereby improving access to timely and targeted mental health intervention for children at significant risk for poor outcomes. The present paper will describe our planned protocol to evaluate the efficacy of CoolTaCo via randomized control trial (RCT).Methods/designWe will recruit 60 children (ages 8–12) with ADHD who will be randomized to either immediate (n = 30) or delayed (n = 30) treatment (i.e., a waitlist control group). Among those randomized to immediate treatment, half will be assigned to DHI (delivered via a smartwatch and smartphone application), the other half to an active control treatment as usual (TAU). Unlike the DHI group, the TAU group will receive the smartwatch with no assigned activities, applications, or interventions on the devices. The intervention period will last 16 weeks; after a participant has been in the delayed treatment group for 16 weeks and has completed the post-waiting period assessment, they will be randomly assigned to either the intervention or active control group. Thus, 30 participants will complete the intervention, and 30 will complete the active control, with half of the total sample completing a waitlist period.DiscussionIndividuals with ADHD have complex needs. Despite improvement in outcomes following cognitive behavioral therapies (CBT) and pharmaceutical treatment, long-term maintenance is a challenge often not addressed by traditional medical approaches, and, as we described, ineffective approaches to information sharing across points of care create further barriers to progress. Our research will fill a significant gap in translating early treatment investments and gains into long-term, sustainable outcomes.This study was registered as a clinic trial at ClinicalTrials.gov (Digital Health Intervention for Children With ADHD, ID# NCT06456372) on 06/13/2024.

Testing the impact of hatha yoga on task switching: a randomized controlled trial

Switching attention between or within tasks is part of the implementation and maintenance of executive control processes and plays an indispensable role in our daily lives: It allows us to perform on distinct tasks and with variable objects, enabling us to adapt to and respond in dynamically changing environments. Here, we tested if yoga could benefit switching of attention between distinct objects of one’s focus (e.g., through practicing switching between one’s own body, feelings, and different postures) in particular and executive control in general. We therefore conducted a randomized controlled trial with 98 participants and a waitlisted control group. In the intervention group, healthy yoga novices practiced Hatha yoga 3x a week, for 8 weeks. We conducted two experiments: A purely behavioral task investigating changes in behavioral costs during switching between attentional control sets (74 participants analyzed), and a modality-switching task focusing on electrophysiology (EEG data of 47 participants analyzed). At the electrophysiological level, frequency-tagging indicated no interventional effect on participants’ ability to switch between the auditory and visual modalities. However, increases in task-related frontocentral theta activity, resulting from the intervention, indicated an ability to increasingly deploy executive resources to the prioritized task when needed. At the behavioral level, our intervention resulted in more efficient holding of target representations in working memory, indicated by decreased mixing costs. Again, however, intervention effects on switching costs were missing. We, thus, conclude that Hatha yoga has a positive influence on executive control, potentially through improvements in working memory rather than directly on switching.Clinical trial registrationclinicaltrials.gov, identifier [NCT05232422].

The effect of trauma-focused therapy on voice-hearing: An experience sampling study.

We aimed to investigate the effect of TFT on voice-hearing in people with PTSD and psychosis using experience sampling method (ESM). A secondary aim was to explore how changes in voice-hearing are related to changes in PTSD. This is an adjunct longitudinal ESM study of a sub-group of participants (N = 39) from a randomised controlled trial that compared TFT to a waiting-list control group. Voice-hearing participants filled in 10 daily voice-hearing-related questionnaires for six consecutive days at baseline and post-treatment at pseudo-random times during the day. PTSD symptom severity was assessed at baseline and post-treatment. Multilevel linear regression was used to test the effect of TFT on voice-hearing and to analyse the relationship between changes in voice-hearing and changes in PTSD. The intention-to-treat analysis showed a significant interaction effect between time and treatment condition (p < .00001) with a small effect size (dppc2 = -0.27), indicating a larger decrease in voice-hearing in the TFT group than in the waiting-list control group. Also, a significant association was observed between changes in PTSD symptoms and changes in voice-hearing (p < .00001). Our findings tentatively suggest that, even when voices are not targeted directly, TFT for PTSD can alleviate distressing voices.

The Effect of Mindfulness-Based Cognitive Therapy on PTSD and Depression Symptoms in Trauma-Exposed Black Adults: Pilot Randomized Controlled Trial Results

Low-income, urban-dwelling Black adults are disproportionately affected by traumatic experiences, posttraumatic stress disorder (PTSD), and depression and encounter inequities in treatment access. In addition to the benefits Mindfulness-Based Cognitive Therapy (MBCT) for depression, there is preliminary evidence of successful symptom reduction in PTSD via MBCT across two prior pilot studies in veterans. Studies examining the effects of MBCT among trauma-exposed Black adults remains limited, and examination of effects across specific PTSD clusters is almost nonexistent. We examined the preliminary efficacy of adapted MBCT versus waitlist control (WLC) on PTSD and depression symptoms in a pilot randomized controlled trial (RCT). Black adults (N = 80; 86.10% women) with repeated trauma exposure, who screened positive for PTSD and depression, were recruited from an urban public hospital and randomized to 8-week adapted MBCT or WLC. Symptoms were measured pretreatment and posttreatment with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) and the Beck Depression Inventory-II (BDI-II). Mixed model analyses were conducted with an intent-to-treat approach, examining change in PTSD and depression scores between MBCT and WLC over time. There was no significant difference in total PTSD and depression symptom change between MBCT and WLC. CAPS-5 avoidance symptoms showed a nominally significant decrease in the MBCT group (F[1, 68.10] = 5.98, p =.017; t[71.60] = 3.61, p <.001). Findings suggest MBCT might be helpful for addressing avoidance symptoms among Black adults with comorbid PTSD and depression. Although lacking power to draw final conclusions about treatment efficacy, this study provides preliminary data suggesting the importance of future fully powered trials.

Effectiveness of Virtual Yoga for Chronic Low Back Pain

Chronic low back pain (CLBP) is a common condition with substantial impact on patients, in the form of physical and emotional suffering; health care costs; productivity; and health care professional burden. Although clinical guidelines recommend use of nonpharmacologic treatments first, such as yoga, there is a gap between guidelines and implementation in clinical practice. To compare the effects of virtual yoga classes vs a wait-list control on CLBP intensity, back-related function, sleep quality, and pain medication use. Single-blinded, 24-week, 2-arm, randomized clinical trial conducted from May 3, 2022, through May 23, 2023, comparing live streamed yoga classes (the yoga now group) with a wait-list control (the yoga later group, in which participants were offered the virtual intervention after the study but without assessments) among adults with CLBP. Adults 18 to 64 years of age with CLBP were recruited from the Cleveland Clinic Employee Health Plan, a large health system self-insured health plan. Inclusion criteria included a mean LBP intensity score of at least 4 on an 11-point numerical rating scale (scores ranged from 0 to 10, with higher scores indicating worse pain) and daily back pain interference about half or more of the days. Twelve consecutive weekly, 60-minute, virtual, live streamed hatha yoga group classes. Coprimary outcomes were mean pain intensity in the previous week on the 11-point numerical rating scale and back-related function as assessed using the 23-point modified Roland Morris Disability Questionnaire ([RMDQ], with higher scores reflecting poorer function) at 12 weeks. Secondary and exploratory outcomes included these measures at 24 weeks, pain medication use, and PROMIS sleep quality assessed using the Sleep Disturbance Short Form 8a, item 1 (scores ranged from 0 to 4, with higher scores reflecting better sleep quality). Analyses followed the intention-to-treat principle. Among 140 participants enrolled (yoga now = 71; yoga later = 69), the mean (SD) age was 47.8 (11.7) years and most were female (113 [80.7%]) and college-educated (103 [73.5%]). Mean (SD) baseline pain intensity (5.7 [1.5]) and RMDQ ([12.1 [4.4]) scores reflected moderate back pain and impairment. At week 12, yoga now compared with yoga later had greater reductions in mean pain intensity (-1.5 [95% CI, -2.2 to -0.7] points; P < .001) and mean RMDQ (-2.8 [95% CI, -4.3 to -1.3] points; P < .001) scores. At 24 weeks, the improvements in pain (mean change, -2.3 [95% CI, -3.1 to -1.6] points; P < .001) and RMDQ (mean change, -4.6 [95% CI, -6.1 to -3.1] points; P < .001) scores were sustained. At 12 weeks, yoga now participants reported 21.4 (95% CI, 5.2-37.6) absolute percentage points less use of any analgesic medication during the past week than yoga later participants and at 24 weeks, 21.2 absolute percentage points (95% CI, 5.2%-37.3%). Improvements in sleep quality were greater for participants in yoga now than among participants in yoga later at 12 weeks (mean change, 0.4 [95% CI, 0.1-0.7] points; P = .008) and 24 weeks (mean change, 0.4 [95% CI, 0.1-0.7] points; P = .005). Results of this randomized clinical trial of 140 adults with CLBP who were members of a large health system self-insured health plan suggest that virtual yoga classes may be a feasible, safe, and effective treatment option. ClinicalTrials.gov Identifier: NCT05319691.

Mobile Heart Rate Variability Biofeedback for Work-Related Stress in Employees and the Influence of Instruction Format (Digital or Live) on Training Outcome: A Non-Randomized Controlled Trial.

Work-related stress is a major health issue in most industrialized countries. Heart rate variability biofeedback (HRV-BfB) can promote resilience and stress coping capacity. Mobile HRV-BfB could contribute to stress prevention in the workplace. Little is known about whether the type of training, with digital or live instruction, has an impact on the training outcome. This study analyzes the psychophysiological effects of four-week workplace resilience training with mobile HRV-BfB and the influence of instruction format (digital or live) on training success. This was a prospective, three-arm, non-randomized controlled trial with parallel group design. 73 employees of a bearing and seal manufacturer (58.9% male, 86.3% full-time employment, 67.1% office workers) attended resilience training with HRV-BfB, live (n = 24) or digital (n = 19) format, or served as waitlist controls (n = 30). HRV-BfB training spanned four weeks. Participants applied resilience techniques to increase HRV using visual biofeedback. Data were collected at baseline (T0), post-intervention (T1), and another four weeks later (T2). Primary outcome measure was the Burnout scale of the Copenhagen Psychosocial Questionnaire (COPSOQ) at T1. Secondary outcome measures included further COPSOQ scales, self-reported sleep quality (Pittsburgh Sleep Quality Index, PSQI), and HRV parameters. Burnout parameters decreased significantly in HRV-BfB and waitlist. The decrease (T0-T1 and T0-T2) showed higher effect sizes in HRV-BfB (Cohen's d: 0.63; 0.69) than in waitlist (d: 0.27; 0.36). Sleep quality improved in HRV-BfB with small effect sizes (no change for waitlist). SDNN (standard deviation of beat-to-beat intervals) increased in HRV-BfB between T0 and T1 (d: 0.23;). In subgroup analysis, digital reached higher effect sizes for improvement in burnout (d: 0.87; 0.92) and sleep quality (d: 0.59; 0.64) than live learning (burnout: d: 0.43; 0.51; sleep quality: d: 0.28; 0.22). HRV-analysis revealed no differences between subgroups. Four-week mobile HRV-BfB resilience training reduced stress and burnout symptoms in employees. No significant differences were found between HRV-BfB digital or live. Hence, companies should choose the approach that fits their company profile or, if possible, offer both formats to accommodate the different needs of employees. However, findings were nonhomogeneous and should be verified by further studies.Trial Registration: ClinicalTrials.gov , NCT04897165, 05/18/2021, retrospectively registered.

Predictors of study dropout in cognitive-behavioural therapy with a trauma focus for post-traumatic stress disorder in adults: An individual participant data meta-analysis

BackgroundAvailable empirical evidence on participant-level factors associated with dropout from psychotherapies for post-traumatic stress disorder (PTSD) is both limited and inconclusive. More comprehensive understanding of the various factors that contribute to study dropout from cognitive-behavioural therapy with a trauma focus (CBT-TF) is crucial for enhancing treatment outcomes.ObjectiveUsing an individual participant data meta-analysis (IPD-MA) design, we examined participant-level predictors of study dropout from CBT-TF interventions for PTSD.MethodsA comprehensive systematic literature search was undertaken to identify randomised controlled trials comparing CBT-TF with waitlist control, treatment-as-usual or another therapy. Academic databases were screened from conception until 11 January 2021. Eligible interventions were required to be individual and in-person delivered. Participants were considered dropouts if they did not complete the post-treatment assessment.FindingsThe systematic literature search identified 81 eligible studies (n=3330). Data were pooled from 25 available CBT-TF studies comprising 823 participants. Overall, 221 (27%) of the 823 dropped out. Of 581 civilians, 133 (23%) dropped out, as did 75 (42%) of 178 military personnel/veterans. Bivariate and multivariate analyses indicated that military personnel/veterans (RR 2.37) had a significantly greater risk of dropout than civilians. Furthermore, the chance of dropping out significantly decreased with advancing age (continuous; RR 0.98).ConclusionsThese findings underscore the risk of premature termination from CBT-TF among younger adults and military veterans/personnel.Clinical implicationUnderstanding predictors can inform the development of retention strategies tailored to at-risk subgroups, enhance engagement, improve adherence and yield better treatment outcomes.

Efficacy of the CARES® Dementia 5-Step Method for Hospitals™ Online Training and Certification Program for hospital staff

The main objective of the current study was to ascertain the efficacy of a newly developed online, video-based dementia training and certification program for hospital staff, the CARES® Dementia 5-Step Method for Hospitals™ Online Training and Certification Program. A parallel randomized waitlist control design was utilized. Participants (N = 272) completed online pre-evaluation measures. Forty-five days after completion of CARES® (treatment) or pre-evaluation measures (control), participants completed a post-evaluation online assessment. Analyses of variance found that participants in the treatment condition indicated greater and statistically significant (p < .001) increases in sense of competence, approaches to dementia, and patient care. The results implied that the CARES® Dementia 5-Step Method for Hospitals™ program could serve as a dynamic resource for hospitals nationwide to update training and share experiences, perspectives, and resources. The inherent scalability of the program regarding its acceptability, feasibility, and potential to incorporate seamlessly into routine workflows and staff training suggests high implementation potential.

E-Learning Modules for the Care of Caregivers of Older Filipinos

As the population ages, so does the challenge to the care of older people with mental health problems. Geriatric syndromes such as delirium, dementia, and depression are amenable to medical management. Beyond care of the patient, however, is care for the caregiver. Behavioral and Psychological symptoms of Dementia (BPSD) such as agitation, aggression, and delusions increase the risk of caregiver stress. This may lead to strain of individual carers and household members, increasing the patient’s risk for poor care, abuse, or institutionalization. Caregiver education and skills training help reduce the level of caregiver stress. These are usually delivered face to face during clinic visits or training modules by dementia care professionals. However, remote alternatives for education, learning and counselling became essential during the COVID-19 pandemic. E-workbooks and online learning modules on dementia, delirium, and depression written by professionals in the Philippines and Asia Pacific are available. An example is the Dementia Community Toolkit in English and its Filipino adaptation. The latter was developed by the Institute on Aging, National Institutes of Health, University of the Philippines Manila, with support from the Mental Health Unit of WHO WPRO. Patient support groups such as the Alzheimer’s Disease Association of the Philippines likewise developed online learning materials. These were and are still freely available via their websites and the webinars have been uploaded in internet and social media sites. The efficacy and acceptability of remote education to reduce informal caregiver burden, negative mood, and quality of life was published in a Cochrane meta-analysis. The authors analyzed experimental trials on information, training, or support compared to usual treatment, waitlist, or attention controls. Following several eligibility criteria, they identified 26 studies with 2367 participants in their review. Although most studies were of low quality and had uncertain risks of bias, there was small evidence that training plus support modules resulted in an improvement of caregiver knowledge. Training alone had no benefit on knowledge. Furthermore, there was no significant effect on patient institutionalization, caregiver burden depression, or quality of life. The article on E-Learning on knowledge on the 3Ds of Geriatric Psychiatry is a good start in understanding the capacity of well-educated Filipino caregivers to improve their knowledge on the subject. Beyond individual knowledge, E-learning modules have the capacity to guide families and communities in reducing ageism and improve patient care for older people with dementia, depression, and delirium. Further experimental studies are needed using locally developed modules. The bigger challenge is accessibility and acceptability of remote learning materials for the greater majority of informal caregivers with lower levels of education and poor access to online resources.

Implementing a stabilizing intervention for traumatized refugees in temporary accommodations in South-West Germany - a randomized controlled pilot trial

The prevalence of trauma-related disorders, such as post-traumatic stress disorder (PTSD), as well as depressive or anxiety disorders, are significantly increased in refugees compared to the general population. This is due to the high risk of burdening and potentially traumatic experiences before, during and after their flight. However, the treatment options for these mental illnesses are significantly limited due to the legal uncertainties surrounding the asylum procedure as well as language and cultural barriers. In this study, a randomized controlled pilot trial was conducted to assess the effectiveness of self-applied audio-based mindfulness and guided imagery techniques for refugees with symptoms of post-traumatic stress disorder living in temporary accommodations. The symptom burden of PTSD, depression, and anxiety symptoms, as well as perceived stress and emotional state was assessed using the PC-PTSD-5, PHQ-4, Self-Assessment Manikin, and Stress Thermometer. N=32 refugees were included in the intervention study, n=24 participants completed the study. The audio-based mindfulness and guided imagery techniques were presented to n =17 refugees in the intervention group between T1 and T2 over 4 weeks; n=15 refugees from the waiting list control group received the audio-files 6 weeks after follow-up. Efficacy was evaluated using a mixed analysis of variance. There were no significant changes in the symptoms of post-traumatic stress disorder, depression and anxiety disorder. Moreover, no changes were observed in the level of perceived stress or emotional state. Only few participants used the exercises in self-administered application during the study period. This was mainly due to the stressors of the post-migratory phase, such as job search or worries about residence status. Due to the self-administered nature of the intervention, common factors, such as therapeutic alliance or expectations regarding the intervention’s effectiveness, had minimal influence and did not contribute to the sustained use of the exercises. Additionally, regarding the life circumstances of refugees in temporary shelters, the intervention intensity may not have been sufficient to have a significant impact on the examined symptom burden. Small sample size and limited use of the exercises limit the reliability of the results.Clinical trial registrationhttps://drks.de/search/de/trial/DRKS00022862 Deutsches Register Klinischer Studien identifier, DRKS00022862.