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To synthesize results of six controlled trials of self-care interventions for depression and/or anxiety, focusing on five trials in which lay guidance was compared to self-directed use of the same self-care tools. The trials were conducted in Canada in different target populations. Self-care tools were adapted to each population. Guidance was provided in 3–15 calls over a period of 6–26 weeks. Depression and/or anxiety were assessed at follow-up (6–26 weeks). Pooled analyses used a meta-analytic approach. Engagement with the self-care tools was compared using the standardized difference or Cohen's d effect size. In studies with homogeneous outcomes (three for depression, four for anxiety), the pooled effect sizes of guidance vs. self-directed use of the self-care tools were 0.36 (95% CI 0.10, 0.62, N = 235) for depression and 0.21 (95% CI -0.03, 0.44, N = 285) for anxiety. Guidance consistently led to greater engagement with the tools. The intervention model is a potentially sustainable and accessible alternative to professionally guided self-care for people with mild-moderate depression. Factors which may have limited implementation success include: co-interventions, reduced number of guide calls (3 vs 6 or more), and delivery to dyads (patient-caregiver). [ABSTRACT FROM AUTHOR]

• A home-delivered non-pharmacological intervention contributed to reducing the immediate total and social loneliness of homebound older adults. • The decrease in perceived social loneliness mediated the improvement of depressive symptom levels. • Social loneliness may be a relevant target of intervention to improve depressive symptomatology. The present study aimed to explore whether the Homebound Elderly People Psychotherapeutic Intervention (HEPPI), a home-delivered ten-week cognitive-emotional intervention, was effective in reducing self-reported loneliness among homebound older adults presenting mild cognitive impairment and psychological symptomatology. Effects of HEPPI in total, social, and emotional loneliness, compared with a treatment-as-usual group, were investigated at post-intervention and 3-month follow-up. In addition, the potential role of social and emotional loneliness as mediators of the HEPPI impact on episodic memory and symptoms of depression and anxiety was examined. This study built upon the data of a previously conducted randomized controlled trial. Participants were randomly assigned to the HEPPI group (n = 98) or the treatment-as-usual group (n = 101) and completed baseline, post-intervention, and 3-month follow-up assessments, including measures of loneliness (UCLA - Loneliness scale), episodic memory (Wechsler Memory Scale-III), depressive symptoms (Geriatric Depression Scale-30), and anxiety symptoms (Geriatric Anxiety Inventory). Data were analyzed on an intention-to-treat basis employing linear mixed models and mediation analyses for repeated measures. ClinicalTrials.gov identifier: NCT05499767. Compared with usual care controls, the HEPPI participants reported a significant immediate decrease in total and social loneliness, but these effects were not maintained at a 3-month follow-up. The reduction in immediate perceived social loneliness significantly mediated the improvement of depressive symptoms. The current findings suggest that HEPPI potentially reduced total and social loneliness of the homebound older population immediately post-intervention, and such decrease in social loneliness may be a relevant mechanism for improving their short-term depressive symptomatology. [ABSTRACT FROM AUTHOR]

Parenting of preterm infants presents unique challenges, particularly during their transition from hospital to home. Early discharge programs can assist parents during this critical period. However, the feasibility of delivering a family-focused online discharge program remains understudied. This study was conducted to investigate the impact of a family-focused online parenting support intervention on parents' sense of competence, depression, caregiving, social support, family functioning, and the weight and length of preterm infants. We conducted a single-blind, two-arm randomized controlled trial with a repeated-measures design. Participants were recruited from a specialized tertiary hospital in China between May and December 2022. Forty-five families were randomly assigned to the intervention group and 44 to the control group. The intervention included three components: (1) two one-hour group sessions and three 30-minute individual sessions of online parenting support; (2) two follow-up telephone calls (15–30 min each) post-discharge; and (3) access to online parenting resources. Primary outcomes included parenting sense of competence, parental care ability, and preterm infants' weight and length. Secondary outcomes included depression, social support, and family functioning. Measurements were taken at baseline, preterm infant discharge, one month post-discharge, and three months post-discharge. A generalized estimating equation model was employed based on the intention-to-treat principle for outcome comparison. Parents in the intervention group showed significant improvements in parenting sense of competence (P < 0.001), parental care ability (P < 0.001), depression (P < 0.001), and social support (P = 0.002). However, no statistically significant differences were observed in preterm infants' weight and length, or in family functioning (P > 0.05). Although the intervention did not affect preterm infants' outcomes, the positive enhancements in parenting sense of competence, care ability, depression, and social support indicate that online family-focused parenting support can effectively prepare parents for hospital discharge and the early transition period. [ABSTRACT FROM AUTHOR]

Sleep disturbance is commonly reported among individuals meeting criteria for cannabis use disorder (CUD), and people who use cannabis frequently report sleep disturbance as a contributor to failed quit attempts. The purpose of this study was to measure sleep in individuals enrolled in treatment for CUD, and to determine whether use of hypnotic medication during treatment increased abstinence rates. The study enrolled 127 adults seeking treatment for CUD in a 12-week clinical trial and randomized to receive extended-release zolpidem (zolpidem-XR) or placebo. All participants received computerized behavioral therapy and abstinence-based contingency management. The study conducted in-home ambulatory polysomnography (PSG) assessments at baseline and during treatment to objectively measure sleep. Self-report measures of recent sleep, Insomnia Severity Index (ISI), and drug use (Timeline Follow-Back) were collected at each study visit, and the study confirmed self-reported abstinence via quantitative urine drug testing. Participants randomized to placebo, but not zolpidem-XR exhibited significant sleep disturbance during week 1 of treatment. Sleep disturbance emerged in the zolpidem-XR group after study medication was stopped at the end of treatment. Though participants assigned to the zolpidem-XR condition had qualitatively greater rates of abstinence compared with placebo (27 % versus 15 % negative at end of treatment), the difference was not statistically significant. Treatment retention was poor (about 50 % drop out in both groups) and medication adherence was a challenge without the use of contingent incentives. Results from this randomized controlled trial suggest that zolpidem-XR can attenuate abstinence-induced sleep disturbance early in treatment for CUD, but that sleep problems are likely to emerge after the medication is stopped. Further research should identify alternative pharmacotherapies and behavioral treatments for CUD and elucidate the role of sleep disturbance in the development and maintenance of CUD. • Sleep disturbance is commonly reported among individuals with cannabis use disorder. • This RCT evaluated extended-release zolpidem for cannabis-related sleep disturbance. • Zolpidem-XR attenuated sleep disturbance but sleep problems re-emerged at EoT. • Zolpidem-XR resulted in non-significant improvement in cannabis abstinence relative to placebo. [ABSTRACT FROM AUTHOR]

• We will monitor compliance with the intervention and adverse events. • Data will be analyzed following intention-to-treat principles. • A cost-effectiveness analysis will be performed. This a priori statistical analysis plan describes the methods of analysis for the Trial Of Prevention Strategies for low back pain (TOPS). TOPS aimed to investigate the effectiveness and cost-effectiveness of exercise and education classes compared with a minimal intervention control in preventing recurrence of low back pain (LBP) in people who have recently recovered from an episode of LBP. TOPS is a superiority, pragmatic, parallel-group randomized controlled trial with allocation concealment, blinded outcome assessors, and intention-to-treat analysis. Participants were randomized to a physical therapist-led exercise and education program for 12 weeks or minimal intervention. The primary outcome was days to recurrence of an episode of LBP. The three key secondary outcomes were days to recurrence of an episode of LBP resulting in (1) activity limitation, (2) care seeking for LBP; and (3) work absence of at least 1 day. Differences in survival curves for the primary (days to recurrence) and secondary outcome (days to LBP with activity limitation, days to care seeking due to LBP, and days to work absence due to LBP) will be compared using Cox regression. Hazard ratios (HRs) and median survival times with 95% confidence intervals (CI) will be calculated. The number of adverse events, including serious adverse events will be reported and the proportion of adverse events between groups will be compared using a Chi-squared test. This paper will provide a detailed description of the planned analyses for the TOPS trial. Australian New Zealand Clinical Trials Registry (ACTRN12615000939594). [ABSTRACT FROM AUTHOR]

• There is a lack of information about the effectiveness of foot-ankle muscle strengthening program on pain and functioning in people with KOA. • An 8-week foot-ankle muscle strengthening program decreased knee pain and enhanced physical function in individuals with KOA, presenting a potential to be clinically meaningful. • Foot-ankle muscle strengthening program can be a treatment option for individuals with knee osteoarthritis (KOA) who do not tolerate exercises with excessive load on the knee. Foot-ankle exercises could improve pain and function of individuals with KOA and need to be tested. To investigate whether an 8-week foot-ankle muscle strengthening program is effective for individuals with KOA to reduce pain and improve function. In this randomized controlled trial, individuals diagnosed with clinical and radiographic KOA were randomized into the intervention (supervised foot-ankle strengthening exercise program three times a week for 8 weeks) or control (usual care and recommendations of the healthcare team) group. Effectiveness was assessed by changes in clinical and functional outcomes between baseline and 8 weeks with pain as the primary outcome. ANCOVA tests using the intervention group as a reference and sex, body mass index, and baseline values as covariates assessed between-group differences. The intervention group showed lower pain scores (−4.4 units; 95%CI = −7.5, −1.1), better function (−7.1 units; 95%CI = −12.7, −1.4), higher total functional score (−11.9 units; 95%CI = −20.7, −3.1), with confidence intervals indicating a potential for the differences to be clinically meaningful, and better scores for the 30-s chair stand test (2.7 repetitions; 95%CI = 1.1, 4.1), with a confidence interval indicating a moderate clinically meaningful difference, compared to the controls. The 8-week foot-ankle exercise program showed positive, and potentially clinically meaningful, effects on knee pain and physical function among individuals with KOA, when compared to usual care. NCT04154059. https://clinicaltrials.gov/ct2/show/NCT04154059 [ABSTRACT FROM AUTHOR]

Objectives: To compare the effectiveness of quitting immediately and cutting down to quit in promoting smoking abstinence among smokers in an outpatient clinic.Methods: A total of 100 subjects were randomized into two groups, 50 in the quit immediately group, who received an intervention on abruptly quitting, and 50 in the cut down to quit group, who received an intervention on gradual reduction. All subjects were followed up at 6 and 12 months via telephone. The intention-to-treat principle was used.Results: At the 6-month follow-up, the self-reported quit rate of subjects in the quit immediately group was significantly higher than in the cut down to quit group (18.0% vs. 4.0%, p = 0.04). However, this difference was not significant at the 12-month follow-up (12.0% vs. 4.0%, p = 0.16).Conclusion: These data suggest that quitting immediately might be more effective than cutting down to quit at 6 months but not at 12 months.Practice Implications: It is crucial to allow smokers to select quitting immediately or reducing the number of cigarettes smoked. Further studies are warranted to compare the effectiveness of various approaches for achieving smoking abstinence. [ABSTRACT FROM AUTHOR]

Physical activity in people with dementia (PwD) may enhance physical and mental functioning. Exergaming, which combines physical exercise with cognitive stimulation in a gaming environment, was developed to overcome barriers in performing physical activities. We evaluated the effects of exergaming in day care centers (DCCs) for PwD and informal caregivers (ICs). A randomized controlled trial among 23 DCCs across the Netherlands randomized to exergaming (interactive cycling during 6 months) or a care-as-usual control group. A total of 112 (73 exergaming, 39 control) community-dwelling dyads (PwD, IC), with the PwD visiting a DCC at least twice per week. All outcomes were assessed using structured questionnaires during interviews with PwD and ICs at baseline (T0), 3 months (T1), and 6 months (T2). Primary outcomes: physical activity and mobility of the PwD. Secondary outcomes: physical, cognitive, emotional and social functioning, and quality of life for PwD. For ICs: experienced burden, quality of life, and positive care experiences. Mixed-model analyses showed no statistically significant effects on primary outcomes. There were statistically significant positive effects on PwD's secondary outcomes at T2 on cognition [Mini-Mental State Examination (MMSE): r = 2.30, 95% confidence interval (CI): 0.65, 3.96, P =.007; and Trail Making Test part A (TMT-A): r = −28.98, 95% CI: −54.89, −3.08, P =.029], social functioning (Behavior Observation Scale for Intramural Psychogeriatrics subscale 1 (GIP): r = −1.86, 95% CI: −3.56, −0.17, P =.031), and positive post-test effects in ICs on distress caused by the PwD's neuropsychiatric symptoms (NPI-Q total distress: r = −3.30, 95% CI: −6.57, −0.03, P =.048) and on sense of competence (SSCQ: r = 2.78, 95% CI: 0.85, 4.71, P =.005). Exergaming appeared not effective on the primary outcomes. Despite the study being underpowered, we found positive effects on secondary outcomes for PwD and ICs, and no negative effects. We therefore recommend further study, dissemination, and implementation. [ABSTRACT FROM AUTHOR]

To determine the short- (4 weeks) and long-term (6 month) effectiveness of Tibetan medicated bathing therapy in patients with post-stroke limb spasticity. Prospective, blinded, randomized controlled trial. Post-stroke patients with limb spasticity were recruited between December 2013 and February 2017 and randomly assigned 1:1 to a control group that received conventional rehabilitation (n = 222) or an experimental group that received Tibetan medicated bathing therapy in combination with conventional rehabilitation (n = 222). All patients received conventional rehabilitation. In addition, the experimental group received Tibetan medicated bathing therapy. The interventions were conducted 5 times per week for 4 weeks. The primary endpoint was changes from baseline after 4 weeks of therapy in muscle tone in the spastic muscles (elbow flexors, wrist flexors, finger flexors, knee extensors, ankle plantar flexors), as measured by the Modified Ashworth Scale (MAS). The mean change from baseline after 4 weeks of therapy in the MAS score for the elbow flexors (P =.017), wrist flexors (P <.001), and ankle plantar flexors (P <.001) was significantly greater in patients in the experimental group compared to the control group. The benefit was maintained for 3 muscle groups (elbow flexors P <.001, wrist flexors P =.001, and ankle plantar flexors P <.001) and 6 months (elbow flexors P <.001, wrist flexors P =.002, and ankle plantar flexors P <.001) after therapy. All adverse events were mild, and no serious adverse reactions to Tibetan medicated bathing therapy were recorded. Tibetan medicated bathing therapy, in combination with conventional rehabilitation, has potential as a safe, effective treatment for the alleviation of post-stroke upper limb spasticity. Tibetan medicated bathing therapy was most advantageous for patients who had a baseline muscle tone score of 1+ to 2 on the MAS in the affected limb and recent onset of stroke (duration of the disease of 1-3 months). [ABSTRACT FROM AUTHOR]

Objective To compare the immunogenicity and safety between full-dose (15 μg) intramuscular (IM) and full-dose (15 μg) intradermal (ID) immunization of the trivalent influenza vaccine in nursing home older adults. Design A single-center, randomized, controlled, open-label, parallel group trial from October 2013 to April 2014. Setting Nine nursing homes in Hong Kong. Participants Hundred nursing home older adults (mean age: 82.9 ± 7.4 years). Intervention Fifty received ID (Intanza) and 50 received IM (Vaxigrip) vaccination. Measurements Baseline measurements included demographics, comorbidity, frailty and nutritional status. Day 21 and day 180 immunogenicity (seroconversion rate, seroprotection rate, geometric mean titer [GMT] fold increase in antibody titer) using hemagglutination-inhibition and adverse events were measured. Noninferiority and superiority of ID compared with IM vaccination in immunogenicity were analyzed. Results At day 21, noninferiority in immunogenicity of the ID vaccination was demonstrated. The seroconversion rate of the H1N1 strain was significantly higher in the ID group. At day 180, immunogenicity of both groups fell but the GMT of all strains in ID group was higher and the difference was significant for H3N2 strain. The seroconversion rate and GMT fold increase of H3N2 strain was significantly higher in the ID group. Local adverse events was significantly more in ID group, but they were mild and resolved in 72 hours. Conclusions ID vaccination is noninferior, and even superior in some parts of immunogenicity assessment, to IM vaccination without compromising safety in nursing home older adults. ID vaccination is a good alternative to IM vaccination in this population. [ABSTRACT FROM AUTHOR]