A study protocol for the randomized controlled trial SAFIR FAMILY TALK: a selective primary preventive intervention vs. service as usual for children of parents with mental illness.

BACKGROUND: Children of parents with mental illness have an increased risk of developing mental illness themselves throughout their lifespan. This is due to genetic factors but also environmental disadvantages during childhood associated with parental mental illness. Selective primary preventive interventions for the children are recommended to mitigate risk factors and strengthen protective factors, but large-scale, longitudinal studies are needed. This study aims to investigate the effect of the Family Talk Preventive Intervention in a cohort of children and their parents with mental illness. METHODS: The study is a randomized controlled trial with 286 planned families with at least one parent with any mental illness and at least one child aged 7 to 17 years. It will be carried out in the mental healthcare system in the Capital Region of Denmark. Families will be referred from hospitals and municipalities. The children and parents will be assessed at baseline and then randomized and allocated to either the Family Talk Preventive Intervention or service as usual. The intervention group will be assigned to Family Talk Preventive Intervention, a manualized programme consisting of ~ seven sessions for the family, including psychoeducation about parental mental illness and resilience in children, stimulating dialogue between family members and creating a common family narrative. The study period for both groups will be 12 months. Follow-up assessments will be conducted after 4 months and 12 months. The primary outcomes are the children's level of functioning, parental sense of competence and family functioning. DISCUSSION: Given the prevalence of transgenerational transmission of mental illness, a systematic approach to prevention is needed in the mental healthcare setting. This study provides valuable knowledge on the Family Talk Preventive Intervention with a large sample size, inclusion of any parental mental illness and examination of the primary outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT05615324. Registered on 26 October 2022. Retrospectively registered.

Predictors of return to work for people on sick leave with depression, anxiety and stress: secondary analysis from a randomized controlled trial.

PURPOSE: Knowledge about predictors of return to work (RTW) in people on sick leave with common mental disorders (CMDs) may inform the development of effective vocational rehabilitation interventions for this target group. In this study, we investigated predictors of RTW at 6 and 12 months in people on sick leave with depression, anxiety disorders or stress-related disorders. METHODS: We have performed a secondary analysis, utilizing data from two RCTs that evaluated the efficacy of an integrated health care and vocational rehabilitation intervention. Data were obtained from mental health assessments, questionnaires and registers. Using Cox regression analysis, the relationship between baseline variables and RTW was analysed at 6 and 12 months after randomization within the group of CMD as a whole and within the subgroups of depression, anxiety and stress-related disorders. RESULTS: Symptom burden and employment status at baseline predicted RTW in the CMD group (n = 1245) and in the three diagnostic subgroups at both time points. RTW self-efficacy predicted RTW in the depression group but not in the anxiety or stress subgroups. CONCLUSION: Many predictors of RTW were similar over time and, to some extent, across the CMD subgroups. Findings highlight the need not only to take health-related and psychological factors into account when developing vocational rehabilitation interventions but also to consider workplace strategies and options for support.

Integrating vocational rehabilitation and mental healthcare to improve the return-to-work process for people on sick leave with stress-related disorders: results from a randomized trial.

OBJECTIVE: Stress-related disorders are common, associated with substantial individual suffering, and place a large economic burden on society. While treatment appears to be able to reduce symptoms, evidence of interventions to improve vocational outcomes is flimsy. Lack of integration of vocational rehabilitation and healthcare services has been suspected to be a major potential barrier in return-to-work (RTW) processes; therefore, we aimed to test the effectiveness of such integration. METHODS: We randomized participants who were on sick leave for ≥ 4 weeks with a stress-related disorder. They were allocated to (i) service as usual (SAU), (ii) improved mental healthcare (MHC), or (iii) integrated interventions (INT). The primary outcome was RTW rates measured at 12 months. Secondary outcome were RTW rates measured at 6 months, proportion in work at 12 months, and levels of stress, anxiety, depression, and functioning at 6 months. RESULTS: We included 666 participants. On the primary outcome and almost all other vocational outcomes, SAU was superior to both INT and MHC. MHC and INT did not differ on any vocational outcome. On several symptom scales, MHC showed lower values than SAU, whilst INT did not differ from the two other groups. CONCLUSION: Both the INT and the MHC intervention lowered RTW rates compared with SAU, and thereby yielded a worse outcome. However, the MHC group showed a tendency towards having lower symptom levels compared with those in the SAU group; accordingly, the SAU group is not unequivocally superior. MHC and INT showed no general differences.

[Collaborative care in treatment of anxietyanddepression].

This review summarises the current knowledge of the use of collaborative care (CC) in Denmark. CC is an evidence-based approach to the treatment of depression and anxiety in primary care services. An optimised treatment is needed in Denmark, and a Danish CC model called Collabri, later Collabri Flex, was developed and evaluated in randomised controlled trials. The evaluation in the randomised controlled trials was needed since CC is an organizational model primarily tested in countries outside of Scandinavia. The effect evaluated is promising, but the cost-effectiveness of the model still needs to be established (ongoing study).

Predictors of return to work for people on sick leave with common mental disorders: a systematic review and meta-analysis.

PURPOSE: To support the return to work following common mental disorders knowing which factors influence the return to work is important. We aimed to identify factors predicting return to work for people on sick leave with disorders like stress, anxiety, and depression. METHODS: A systematic review and meta-analyses were conducted regarding return to work at any time point, < 3 months, 3-12 months, and > 12 months of sick leave, respectively, and diagnostic subgroups. RESULTS: The meta-analyses included 29 studies. Predictors decreasing return to work probability at any time point were higher age, being male, neuroticism and openness, previous sickness absence, and higher symptom scores. Predictors increasing return to work probability were positive return to work expectations, high return to work- and general self-efficacy, conscientiousness, and high workability index. Return to work within < 3 months of sick leave was associated with positive return to work expectations. Return to work after > 12 months was increased by higher education. Higher age was associated with decreased return to work probability after > 12 months. No significant predictors were found in diagnostic subgroups. CONCLUSION: Results are overall consistent with earlier reviews. Future studies should focus on specific time points, diagnostic subgroups, and work-related factors. PROSPERO REGISTRATION ID: CRD42018073396.

Group cognitive behavioural therapy with virtual reality exposure versus group cognitive behavioural therapy with in vivo exposure for social anxiety disorder and agoraphobia: a protocol for a randomised clinical trial.

INTRODUCTION: Anxiety disorders have a high lifetime prevalence, early-onset and long duration or chronicity. Exposure therapy is considered one of the most effective elements in cognitive behavioural therapy (CBT) for anxiety, but in vivo exposure can be challenging to access and control, and is sometimes rejected by patients because they consider it too aversive. Virtual reality allows flexible and controlled exposure to challenging situations in an immersive and protected environment. AIM: The SoREAL-trial aims to investigate the effect of group cognitive behavioural therapy (CBT-in vivo) versus group CBT with virtual reality exposure (CBT-in virtuo) for patients diagnosed with social anxiety disorder and/or agoraphobia, in mixed groups. METHODS AND ANALYSIS: The design is an investigator-initiated randomised, assessor-blinded, parallel-group and superiority-designed clinical trial. Three hundred two patients diagnosed with social anxiety disorder and/or agoraphobia will be included from the regional mental health centres of Copenhagen and North Sealand and the Northern Region of Denmark. All patients will be offered a manual-based 14-week cognitive behavioural group treatment programme, including eight sessions with exposure therapy. Therapy groups will be centrally randomised with concealed allocation sequence to either CBT-in virtuo or CBT-in vivo. Patients will be assessed at baseline, post-treatment and 1-year follow-up by treatment blinded researchers and research assistants. The primary outcome will be diagnosis-specific symptoms measured with the Liebowitz Social Anxiety Scale for patients with social anxiety disorder and the Mobility Inventory for Agoraphobia for patients with agoraphobia. Secondary outcome measures will include depression symptoms, social functioning and patient satisfaction. Exploratory outcomes will be substance and alcohol use, working alliance and quality of life. ETHICS AND DISSEMINATION: The trial has been approved by the research ethics committee in the Capital Region of Denmark. All results, positive, negative as well as inconclusive, will be published as quickly as possible and still in concordance with Danish law on the protection of confidentially and personal information. Results will be presented at national and international scientific conferences. The trial has obtained approval by the Regional Ethics Committee of Zealand (H-6-2013-015) and the Danish Data Protection Agency (RHP-2014-009-02670). The trial is registered at ClinicalTrial.gov as NCT03845101. The patients will receive information on the trial both verbally and in written form. Written informed consent will be obtained from each patient before inclusion in the trial. The consent form will be scanned and stored in the database system and the physical copy will be destroyed. It is emphasised that participation in the trial is voluntary and that the patient can withdraw his or her consent at any time without consequences for further and continued treatment. TRIAL REGISTRATION NUMBER: NCT03845101.

Transdiagnostic versus Diagnosis-Specific Group Cognitive Behavioral Therapy for Anxiety Disorders and Depression: A Randomized Controlled Trial.

INTRODUCTION: The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) delivered in a group format could facilitate the implementation of evidence-based psychological treatments. OBJECTIVE: This study compared the efficacy of group UP and diagnosis-specific cognitive behavioral therapy (dCBT) for anxiety and depression in outpatient mental health services. METHODS: In this pragmatic, multi-center, single-blinded, non-inferiority, randomized controlled trial (RCT), we assigned 291 patients with major depressive disorder, social anxiety disorder, panic disorder, or agoraphobia to 14 weekly sessions in mixed-diagnosis UP or single-diagnosis dCBT groups. The primary test was non-inferiority, using a priori criteria, on the World Health Organisation 5 Well-Being Index (WHO-5) at the end of the treatment. Secondary outcomes were functioning and symptoms. We assessed outcomes at baseline, end-of-treatment, and at a 6-month follow-up. A modified per-protocol analysis was performed. RESULTS: At end-of-treatment, WHO-5 mean scores for patients in UP (n = 148) were non-inferior to those of patients in dCBT (n = 143; mean difference -2.94; 95% CI -8.10 to 2.21). Results were inconclusive for the WHO-5 at the 6-month follow-up. Results for secondary outcomes were non-inferior at end-of-treatment and the 6-month follow-up. Client satisfaction and rates of attrition, response, remission, and deterioration were similar across conditions. CONCLUSIONS: This RCT demonstrated non-inferior acute-phase outcomes of group-delivered UP compared with dCBT for major depressive disorder, social anxiety disorder, panic disorder, and agoraphobia in outpatient mental health services. The long-term effects of UP on well-being need further investigation. If study findings are replicated, UP should be considered a viable alternative to dCBT for common anxiety disorders and depression in outpatient mental health services.

Integrating vocational rehabilitation and mental healthcare to improve the return-to-work process for people on sick leave with depression or anxiety: results from a three-arm, parallel randomised trial.

OBJECTIVE: The aim of this study was to investigate an integrated mental healthcare and vocational rehabilitation intervention to improve and hasten the process of return-to-work of people on sick leave with anxiety and depression. METHODS: In this three-arm, randomised trial, participants were assigned to (1) integrated intervention (INT), (2) improved mental healthcare (MHC) or (3) service as usual (SAU). The primary outcome was time to return-to-work measured at 12-month follow-up. The secondary outcomes were time to return-to-work measured at 6-month follow-up; levels of anxiety, depression, stress symptoms, and social and occupational functioning at 6 months; and return-to-work measured as proportion in work at 12 months. RESULTS: 631 individuals were randomised. INT yielded a higher proportion in work compared with both MHC (56.2% vs 43.7%, p=0.012) and SAU (56.2% vs 45%, p=0.029) at 12-month follow-up. We found no differences in return-to-work in terms of sick leave duration at either 6-month or 12-month follow-up, with the latter being the primary outcome. No differences in anxiety, depression or functioning between INT, MHC and SAU were identified, but INT and MHC showed lower scores on Cohen's Perceived Stress Scale compared with SAU at 12-month follow-up. CONCLUSIONS: Although INT did not hasten the process of return-to-work, it yielded better outcome with regard to proportion in work compared with MHC and SAU. The findings suggest that INT compared with SAU is associated with a few, minor health benefits. Overall, INT yielded slightly better vocational and health outcomes, but the clinical significance of the health advantage is questionable. TRIAL REGISTRATION NUMBER: NCT02872051.

Comparison of Outcomes Following Glaucoma Drainage Tube Surgery Between Primary and Secondary Glaucomas, and Between Phakic and Pseudophakic eyes.

PURPOSE: To report outcomes of glaucoma drainage device (GDD) surgery based on primary or secondary glaucoma diagnosis and lens status. DESIGN: Single-center, retrospective, consecutive cohort study. METHODS: University of Florida patients aged 18 to 93 years who underwent nonvalved GDD surgery between 1996 and 2015 with a minimum of 1-year follow-up were examined. Of the 186 eyes of 186 patients enrolled, 108 had a primary glaucoma and 78 a secondary glaucoma diagnosis. Excluding 13 aphakic patients, 57 eyes were phakic and 116 pseudophakic. Mean intraocular pressure (IOP), mean number of medications, visual acuity (VA), surgical complications, and failure (IOP ≥18 mm Hg, IOP <6 mm Hg, reoperation for glaucoma, or loss of light perception) were the main outcome measures. RESULTS: No significant difference was noted in mean IOP and mean medication use (12.8 ±â€Š4.5 and 13.0 ±â€Š6.6 mm Hg on 2.0 ±â€Š1.2 and 1.5 ±â€Š1.1 medication classes, respectively), mean VA (1.08 ±â€Š0.98 and 0.94 ±â€Š0.89, respectively), failure, or numbers of complications and reoperations (P > 0.05) between eyes with primary and secondary glaucomas at up to 5 years postoperatively. Comparison of phakic and pseudophakic eyes showed a statistically significant higher success rate for the pseudophakic patient group at the ≥18 mm Hg upper limit and <6 mm Hg lower limit (P = 0.01), and significantly fewer eyes required reoperation to lower IOP (6.9% vs 23%). CONCLUSIONS: GDD surgery appears equally effective for secondary glaucomas as for primary glaucomas, and has a better outcome for pseudophakic eyes than phakic eyes.

Comparison of Outcomes of Glaucoma Drainage Implant Surgery With or Without Prior Failed Trabeculectomy.

PRECIS: A comparison of 186 glaucoma patients with mixed diagnoses who underwent nonvalved glaucoma drainage device (GDD) implant surgery showed similar long-term intraocular pressure (IOP), medication, and visual acuity (VA) outcomes between those with prior failed trabeculectomy surgery versus those without. PURPOSE: The purpose of this study was to evaluate whether prior failed trabeculectomy adversely affects the outcome of glaucoma tube surgery. PATIENTS AND METHODS: A total of 186 eyes of 186 patients who underwent a nonvalved GDD implant surgery by a single surgeon between 1996 and 2015 at a University practice were included. Patients were of mixed diagnoses and over 18 years old. Before the GDD surgery, 65 had a previous failed glaucoma filtering surgery and 121 had no prior glaucoma surgery. Demographic information, preoperative and postoperative IOP, medication, VA, and complications were collected from chart review. RESULTS: No significant difference was noted in mean IOP and mean medication use (13.0 and 12.6 mm Hg on 2.0 and 1.7 medication classes at 5 y postoperatively, respectively), mean VA and change in VA from baseline, or numbers of complications (P>0.05), between eyes that had a prior failed filtration surgery and those that had not. Kaplan-Meier plots for failure over 5 years using a lower limit of <5 mm Hg and an upper limit of ≥18, ≥15, or ≥12 mm Hg did not show a significant difference between groups. Subanalyses were performed to examine only primary glaucoma eyes and results were similar. Further group subanalyses comparing those with baseline IOP ≥25 or <25 mm Hg, age 65 and above or below 65 years and those specifically with Baerveldt 350 mm2 implants also did not show significant differences. CONCLUSION: Prior failed filtration surgery does not appear to affect the outcome of future GDD surgery.

The effect of smartphone-based monitoring and treatment on the rate and duration of psychiatric readmission in patients with unipolar depressive disorder: The RADMIS randomized controlled trial.

BACKGROUND: Patients with unipolar depressive disorder are frequently hospitalized, and the period following discharge is a high-risk-period. Smartphone-based treatments are receiving increasing attention among researchers, clinicians, and patients. We aimed to investigate whether a smartphone-based monitoring and treatment system reduces the rate and duration of readmissions, more than standard treatment, in patients with unipolar depressive disorder following hospitalization. METHODS: We conducted a pragmatic, investigator-blinded, randomized controlled trial. The intervention group received a smartphone-based monitoring and treatment system in addition to standard treatment. The system allowed patients to self-monitor symptoms and access psycho-educative information and cognitive modules. The patients were allocated a study-nurse who, based on the monitoring data, guided and supported them. The control group received standard treatment. The trial lasted six months, with outcome assessments at 0, 3, and 6 months. RESULTS: We included 120 patients with unipolar depressive disorder (ICD-10). Intention-to-treat analyses showed no statistically significant differences in time to readmission (Log-Rank p=0.9) or duration of readmissions (B=-16.41,95%CI:-47.32;25.5,p=0.3) (Primary outcomes). There were no differences in clinically rated depressive symptoms (p=0.6) or functioning (p=0.1) (secondary outcomes). The intervention group had higher levels of recovery (B=7,29, 95%CI:0.82;13,75,p=0.028) and a tendency towards higher quality of life (p=0.07), wellbeing (p=0,09) satisfaction with treatment (p=0.05) and behavioral activation (p=0.08) compared with the control group (tertiary outcomes). LIMITATIONS: Patients and study-nurses were unblinded to allocation. CONCLUSIONS: We found no effect of the intervention on primary or secondary outcomes. In tertiary outcomes, patients in the intervention group reported higher levels of recovery compared to the control group.

Reducing the rate of psychiatric re-admissions in bipolar disorder using smartphones-The RADMIS trial.

OBJECTIVES: The MONARCA I and II trials were negative but suggested that smartphone-based monitoring may increase quality of life and reduce perceived stress in bipolar disorder (BD). The present trial was the first to investigate the effect of smartphone-based monitoring on the rate and duration of readmissions in BD. METHODS: This was a randomized controlled single-blind parallel-group trial. Patients with BD (ICD-10) discharged from hospitalization in the Mental Health Services, Capital Region of Denmark were randomized 1:1 to daily smartphone-based monitoring including a feedback loop (+ standard treatment) or to standard treatment for 6 months. Primary outcomes: the rate and duration of psychiatric readmissions. RESULTS: We included 98 patients with BD. In ITT analyses, there was no statistically significant difference in rates (hazard rate: 1.05, 95% CI: 0.54; 1.91, p = 0.88) or duration of readmission between the two groups (B: 3.67, 95% CI: -4.77; 12.11, p = 0.39). There was no difference in scores on the Hamilton Depression Rating Scale (B = -0.11, 95% CI: -2.50; 2.29, p = 0.93). The intervention group had higher scores on the Young Mania Rating Scale (B: 1.89, 95% CI: 0.0078; 3.78, p = 0.050). The intervention group reported lower levels of perceived stress (B: -7.18, 95% CI: -13.50; -0.86, p = 0.026) and lower levels of rumination (B: -6.09, 95% CI: -11.19; -1.00, p = 0.019). CONCLUSIONS: Smartphone-based monitoring did not reduce rate and duration of readmissions. There was no difference in levels of depressive symptoms. The intervention group had higher levels of manic symptoms, but lower perceived stress and rumination compared with the control group.

Web-Based Bereavement Care: A Systematic Review and Meta-Analysis.

BACKGROUND: Web-based interventions have been introduced as novel and effective treatments for mental disorders and, in recent years, specifically for the bereaved. However, a systematic summary of the effectiveness of online interventions for people experiencing bereavement is still missing. OBJECTIVE: A systematic literature search was conducted by four reviewers who reviewed and meta-analytically summarized the evidence for web-based interventions for bereaved people. METHODS: Systematic searches (PubMed, Web of Science, PsycInfo, PsycArticles, Medline, and CINAHL) resulted in seven randomized controlled trials (N = 1,257) that addressed adults having experienced bereavement using internet-based interventions. We used random effects models to summarize treatment effects for between-group comparisons (treatment vs. control at post) and stability over time (post vs. follow-up). RESULTS: All web-based interventions were based on cognitive behavioral therapy (CBT). In comparison with control groups, the interventions showed moderate (g = .54) to large effects (g = .86) for symptoms of grief and posttraumatic stress disorder (PTSD), respectively. The effect for depression was small (g = .44). All effects were stable over time. A higher number of treatment sessions achieved higher effects for grief symptoms and more individual feedback increased effects for depression. Other moderators (i.e. dropout rate, time since loss, exposure) did not significantly reduce moderate degrees of heterogeneity between the studies. LIMITATIONS: The number of includable studies was low in this review resulting to lower power for moderator analyses in particular. CONCLUSIONS: Overall, the results of web-based bereavement interventions are promising, and its low-threshold approach might reduce barriers to bereavement care. Nonetheless, future research should further examine potential moderators and specific treatment components (e.g. exposure, feedback) and compare interventions with active controls.

Alexithymia and automatic processing of facial emotions: behavioral and neural findings.

BACKGROUND: Alexithymia is a personality trait characterized by difficulties identifying and describing feelings, an externally oriented style of thinking, and a reduced inclination to imagination. Previous research has shown deficits in the recognition of emotional facial expressions in alexithymia and reductions of brain responsivity to emotional stimuli. Using an affective priming paradigm, we investigated automatic perception of facial emotions as a function of alexithymia at the behavioral and neural level. In addition to self-report scales, we applied an interview to assess alexithymic tendencies. RESULTS: During 3 T fMRI scanning, 49 healthy individuals judged valence of neutral faces preceded by briefly shown happy, angry, fearful, and neutral facial expressions. Alexithymia was assessed using the 20-Item Toronto Alexithymia Scale (TAS-20), the Bermond-Vorst Alexithymia Questionnaire (BVAQ) and the Toronto Structured Interview for Alexithymia (TSIA). As expected, only negative correlations were found between alexithymic features and affective priming. The global level of self-reported alexithymia (as assessed by the TAS-20 and the BVAQ) was found to be related to less affective priming owing to angry faces. At the facet level, difficulties identifying feelings, difficulties analyzing feelings, and impoverished fantasy (as measured by the BVAQ) were correlated with reduced affective priming due to angry faces. Difficulties identifying feelings (BVAQ) correlated also with reduced affective priming due to fearful faces and reduced imagination (TSIA) was related to decreased affective priming due to happy faces. There was only one significant correlation between alexithymia dimensions and automatic brain response to masked facial emotions: TAS-20 alexithymia correlated with heightened brain response to masked happy faces in superior and medial frontal areas. CONCLUSIONS: Our behavioral results provide evidence that alexithymic features are related in particular to less sensitivity for covert facial expressions of anger. The perceptual alterations could reflect impaired automatic recognition or integration of social anger signals into judgemental processes and might contribute to the problems in interpersonal relationships associated with alexithymia. Our findings suggest that self-report measures of alexithymia may have an advantage over interview-based tests as research tools in the field of emotion perception at least in samples of healthy individuals characterized by rather low levels of alexithymia.

Group rumination-focused cognitive-behavioural therapy (CBT) v. group CBT for depression: phase II trial.

BACKGROUND: 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. METHODS: 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). RESULTS: 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. CONCLUSIONS: 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.

Attaining Intraocular Pressure of ≤10 mm Hg: Comparison of Tube and Trabeculectomy Surgery in Pseudophakic Primary Glaucoma Eyes.

PURPOSE: The aim of this study is to evaluate whether trabeculectomy with antimetabolites or glaucoma drainage device (GDD) surgery is more likely to achieve an intraocular pressure (IOP) ≤10 mm Hg. DESIGN: Retrospective, nonrandomized, cohort study of pseudophakic, primary glaucoma patients. METHODS: 53 pseudophakic patients underwent trabeculectomy and 65 received GDD at the University of Florida by one surgeon between 1993 and 2015. The main outcome measures were mean IOP and percentage of patients obtaining an IOP ≤10 mm Hg for up to 5 years postoperatively. A subgroup undergoing a first time glaucoma surgery was also analyzed because there were more redo glaucoma procedures in the GDD group. RESULTS: Over 5 years, the mean annual IOP for the trabeculectomy eyes was between 6.9 and 7.8 mm Hg on an average of 0.2 medications, and that for GDD eyes was between 11.4 and 12.1 mm Hg on a mean of 1.6 to 1.9 medications (P < 0.002). A significantly higher percentage of trabeculectomy eyes than GDD eyes achieved a pressure of ≤10 mm Hg, for years 1 to 4 (P < 0.05). Visual acuity (VA) change was not statistically different between the groups, both for mean logMAR acuity and percentage of patients that lost ≥2 Snellen lines. Complication rates were similar between the groups. Postoperative VA change was similar for eyes achieving low IOP ≤5 mm Hg and those eyes with an IOP ≥10 mm Hg. CONCLUSIONS: Trabeculectomy provided significantly lower IOP for 5 years postoperatively in pseudophakic primary glaucoma patients, and was more likely to achieve an IOP ≤10 mm Hg.

The impact of conjunctival flap method and drainage cannula diameter on bleb survival in the rabbit model.

PURPOSE: To examine the effect of cannula diameter and conjunctival flap method on bleb survival in rabbits undergoing cannula-based glaucoma filtration surgery (GFS). METHODS: Twelve New Zealand White rabbits underwent GFS in both eyes. The twenty-four eyes were divided into four groups. Two of the four groups (N = 12) received limbus-based conjunctival flaps (LBCF), and the other two (N = 12) received fornix-based conjunctival flaps (FBCF). Six FBCF rabbit eyes were implanted with 22-gauge drainage tubes, and the other six were implanted with 26-gauge tubes. Likewise, six LBCF rabbits received 22-gauge drainage tubes and six received 26-gauge tubes. Filtration blebs were evaluated every three days by a masked observer. Bleb failure was defined as the primary endpoint in this study and was recorded after two consecutive flat bleb evaluations. RESULTS: Group 1 (LBCF, 22- gauge cannula) had a mean bleb survival time (Mean ± SD) of 18.7 ± 2.9 days. Group 2 (LBCF, 26-gauge cannula) also had a mean bleb survival time of 18.7 ± 2.9 days. Group 3 (FBCF, 22-gauge cannula) had a mean bleb survival time of 19.2 ± 3.8 days. Group 4 (FBCF, 26-gauge cannula) had a mean bleb survival time of 19.7 ± 4.1 days. A 2-way analysis of variance showed that neither surgical approach nor cannula gauge made a statistically significant difference in bleb survival time (P = 0.634 and P = 0.874). Additionally, there was no significant interaction between cannula gauge and conjunctival flap approach (P = 0.874), suggesting that there was not a combination of drainage gauge and conjunctival flap method that produced superior bleb survival. CONCLUSION: Limbus and fornix-based conjunctival flaps are equally effective in promoting bleb survival using both 22 and 26-gauge cannulas in the rabbit model. The 26-gauge drainage tube may be preferred because its smaller size facilitates the implantation process, reducing the risk of corneal contact.

Changes in perceived centrality of anxious events following cognitive behavioral therapy for social anxiety disorder and panic disorder.

BACKGROUND AND OBJECTIVE: The purpose of the present study was to explore the association between reductions in symptoms of psychopathology and perceived centrality of negative autobiographical memories in participants with social anxiety disorder (SAD) or panic disorder (PD). METHODS: Thirty-nine individuals with SAD or PD recalled and rated four negative autobiographical memories before and after ten sessions of cognitive behavioral therapy (CBT) over a three-month period. Twenty-eight healthy controls did the same before and after a three-month period. RESULTS: As hypothesized, results showed a decrease in perceived centrality following CBT. This decrease in perceived centrality was larger, although at the trend level, for individuals who experienced reliable change on disorder-specific symptoms. LIMITATIONS: The correlational nature of the study prevents establishing the causal relationship between changes in perceived centrality and psychopathology, and future studies should explore such mechanisms. CONCLUSIONS: The present study adds to the emerging body of literature, investigating changes in centrality of event following psychotherapy.

Comparing glaucomatous disc change using stereo disc viewing and the MatchedFlicker programme in glaucoma experts and trainees.

BACKGROUND/AIMS: The objective of this study is to evaluate the accuracy and speed of trainees and experienced glaucoma specialists using the MatchedFlicker software against the manual examination of stereoscopic disc photographs for detecting glaucomatous optic disc change. METHODS: Three experienced glaucoma specialists, two resident ophthalmologists and one glaucoma fellow from multiple institutions independently evaluated the same 140 image pairs from 100 glaucomatous/ocular hypertensive eyes using a handheld stereo viewer and the MatchedFlicker programme. Fifty had progression to glaucoma as determined by the Ocular Hypertension Treatment Study (OHTS) Optic Disc Reading Group and endpoint committee, and 50 more were negative controls for progression with photos taken a few minutes apart. Twenty photo pairs from each of the two groups were duplicated for reviewer variability analysis. The initial viewing method was randomised and then alternated for each group of 70 image pairs. Reviewer accuracy and evaluation time for each method were measured. RESULTS: Evaluators averaged 8.6 s faster per image pair (26%) with the MatchedFlicker programme than with the stereo viewer (p=0.0007). Evaluators correctly identified more image pairs when using the MatchedFlicker software over the stereo viewer (p=0.0003). There was no significant difference between the expert and trainee group in speed or overall accuracy for either method. Experts were significantly more consistent than trainees with the duplicate image pairs (p=0.029). Trainees appeared more reluctant to designate eyes as showing glaucoma progression than experts. CONCLUSIONS: Both expert glaucoma specialists and ophthalmologists in various stages of training had greater accuracy and speed with the MatchedFlicker programme than with a handheld stereoscopic viewer.

Reducing the rate and duration of Re-ADMISsions among patients with unipolar disorder and bipolar disorder using smartphone-based monitoring and treatment - the RADMIS trials: study protocol for two randomized controlled trials.

BACKGROUND: Unipolar and bipolar disorder combined account for nearly half of all morbidity and mortality due to mental and substance use disorders, and burden society with the highest health care costs of all psychiatric and neurological disorders. Among these, costs due to psychiatric hospitalization are a major burden. Smartphones comprise an innovative and unique platform for the monitoring and treatment of depression and mania. No prior trial has investigated whether the use of a smartphone-based system can prevent re-admission among patients discharged from hospital. The present RADMIS trials aim to investigate whether using a smartphone-based monitoring and treatment system, including an integrated clinical feedback loop, reduces the rate and duration of re-admissions more than standard treatment in unipolar disorder and bipolar disorder. METHODS: The RADMIS trials use a randomized controlled, single-blind, parallel-group design. Patients with unipolar disorder and patients with bipolar disorder are invited to participate in each trial when discharged from psychiatric hospitals in The Capital Region of Denmark following an affective episode and randomized to either (1) a smartphone-based monitoring system including (a) an integrated feedback loop between patients and clinicians and (b) context-aware cognitive behavioral therapy (CBT) modules (intervention group) or (2) standard treatment (control group) for a 6-month trial period. The trial started in May 2017. The outcomes are (1) number and duration of re-admissions (primary), (2) severity of depressive and manic (only for patients with bipolar disorder) symptoms; psychosocial functioning; number of affective episodes (secondary), and (3) perceived stress, quality of life, self-rated depressive symptoms, self-rated manic symptoms (only for patients with bipolar disorder), recovery, empowerment, adherence to medication, wellbeing, ruminations, worrying, and satisfaction (tertiary). A total of 400 patients (200 patients with unipolar disorder and 200 patients with bipolar disorder) will be included in the RADMIS trials. DISCUSSION: If the smartphone-based monitoring system proves effective in reducing the rate and duration of re-admissions, there will be basis for using a system of this kind in the treatment of unipolar and bipolar disorder in general and on a larger scale. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03033420 . Registered 13 January 2017. Ethical approval has been obtained.