Attention Placebo Research Articles

The effect of a single session of psychological first aid in the emergency department on PTSD and depressive symptoms three months post-intervention: results of a randomised controlled trial

ABSTRACT Background: Despite its popularity, evidence of the effectiveness of Psychological First Aid (PFA) is scarce. Objective: To assess whether PFA, compared to psychoeducation (PsyEd), an attention placebo control, reduces PTSD and depressive symptoms three months post-intervention. Methods: In two emergency departments, 166 recent-trauma adult survivors were randomised to a single session of PFA (n = 78) (active listening, breathing retraining, categorisation of needs, assisted referral to social networks, and PsyEd) or stand-alone PsyEd (n = 88). PTSD and depressive symptoms were assessed at baseline (T0), one (T1), and three months post-intervention (T2) with the PTSD Checklist (PCL-C at T0 and PCL-S at T1/T2) and the Beck Depression Inventory-II (BDI-II). Self-reported side effects, post-trauma increased alcohol/substance consumption and interpersonal conflicts, and use of psychotropics, psychotherapy, sick leave, and complementary/alternative medicine were also explored. Results: 86 participants (51.81% of those randomised) dropped out at T2. A significant proportion of participants in the PsyEd group also received PFA components (i.e. contamination). From T0 to T2, we did not find a significant advantage of PFA in reducing PTSD (p = .148) or depressive symptoms (p = .201). However, we found a significant dose–response effect between the number of delivered components, session duration, and PTSD symptom reduction. No significant difference in self-reported adverse effects was found. At T2, a smaller proportion of participants assigned to PFA reported increased consumption of alcohol/substances (OR = 0.09, p = .003), interpersonal conflicts (OR = 0.27, p = .014), and having used psychotropics (OR = 0.23, p = .013) or sick leave (OR = 0.11, p = .047). Conclusions: Three months post-intervention, we did not find evidence that PFA outperforms PsyEd in reducing PTSD or depressive symptoms. Contamination may have affected our results. PFA, nonetheless, appears to be promising in modifying some post-trauma behaviours. Further research is needed.

Intentional Imperfection Program: A pilot randomised controlled trial to help university students manage perfectionism

Given that perfectionism has been associated with interpersonal, academic, and mental health difficulties in university students, helping them manage their perfectionism is crucial. This pilot trial examined the feasibility, acceptability, and potential efficacy of an online perfectionism program designed to target the mechanisms that link perfectionism to psychological distress. Seventy first-year psychology students from Macquarie University with high levels of perfectionism were recruited into this two-arm pilot trial and randomised to either the intervention (i.e., perfectionism program) or attention placebo control (i.e., lifestyle program) condition. We assessed indicators of feasibility and acceptability, as well as measures related to perfectionism, psychological distress, emotion regulation skills, interpersonal and academic functioning at baseline, one-month post treatment, and three-month follow-up (blinded outcome assessment). Our analyses revealed that, while participants expressed overall satisfaction with the program, there was low engagement with it (Mcompletion rate=36.23%), and retention in the study was low (response rates for post-treatment: 65.71% and follow-up: 48.57%). Bearing this in mind, our linear mixed model analyses revealed greater reductions in perfectionistic traits and cognitions, interpersonal hostility, and loneliness, as well as increases in self-compassion in the intervention group compared to the control group at post-treatment and/or follow-up. However, we did not observe statistically significant changes in other important treatment outcomes (e.g.,psychological distress). Given these findings, adjustments to improve engagement and retention should occur before proceeding with a larger, definitive trial. This trial was retrospectively registered on the Australian and New Zealand Clinical Trials Registry (no. ACTRN12622000960752).

Evaluating the impact of short animated videos on COVID-19 vaccine hesitancy: An online randomized controlled trial

Addressing the global challenge of vaccine hesitancy, amplified during the COVID-19 pandemic due to misinformation propagated via social media, necessitates innovative health communication strategies. This investigation scrutinizes the efficacy of Short, Animated, Story-based (SAS) videos in fostering knowledge, behavioral intent, and engagement around COVID-19 vaccination.We conducted an online three-arm parallel randomized controlled trial (RCT) involving 792 adult participants (≥18 years, English-speaking) from the United States. The intervention group viewed a SAS video on COVID-19 vaccination, the attention placebo control group watched a SAS video on hope, and the control group received no intervention. Our primary objectives were to assess the influence of SAS videos on knowledge, behavioral intent, and engagement regarding COVID-19 vaccination.Participants in the intervention group displayed significantly higher mean knowledge scores (20.6, 95 % CI: 20.3–20.9) compared to both the attention placebo control (18.8, 95 % CI: 18.5–19.1, P < .001) and control groups (18.7, 95 % CI: 18.4–19.0, P < .001). However, SAS videos did not notably affect behavioral intent. Perception of COVID-19 as a significant health threat emerged as a strong predictor for engaging with the post-trial video without further incentives (OR: 0.44; 95 % CI: 0.2–0.96). The 35–44 age group exhibited the highest post-trial engagement (P = .006), whereas right-wing political inclination negatively associated with engagement (OR: 1.98; 95 % CI: 3.9–1.01). Vaccination status correlated significantly with self-efficacy (P < .001), perceived social norms (P < .001), and perceived response efficacy of the COVID-19 vaccine (P < .001), all heightened in the intervention group.These findings suggest that while SAS videos effectively amplify COVID-19 vaccination knowledge, their impact on behavioral intent is not direct. They do, however, affect determinants of vaccination status, thereby indirectly influencing vaccination behavior. The study highlights the appeal of SAS videos among younger audiences, but underscores the need for further examination of factors impeding vaccination engagement. As SAS videos closely mirror conventional social media content, they hold significant potential as a public health communication tool on these platforms.Trial Registration: Trial was registered at drks.de with the identifier DRKS00027938, on 5 January 2022.

Correction to Maheu et al. (2023).

Most fear of cancer recurrence (FCR) interventions have small effects, and few target FCR. This randomized controlled trial (RCT) with breast and gynecological cancer survivors evaluated the efficacy of a cognitive-existential fear of recurrence therapy (FORT) compared to an attention placebo control group (living well with cancer [LWWC]) on FCR. One hundred and sixty-four women with clinical levels of FCR and cancer distress were randomly assigned to 6-weekly, 120 min FORT (n = 80) or LWWC (n = 84) group sessions. They completed questionnaires at baseline (T1), posttreatment (T2; primary endpoint), 3 (T3), and 6 months (T4) posttreatment. Generalized linear models were used to compare group differences in the fear of cancer recurrence inventory (FCRI) total score and secondary outcomes. FORT participants experienced greater reductions from T1 to T2 on FCRI total with a between-group difference of -9.48 points (p = .0393), resulting in a medium effect of -0.530, with a maintained effect at T3 (p = .0330) but not at T4. For the secondary outcomes, improvements were in favor of FORT, including FCRI triggers (p = .0208), FCRI coping (p = .0351), cognitive avoidance (p = .0155), need for reassurance from physicians (p = .0117), and quality of life (mental health; p = .0147). This RCT demonstrated that FORT, compared to an attention placebo control group, resulted in a greater reduction in FCR posttreatment and at 3 months posttreatment in women with breast and gynecological cancer, indicating its potential as a new treatment strategy. We recommend a booster session to sustain gains. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Effectiveness of Group Cognitive Behavioral Therapy in Insight and Treatment Adherence in Schizophrenic Patients: A Randomized Controlled Trial

Background: The rate of treatment adherence in patients with schizophrenia is lower than average, and they have insufficient insight in this regard. Objectives: The present study was designed to assess the effectiveness of group cognitive behavioral therapy (GCBT) in the improvement of insight and treatment adherence in schizophrenic patients. Methods: In this randomized controlled trial, accomplished in Shiraz Psychiatric Hospital, Shiraz, Iran, from October 2021 to January 2022, 22 eligible participants were assigned to either intervention, therapist’s attention placebo, and control groups via simple randomization. In the intervention group, a treatment program was performed in seven 90-minute sessions based on a treatment protocol adapted from Robert Paul Lieberman’s 16-session community return program. The therapist’s placebo group also watched documentaries for seven sessions. The control group received only their usual treatments, which included a visit to a psychiatrist. The data were gathered using the Insight and Treatment Attitudes Questionnaire and the Medication Adherence Rating Scale at three different time points. Results: At baseline, the mean scores of insight and medication adherence were not significantly different between all the groups. After the intervention, the results showed significant differences in insight levels (P = 0.001) and medication adherence (P = 0.003). Three months after the intervention, the results showed significant differences in insight levels and medication adherence (P = 0.001). The differences in the mean scores of insight levels and medication adherence in post-intervention and 3-month follow-up were only significant in the intervention group (P = 0.001). Conclusions: Based on the evidence from this study, GCBT is an effective treatment for improving insight and medication adherence in schizophrenic patients. Therefore, it is necessary to pay attention to the use of GCBT to increase compliance with drug treatment.

A short, animated storytelling video about sodium intake as a major cardiovascular risk factor and recommendations for a healthy diet: an online, randomized, controlled trial

BackgroundIncreased uptake of sodium is a major cause for cardiovascular disease and mortality. Reduction of daily salt intake below a reference level of 2 g per day (the equivalent to 5 g salt/day) is known to effectively reduce cardiovascular mortality. The widespread use of social media, with a constant increase in video consumption, is opening new avenues for the dissemination of innovative and scalable approaches to health-related information and recommendations for a healthy diet, such as via video interventions with short animated stories (SAS).ObjectiveThis study will evaluate the effect of a sodium intake-SAS video intervention on immediate and medium-term knowledge about dietary sodium. Beyond that, immediate and medium-term effects on behavioral expectation to reduce sodium intake as well as voluntary post-trial engagement with the video content will be examined.MethodsIn this 4-armed, parallel, randomized controlled trial, 10,000 adult, US participants will be randomly assigned to (1) a short, animated storytelling intervention video on sodium as a cardiovascular disease risk factor followed by surveys assessing the facts on sodium and cardiovascular disease conveyed in the video (2) the surveys only, (3) an attention placebo control video followed by the before mentioned surveys, and (4) an arm that is exposed to neither the video nor the surveys. Two weeks later, participants in all four arms will complete all of the surveys.ResultsPrimary outcomes are the immediate and medium-term effects of the short, animated storytelling intervention video on knowledge about dietary sodium. Secondary outcomes are immediate and medium-term effects of the short, animated storytelling intervention on behavioral expectation to reduce sodium intake as well as voluntary post-trial engagement with the video content.ConclusionThis study will extend the knowledge on the effects of short, animated storytelling for the containment of the global cardiovascular disease burden. Knowledge on the groups that may be more likely to voluntarily engage with SAS video content will help to improve targeting of future interventions towards audiences at risk.Trial registration {2a}ClinicalTrials.gov NCT05735457. Registered on February 21, 2023.

Fear of cancer recurrence therapy (FORT): A randomized controlled trial.

Most fear of cancer recurrence (FCR) interventions have small effects, and few target FCR. This randomized controlled trial (RCT) with breast and gynecological cancer survivors evaluated the efficacy of a cognitive-existential fear of recurrence therapy (FORT) compared to an attention placebo control group (living well with cancer [LWWC]) on FCR. One hundred and sixty-four women with clinical levels of FCR and cancer distress were randomly assigned to 6-weekly, 120 min FORT (n = 80) or LWWC (n = 84) group sessions. They completed questionnaires at baseline (T1), posttreatment (T2; primary endpoint), 3 (T3), and 6 months (T4) posttreatment. Generalized linear models were used to compare group differences in the fear of cancer recurrence inventory (FCRI) total score and secondary outcomes. FORT participants experienced greater reductions from T1 to T2 on FCRI total with a between-group difference of -9.48 points (p = .0393), resulting in a medium effect of -0.530, with a maintained effect at T3 (p = .0330) but not at T4. For the secondary outcomes, improvements were in favor of FORT, including FCRI triggers (p = .0208), FCRI coping (p = .0351), cognitive avoidance (p = .0155), need for reassurance from physicians (p = .0117), and quality of life (mental health; p = .0147). This RCT demonstrated that FORT, compared to an attention placebo control group, resulted in a greater reduction in FCR posttreatment and at 3 months posttreatment in women with breast and gynecological cancer, indicating its potential as a new treatment strategy. We recommend a booster session to sustain gains. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Should cognitive restructuring precede imagery rescripting? An experimental pilot study

Background and objectivesImagery rescripting (ImRs) is a promising therapeutic technique used in treatment for a variety of psychiatric disorders. During an ImRs session, an aversive disorder-related memory, is activated in imagination and rescripted to a more positive outcome. It has been shown to successfully weaken the negative cognitive meaning, so-called encapsulated beliefs of the targeted aversive memory. In many studies, ImRs is preceded by a cognitive restructuring (CR) technique focused on the encapsulated belief of the target memory. It is not clear whether adding such a CR technique is necessary or that ImRs as standalone technique can achieve comparable effects. MethodsStudents with mild psychological distress (N = 53) were randomized over one session of cognitive restructuring plus imagery rescripting (CR + ImRs), a therapist attention placebo plus imagery rescripting (PLA + ImRs) and a double therapist attention placebo (PLA + PLA). Believability of the idiosyncratic encapsulated belief (primary outcome) and quality (vividness, distress and emotional connotation: secondary outcome) of the target memory were assessed at pre, post and at 1-week follow-up. ResultsResults indicate that both, CR + ImRs and PLA + ImRs, reduced the believability of the encapsulated beliefs in greater extent than PLA + PLA. No differences appeared between the two ImRs conditions. For the secondary outcomes no differences between the three conditions were found. LimitationsThis study should be seen as a pilot study, moreover a non-clinical sample was used. ConclusionFindings suggest that a CR technique preceding ImRs is redundant. However, this study needs replication in a larger sample.

Effect of Telmisartan on Walking Performance in Patients With Lower Extremity Peripheral Artery Disease

Patients with lower extremity peripheral artery disease (PAD) have reduced lower extremity perfusion, impaired lower extremity skeletal muscle function, and poor walking performance. Telmisartan (an angiotensin receptor blocker) has properties that reverse these abnormalities. To determine whether telmisartan improves 6-minute walk distance, compared with placebo, in patients with lower extremity PAD at 6-month follow-up. Double-blind, randomized clinical trial conducted at 2 US sites and involving 114 participants. Enrollment occurred between December 28, 2015, and November 9, 2021. Final follow-up occurred on May 6, 2022. The trial randomized patients using a 2 × 2 factorial design to compare the effects of telmisartan plus supervised exercise vs telmisartan alone and supervised exercise alone and to compare telmisartan alone vs placebo. Participants with PAD were randomized to 1 of 4 groups: telmisartan plus exercise (n = 30), telmisartan plus attention control (n = 29), placebo plus exercise (n = 28), or placebo plus attention control (n = 27) for 6 months. The originally planned sample size was 240 participants. Due to slower than anticipated enrollment, the primary comparison was changed to the 2 combined telmisartan groups vs the 2 combined placebo groups and the target sample size was changed to 112 participants. The primary outcome was the 6-month change in 6-minute walk distance (minimum clinically important difference, 8-20 m). The secondary outcomes were maximal treadmill walking distance; Walking Impairment Questionnaire scores for distance, speed, and stair climbing; and the 36-Item Short-Form Health Survey physical functioning score. The results were adjusted for study site, baseline 6-minute walk distance, randomization to exercise vs attention control, sex, and history of heart failure at baseline. Of the 114 randomized patients (mean age, 67.3 [SD, 9.9] years; 46 were women [40.4%]; and 81 were Black individuals [71.1%]), 105 (92%) completed 6-month follow-up. At 6-month follow-up, telmisartan did not significantly improve 6-minute walk distance (from a mean of 341.6 m to 343.0 m; within-group change: 1.32 m) compared with placebo (from a mean of 352.3 m to 364.8 m; within-group change: 12.5 m) and the adjusted between-group difference was -16.8 m (95% CI, -35.9 m to 2.2 m; P = .08). Compared with placebo, telmisartan did not significantly improve any of the 5 secondary outcomes. The most common serious adverse event was hospitalization for PAD (ie, lower extremity revascularization, amputation, or gangrene). Three participants (5.1%) in the telmisartan group and 2 participants (3.6%) in the placebo group were hospitalized for PAD. Among patients with PAD, telmisartan did not improve 6-minute walk distance at 6-month follow-up compared with placebo. These results do not support telmisartan for improving walking performance in patients with PAD. ClinicalTrials.gov Identifier: NCT02593110.

Systems analysis and improvement approach to optimize outpatient mental health treatment cascades in Mozambique (SAIA-MH): study protocol for a cluster randomized trial

BackgroundSignificant investments are being made to close the mental health (MH) treatment gap, which often exceeds 90% in many low- and middle-income countries (LMICs). However, limited attention has been paid to patient quality of care in nascent and evolving LMIC MH systems. In system assessments across sub-Saharan Africa, MH loss-to-follow-up often exceeds 50% and sub-optimal medication adherence often exceeds 60%. This study aims to fill a gap of evidence-based implementation strategies targeting the optimization of MH treatment cascades in LMICs by testing a low-cost multicomponent implementation strategy integrated into routine government MH care in Mozambique.MethodsUsing a cluster-randomized trial design, 16 clinics (8 intervention and 8 control) providing primary MH care will be randomized to the Systems Analysis and Improvement Approach for Mental Health (SAIA-MH) or an attentional placebo control. SAIA-MH is a multicomponent implementation strategy blending external facilitation, clinical consultation, and provider team meetings with system-engineering tools in an overall continuous quality improvement framework. Following a 6-month baseline period, intervention facilities will implement the SAIA-MH strategy for a 2-year intensive implementation period, followed by a 1-year sustainment phase. Primary outcomes will be the proportion of all patients diagnosed with a MH condition and receiving pharmaceutical-based treatment who achieve functional improvement, adherence to medication, and retention in MH care. The Consolidated Framework for Implementation Research (CFIR) will be used to assess determinants of implementation success. Specific Aim 1b will include the evaluation of mechanisms of the SAIA-MH strategy using longitudinal structural equation modeling as well as specific aim 2 estimating cost and cost-effectiveness of scaling-up SAIA-MH in Mozambique to provincial and national levels.DiscussionThis study is innovative in being the first, to our knowledge, to test a multicomponent implementation strategy for MH care cascade optimization in LMICs. By design, SAIA-MH is a low-cost strategy to generate contextually relevant solutions to barriers to effective primary MH care, and thus focuses on system improvements that can be sustained over the long term. Since SAIA-MH is integrated into routine government MH service delivery, this pragmatic trial has the potential to inform potential SAIA-MH scale-up in Mozambique and other similar LMICs.Trial registrationClinicalTrials.gov; NCT05103033; 11/2/2021.

Characterizing Nature Videos for an Attention Placebo Control for MBSR: The Development of Nature-Based Stress Reduction (NBSR)

Characterizing Nature Videos for an Attention Placebo Control for MBSR: The Development of Nature-Based Stress Reduction (NBSR)

Unguided Computer-Assisted Self-Help Interventions Without Human Contact in Patients With Obsessive-Compulsive Disorder: Systematic Review and Meta-analysis.

BackgroundComputer-assisted treatment may reduce therapist contact and costs and promote client participation. This meta-analysis examined the efficacy and acceptability of an unguided computer-assisted therapy in patients with obsessive-compulsive disorder (OCD) compared with a waiting list or attention placebo.ObjectiveThis study aimed to evaluate the effectiveness and adherence of computer-assisted self-help treatment without human contact in patients with OCD using a systematic review and meta-analysis approach.MethodsRandomized controlled trials with participants primarily diagnosed with OCD by health professionals with clinically significant OCD symptoms as measured with validated scales were included. The interventions included self-help treatment through the internet, computers, and smartphones. We excluded interventions that used human contact. We conducted a search on PubMed, Cochrane Central Register of Controlled Trials, EMBASE, World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov, as well as the reference lists of the included studies. The risk of bias was evaluated using version 2 of the Cochrane risk-of-bias tool for randomized trials. We calculated the standardized mean differences for continuous outcomes and risk ratios for dichotomous outcomes. The primary outcomes were short-term improvement of OCD symptoms measured by validated scales and dropout for any reason.ResultsWe included 11 randomized controlled trials with a total of 983 participants. The results indicated that unguided computer-assisted self-help therapy was significantly more effective than a waiting list or psychological placebo (standard mean difference −0.47, 95% CI −0.73 to −0.22). Unguided computer-assisted self-help therapy had more dropouts for any reason than waiting list or psychological placebo (risk ratio 1.98, 95% CI 1.21 to 3.23). However, the quality of evidence was very low because of the risk of bias and inconsistent results among the included studies. The subgroup analysis showed that exposure response and prevention and an intervention duration of more than 4 weeks strengthen the efficacy without worsening acceptability. Only a few studies have examined the interaction between participants and systems, and no study has used gamification. Most researchers only used text-based interventions, and no study has used a mobile device. The overall risk of bias of the included studies was high and the heterogeneity of results was moderate to considerable.ConclusionsUnguided computer-assisted self-help therapy for OCD is effective compared with waiting lists or psychological placebo. An exposure response and prevention component and intervention duration of more than 4 weeks may strengthen the efficacy without worsening the acceptability of the therapy.Trial RegistrationPROSPERO (International Prospective Register of Systematic Reviews) CRD42021264644; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=264644

Emotional distress in neuro-ICU survivor-caregiver dyads: The recovering together randomized clinical trial.

Emotional distress is common in both survivors and their informal caregivers following admission to a neuroscience intensive care unit (Neuro-ICU) and can negatively affect their individual recovery and quality of life. Neuro-ICU survivor-caregiver dyads can influence each other's emotional distress over time, but whether such influence emerges during dyadic treatment remains unknown. The present study involved secondary data analysis of Neuro-ICU dyads enrolled in a randomized clinical trial of a dyadic resiliency intervention, Recovering Together (RT), versus a health education attention placebo control to test dyadic similarities in emotional distress before and after treatment. Data were collected from 58 dyads following Neuro-ICU admission. Emotional distress (depression, anxiety, and posttraumatic stress) was assessed at baseline, 6 weeks (postintervention), and 12 weeks later. Nonindependence within survivor-caregiver dyads was examined (i.e., correlations between cross-sectional symptoms and changes in symptoms over time); mutual influence of emotional functioning over time (i.e., "partner effects") was examined using cross-lagged path analyses. There were strong, positive cross-sectional correlations between survivor and caregiver distress at postintervention and follow-up and between changes in survivor and caregiver distress from baseline to postintervention and postintervention to follow-up. There were no partner effects. Neuro-ICU survivors and their informal caregivers show similar changes in emotional distress after treatment. These findings highlight the potential benefits of intervening on both survivor and caregiver distress following Neuro-ICU admission. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

A first remotely-delivered guided brief intervention to reduce intrusive memories of psychological trauma for healthcare staff working during the ongoing COVID-19 pandemic: Study protocol for a randomised controlled trial

Addressing the mental health needs of healthcare staff exposed to psychologically traumatic events at work during the COVID-19 pandemic is a pressing global priority. We need to swiftly develop interventions to target the psychological consequences (e.g., persistent intrusive memories of trauma). Interventions for healthcare staff must be brief, flexible, fitted around the reality and demands of working life under the pandemic, and repeatable during ongoing/further trauma exposure. Intervention delivery during the pandemic should be remote to mitigate risk of infection; e.g., here using a blend of digitalized self-administered materials (e.g., video instructions) and guided (remote) support from a researcher. This parallel groups, two-arm, randomised controlled trial (RCT) with healthcare staff working during the COVID-19 pandemic is the first evaluation of whether a digitalized form of a brief cognitive task intervention, which is remotely-delivered (guided), reduces intrusive memories. Healthcare staff who experience intrusive memories of work-related traumatic event(s) during the COVID-19 pandemic (≥2 in the week before inclusion) will be randomly allocated (1:1) to receive either the cognitive task intervention or an active (attention placebo) control, and followed up at 1-week, 1-month, 3-months, and 6-months post-intervention. The primary outcome will be the number of intrusive memories reported during Week 5; secondary and other outcomes include the number of intrusive memories reported during Week 1, and other intrusive symptoms. Findings will inform further development and dissemination of a brief cognitive task intervention to target intrusive memories.

Virtual Reality Game and Autogenic Relaxation on Pruritus, Anxiety and Dermatologic Quality of Life in Hemodialysis Patients: Attention Placebo Controlled Randomized Trial

Virtual Reality Game and Autogenic Relaxation on Pruritus, Anxiety and Dermatologic Quality of Life in Hemodialysis Patients: Attention Placebo Controlled Randomized Trial

Behavioural and cognitive behavioural therapy for obsessive compulsive disorder (OCD) in individuals with autism spectrum disorder (ASD).

Autistic spectrum disorder (ASD) is an increasingly recognised neurodevelopmental condition; that is, a neurologically-based condition which interferes with the acquisition, retention or application of specific skills. ASD is characterised by challenges with socialisation and communication, and by stereotyped and repetitive behaviours. A stereotyped behaviour is one which is repeated over and over again and which seems not to have any useful function. ASD often co-occurs with mental health disorders, including obsessive compulsive disorder (OCD). People with ASD may show certain cognitive differences (i.e. differences in ways of thinking) which influence their response to therapies. Thus, there is a need for evidence-based guidelines to treat mental health issues in this group. OCD,a common condition characterised by repeated obsessional thoughts and compulsive acts, occurs with greater frequency in persons with ASD than in the general population. Genetic, anatomic, neurobiologicaland psychological factors have been proposed to explain this co-occurrence. However, care should be taken to distinguish stereotyped and repetitive behaviours characteristic of ASD from obsessive compulsive acts in OCD. Cognitive behavioural therapy (CBT) is the recommended treatment for OCD, but studies have suggested that this treatment may be less effective in those with OCD co-occurring with ASD. Hence, modifications to CBT treatment may be helpful when treating OCD co-occurring with ASD to optimise outcomes. To assess the effectiveness of behavioural and cognitive behavioural therapy for obsessive compulsive disorder (OCD) in children and adults with autism spectrum disorder (ASD). We searched for studies in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, PsycINFO, five other bibliographic databases, international trial registries and other sources of grey literature (to 24 August 2020). We checked the reference lists of included studies and relevant systematic reviews to identify additional studies missed from the original electronic searches. We contacted subject experts for further information when needed. We included randomised controlled trials (RCTs), cross-over, cluster- and quasi-randomised controlled trials involving both adults and children with diagnoses of OCD and ASD. We included studies of participants with co-occurring conditions (i.e. those experiencing other mental illnesses or neurodevelopmental conditions at the same time), but we did not include individuals who had a co-occurring global learning difficulty. Treatment could be in any setting or format and include behavioural therapy (BT) and cognitive behavioural therapy (CBT), which may have been adapted for those with ASD. Comparator interventions included no treatment, waiting list, attention placebo (where the control group receives non-specific aspects of therapy, but not the active ingredient) and treatment as usual (TAU, where the control group receives the usual treatment, according to accepted standards). Three review authors independently screened studies for inclusion. The authors extracted relevant data from the one eligible study, assessed the risk of bias and certainty of evidence (GRADE). Outcomes of interest were changes in OCD symptoms and treatment completion (primary outcome), and severity of depressive symptoms, anxiety symptoms and behavioural difficulties, as well as degree of family accommodation (secondary outcomes). We did not conduct meta-analyses as only one study met the selection criteria. We included only one RCT of 46 participants in our analysis. This study compared CBT for OCD in persons with high-functioning ASD with a control group who received anxiety management only. There were no differences in rates of treatment completion between the CBT (87%) and anxiety management (87%) groups (risk ratio (RR) 1.00, 95% confidence interval (CI) 0.80 to 1.25; low-certainty evidence). Behavioural difficulties were not included as an outcome measure in the study.This study showed that there may be a benefit at the end of treatment favouring CBT compared with anxiety management in OCD symptoms (mean difference (MD) -3.00, 95% CI -8.02 to 2.02), depression symptoms (MD -1.80, 95% CI -11.50 to 7.90), anxiety symptoms (MD -3.20, 95% CI -11.38 to 4.98), and quality of life (MD 5.20, 95% CI -1.41 to 11.81), but the evidence was of low certainty. AUTHORS' CONCLUSIONS: Evidence is limited regarding the efficacy of CBT for treatment of OCD in ASD. There is much scope for future study, not only examining the efficacy of CBT for OCD in ASD, but also the particular ways that OCD manifests in and affects people with ASD and the role of the family in treatment response.

The Effect of a Wordless, Animated, Social Media Video Intervention on COVID-19 Prevention: Online Randomized Controlled Trial.

BackgroundInnovative approaches to the dissemination of evidence-based COVID-19 health messages are urgently needed to counter social media misinformation about the pandemic. To this end, we designed a short, wordless, animated global health communication video (the CoVideo), which was rapidly distributed through social media channels to an international audience.ObjectiveThe objectives of this study were to (1) establish the CoVideo’s effectiveness in improving COVID-19 prevention knowledge, and (2) establish the CoVideo’s effectiveness in increasing behavioral intent toward COVID-19 prevention.MethodsIn May and June 2020, we enrolled 15,163 online participants from the United States, Mexico, the United Kingdom, Germany, and Spain. We randomized participants to (1) the CoVideo arm, (2) an attention placebo control (APC) arm, and (3) a do-nothing arm, and presented 18 knowledge questions about preventive COVID-19 behaviors, which was our first primary endpoint. To measure behavioral intent, our second primary endpoint, we randomized participants in each arm to five list experiments.ResultsGlobally, the video intervention was viewed 1.2 million times within the first 10 days of its release and more than 15 million times within the first 4 months. Knowledge in the CoVideo arm was significantly higher (mean 16.95, 95% CI 16.91-16.99) than in the do-nothing (mean 16.86, 95% CI 16.83-16.90; P<.001) arm. We observed high baseline levels of behavioral intent to perform many of the preventive behaviors featured in the video intervention. We were only able to detect a statistically significant impact of the CoVideo on one of the five preventive behaviors.ConclusionsDespite high baseline levels, the intervention was effective at boosting knowledge of COVID-19 prevention. We were only able to capture a measurable change in behavioral intent toward one of the five COVID-19 preventive behaviors examined in this study. The global reach of this health communication intervention and the high voluntary engagement of trial participants highlight several innovative features that could inform the design and dissemination of public health messages. Short, wordless, animated videos, distributed by health authorities via social media, may be an effective pathway for rapid global health communication during health crises.Trial RegistrationGerman Clinical Trials Register DRKS00021582; https://tinyurl.com/6r4zkbbnInternational Registered Report Identifier (IRRID)RR2-10.1186/s13063-020-04942-7

Motivational interviewing with community-dwelling older adults after hip fracture (MIHip): protocol for a randomised controlled trial

IntroductionCommunity-dwelling people recovering from hip fracture have the physical capacity to walk in their community but lack the confidence to do so. The primary aim of this trial is to...

Can a Dyadic Resiliency Program Improve Quality of Life in Cognitively Intact Dyads of Neuro-ICU Survivors and Informal Caregivers? Results from a Pilot RCT.

Neuro-ICU hospitalization for an acute neurological illness is often traumatic and associated with heightened emotional distress and reduced quality of life (QoL) for both survivors and their informal caregivers (i.e., family and friends providing unpaid care). In a pilot study, we previously showed that a dyadic (survivor and caregiver together) resiliency intervention (Recovering Together [RT]) was feasible and associated with sustained improvement in emotional distress when compared with an attention placebo educational control. Here we report on changes in secondary outcomes assessing QoL. Survivors (n = 58) and informal caregivers (n = 58) completed assessments at bedside and were randomly assigned to participate together as a dyad in the RT or control intervention (both 6weeks, two in-person sessions at bedside and four sessions via live video post discharge). We measured QoL domain scores (physical health, psychological, social relations, and environmental), general QoL, and QoL satisfaction using the World Health Organization Quality of Life Abbreviated Instrument at baseline, post treatment, and 3months' follow-up. We conducted mixed model analyses of variance with linear contrasts to estimate (1) within-group changes in QoL from baseline to post treatment and from post treatment to 3months' follow-up and (2) between-group differences in changes in QoL from baseline to post treatment and from post treatment to 3months' follow-up. We found significant within-group improvements from baseline to post treatment among RT survivors for physical health QoL (mean difference 1.73; 95% confidence interval [CI] 0.39-3.06; p = 0.012), environmental QoL (mean difference 1.29; 95% CI 0.21-2.36; p = 0.020), general QoL (mean difference 0.55; 95% CI 0.13-0.973; p = 0.011), and QoL satisfaction (mean difference 0.87; 95% CI 0.36-1.37; p = 0.001), and those improvements sustained through the 3-month follow-up. We found no significant between-group improvements for survivors or caregivers from baseline to post treatment or from post treatment to 3months' follow-up for any QoL variables (i.e., domains, general QoL, and QoL satisfaction together). In this pilot study, we found improved QoL among survivors, but not in caregivers, who received RT and improvements sustained over time. These RT-related improvements were not significantly greater than those observed in the control. Results support a fully powered randomized controlled trial to allow for a definitive evaluation of RT-related effects among dyads of survivors of acute brain injury and their caregivers.

An entertainment-education approach to prevent COVID-19 spread: study protocol for a multi-site randomized controlled trial

BackgroundEntertainment-education (E-E) media can improve behavioral intent toward health-related practices. In the era of COVID-19, millions of people can be reached by E-E media without requiring any physical contact. We have designed a short, wordless, animated video about preventive COVID-19 behaviors that can be rapidly distributed through social media channels to a global audience. The E-E video’s effectiveness, however, remains unclear.Methods/designThis is a multi-site, parallel group, randomized controlled trial comparing the effectiveness of an E-E video on COVID-19 against (i) an attention placebo control (APC) video and (ii) no video. For our primary outcomes, we will measure knowledge about preventive COVID-19 behaviors. We will also use a list randomization approach to measure behavioral intent toward preventative COVID-19 behaviors. In each trial arm, participants will be randomized to a control list or a control list plus an item about social distancing, washing hands, cleaning household surfaces, sharing of eating utensils, and the stockpiling of essential goods. Using an online platform, we will recruit 17,010 participants (aged 18–59 years) from the USA, the UK, Germany, Spain, France, and Mexico.Trial registrationGerman Clinical Trials Register #DRKS00021582. Registered on May 12, 2020.DiscussionThis trial will utilize several randomization procedures, list experimentation methods, and state-of-the-art online technology to demonstrate the effectiveness of an E-E video to improve knowledge of, and behavioral intent toward, the prevention of COVID-19. Our results will inform future E-E video campaigns for COVID-19 and similar public health intervention needs.