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IntroductionThe DiSCoVeR Project: ‘Examining the synergistic effects of a cognitive control videogame and a self-administered non-invasive brain stimulation on alleviating depression’ is a double-blind, sham controlled, randomized controlled trial investigating the feasibility and efficacy of an innovative, self-applied treatment approach for patients diagnosed with major depressive disorder. The trial is conducted at three clinical trial sites (Hadassah, Israel; Riga Stradiņš University, Latvia; Ludwig-Maximilian-University, Germany). The treatment approach combines prefrontal transcranial direct current stimulation with a videogame designed to enhance cognitive and emotional control. This treatment is self-applied at home and remotely monitored. At the beginning of the intervention the patients are randomized in an active group receiving both active stimulation and videogame and the other group receiving sham stimulation and visually similar but not active videogame.ObjectivesThe present interims analysis after half of the patients included examines patients’ intrinsic motivation after completing the first five sessions (of 30) of the treatment. We also examine patients’ interest/enjoyment, perceived competence, effort, felt pressure/tension, and perceived choice following the first week of treatment. Intrinsic motivation has been associated with enhanced learning and performance, so it can be used as one of the predictors for patient compliance.MethodsAt the end of the 5th session, the patients filled in the Intrinsic Motivation Inventory (IMI) including the following subscales: interest/enjoyment, perceived choice, perceived competence, effort/importance and felt pressure/tension (scored on a 7-point Likert scale, ranging from 1 “not at all true” to 7 “very true”).ResultsThis report includes the first 55 patients randomized (27 patients in the active group and 28 patients in placebo group) for the DiSCoVeR trial. Patients rated their overall interest/enjoyment at 4.50 out of 7 (SD±0.17 95% CI 4.16 to 4.84), their perceived choice at 5.55 (SD±0.16; 95% CI 5.23 to 5.87), their perceived competence at 4.52 (SD±0.15; 95%CI 4.22 to 4.82), their effort/importance at 5.07 (SD±0.16; 95%CI 4.74 to 5.40) and their pressure/tension at 3.00 (SD±0.13; 95% CI 2.73 to 3.26).ConclusionsWe conclude that overall patients were quite interested in the treatment and had inherent pleasure while doing the sessions, felt that it was their choice to do them, felt that they performed the task quite effectively, were invested in doing the sessions and the experienced pressure and tension were low. The perceived choice and competence are positive predictors of intrinsic motivation. This aligns with the previous published data of a smaller patient subset (L. Konosonoka et al Medicina (Kaunas) 2022;58(Supplement 1):72) with the standard deviations being smaller in our larger patient sample.Disclosure of InterestNone Declared

Background/Objective: The present study evaluated the mental health and psychological functioning of bariatric patients before surgery, and after 1 year and 10 year follow-ups, and compared them with participants in a dietary program. Such long follow-up is rare, but strongly recommended by the American Association of Bariatric Surgeons. Subjects/Methods: Thirty-six bariatric surgery patients and 34 participants of a weight loss program were weighed and assessed at all 3 points in time. Participants were administered the mental health inventory, neuroticism, sense of control and fear of intimacy scales. Along with these mental and psychological measurements, the medical outcome short form (SF-36) was used. Results: The surgery group achieved successful weight loss outcomes (27% reduction of pre-operative weight) after 10 years and better than baseline health-related quality-of-life scores. However, their general mental health, neuroticism, sense of control and fear of intimacy scores showed significant deterioration in comparison to pre-operative levels after 10 years. The dietary group participants remained psychologically stable among all three points in time. Conclusions: This study highlights the importance of identifying a risk group among bariatric patients for which the dietary and psychological follow-up may be of special significance.

IntroductionThe DiSCoVeR trial is a multi-site, double-blind, sham controlled, randomized controlled trial (RCT) investigating the feasibility and efficacy of an innovative, self-applied treatment approach for patients suffering from major depressive disorder (MDD). The treatment approach incorporates non-invasive brain stimulation, i.e. prefrontal transcranial direct current stimulation (tDCS), and a videogame designed to enhance emotional cognitive control. This treatment is aimed to be applied at home and monitored remotely.ObjectivesIn this study we are looking at the first 10 single-site patients and comparing expected in person visits (according to the study protocol) versus actual in person visits as well as looking at the patients initial view of the therapy using the therapy evaluation form (CEQ) submitted after the 5th session.MethodsBefore continuing to self-administer the treatment at home patients undergo supervised training, during clinic visits, for up to 5 sessions. At the end of the 5th session, they are asked to fill out a therapy evaluation form (CEQ).ResultsPatients needed on average 2.3 in person training sessions before continuing the intervention remotely. Nine patients completed CEQ. Results show that on average patients thought that this course will be 4.78 (with probability 95% CI 4.74 to 4.82) points successful at raising their level of functioning and thought that their functioning will have increased on average by 37.8% (CI 37.2% to 38.4%) by the end of the study.ConclusionsPatients needed less than half of planned in person training visits. Most patients felt like they will gain some improvement from this intervention.DisclosureNo significant relationships.

IntroductionCognitive models of depression highlight the role of inhibitory control - the cognitive control ability which supports our goal directed behavior – as key and even causal feature of the disorder. According to these models, deficits in inhibitory control prevent the exclusion of irrelevant negative information, leading to rumination and sustained negative mood which result in depressive episodes. However, the scientific evidence linking deficits in inhibitory control to depression is thus far mixed. Moreover, although one’s inhibitory control ability may fluctuate, it is often assessed using a single-time measurement in the lab.ObjectivesHere we aimed to assess the association between intra-individual fluctuations in inhibitory control measured in ecological settings, daily mood states, and depressive symptoms.MethodsN=106 participants (Mean age: 38 ± 10 years; range: 19-62 years; 68% female) reported their depressive symptoms (using the PHQ-9 scale) and completed a mobile version of the Go-NoGo inhibition task at baseline. They then completed a 5-day ecological-momentary-assessment (EMA) protocol, in which they reported their current mood (using the IMS-12 scale) and performed a shortened version of the Go-NoGo task twice/day using a mobile application. Depressive symptoms were assessed again following the 5-day EMA. Hierarchical-linear-modeling (HLM) was applied to examine the association between momentary IC and mood, with post-EMA depressive symptoms as a moderator. Inhibitory control was included as a time-varying predictor for mood in the 1st step, and depressive symptoms post-EMA and their interaction with inhibition were included in the 2nd step.ResultsAt baseline, there were no correlations between depressive symptoms and inhibitory control (rp = .035, n.s). However, individuals with elevated depressive symptoms demonstrated worse and more variable inhibition performance over time (rp = .29, p = .002), as captured in the EMA measures. In addition, participants with more variable inhibitory control performance over time also reported more depressive symptoms at the end of the 5-day period (rp = .27, p = .006). Finally, post-EMA depressive symptoms moderated the association between momentary inhibitory control and daily mood, such that reduced inhibition was associated with more negative mood only for those with lower, but not with higher, depressive symptoms (Figure 1).Image:ConclusionsVariable, rather than mere reduced inhibitory control is related to depressive symptoms. Moreover, the role of inhibition in modulating mood differs in non-depressed vs. depressed individuals. These findings contribute to our understanding of inhibition and mood in real life and help account for some of the discrepant findings related to cognitive control models of depression. Future investigations should examine the validity of these outcomes in other, clinical samples.Disclosure of InterestNone Declared

IntroductionIn recent years, cannabis use among PTSD patients has become more common than ever. However, data available today regarding the effectiveness and safety of medical cannabis in PTSD treatment is limited, based on cross sectional studies, self-report surveys and a few clinical studies with small sample size.ObjectivesTo characterize patterns of use and adverse effects over time in patients with PTSD using medical cannabis in real life setting.MethodsData were acquired from the Israeli national database of all patients licensed to use medical cannabis from January 2014 to December 2021. A license for medical cannabis is given to patients with PTSD of at least moderate intensity after treatment failure of at least two drugs and two psychological interventions. Comparative statistics were used to evaluate patterns of use and adverse effects.Results12,977 patients were licensed to use medical cannabis in the study period for PTSD (8.2% of all users; 70% men) during the above-mentioned time period. PTSD was the 3rd most common indication after chronic pain and symptoms related to oncological disease and chemotherapy treatment. Over time, the relative increase in use of medical cannabis among PTSD patients was higher than that found in non-PTSD patients. In 2021 36.2% of all PTSD patients using medical cannabis had their license issued that year compared to 28.1% of all non-PTSD patients. PTSD patients were significantly younger compared to non-PTSD patients (40.9 years vs. 52.9 years). PTSD patients consume slightly higher monthly amount at the beginning of treatment compared to non-PTSD patients (32.1gr vs. 30.6gr) with higher Tetrahydrocannabinol (THC) concentration (15.2% vs. 12.9%) and lower Cannabidiol (CBD) concentration (4.7% vs. 6.0%). Over two years of use, amount, and composition of cannabis among the two groups were comparable and showed an increase in total amount and THC concentration, reaching the maximal available THC concentration of 20%. Data regarding adverse effects were available for 6,242 PTSD patients (48.1%) and 39,497 non-PTSD patients (26.6%). PTSD patients reported more physical adverse effects (RR 1.45 [95%CI 1.34-1.56]), anxiety (RR 1.47 [95%CI 1.13-1.92]), and derealization (RR 3.44 [95%CI 2.42-4.89]).ConclusionsPTSD is one of the leading indications for medical cannabis use in Israel, despite scarcity in good quality data supporting its effectiveness and safety. The increased risk of mental adverse effects among PTSD patients emphasizes the need for cautious use in cannabis in this population. Expanding the knowledge regarding patterns of use and risks in medical cannabis use among PTSD patients is important for understanding the role of cannabis in PTSD treatment and to ensure an effective and safe treatment.Disclosure of InterestNone Declared

IntroductionInhibitory control is the executive function component which underlies one’s ability to maintain goal-directed behavior by inhibiting prepotent responses or ignoring irrelevant information. Recent models suggest that impaired inhibition of negative information may contribute to depressive symptoms, and that this association is mediated by rumination. However, the exact nature of this association, particularly in non-clinical samples, is unclear.ObjectivesThe goal of the current study was to assess the relationship between inhibitory control over emotional vs. non-emotional information, rumination and depressive symptoms.MethodsA non-clinical sample of 119 participants (mean age: 36.44 ± 11.74) with various levels of depressive symptoms completed three variations of a Go/No-Go task online; two of the task variations required either explicit or implicit processing of emotional expressions, and a third variation contained no emotional expressions (i.e., neutral condition).ResultsWe found that for participants who reported elevated depressive symptoms, their inhibitory control ability was reduced for all three task variations, relative to less depressed participants. However, for the task variation that required implicit emotion processing (rather than explicit), depressive symptoms were associated with inhibitory deficits for sad and neutral, but not for happy facial expressions. An exploratory analysis showed that the relationship between inhibition and depressive symptoms occurs in part through trait rumination for all three tasks, regardless of emotional content.ConclusionsCollectively, these results indicate that elevated depressive symptoms are associated with both a general inhibitory control deficit, as well as affective interference from negative emotions, with implications for the assessment and treatment of mood disorders.DisclosureNo significant relationships.

Introduction Cannabis use is associated with mental illness among men and women, especially induction or exacerbation of psychosis, anxiety, and depression. Although safety and efficacy of cannabis in most medical conditions have not been established, use of medical cannabis is growing exponentially. In particular, albeit sex-related differences in the activity of the endocannabinoid system in animals and humans, differential effects of cannabis on men and women have rarely been sought. Objectives To characterize patterns of use and adverse effects experienced by men and women using medical cannabis. Methods Data from the Israeli national database of patients licensed to use medical cannabis in Israel from January 2014 to December 2021 was analyzed. The database includes indications for cannabis use, monthly cannabis quantities, Tetrahydrocannabinol (THC) and Cannabidiol (CBD) concentrations, and reports of adverse effects. Comparative statistics were used to evaluate the sex related differences. Results 161,644 persons (62% men) were issued a license to use medical cannabis during the study period. Men are significantly younger than women (50.5±19.1 vs. 56.5±18.4). The leading indications among both men and women are chronic pain (58% of men, 57% of women), symptoms related to oncological disease and chemotherapy treatment (21% of men, 24% of women) and post-traumatic stress disorder (9% of men, 6% of women). Men consume significantly higher monthly quantities at the beginning of treatment compared to women (31.6 gram vs. 29.3 gram) with a higher THC concentration (13.9% vs. 11.6%) and lower CBD concentration (5.3% vs. 6.7%). Over two years of use, there is an increase among both men and women in the amount and THC concentration, and a decrease in the CBD concentration. The differences between men and women remain significant throughout the whole period. Data on adverse effects are available for 28,629 men and 17,204 women (28.6% of men, 28.0% of women). Women report significantly more physical adverse effects (RR 1.48 [95%CI 1.39-1.57]), anxiety (RR 1.45 [95%CI 1.35-1.56]), depression (RR 1.36 [95%CI 0.95-1.96]) and derealization (RR 3.44 [95%CI 2.42-4.89]). Conclusions Although the prevalence of medical conditions for which medical cannabis is indicated are similar for both genders, approximately 60% more men consume medical cannabis. While consuming lower cannabis amount and THC concentration, women report more physical and psychiatric adverse effects than men. Understanding the differences in usage patterns and adverse effects between men and women will enable more accurate policy determinations and more effective and safer treatment strategies. Disclosure of InterestNone Declared

ObjectivePsychiatry is a low-risk specialisation; however, there is a steady increase in malpractice claims against psychiatrists. Defensive psychiatry (DP) refers to any action undertaken by a psychiatrist to avoid malpractice liability that is not for the sole benefit of the patient's mental health and well-being. The objectives of this study were to assess the scope of DP practised by psychiatrists and to understand whether awareness of DP correlated with defensive behaviours.MethodsA questionnaire was administered to 213 Israeli psychiatry residents and certified psychiatrists during May and June 2015 regarding demographic data and experience with malpractice claims, medicolegal literature and litigation. Four clinical scenarios represented defensive behaviours and reactions (feelings and actions) to malpractice claims.ResultsForty-four (20.6%) certified psychiatrists and four (1.9%) residents were directly involved in malpractice claims, while 132 (62.1%) participants admitted to practising DP. Residents acknowledged the practice of DP more than did senior psychiatrists (p=0.038).Awareness of DP correlated with unnecessary hospitalisation of suicidal patients, increased unnecessary follow-up visits and prescribing smaller drug dosages than required for pregnant women and elderly patients.ConclusionsThis study provides evidence that DP is well established in the routine clinical daily practice of psychiatrists. Further studies are needed to reveal whether DP effectively protects psychiatrists from malpractice suits or, rather, if it impedes providing quality psychiatric care and represents an economic burden that leads to more harm for the patient.

IntroductionPremenstrual dysphoric disorder (PMDD), a severe form of the premenstrual syndrome (PMS), negatively impacts women’s quality of life, including physical and mental aspects. Difficulties in emotion regulation, more prevalent among women with PMDD, are also associated with poor quality of life.ObjectivesTo determine whether the negative impact of premenstrual symptoms on quality of life is partially explained by emotional dysregulation.MethodsA total of 112 women completed self-report questionnaires, including a demographic questionnaire, the Premenstrual Symptoms Screening Tool (PSST), Medical Outcomes Study Short Form-36 (SF-36), and the Difficulties in Emotion Regulation Scale (DERS). To test the mediation hypothesis, direct and indirect effects of premenstrual symptoms on quality of life were calculated.ResultsQuality of life was impaired in the PMS/PMDD group compared to controls. The PMS/PMDD group showed significantly greater emotion regulation difficulties as compared to the No/mild PMS group. Emotion regulation difficulties partially mediates the relationship between premenstrual symptoms and quality of life, for both SF-36 total score and mental subscale, but not for physical subscale.Image:Image 2:ConclusionsEmotion regulation difficulties could be a possible target for interventions that could improve the quality of life among women who experience premenstrual symptoms.Disclosure of InterestNone Declared

Post-traumatic stress disorder (PTSD) is psychiatric disease, which can occur following exposure to traumatic events. PTSD may be acute or chronic, and can have a waxing and waning course of symptoms. It has been hypothesized that proinflammatory cytokines and chemokines in the cerebrospinal fluid (CSF) or plasma might be mediators of the psychophysiological mechanisms relating a history of trauma exposure to changes in behavior and mental health disorders, and medical morbidity. Here we test the cytokine/chemokine hypothesis for PTSD by examining levels of 17 classical cytokines and chemokines in CSF, sampled at 0900 hours, and in plasma sampled hourly for 24 h. The PTSD and healthy control patients are from the NIMH Chronic PTSD and healthy control cohort, initially described by Bonne et al. (2011), in which the PTSD patients have relatively low comorbidity for major depressive disorder (MDD), drug or alcohol use. We find that in plasma, but not CSF, the bivariate MCP4 (CCL13)/ MCP1(CCL2) ratio is ca. twofold elevated in PTSD patients compared with healthy controls. The MCP-4/MCP-1 ratio is invariant over circadian time, and is independent of gender, body mass index or the age at which the trauma was suffered. By contrast, MIP-1β is a candidate biomarker for PTSD only in females, whereas TARC is a candidate biomarker for PTSD only in males. It remains to be discovered whether these disease-specific differences in circadian expression for these specific immune signaling molecules are biomarkers, surrogates, or drivers for PTSD, or whether any of these analytes could contribute to therapy.