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This study aimed to examine the efficacy of combining paroxetine and mirtazapine v. switching to mirtazapine, for patients with major depressive disorder (MDD) who have had an insufficient response to SSRI monotherapy (paroxetine) after the first 2 weeks of treatment.
This double-blind, randomized, placebo-controlled, three-arm study recruited participants from five hospitals in China. Eligible participants were aged 18–60 years with MDD of at least moderate severity. Participants received paroxetine during a 2-week open-label phase and patients who had not achieved early improvement were randomized to paroxetine, mirtazapine or paroxetine combined with mirtazapine for 6 weeks. The primary outcome was improvement on the Hamilton Rating Scale for Depression 17-item (HAMD-17) scores 6 weeks after randomization.
A total of 204 patients who showed early non-response to paroxetine monotherapy were randomly assigned to receive either mirtazapine and placebo (n = 68), paroxetine and placebo (n = 68) or mirtazapine and paroxetine (n = 68), with 164 patients completing the outcome assessment. At week 8, the least squares (LS) mean change of HAMD-17 scores did not significantly differ among the three groups, (12.98 points) in the mirtazapine group, (12.50 points) in the paroxetine group and (13.27 points) in the mirtazapine plus paroxetine combination group. Participants in the paroxetine monotherapy group were least likely to experience adverse effects.
After 8 weeks follow-up, paroxetine monotherapy, mirtazapine monotherapy and paroxetine/mirtazapine combination therapy were equally effective in non-improvers at 2 weeks. The results of this trial do not support a recommendation to routinely offer additional treatment or a switch in treatment strategies for MDD patients who do not show early improvement after 2 weeks of antidepressant treatment.
This umbrella review provides an overview of the consistency and gaps in the evidence base on eggs and cardiometabolic health.
PubMed, Web of Science, Cochrane Library, the Nutrition Evidence Systematic Review and Agency for Healthcare Research and Quality databases were screened for evidence-based reviews in English that assessed human studies on egg consumption and cardiometabolic outcomes.
Seven systematic reviews and fifteen meta-analyses were identified, with eighteen of these published since 2015. Overall, the systematic reviews were of low quality, while meta-analyses were of moderate- to high-quality. No association of increased egg intake and risks of heart disease or stroke in the general population were found in the meta-analyses. Increased risk of heart failure was noted in two meta-analyses that analysed the same three cohort studies. Five recent meta-analyses reported no increased risk of type 2 diabetes mellitus (T2DM) in the general population, although increased risk in US-based populations only has been reported. Older (<2013) meta-analyses reported increased risks of cardiovascular disease (CVD) or heart disease in T2DM populations, and no recent evidence-based reviews were identified. Finally, only one meta-analysis reported intervention studies specifically on eggs and biomarkers (i.e. lipids), and the results contradicted those from observation studies.
Recent evidence-based reviews conclude that increased egg consumption is not associated with CVD risk in the general population. More research is needed on the positive associations between egg consumption and heart failure and T2DM risk, as well as CVD risk in diabetics, before firm conclusions can be made.
‘DISCOVER’ one-day cognitive behavioural therapy (CBT) workshops have been developed to provide accessible, developmentally sensitive psychological support for older adolescents experiencing emotional difficulties. Previous school-based evaluations of the DISCOVER model have shown positive outcomes.
The current study aimed to test the model for clinically referred adolescents, in real-world settings.
A randomized controlled trial (RCT) assessed feasibility, acceptability and preliminary outcomes of the DISCOVER intervention, in comparison with usual care, for 15- to 18-year-olds with emotional difficulties. Participants were recruited from outpatient clinic waiting lists in UK child and adolescent mental health services (CAMHS). Research feasibility indicators included rates of recruitment, randomization, intervention participation (group workshops and individualized follow-up telephone calls), and data collection (at baseline and 8-week follow-up). Intervention acceptability was assessed using a structured service satisfaction questionnaire and semi-structured qualitative interviews with intervention participants. Preliminary clinical outcomes were explored using adolescent-reported validated measures of depression, anxiety and well-being.
n = 24 participants were randomized to intervention and usual care groups. Workshop attendance was good and high levels of treatment satisfaction were reported, although feasibility challenges emerged in recruitment and randomization. Trends were found towards potential improvements in anxiety and well-being for the intervention group, but the effect estimate for depression was imprecise; interpretability was also limited due to the small sample size.
DISCOVER appears to be a feasible and acceptable intervention model for clinically referred 15- to 18-year-olds with emotional difficulties. A full-scale RCT is warranted to evaluate effectiveness; protocol modifications may be necessary to ensure feasible recruitment and randomization procedures.
Older adults, especially those above age 80, are the fastest growing segment of the population in the United States and at risk for age-related cognitive decline and dementia. There is growing evidence that cognitive activity and training may allow adults to maintain or improve cognitive functioning, but little is known about the potential benefit in the oldest old. In this randomized trial, the effectiveness of a computerized cognitive training program (CCT program) was compared to an active control games program to improve cognition in cognitively normal individuals aged 80 and older.
Sixty-nine older adults were randomized to a 24-session CCT program (n = 39) or an active control program (n = 30). Participants completed a pre- and post- training neuropsychological assessment. The primary outcome measure was a global cognitive composite, and the secondary outcomes were the scores on specific cognitive domains (of memory, executive function/attention, and language).
Using linear mixed models, there were no significant differences between the CCT and the active control program on the primary (p = 0.662) or any of the secondary outcomes (language functioning, p = .628; attention/executive functioning, p = .428; memory, p = .749).
This study suggests that short-term CCT had no specific benefit for cognitive functioning in non-demented individuals aged 80 and older.
Although cognitive-behavioural therapy (CBT) is an effective treatment for depression, less than half of patients achieve satisfactory symptom reduction during treatment. Targeting known psychopathological processes such as rumination may increase treatment efficacy. The aim of this study was to test whether adding group rumination-focused CBT (RFCBT) that explicitly targets rumination to routine medical management is superior to adding group CBT to routine medical management in treating major depression.
A total of 131 outpatients with major depression were randomly allocated to 12 sessions group RFCBT v. group CBT, each in addition to routine medical management. The primary outcome was observer-rated symptoms of depression at the end of treatment measured on the Hamilton Rating Scale for Depression. Secondary outcomes were rumination at post-treatment and depressive symptoms at 6 months follow-up (Trial registered: NCT02278224).
RFCBT significantly improved observer-rated depressive symptoms (Cohen's d 0.38; 95% CI 0.03–0.73) relative to group CBT at post-treatment on the primary outcome. No post-treatment differences were found in rumination or in depressive symptoms at 6 months follow-up, although these secondary analyses may have been underpowered.
This is the first randomized controlled trial providing evidence of benefits of RFCBT in major depression compared with CBT. Group RFCBT may be a beneficial alternative to group CBT for major depression.
Randomized control trials (RCTs) comparing attention control training (ACT) and attention bias modification (ABM) in posttraumatic stress disorder (PTSD) have shown mixed results. The current RCT extends the extant literature by comparing the efficacy of ACT and a novel bias-contingent-ABM (BC-ABM), in which direction of training is contingent upon the direction of pre-treatment attention bias (AB), in a sample of civilian patients with PTSD.
Fifty treatment-seeking civilian patients with PTSD were randomly assigned to either ACT or BC-ABM. Clinician and self-report measures of PTSD and depression, as well as AB and attention bias variability (ABV), were acquired pre- and post-treatment.
ACT yielded greater reductions in PTSD and depressive symptoms on both clinician-rated and self-reported measures compared with BC-ABM. The BC-ABM condition successfully shifted ABs in the intended training direction. In the ACT group, there was no significant change in ABV or AB from pre- to post-treatment.
The current RCT extends previous results in being the first to apply ABM that is contingent upon AB at pre-treatment. This personalized BC-ABM approach is associated with significant reductions in symptoms. However, ACT produces even greater reductions, thereby emerging as a promising treatment for PTSD.
40% of people with dementia have disturbed sleep but there are currently no known effective treatments. Studies of sleep hygiene and light therapy have not been powered to indicate feasibility and acceptability and have shown 40–50% retention. We tested the feasibility and acceptability of a six-session manualized evidence-based non-pharmacological therapy; Dementia RElAted Manual for Sleep; STrAtegies for RelaTives (DREAMS-START) for sleep disturbance in people with dementia.
We conducted a parallel, two-armed, single-blind randomized trial and randomized 2:1 to intervention: Treatment as Usual. Eligible participants had dementia and sleep disturbances (scoring ≥4 on one Sleep Disorders Inventory item) and a family carer and were recruited from two London memory services and Join Dementia Research. Participants wore an actiwatch for two weeks pre-randomization. Trained, clinically supervised psychology graduates delivered DREAMS-START to carers randomized to intervention; covering Understanding sleep and dementia; Making a plan (incorporating actiwatch information, light exposure using a light box); Daytime activity and routine; Difficult night-time behaviors; Taking care of your own (carer's) sleep; and What works? Strategies for the future. Carers kept their manual, light box, and relaxation recordings post-intervention. Outcome assessment was masked to allocation. The co-primary outcomes were feasibility (≥50% eligible people consenting to the study) and acceptability (≥75% of intervention group attending ≥4 intervention sessions).
In total, 63out of 95 (66%; 95% CI: 56–76%) eligible referrals consented between 04/08/2016 and 24/03/2017; 62 (65%; 95% CI: 55–75%) were randomized, and 37 out of 42 (88%; 95% CI: 75–96%) adhered to the intervention.
DREAM-START for sleep disorders in dementia is feasible and acceptable.
Assertive Community Treatment (ACT) is an evidence-based treatment program for people with severe mental illness developed in high-income countries. We report the first randomized controlled trial of ACT in mainland China.
Sixty outpatients with schizophrenia with severe functional impairments or frequent hospitalizations were randomly assigned to ACT (n = 30) or standard community treatment (n = 30). The severity of symptoms and level of social functioning were assessed at baseline and every 3 months during the 1-year study. The primary outcome was the duration of hospital readmission. Secondary outcomes included a pre-post change in symptom severity, the rates of symptom relapse and gainful employment, social and occupational functioning, and quality of life of family caregivers.
Based on a modified intention-to-treat analysis, the outcomes for ACT were significantly better than those of standard community treatment. ACT patients were less likely to be readmitted [3.3% (1/30) v. 25.0% (7/28), Fisher's exact test p = 0.023], had a shorter mean readmission time [2.4 (13.3) v. 30.7 (66.9) days], were less likely to relapse [6.7% (2/30) v. 28.6% (8/28), Fisher's exact test p = 0.038], and had shorter mean time in relapse [3.5 (14.6) v. 34.4 (70.6) days]. The ACT group also had significantly longer times re-employed and greater symptomatic improvement and their caregivers experienced a greater improvement in their quality of life.
Our results show that culturally adapted ACT is both feasible and effective for individuals with severe schizophrenia in urban China. Replication studies with larger samples and longer duration of follow up are warranted.
Psychological treatment for functional somatic syndromes (FSS) has been found moderately effective. Information on how much treatment is needed to obtain improvement is sparse. We assessed the efficacy of a brief and extended version of group-based Acceptance and Commitment Therapy (ACT) v. enhanced care (EC) for patients with multiple FSS operationalised as Bodily Distress Syndrome multi-organ type.
In a randomised controlled three-armed trial, consecutively referred patients aged 20–50 with multiple FSS were randomly assigned to either (1) EC; (2) Brief ACT: EC plus 1-day workshop and one individual consultation; or (3) Extended ACT: EC plus nine 3-h group-based sessions. Primary outcome was patient-rated overall health improvement on the five-point clinical global improvement scale 14 months after randomisation. A proportional odds model was used for the analyses.
A total of 180 patients were randomised; 60 to EC, 61 to Brief ACT, and 59 to Extended ACT. Improvement on the primary outcome after Extended ACT was significantly greater than after EC with an unadjusted OR of 2.9 [95% CI (1.4–6.2), p = 0.006]. No significant differences were found between Brief ACT and EC. Of the 18 secondary outcomes, the only significant difference found was for physical functioning in the comparison of Extended ACT with EC.
Patients rated their overall health status as more improved after Extensive ACT than after EC; however, clinically relevant secondary outcome measures did not support this finding. Discrepancies between primary and secondary outcomes in this trial are discussed.
Recent open-label trials show that psychedelics, such as ayahuasca, hold promise as fast-onset antidepressants in treatment-resistant depression.
To test the antidepressant effects of ayahuasca, we conducted a parallel-arm, double-blind randomized placebo-controlled trial in 29 patients with treatment-resistant depression. Patients received a single dose of either ayahuasca or placebo. We assessed changes in depression severity with the Montgomery-Åsberg Depression Rating Scale (MADRS) and the Hamilton Depression Rating scale at baseline, and at 1 (D1), 2 (D2), and 7 (D7) days after dosing.
We observed significant antidepressant effects of ayahuasca when compared with placebo at all-time points. MADRS scores were significantly lower in the ayahuasca group compared with placebo at D1 and D2 (p = 0.04), and at D7 (p < 0.0001). Between-group effect sizes increased from D1 to D7 (D1: Cohen's d = 0.84; D2: Cohen's d = 0.84; D7: Cohen's d = 1.49). Response rates were high for both groups at D1 and D2, and significantly higher in the ayahuasca group at D7 (64% v. 27%; p = 0.04). Remission rate showed a trend toward significance at D7 (36% v. 7%, p = 0.054).
To our knowledge, this is the first controlled trial to test a psychedelic substance in treatment-resistant depression. Overall, this study brings new evidence supporting the safety and therapeutic value of ayahuasca, dosed within an appropriate setting, to help treat depression. This study is registered at http://clinicaltrials.gov (NCT02914769).
Background: Past reviews of cognitive behavioural therapy (CBT) for anger have focused on outcome in specific subpopulations, with few questions posed about research design and methodology. Since the turn of the century, there has been a surge of methodologically varied studies awaiting systematic review. Aims: The basic aim was to review this recent literature in terms of trends and patterns in research design, operationalization of anger, and covariates such as social desirability bias (SDB). Also of interest was clinical outcome. Method: After successive culling, 42 relevant studies were retained. These were subjected to a rapid evidence assessment (REA) with special attention to design (ranked on the Scientific Methods Scale) measurement methodology (self-monitored behaviour, anger questionnaires, and others’ ratings), SDB assessment, and statistical versus clinical significance. Results: The randomized controlled trial characterized 60% of the studies, and the State Trait Anger Expression Inventory was the dominant measure of anger. All but one of the studies reported statistically significant outcome, and all but one of the 21 studies evaluating clinical significance laid claim to it. The one study with neither statistical nor clinical significance was the only one that had assessed and corrected for SDB. Conclusions: Measures remain relatively narrow in scope, but study designs have improved, and the outcomes suggest efficacy and clinical effectiveness. In conjunction with previous findings of an inverse relationship between anger and SDB, the results raise the possibility that the favourable picture of CBT for anger may need closer scrutiny with SDB and other methodological details in mind.
Monozygotic (MZ) and dizygotic (DZ) twins participate in research that partitions variance in health, disease, and behavior into genetic and environmental components. However, there are other innovative roles for twins in medical research. One such way is involving MZ and/or DZ twins in co-twin control-designed randomized controlled trials (RCTs). To our knowledge, no reviews have been conducted that summarizes the involvement of twins in RCTs. Therefore, we conducted a systematic literature search using the U.S. Clinical Trials Database, NHS electronic databases, MEDLINE, EMBASE, and PsychINFO for RCTs on publications involving MZ and/or DZ twins as RCT participants. Out of the 186,027 clinical trials registered in the U.S. clinical trial register ClinicaTrails.gov, only six RCTs used twins as participants. From 1,598 articles identified in our search, 50 peer-reviewed English language publications met our pre-defined inclusion criteria. Sample sizes for RCTs have ranged from a total number of participants from 2 to 1,162; however, 32 (64%) studies had a sample size of 100 or less, and of those, 12 (24%) had fewer than 10. Both MZ and DZ twins have been recruited to the RCTs. In most instances (33/50) each twin from a pair were assigned to different study arms. Most of those studies included MZ twins only. Despite the methodological advantages, the use of MZ and DZ twins as participants in interventional RCTs appeared limited. The continuous development of innovative twin designs, especially RCTs, indicates that twin research can extend beyond the more widely recognized heritability estimates.
While junior clinical researchers at academic medical institutions across the US often desire to be actively engaged in randomized-clinical trials, they often lack adequate resources and research capacity to design and implement them. This insufficiency hinders their ability to generate a rigorous randomization scheme to minimize selection bias and yield comparable groups. Moreover, there are limited online user-friendly randomization tools. Thus, we developed a free robust randomization app (RRApp). RRApp incorporates 6 major randomization techniques: simple randomization, stratified randomization, block randomization, permuted block randomization, stratified block randomization, and stratified permuted block randomization. The design phase has been completed, including robust server scripts and a straightforward user-interface using the “shiny” package in R. Randomization schemes generated in RRApp can be input directly into the Research Electronic Data Capture (REDCap) system. RRApp has been evaluated by biostatisticians and junior clinical faculty at the Icahn School of Medicine at Mount Sinai. Constructive feedback regarding the quality and functionality of RRApp was also provided by attendees of the 2016 Association for Clinical and Translational Statisticians Annual Meeting. RRApp aims to educate early stage clinical trialists about the importance of randomization, while simultaneously assisting them, in a user-friendly fashion, to generate reproducible randomization schemes.
To examine the feasibility, efficacy, and effectiveness of PEGASUS, a group-based structured psychoeducation for adults with ADHD and their significant others.
A pragmatic parallel group add-on design multicenter randomized controlled trial was conducted, comparing an 8-session treatment with PEGASUS (allocated n = 97; 48 with ADHD and 49 with significant others) to treatment as usual (TAU, allocated n = 82; 39 with ADHD and 43 significant others). Participants (individuals with ADHD and significant others) were recruited from five psychiatric outpatient departments and block randomized to PEGASUS or TAU. Knowledge about ADHD was measured using the ADHD 20 scale pre- and post-intervention and served as primary outcome.
Knowledge about ADHD (d = 0.97 [95% CI: 0.61–1.31]) increased following PEGASUS participation compared to TAU. Improvements were also observed in secondary outcomes e.g. global life satisfaction (d = 0.25 [95% CI: from –0.09 to 0.59]). Overall treatment satisfaction was good. Over 90% of the participants completed the program. Post-intervention data was obtained from n = 89 in PEGASUS group and n = 70 in TAU group and analyses were conducted per protocol. No important adverse effects or side effects were observed.
Group-based structured psychoeducation PEGASUS for adults with ADHD and their significant others is a feasible, efficacious, and effective treatment option to increase ADHD knowledge and general life satisfaction in psychiatric outpatient care.
Cognitive behaviour therapy (CBT) and interpersonal psychotherapy (IPT) are the most studied psychotherapies for treatment of depression, but they are rarely directly compared particularly over the longer term. This study compares the outcomes of patients treated with CBT and IPT over 10 months and tests whether there are differential or general predictors of outcome.
A single centre randomised controlled trial (RCT) of depressed outpatients treated with weekly CBT or IPT sessions for 16 weeks and then 24 weeks of maintenance CBT or IPT. The principle outcome was depression severity measured using the MADRS. Pre-specified predictors of response were in four domains: demographic depression, characteristics, comorbidity and personality. Data were analysed over 16 weeks and 40 weeks using general linear mixed effects regression models.
CBT was significantly more effective than IPT in reducing depressive symptoms over the 10 month study largely because it appeared to work more quickly. There were no differential predictors of response to CBT v. IPT at 16 weeks or 40 weeks. Personality variables were most strongly associated with overall outcome at both 16 weeks and 40 weeks. The number of personality disorder symptoms and lower self-directness and reward dependence scores were associated with poorer outcome for both CBT and IPT at 40 weeks.
CBT and IPT are effective treatments for major depression over the longer term. CBT may work more quickly. Personality variables are the most relevant predictors of outcome.
The aim of this study was to assess the efficacy of meaning-centered group psychotherapy for cancer survivors (MCGP-CS) to improve personal meaning, compared with supportive group psychotherapy (SGP) and care as usual (CAU).
A total of 170 cancer survivors were randomly assigned to one of the three study arms: MCGP-CS (n = 57); SGP (n = 56); CAU (n = 57). The primary outcome measure was the Personal Meaning Profile (PMP; total score). Secondary outcome measures were subscales of the PMP, psychological well-being (Scales of Psychological Well-being; SPWB), post-traumatic growth (Posttraumatic Growth Inventory), Mental Adjustment to Cancer (MAC), optimism (Life Orientation Test-Revised), hopelessness (Beck's Hopelessness Scale), psychological distress (anxiety and depression, Hospital Anxiety and Depression Scale; HADS) and quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire; EORTC QLQ-C30). Outcome measures were assessed before randomization, post-intervention, and after 3 and 6 months of follow-up (FU).
Linear mixed model analyses (intention-to-treat) showed significant differences between MCGP-CS, SGP and CAU on the total PMP score, and on (sub)scales of the PMP, SPWB, MAC and HADS. Post-hoc analyses showed significantly stronger treatment effects of MCGP-CS compared with CAU on personal meaning (d = 0.81), goal-orientedness (d = 1.07), positive relations (d = 0.59), purpose in life (d = 0.69); fighting spirit (d = 0.61) (post-intervention) and helpless/hopeless (d = −0.87) (3 months FU); and distress (d = −0.6) and depression (d = −0.38) (6 months FU). Significantly stronger effects of MCGP-CS compared with SGP were found on personal growth (d = 0.57) (3 months FU) and environmental mastery (d = 0.66) (6 months FU).
MCGP-CS is an effective intervention for cancer survivors to improve personal meaning, psychological well-being and mental adjustment to cancer in the short term, and to reduce psychological distress in the long run.
Traditionally, benefit-cost analyses focus on average benefits and average costs. However, heterogeneous treatment effects and/or costs are most often present, which means that there is an efficiency potential hidden in the implementation of public programs, if policies can be targeted at those who, net of costs, benefit the most. We introduce efficiency potential defined as the ratio between the net benefit achieved under perfect selection of the individuals with significant positive net benefit of program participation, and the actually realized benefits net of costs. Using data from a randomized control-trial experiment of a Danish return-to-work program combined with rich administrative records and survey data, we find that there is indeed a potential for increased efficiency. Results from the treatment literature indicate that, generally, it may be difficult to harvest the full potential. Our application corroborates this finding.
Yoga and physical exercise have been used as adjunctive intervention for cognitive dysfunction in schizophrenia (SZ), but controlled comparisons are lacking.
A single-blind randomised controlled trial was designed to evaluate whether yoga training or physical exercise training enhance cognitive functions in SZ, based on a prior pilot study.
Consenting, clinically stable, adult outpatients with SZ (n=286) completed baseline assessments and were randomised to treatment as usual (TAU), supervised yoga training with TAU (YT) or supervised physical exercise training with TAU (PE). Based on the pilot study, the primary outcome measure was speed index for the cognitive domain of ‘attention’ in the Penn computerised neurocognitive battery. Using mixed models and contrasts, cognitive functions at baseline, 21 days (end of training), 3 and 6 months post-training were evaluated with intention-to-treat paradigm.
Speed index of attention domain in the YT group showed greater improvement than PE at 6 months follow-up (p<0.036, effect size 0.51). In the PE group, ‘accuracy index of attention domain showed greater improvement than TAU alone at 6-month follow-up (p<0.025, effect size 0.61). For several other cognitive domains, significant improvements were observed with YT or PE compared with TAU alone (p<0.05, effect sizes 0.30–1.97).
Both YT and PE improved attention and additional cognitive domains well past the training period, supporting our prior reported beneficial effect of YT on speed index of attention domain. As adjuncts, YT or PE can benefit individuals with SZ.
Family carers of people with dementia frequently report acting abusively toward them and carer psychological morbidity predicts this. We investigated whether START (STrAtegies for RelaTives), a psychological intervention which reduces depression and anxiety in family carers also reduces abusive behavior in carers of people living in their own homes. We also explored the longitudinal course of carer abusive behavior over two year.
We included self-identified family carers who gave support at least weekly to people with dementia referred in the previous year to three UK mental health services and a neurological dementia service. We randomly assigned these carers to START, an eight-session, manual-based coping intervention, or treatment as usual (TAU). Carer abusive behavior (Modified Conflict Tactic Scale (MCTS) score ≥2 representing significant abuse) was assessed at baseline, 4, 8, 12, and 24 months.
We recruited 260 carers, 173 to START and 87 to TAU. There was no evidence that abusive behavior levels differed between randomization groups or changed over time. A quarter of carers still reported significant abuse after two years, but those not acting abusively at baseline did not become abusive.
There was no evidence that START, which reduced carer anxiety and depression, reduced carer abusive behavior. For ethical reasons, we frequently intervened to manage concerning abuse reported in both groups, which may have disguised an intervention effect. Future dementia research should include elder abuse as an outcome, and consider carefully how to manage detected abuse.