Operationalizing multi-site Community Engagement (CE) Studios to inform a research program is valuable for researchers. We describe the process and outcomes of hosting three CE Studios with Community Experts aged 65 years or older with chronic conditions and care partners of older adults. Experts gave feedback about processes for testing the feasibility, efficacy, effectiveness, and implementation of audio recording clinic visits and sharing recordings with patients who have multimorbidity and their care partners.

The CE Cores of the Clinical and Translational Science Awards Programs at three academic health science centers created a joint CE Studio guide. Studios were conducted iteratively by site. Following receipt of the final reports, responses were compared to find themes, similarities, and differences on four topics in addition to overall commentary: Recruitment and Retention, Study Protocol, Study Reminders and Frequency, and Recording Technology.

Eighteen older adults and care partners in three states provided valuable feedback to inform multi-site trials. Feedback influenced multiple aspects of trials in process or subsequently funded. Experts provided critique on the wording of study invitations, information sheets, and reminders to engage in study procedures. Experts were concerned for participants being disappointed by randomization to a control arm and advised how investigators should prepare to address that.

Multi-site CE Studios should be consecutive, so each team can learn from the previous teams. Using the CES Toolkit ensures that final reports were easily comparable and utilized to develop a research program that now includes three federally funded clinical trials.

Anxiety disorders are a major public health burden with limited treatment options.

We investigated the long-term safety and efficacy of lysergic acid diethylamide (LSD)-assisted therapy in patients with anxiety with or without life-threatening illness.

This study was an a priori-planned long-term follow-up of an investigator-initiated, two-centre trial that used a double-blind, placebo-controlled, two-period, random-order, crossover design with two sessions with either oral LSD (200 μg) or placebo per period. Participants (n = 39) were followed up 1 year after the end-of-study visit to assess symptoms of anxiety, depression and long-term effects of psychedelics using Spielberger's State-Trait Anxiety Inventory–Global (STAI-G), the Beck Depression Inventory (BDI), the Persisting Effects Questionnaire and measures of personality traits using the NEO-Five-Factor Inventory.

Participants reported a sustained reduction of STAI-G scores compared with baseline (least square means (95% CI) = −21.6 (−32.7, −10.4), d = 1.04, P < 0.001, for those who received LSD in the first period (94 weeks after the last LSD treatment) and −16.5 (−26.2, −6.8), d = 1.02, P < 0.05, for those who received LSD in the second period (68 weeks after the last LSD treatment)). Similar effects were observed for comorbid depression with change from baseline BDI scores of −8.1 (−13.2, −3.1), d = 0.71, P < 0.01, and −8.9 (−12.9, −4.9), d = 1.21, P < 0.01, for the LSD-first and placebo-first groups, respectively. Personality trait neuroticism decreased (P < 0.0001) and trait extraversion increased (P < 0.01) compared with study inclusion. Individuals attributed positive long-term effects to the psychedelic experience.

Patients reported sustained long-term effects of LSD-assisted therapy for anxiety.

Designing and conducting clinical trials is challenging for some institutions and researchers due to associated time and personnel requirements. We conducted recruitment, screening, informed consent, study product distribution, and data collection remotely. Our objective is to describe how to conduct a randomized clinical trial using remote and automated methods.

A randomized clinical trial in healthcare workers is used as a model. A random group of workers were invited to participate in the study through email. Following an automated process, interested individuals scheduled consent/screening interviews. Enrollees received study product by mail and surveys via email. Adherence to study product and safety were monitored with survey data review and via real-time safety alerts to study staff.

A staff of 10 remotely screened 406 subjects and enrolled 299 over a 3-month period. Adherence to study product was 87%, and survey data completeness was 98.5% over 9 months. Participants and study staff scored the System Usability Scale 93.8% and 90%, respectively. The automated and remote methods allowed the study maintenance period to be managed by a small study team of two members, while safety monitoring was conducted by three to four team members. Conception of the trial to study completion was 21 months.

The remote and automated methods produced efficient subject recruitment with excellent study product adherence and data completeness. These methods can improve efficiency without sacrificing safety or quality. We share our XML file for researchers to use as a template for learning purposes or designing their own clinical trials.

The utilisation of massed therapy for treating posttraumatic stress disorder (PTSD) is gaining strength, especially prolonged exposure. However, it is unknown whether massed prolonged exposure (MPE) is non-inferior to standard prolonged exposure (SPE) protocols in the long term. The current study aimed to assess whether MPE was non-inferior to SPE at 12 months post-treatment, and to ascertain changes in secondary measure outcomes.

A multi-site non-inferiority randomised controlled trial (RCT) compared SPE with MPE in 12 clinics. The primary outcome was PTSD symptom severity (CAPS-5) at 12 months post-treatment commencement. Secondary outcome measures included symptoms of depression, anxiety, anger, disability, and quality of life at 12 weeks and 12 months post-treatment commencement. Outcome assessors were blinded to treatment allocation. The intention-to-treat sample included 138 Australian military members and veterans and data were analysed for 134 participants (SPE = 71, MPE = 63).

Reductions in PTSD severity were maintained at 12 months and MPE remained non-inferior to SPE. Both treatment groups experienced a reduction in depression, anxiety, anger, and improvements in quality of life at 12 weeks and 12 months post-treatment commencement. Treatment effects for self-reported disability in the SPE group at 12 weeks were not maintained, with neither group registering significant effects at 12 months.

The emergence of massed protocols for PTSD is an important advancement. The current study provides RCT evidence for the longevity of MPE treatment gains at 12 months post-treatment commencement and demonstrated non-inferiority to SPE. Promisingly, both treatments also significantly reduced the severity of comorbid symptoms commonly occurring alongside PTSD.

Parent training programs have high potential to promote positive parent-child relationships as well as reach and engage parents to participate. Digitally delivered programs may overcome the barriers associated with face-to-face interventions, such as stigma, logistic challenges and limited resources.

To assess the effectiveness and feasibility of digital universal parent training program for families with 3 years-old children, focusing on parenting skills and child´s behavior.

A non-blinded randomized controlled trial (RCT) with two groups: (I) the intervention group, in which participants receive the parent training and (II) the waiting list group, in which participants are placed on a waiting list to receive the parent training intervention after the first follow-up measurement have been completed. Participants must meet the following inclusion criteria: a) guardians having a child age 3 years, b) participating to annual health checkup in child health clinic, c) at least one of the guardian is able to understand the languages that intervention is provided.

Pilot study with feasibility assessment finished at early 2021. Recruitment of the wider RCT study is currently ongoing. The results from the pilot study and more detailed description about the intervention will be presented.

This study with good national geographical coverage is a unique possibility to evaluate universal parenting program on promoting parenting behaviors associated with the promotion of optimal child emotional development. This study also provides population level information about parenting skills and child´s behavior.

No significant relationships.

No significant relationships.

Depressive symptoms are common in patients with Fibromyalgia (FM), a chronic and disabling pain syndrome. Psychological interventions are mostly focused in negative thinking and behavioural activation. However, several studies suggest that personal identity is also affected by FM.

We aimed to examine the effects of Personal Construct Therapy (PCT), an idiographic approach that emphasizes identity features and interpersonal construal, on depressive symptoms in women with FM.

In the context of a multicentre parallel randomized trial (Trial Registry: NCT02711020), 106 women with FM and presenting depressive symptoms were randomized either to either Cognitive Behavioural Therapy (CBT; n = 55), taken as a gold standard comparison, or PCT (n = 51). In total, 69 patients completed the treatment and the six-month follow-up assessment (CBT = 32 and PCT = 37). Both treatments were applied on case formulation premises.

Linear mixed-effects models were performed to compare depressive symptoms between treatment conditions. Anxiety and pain measures were treated as secondary outcomes. Participants in both conditions significantly reduced their levels of depression and anxiety as well as the impact of FM but no significant between treatment differences were found. Analysis of clinically significant change for depressive symptoms and pain was also similar between both conditions.

PCT resulted equally effective in the treatment of depressive symptoms in women with FM when compared with CBT, both offered in a modular format. Thus, PCT with tis focus on identity issues can be considered as an alternative treatment for these patients.

No significant relationships.

Social contact-based video interventions effectively reduce stigma toward individuals with psychosis.

We recently demonstrated the efficacy of a 90-second social contact–based video intervention in reducing stigma. The current randomized controlled study presents four briefer videos differing in presenter’s gender and race, with baseline, postintervention, and 30-day follow-up assessments. The study aimed to examine whether people changing their attitudes following the intervention.

Using a crowdsourcing platform (CloudResearch), we recruited and assigned 1,993 race and gender-balanced participants ages 18–35 years to one of four brief video-based interventions (Black female, White female, Black male, and White male presenters) or a nonintervention control condition. In the videos, a young presenter with psychosis humanized their illness through an evocative description of living a meaningful and productive life.

Five-by-three ANOVA showed a significant group-by-time interaction for the total score of all five stigma domains: social distance, stereotyping, separateness, social restriction, and perceived recovery. A one-way ANOVA showed greater reductions in video intervention groups than control at post-intervention and 30-day follow-up, but no differences between video groups.

This randomized controlled study replicated and extended previous research findings by showing stigma reduction across videos that differ in the presenter’s gender and race, thus enhancing generalizability. The videos described the experience of psychosis and reduced stigma, suggesting their potential utility on social media platforms to increase the likelihood of seeking services and ultimately may improve access to care among young individuals with psychosis. Future research should address intersectional stigma experienced by culturally tailoring the narrative.

No significant relationships.

Cognitive Bias Modification for paranoia (CBM-pa) is a novel, theory-driven psychological intervention targeting the biased interpretation of emotional ambiguity associated with paranoia. Study objectives were (i) test the intervention's feasibility, (ii) provide effect size estimates, (iii) assess dose–response and (iv) select primary outcomes for future trials.

In a double-blind randomised controlled trial, sixty-three outpatients with clinically significant paranoia were randomised to either CBM-pa or an active control (text reading) between April 2016 and September 2017. Patients received one 40 min session per week for 6 weeks. Assessments were given at baseline, after each interim session, post-treatment, and at 1- and 3-months post-treatment.

A total of 122 patients were screened and 63 were randomised. The recruitment rate was 51.2%, with few dropouts (four out of 63) and follow-up rates were 90.5% (1-month) and 93.7% (3-months). Each session took 30–40 min to complete. There was no statistical evidence of harmful effects of the intervention. Preliminary data were consistent with efficacy of CBM-pa over text-reading control: patients randomised to the intervention, compared to control patients, reported reduced interpretation bias (d = −0.48 to −0.76), improved symptoms of paranoia (d = −0.19 to −0.38), and lower depressed and anxious mood (d = −0.03 to −0.29). The intervention effect was evident after the third session.

CBM-pa is feasible for patients with paranoia. A fully powered randomised control trial is warranted.

A short, effective therapy for posttraumatic stress disorder (PTSD) could decrease barriers to implementation and uptake, reduce dropout, and ameliorate distressing symptoms in military personnel and veterans. This non-inferiority RCT evaluated the efficacy of 2-week massed prolonged exposure (MPE) therapy compared to standard 10-week prolonged exposure (SPE), the current gold standard treatment, in reducing PTSD severity in both active serving and veterans in a real-world health service system.

This single-blinded multi-site non-inferiority RCT took place in 12 health clinics across Australia. The primary outcome was PTSD symptom severity measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at 12 weeks. 138 military personnel and veterans with PTSD were randomised. 71 participants were allocated to SPE, with 63 allocated to MPE.

The intention-to-treat sample included 138 participants, data were analysed for 134 participants (88.1% male, M = 46 years). The difference between the mean MPE and SPE group PTSD scores from baseline to 12 weeks-post therapy was 0.94 [95% confidence interval (CI) −4.19 to +6.07]. The upper endpoint of the 95% CI was below +7, indicating MPE was non-inferior to SPE. Significant rates of loss of PTSD diagnosis were found for both groups (MPE 53.8%, SPE 54.1%). Dropout rates were 4.8% (MPE) and 16.9% (SPE).

MPE was non-inferior to SPE in significantly reducing symptoms of PTSD. Significant reductions in symptom severity, low dropout rates, and loss of diagnosis indicate MPE is a feasible, accessible, and effective treatment. Findings demonstrate novel methods to deliver gold-standard treatments for PTSD should be routinely considered.

People with severe mental illnesses (SMI) have a mortality rate two times higher compared to the general population, with a decade of years of life lost. In this randomized controlled trial (RCT), we assessed in a sample of people with bipolar disorder, major depressive disorder, and schizophrenia spectrum disorder, the efficacy of an innovative psychosocial group intervention compared to a brief psychoeducational group intervention on patients’ body mass index (BMI), body weight, waist circumference, Framingham and HOMA-IR indexes.

This is a multicentric RCT with blinded outcome assessments carried out in six Italian university centers. After recruitment patients were randomized to receive a 6-month psychosocial intervention to improve patients’ physical health or a brief psychoeducational intervention. All recruited patients were assessed with standardized assessment instruments at baseline and after 6 months. Anthropometric parameters and blood samples have also been collected.

Four-hundred and two patients with a diagnosis of bipolar disorder (43.3%), schizophrenia or other psychotic disorder (29.9%), or major depression (26.9%) were randomly allocated to the experimental (N = 206) or the control group (N = 195). After 6 months, patients from the experimental group reported a significant reduction in BMI (odds ratio [OR]: 1.93, 95% confidence intervals [CI]: 1.31–2.84; p < 0.001), body weight (OR = 4.78, 95% CI: 0.80–28.27, p < 0.05), and waist circumference (OR = 5.43, 95% CI: 1.45–20.30, p < 0.05). Participants with impaired cognitive and psychosocial functioning had a worse response to the intervention.

The experimental group intervention was effective in improving the physical health in SMI patients. Further studies are needed to evaluate the feasibility of this intervention in real-world settings.

Lurasidone is an atypical antipsychotic approved for the treatment of patients with schizophrenia. We report on a meta-analysis focusing on both the efficacy and safety/tolerability of lurasidone in the treatment of patients with schizophrenia.

To obtain pooled estimates from placebo-controlled clinical trials on the efficacy and safety/tolerability of lurasidone in schizophrenia.

We selected acute, randomized placebo-controlled trials of lurasidone for schizophrenia. Primary outcome for efficacy was the Positive and Negative Syndrome Scale (PANSS) change and for “acceptability” was all-cause discontinuation. Secondary outcomes included specific adverse events, body weight change, ≥7% weight gain, and glucose and lipid parameter change.

Across 10 RCTs (n=3,963, age=40.5±2.3 years, males=64.7 %, trial duration=6.0 weeks), lurasidone outperformed placebo regarding the PANSS total score (N=10, n=3,354, SMD=-0.34, 95% CI: -0.47−-0.21, p<0.001). Stratifying the analysis by dose, lurasidone significantly outperformed placebo at doses 40-160 mg/day. Lurasidone was associated with significantly lower all-cause discontinuation than placebo (N=10, n=3,410, RR=0.87, 95% CI: 0.78−0.97, p=0.014). Lurasidone had significantly higher body weight change compared with placebo (N=10, n=3,359, SMD=0.17, 95% CI: 0.09−0.24, p<0.001), but without significant differences regarding ≥7% body weight gain (N=9, n=3,186, p=0.112). Lurasidone did not differ from placebo in total cholesterol (N=10, n=3,140, p=0.439), LDL-cholesterol (N=7, n=2,414, p=0.849), triglycerides (N=10, n=3,140, p=0.238), and fasting glucose change (N=10, n=3,112, p=0.633).

In short-term trials, lurasidone was efficacious, acceptable and safe, having minimal effect on body weight gain and glucose and lipid metabolism.

K. Hagi is a full time employee of Sumitomo Dainippon Phrma Co., Ltd.