Education Control Condition Research Articles

Multi-domain Online Therapeutic Investigation Of Neurocognition (MOTION) - A randomized comparative-effectiveness study of two remotely delivered mind-body interventions for older adults with cognitive decline.

Research suggest that mind-body movement programs have beneficial effects on cognitive outcomes for older adults with cognitive decline. However, few studies have directly compared specific approaches to mind-body movement or studied the impact of remote program delivery. In a 3-arm randomized controlled trial (RCT) for older adults with cognitive impairment, we are comparing a multidomain mind-body program that emphasizes movement, body awareness, personal meaningfulness, and social connection, and a traditional Chinese mind-body exercise (Tai Chi) to a health and wellness education control condition. All 3 interventions are delivered remotely two times per week (onehour per session) for 12weeks. The two active interventions are live-streamed. Outcomes are assessed prior to, after, and 6-months after the interventions. The co-primary outcomes are changes on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) and brain functional connectivity in the Default Mode Network (DMN). Secondary outcomes include measures of specific cognitive domains (e.g., executive function, attention), mobility, and self-report measures of general well-being, quality of life, social engagement, self- and attention-regulation. This RCT will directly compare the effects of two mind-body movement programs versus an education control delivered remotely over 12weeks on cognitive, neuroimaging, and participant-reported outcomes. If successful, these programs may provide scalable strategies for slowing cognitive decline, which could potentially delay dementia onset in some individuals. NCT05217849.

Health impacts of a remotely delivered prolonged nightly fasting intervention in stressed adults with memory decline and obesity: A nationwide randomized controlled pilot trial.

Cognitive decline is intricately linked to various factors such as obesity, stress, poor sleep, and circadian rhythm misalignment, which are interrelated in their impact on cognitive health. Irregular food-intake timing further compounds these issues. The practice of prolonged nightly fasting (PNF) may help synchronize food intake with circadian rhythms, potentially mitigating adverse effects of cognitive decline and associated factors. A pilot nationwide, remotely delivered, 2-arm randomized controlled trial was conducted to assess the 8-week outcomes of cognition, stress, and sleep, after a PNF intervention (14-hr nightly fast, 6 nights/week, no calories after 8 pm) compared to a health education (HED) control condition. Participants were living with memory decline, stress, and obesity and had weekly check-in calls to report fasting times (PNF) or content feedback (HED). Participants were enrolled from 37 states in the US; N = 58, 86% women, 71% white, 93% non-Latinx, mean (SD) age 50.1 (5.1) years and BMI 35.6 (3.6) kg/m2. No group differences existed at baseline. Linear mixed-effects models were used to compare outcome change differences between groups. Compared to the HED control, the PNF intervention was associated with improved sleep quality (B = -2.52; SE = 0.90; 95% CI -4.30--0.74; p = 0.006). Perceived stress and everyday cognition significantly changed over time (p < 0.02), without significant difference by group. Changing food intake timing to exclude nighttime eating and promote a fasting period may help individuals living with obesity, memory decline, and stress to improve their sleep. Improved sleep quality may lead to additional health benefits.

Predicting psychosocial intervention response from baseline gene expression

To address the challenge of predicting psychological response to a psychosocial intervention we tested the possibility that baseline gene expression profiles might provide information above and beyond baseline psychometric measures. The genomics strategy utilized individual level inferences of transcription factor activity to predict changes in loneliness and affect in response to two well-established meditation interventions. Initial algorithm development analyses focused on three a-priori defined stress-related gene regulation pathways (CREB, GR, and NF-ĸB) as inferred from TELiS promoter-based bioinformatic analysis of basal (pre-intervention) blood samples from a randomized-controlled trial comparing a compassion-based meditation (CM, n = 45) with mindfulness meditation (MM, n = 44). Greater baseline CREB activity (but not GR or NF-ĸB) predicted greater reductions from pre- to post-intervention in loneliness (b = −0.24, p = 0.016) and negative emotions (b = −0.23, p = 0.017) for CM, but not for MM. A second algorithm validation analysis applied the same approach to another randomized controlled trial comparing CM (n = 42) with MM (n = 38) and a health education control condition (n = 41). Similarly, greater baseline CREB activity predicted greater pre- to post-intervention decreases in loneliness (b = −0.24, p = 0.029) and greater increases in satisfaction with life (b = 0.21, p = 0.046) for the CM condition only. Baseline CREB activity was not associated with baseline psychometric measures in either study. Results raise the possibility that pre-intervention gene expression profiles may reflect non-conscious psychobiological states that affect psychological responses to distinct psychosocial interventions, and thereby help personalize intervention selection.

Digital cognitive behavioral therapy for insomnia for people with comorbid psychological distress: A large scale randomized controlled trial

Study objectivesTo examine if comorbid anxiety and depression symptoms (psychological distress) moderate intervention effect in participants receiving digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) in a large-scale randomized controlled trial (RCT), compared to a patient education (PE) control condition. Further, we investigate if dCBT-I reduced levels of psychological distress for those with insomnia and comorbid psychological distress. Methods1721 participants with insomnia completed online assessments of sleep, fatigue and psychological distress, at baseline and at nine-week follow-up. Primary outcome was Insomnia Severity Index (ISI), and secondary outcomes included self-reported sleep (diary), cognition, fatigue, and psychological distress. Participants with psychological distress (HADS>16) were separated from participants without psychological distress. Linear mixed models in SPSS were conducted to test the effects of the intervention. ResultsAt nine-week follow-up we found no difference in effect of the intervention between those who had comorbid psychological distress vs. those without psychological distress in terms of insomnia severity (p = 0.552) and fatigue (p = 0.744). Both groups had large effect size improvements on insomnia severity (p < 0.001=), small to medium (Cohen d < 0.08) improvements on fatigue (p < 0.01=) and sleep efficiency (p < 0.001), and small improvement on other sleep diary measures, compared to their respective control group. The psychological distress group showed a small, but statistically significant decrease in psychological distress (d = 0.2, p < 0.05) with dCBT-I compared to PE. ConclusiondCBT-I is a viable treatment for Insomnia also for those who have comorbid psychological distress.

Study protocol for the Treating Opioid Patients' Pain and Sadness (TOPPS) study — A randomized control trial to lower depression and chronic pain interference, and increase care retention among persons receiving buprenorphine

BackgroundPersons receiving prescription buprenorphine for opioid use disorder experience high rates of comorbid conditions such as chronic pain and depression, which present barriers to buprenorphine care retention. This paper describes the protocol of the TOPPS (Treating Opioid Patients' Pain and Sadness) study, which compares a values-based, behavioral activation intervention with a health education contact-control condition, with the aim of decreasing chronic pain and depression, and increasing buprenorphine care retention for persons with opioid use disorder. MethodsThis randomized controlled trial (RCT) enrolls and randomizes up to 250 participants currently being treated with buprenorphine to receive three months of either TOPPS, a six-session phone-based behavioral intervention, or a health education (HE) control condition. We compare the TOPPS intervention to HE on the following outcomes: 1) pain interference and pain severity over the 3-month treatment phrase; 2) depressive symptoms over the 3-month treatment phase; and 3) sustained improvements in pain interference, depressive symptoms, and buprenorphine treatment retention over the 12-month study period. We also examine mechanisms by which the intervention may reduce pain interference. DiscussionThis RCT explores a novel intervention to address chronic pain and depression for individuals receiving buprenorphine in office-based settings. TOPPS may lead to improved pain, depression, and substance use outcomes, and can utilize providers available within buprenorphine programs, broadening the disseminability of this intervention and heightening its public health impact. Clinical Trial#NCT03698669

549 A Nationwide Pilot Study Testing a Remotely-Delivered Prolonged Nightly Fasting Intervention in Stressed Midlife Adults Living with Obesity and Memory Decline

OBJECTIVES/GOALS: Cognitive decline is associated with obesity, stress, poor sleep, and circadian rhythm misalignment, which are themselves functionally intertwined. Irregular food intake timing exacerbates these all. Prolonged nightly fasting (PNF) aligns food intake with innate circadian rhythms. METHODS/STUDY POPULATION: A nationwide, remotely-delivered, 2-arm randomized controlled trial was conducted to assess feasibility and 8-week outcomes of cognition, stress, sleep, eating behaviors, and general eating habits, after a PNF intervention (14-hr nightly fast, 6 nights/week, no calories after 8pm) compared to a health education control (HEC) condition. Eligible participants were living with obesity, stress (Perceived stress scale-4 (PSS-4) total score ≥5), and memory “not as good as it used to be.” Data were collected via Zoom meetings with participants and trained staff and entered into REDCap. All participants had weekly staff check-in calls to report fasting times (PNF group only) and feedback. RESULTS/ANTICIPATED RESULTS: Eligible participants were enrolled from 37 of 50 US states; N=58, 86% women, 71% white, 93% non-Latinx, mean (SD) 50.1 (5.1) years of age, BMI 35.6 (3.6) kg/m^2. No group differences existed at baseline. Linear mixed-effects models were used to compare group differences across all outcome changes. Compared to the HEC condition, the PNF intervention was associated with improved sleep quality (Pittsburgh Sleep Quality Index; B = -2.52; SE = 0.90; 95% CI-4.30 to -0.74; p=0.006). Stress, everyday cognition, and emotional eating behavior significantly changed over time (p&lt;0.02), but there were no group differences. Analysis of feasibility outcomes are on-going. DISCUSSION/SIGNIFICANCE: Changing food intake timing 6 days per week, to exclude nighttime eating without mandating food quality/quantity change, may benefit many individuals living with obesity, stress and memory decline to improve their sleep. Improved sleep quality may lead to more health benefits over time.

Abstract P422: Lifestyle Intervention Improved Blood Pressure and Cardiovascular Disease Biomarkers in Patients With Chronic Kidney Disease and Resistant Hypertension: Insights From the TRIUMPH Randomized Clinical Trial

Introduction: Evidence is limited regarding the effect of lifestyle modification on health outcomes in patients with chronic kidney disease (CKD). Hypothesis: We hypothesized that lifestyle modification involving the DASH diet, exercise and weight loss would improve blood pressure (BP) and cardiovascular disease (CVD) biomarkers in CKD patients with resistant hypertension. Methods: The Treating Resistant Hypertension Using Lifestyle Modification to Promote Health (TRIUMPH) trial randomized patients with resistant hypertension to either a 16-week cardiac rehabilitation (CR) facility-based lifestyle modification program involving thrice weekly aerobic exercise and weekly classes on DASH diet and behavioral weight loss (C-LIFE) or to a standard education and physician advice (SEPA) control condition. We conducted a secondary analysis involving participants with CKD. CKD was defined as having eGFR &lt;60 mL/min/1.73 m 2 or albuminuria at baseline. Primary outcome was mean change in clinic systolic BP. Secondary outcomes were mean changes in clinic diastolic BP, 24-hour ambulatory BP, and CVD biomarkers including baroreflex sensitivity (BRS), high-frequency heart rate variability, flow-mediated dilation, pulse wave velocity, and left ventricular mass index. Results: Ninety-seven (69%) of 140 TRIUMPH participants were considered to have CKD. Mean age was 62 years, 57% self-identified as Black race, 67% were male, and the majority (82%) had CKD stage 3. Participants with CKD randomized to C-LIFE achieved greater reduction in clinic SBP and greater improvement in BRS compared to SEPA. There were no differences between groups in ambulatory BP or other CVD biomarkers. Conclusions: A structured 16-week diet, exercise and weight management program conducted in a CR setting improved BP and resting BRS in resistant hypertension patients with CKD. Future studies are needed to confirm the beneficial effect of multi-component lifestyle modification on CVD biomarkers in CKD and to determine the persistence of benefit over time.

Study protocol for a comparative randomized controlled trial of Tai Chi and conventional exercise training on alleviating depression in older insomniacs

BackgroundInsomnia and depression are prevalent mental disorders that are often comorbid among older adults. Lifestyle intervention strategies incorporating Tai Chi or conventional exercise have been shown to alleviate symptoms of insomnia and depression. However, the comparative efficacy of these exercise modalities in individuals with both disorders has yet to be determined. Therefore, the aim of this study is to examine the efficacy of Tai Chi and conventional exercise for reducing depressive symptoms in older adults with chronic insomnia and depressive symptoms, when compared to a health education control. MethodsThis study is a prospective, assessor-blinded, three-arm, parallel group, randomized controlled trial. Older adults aged ≥60 years with a diagnosis of chronic insomnia and depressive symptoms will be randomly assigned to a Tai Chi, conventional exercise or health education control condition on a 1:1:1 basis. Interventions will last for 3 months, with a 6-month follow-up period. The primary outcome is depressive symptoms, assessed using the Hospital Anxiety and Depression Scale. Secondary outcomes include subjective sleep quality, 7-day actigraphy, 7-day sleep diary, anxiety symptoms, quality of life, medication usage and physical function. All measurements will be conducted at baseline, 3 months and 9 months by outcome assessors who are blinded to group allocation. DiscussionThis study will compare the efficacy of Tai Chi and conventional exercise in improving depression outcomes in older adults with chronic insomnia and depressive symptoms. Our results will shed light on the clinical potential of these interventions for combating insomnia and depression in older adults.

THE READYR PROGRAM FOR WELL-BEING IN DEMENTIA: PILOT STUDY AND SIX-MONTH FOLLOW-UP RESULTS AMONG SPOUSE–PARTNER DYADS

Abstract The READyR Program assesses and targets everyday routines of care dyads (older adults with cognitive impairment and their co-habiting partners) using in-home sensors and video-conference sessions in order to understand future care needs, and promote greater well-being. This study aimed to evaluate the feasibility, acceptability, and pilot test of efficacy for READyR. Fifteen dyads (96% married) were enrolled in the 6-month study, and randomized to immediately join READyR (n=8 dyads) or to complete READyR after an educational control condition (n=7 dyads). Feasibility was high: 100% of enrolled dyads completed ≥1 session; 80% completed all sessions. Acceptability was also high: responding participants (n=26) reported that READyR helped them express their care values and understand their care needs (92%), that they were comfortable sharing their views (92%) and doing so with their partner present (96%). Hearing and visual impairments were reported to interfere with online sessions for 4 and 6 participants, respectively, but 93% of participants reported that the digital components were easy to use and understand. After receiving the READyR sessions, awareness of future care needs among care partners increased (d = 0.85) and relationship strain for both dyad members decreased (d = 0.58–0.82), when compared to changes among participants in the active control group. No effect was observed on participants’ quality of life, mood, or care-related strain at post-test or at 6 month follow-up. As a remote dyadic intervention, READyR is feasible, acceptable, and may help dyads decrease strain in the care relationship and prepare for future care needs.

A PILOT STUDY OF EPIGENETIC AGING IN THE CONTEXT OF AN INTENSIVE LIFESTYLE INTERVENTION: THE LOOK AHEAD STUDY

Abstract Type 2 diabetes and obesity increase the rate of accumulation of age-related health deficits and accelerate biological aging. An intervention promoting weight loss among adults with these conditions, the Action for Health in Diabetes (Look AHEAD) Intensive Lifestyle Intervention (ILI), attenuated health deficit accumulation measured by a frailty index, through a variety of diet and exercise strategies and optional weight loss medications to achieve and maintain ≥7% weight loss. To better understand the long-term effects of the Look AHEAD ILI on aging biology, we leveraged biospecimens from 62 women aged 60-71 years who participated in the Look AHEAD randomized clinical trial of ILI (n=32) and diabetes support and education (control condition, n=30), and tested for associations of ILI vs control condition on the rate of epigenetic aging. Five DNA methylation-based aging measures were generated from blood collected at baseline and 14 years later. Unexpectedly, the intervention was associated with a long-term increase in AgeAccelPheno compared to the control condition (t-test, p&amp;lt; 0.05). ILI was not associated with a change in other epigenetic measures over 14 years (AgeAccelHannum, AgeAccelHorvath, AgeAccelGrim and DunedinPACE), or a change in a frailty index reflecting accumulation of 38 health deficits. Overall, the average change in frailty index was higher among participants with advanced epigenetic age at baseline (AgeAccelHannum&amp;gt;0 and AgeAccelGrim&amp;gt;0,p &amp;lt; 0.05), suggesting that epigenetic aging markers may be useful predictors of frailty risk. Well-powered studies are needed to better understand the long-term impact of intensive lifestyle interventions on epigenetic aging in adults with diabetes and obesity.

Evaluation of a novel eating disorder prevention program for young women with type 1 diabetes: A preliminary randomized trial

ObjectiveEvaluate whether the Body Project prevention program adapted for young women with type 1 diabetes (Diabetes Body Project) reduces eating disorder (ED) risk factors and symptoms. MethodsYoung women (aged 15–30) at high-risk for EDs due to having type 1 diabetes and body image concerns (N = 55) were randomized to virtually delivered Diabetes Body Project groups or an educational control condition, completing measures at pretest, posttest, and 3-month follow-up. ResultsDiabetes Body Project versus the control participants showed significantly greater reductions in thin-ideal internalization, body dissatisfaction, diabetes distress, diabetes eating pathology, and ED symptoms by posttest, and greater reductions in diabetes eating pathology and ED symptoms, and greater improvements in quality of life by 3-month follow-up, which were medium to large effects (d’s ranged from −0.43 to −0.90). Although control participants showed a worsening of glycemic control (time in range) verses Diabetes Body Project participants, this difference was non-significant (d = 0.26). ConclusionsVirtually delivered Diabetes Body Project decreased ED risk factors and symptoms in young women with type 1 diabetes. A well powered randomized controlled trial is warranted to evaluate this intervention over longer follow-up.

83 Efficacy of a Tablet-Based Cognitive Flexibility Intervention in Youth with Executive Function Deficits

Objective:Executive functions (EFs) are considered to be both unitary and diverse functions with common conceptualizations consisting of inhibitory control, working memory, and cognitive flexibility. Current research indicates that these abilities develop along different timelines and that working memory and inhibitory control may be foundational for cognitive flexibility, or the ability to shift attention between tasks or operations. Very few interventions target cognitive flexibility despite its importance for academic or occupational tasks, social skills, problem-solving, and goal-directed behavior in general, and the ability is commonly impaired in individuals with neurodevelopmental disorders (NDDs) such as autism spectrum disorder, attention deficit hyperactivity disorder, and learning disorders. The current study investigated a tablet-based cognitive flexibility intervention, Dino Island (DI), that combines a game-based, process-specific intervention with compensatory metacognitive strategies as delivered by classroom aides within a school setting.Participants and Methods:20 children between ages 6-12 years (x̄ = 10.83 years) with NDDs and identified executive function deficits and their assigned classroom aides (i.e., “interventionists”) were randomly assigned to either DI or an educational game control condition. Interventionists completed a 2-4 hour online training course and a brief, remote Q&amp;A session with the research team, which provided key information for delivering the intervention such as game-play and metacognitive/behavioral strategy instruction. Fidelity checks were conducted weekly. Interventionists were instructed to deliver 14-16 hours of intervention during the school day over 6-8 weeks, divided into 3-4 weekly sessions of 30-60 minutes each. Baseline and post-intervention assessments consisted of cognitive measures of cognitive flexibility (Minnesota Executive Function Scale), working memory (Weschler Intelligence Scales for Children, 4th Edn. Integrated Spatial Span) and parent-completed EF rating scales (Behavior Rating Inventory of Executive Function).Results:Samples sizes were smaller than expected due to COVID-19 related disruptions within schools, so nonparametric analyses were conducted to explore trends in the data. Results of the Mann-Whitney U test indicated that participants within the DI condition made greater gains in cognitive flexibility with a trend towards significance (p = 0.115. After dummy coding for positive change, results also indicated that gains in spatial working memory differed by condition (p = 0.127). Similarly, gains in task monitoring trended towards significant difference by condition.Conclusions:DI, a novel EF intervention, may be beneficial to cognitive flexibility, working memory, and monitoring skills within youth with EF deficits. Though there were many absences and upheavals within the participating schools related to COVID-19, it is promising to see differences in outcomes with such a small sample. This poster will expand upon the current results as well as future directions for the DI intervention.

A Brief Online Cognitive Dissonance-Based Intervention to Reduce Consideration of Cosmetic Surgery and Improve Body Image Among Chinese Women

Across many cultures, women are evaluated based on their appearance, with narrow societal beauty ideals as the standard against which they are judged and, eventually, judge themselves. Women who internalize the beauty ideal are more likely to consider cosmetic surgery. Dissonance-based interventions targeting thin-ideal internalization are effective at preventing eating disorders and associated risk factors. In this study, we evaluated an online dissonance-based intervention targeting beauty-ideal internalization to reduce favorable attitudes toward cosmetic surgery among Chinese women. Chinese women who were dissatisfied with their appearance and who were considering cosmetic surgery were randomized to the intervention ( n = 127, Mage = 35.49) or to the educational brochure control condition ( n = 98, Mage = 32.97). Beauty-ideal internalization, favorable attitudes toward cosmetic surgery, facial appearance concerns, body satisfaction, and body appreciation were assessed at pretest, posttest, and 4-week follow-up. Intention-to-treat analyses showed that the intervention reduced beauty-ideal internalization and favorable attitudes toward cosmetic surgery at posttest, with small-to-medium effect sizes; however, effects were not sustained at follow-up. No effects were found for facial appearance concerns, body satisfaction, and body appreciation. This study provides preliminary evidence for the short-term efficacy of the dissonance-based intervention for reducing beauty-ideal internalization and favorable attitudes toward cosmetic surgery, and points to valuable directions for improvement. Additional online materials for this article are available on PWQ's website at http://journals.sagepub.com/doi/suppl/10.1177/03616843231183946 .

Who Benefits the Most From Different Psychological Chronic Pain Treatments? An Exploratory Analysis of Treatment Moderators

Different psychological chronic pain treatments benefit some individuals more than others. Understanding the factors that are associated with treatment response—especially when those factors differ between treatments—may inform more effective patient-treatment matching. This study aimed to identify variables that moderate treatment response to 4 psychological pain interventions in a sample of adults with low back pain or chronic pain associated with multiple sclerosis, spinal cord injury, acquired amputation, or muscular dystrophy (N = 173). The current study presents the results from secondary exploratory analyses using data from a randomized controlled clinical trial which compared the effects of 4 sessions of cognitive therapy (CT), hypnosis focused on pain reduction (HYP), hypnosis focused on changing pain-related cognitions and beliefs (HYP-CT), and a pain education control condition (ED). The analyses tested the effects of 7 potential treatment moderators. Measures of primary (pain intensity) and secondary (pain interference, depression severity) outcome domains were administered before and after the pain treatments, and potential moderators (catastrophizing, hypnotizability, and electroencephalogram (EEG)-assessed oscillation power across five bandwidths) were assessed at pre-treatment. Moderator effects were tested fitting regression analyses to pre- to post-treatment changes in the three outcome variables. The study findings, while preliminary, support the premise that pre-treatment measures of hypnotizability and EEG brain activity predict who is more (or less) likely to respond to different psychological pain treatments. If additional research replicates the findings, it may be possible to better match patients to their more individually suitable treatment, ultimately improving pain treatment outcomes. PerspectivePre-treatment measures of hypnotizability and EEG-assessed brain activity predicted who was more (or less) likely to respond to different psychological pain treatments. If these findings are replicated in future studies, they could inform the development of patient-treatment matching algorithms.

The Electronic Surviving Cancer Competently Intervention Program-a Psychosocial Digital Health Intervention for English- and Spanish-Speaking Parents of Children With Cancer: Protocol for Randomized Controlled Trial.

The psychosocial needs and risks of children with cancer and their families are well-documented including increased risk of parental distress, posttraumatic stress, and anxiety. There is a critical need to provide evidence-based psychosocial care to parents and caregivers of children with cancer. Digital health interventions are important to address many barriers to in-person intervention delivery but are not widely used in pediatric psychosocial cancer care. The COVID-19 pandemic has reinforced the need for flexible, acceptable, and accessible psychosocial digital health interventions. The Electronic Surviving Cancer Competently Intervention Program (eSCCIP) is an innovative digital health intervention for parents and caregivers of children with cancer, delivered through a combination of self-guided web-based content and supplemented by 3 telehealth follow-up sessions with a trained telehealth guide. A Spanish language adaptation of eSCCIP, El Programa Electronico de Intervencion para Superar Cancer Competentemente (eSCCIP-SP), has been developed. The self-guided web-based cores of eSCCIP/eSCCIP-SP are a mix of didactic video content, multifamily video discussion groups featuring parents of children with cancer, and hands-on web-based activities. The objective of this study is to test eSCCIP/eSCCIP-SP in a multisite randomized controlled trial, compared to an internet-based education control condition consisting of information specifically focused on concerns relevant to parents and caregivers of children with cancer. Using a randomized controlled clinical trial design, 350 eligible parents and caregivers of children with cancer will be randomly assigned to the intervention (eSCCIP/eSCCIP-SP) or an education control condition. Data will be collected at 3 time points: preintervention (prior to randomization), immediately post intervention (after 6 weeks), and at a 3-month follow-up (from baseline). Participants randomized to either condition will receive study material (eSCCIP/eSCCIP-SP intervention or education control website) in English or Spanish, based on the primary language spoken in the home and participant preference. The primary study end point is a reduction in acute distress from baseline to postintervention, with secondary end points focused on reductions in symptoms of posttraumatic stress and anxiety, and improvements in coping self-efficacy and cognitive coping. An additional exploratory aim will be focused on implementation strategies and potential costs and cost-savings of eSCCIP/eSCCIP-SP, laying the groundwork for future trials focused on dissemination and implementation, stepped-care models, and intervention refinement. This trial will provide necessary data to evaluate the efficacy of eSCCIP/eSCCIP-SP. This intervention has the potential to be an easily scalable and highly impactful psychosocial treatment option for parents and caregivers of children with cancer. ClinicalTrials.gov NCT05294302; https://clinicaltrials.gov/ct2/show/NCT05294302. PRR1-10.2196/46339.

Testing a Low-Intensity Single-Session Self-Compassion Intervention for State Body Shame in Adult Women: A Dismantling Randomized Controlled Trial

State body shame is a risk factor for eating disorders, and self-compassion is emerging as a potentially effective treatment option in such cases. This study tested the efficacy of a brief (15-minute) self-compassion intervention in reducing state body shame. Using dismantling trial methodology, participants were randomly allocated to an active compassion condition (n = 23), an inactive control compassion condition (n = 23), or an educational control condition (n = 23). Measures of state body image and state shame were collected pre-intervention, immediately after the intervention, and a day after the intervention. Subjective units of state body shame (SUBS) were intensively measured during each invention. Self-compassion interventions were equally efficacious at protecting against deterioration of state body shame and were effective at reducing state shame compared to the educational control condition, with medium effect sizes (respectively – np2 = .07 and np2 = .08). Reductions in state shame were retained at follow-up. None of the interventions had an effect on body image (np2 = .04). Findings demonstrate the clinical promise of brief self-compassion interventions, particularly as evidenced-based “homework” exercises.

Dissonance-based prevention of eating pathology in non-Western cultures: A randomized controlled trial of the Body Project among young Saudi adult women

The aims of this study were to determine the effectiveness of an adapted version of the Body Project for young Saudi women, and to determine the impact of compliance (i.e. adherence to homework and attendance) on outcomes. A randomized controlled trial was used, allocating Saudi undergraduate females (N = 92; mean age = 20.48 years; SD = 2.28) to either a culturally-adapted version of the Body Project or a health education control condition. Participants completed self-report measures of eating pathology, body image, depression and social anxiety before and following the interventions and at three-month follow-up. Interaction terms showed that, relative to the control group, the intervention group had significantly reduced levels of eating concerns, body dissatisfaction and depression, but social anxiety did not change significantly in either group. Levels of session attendance and homework completion did not influence outcomes. Thus, the Body Project was effective for Saudi women in reducing eating pathology, body image dissatisfaction, and depression, though not social anxiety. This outcome indicates the value of the Body Project as a prevention tool when adapted to non-Western cultures.

Rationale and design of a multisite randomized clinical trial examining an integrated behavioral treatment for veterans with co-occurring chronic pain and opioid use disorder: The pain and opioids integrated treatment in veterans (POSITIVE) trial

BackgroundChronic pain and opioid use disorder (OUD) individually represent a risk to health and well-being. Concerningly, there is evidence that they are frequently co-morbid. While few treatments exist that simultaneously target both conditions, preliminary work has supported the feasibility of an integrated behavioral treatment targeting pain interference and opioid misuse. This treatment combined Acceptance and Commitment Therapy (ACT) and Mindfulness-Based Relapse Prevention (ACT+MBRP). This paper describes the protocol for the adequately powered efficacy study of this integrated treatment. MethodsA multisite randomized controlled trial will examine the efficacy of ACT+MBRP in comparison to a parallel education control condition, focusing on opioid safety and pain education. Participants include veterans (n = 160; 21–75 years old) recruited from three Veterans Administration (VA) Healthcare Systems with chronic pain who are on a stable dose of buprenorphine. Both conditions include twelve weekly 90 min group sessions delivered via telehealth. Primary outcomes include pain interference (Patient Reported Outcome Measurement Information System - Pain Interference) and hazardous opioid use (Current Opioid Misuse Measure), which will be examined at the end of the active treatment phase and through 12 months post-intervention. Secondary analyses will evaluate outcomes including pain intensity, depression, pain-related fear, and substance use, as well as treatment mechanisms. ConclusionThis study will determine the efficacy of an integrated behavioral treatment program for pain interference and hazardous opioid use among veterans with chronic pain and OUD who are prescribed buprenorphine, addressing a critical need for more integrated treatments for chronic pain and OUD. Trial registrationClinicalTrials.gov Identifier: NCT04648228

Increasing social and community participation in veterans living with schizophrenia: A treatment outcome study

People living with schizophrenia often face challenges engaging in social and community activities. A critical barrier is negative symptoms that reflect diminished feelings and thoughts that support social interaction. Several years ago, we began a process of specifying an intervention for individuals with schizophrenia and clinically meaningful negative symptoms that could be delivered in an integrated fashion with mental health services offered in VA medical centers with the primary focus of improving social and community engagement. In the present study, we examined the impact of a multi-component intervention to improve social and community participation in a group of Veterans living with schizophrenia and negative symptoms. We compared an intervention called Engaging in Community Roles and Experiences (EnCoRE) - a 12-week program of individual and group meetings that support learning and implementing skills with the goal of helping participants increase engagement in personally-relevant social and community activities – to an active wellness education control condition. Participants in both conditions attended on average of at least half of the groups that were offered, indicating that many individuals living with negative symptoms are willing to participate in an intervention to improve social and community participation. Although there were no significant differences on the two primary outcomes, those in EnCoRE showed better social and general functioning at post treatment and improved social motivational negative symptoms and decreases in perceived limitations at a 3-month follow-up. EnCoRE may be especially beneficial for participants who endorsed more dysfunctional attitudes about their abilities.

Perioperative Mobile Telehealth Program for Post-Prostatectomy Incontinence: A Randomized Clinical Trial.

Perioperative pelvic floor muscle training can hasten recovery of bladder control and reduce severity of urinary incontinence following radical prostatectomy. Nevertheless, most men undergoing prostatectomy do not receive this training. The purpose of this trial was to test the effectiveness of interactive mobile telehealth (mHealth) to deliver an evidence-based perioperative behavioral training program for post-prostatectomy incontinence. This was a 3-site, 2-arm, randomized trial (2014-2019). Men with prostate cancer scheduled to undergo radical prostatectomy were randomized to a perioperative behavioral program (education, pelvic floor muscle training, progressive exercises, bladder control techniques) or a general prostate cancer education control condition, both delivered by mHealth for 1-4 weeks preoperatively and 8 weeks postoperatively. The primary outcome was time to continence following surgery measured by the ICIQ (International Consultation on Incontinence Questionnaire) Short-Form. Secondary outcomes measured at 6, 9 and 12 months included Urinary Incontinence Subscale of Expanded Prostate Cancer Index Composite; pad use; International Prostate Symptom Score QoL Question and Global Perception of Improvement. A total of 245 men (ages 42-78 years; mean=61.7) were randomized. Survival analysis using the Kaplan-Meier estimate showed no statistically significant between-group differences in time to continence. Analyses at 6 months indicated no statistically significant between-group differences in ICIQ scores (mean=7.1 vs 7.0, p=0.7) or other secondary outcomes. mHealth delivery of a perioperative program to reduce post-prostatectomy incontinence was not more effective than an mHealth education program. More research is needed to assess whether perioperative mHealth programs can be a helpful addition to standard prostate cancer care.