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Background: Non-suicidal self-injury (NSSI) is a growing healthcare problem. Individuals with NSSI have an increased risk of suicidality. Because of stigma, they may self-injure in secret, which means they often seek help when events have escalated to suicidal ideation or a mental disorder. Previous studies have shown that interventions delivered via mobile phone applications have the potential to reduce self-injury. This protocol outlines a trial, which examines whether the Zero Self Harm-intervention, which is based on an app created for people with NSSI, can reduce the number of NSSI-episodes, suicide ideation, and depressive symptoms. Methods: The trial will be conducted as a 6-month 2-arm, parallel-group, multicentre, pragmatic, randomized clinical superiority trial. The intervention group will receive the app and instructions on how to use it, while the control group will be allocated to a waitlist and allowed to download the app after 6 months. Participants will be asked to complete questionnaires at 3- and 6 months after date of inclusion and the primary outcome is the number of NSSI-episodes during the last month, as measured at the 3 months follow-up with the Deliberate Self-Harm Inventory. A total of 280 participants, 140 in each arm, will be included.Discussion: This trial will assess the effectiveness of the Zero Self Harm-intervention to reduce the number of NSSI episodes. If effective, the app will have the potential to support to large group of people with NSSI. NSSI is stigmatised and often done in secret. Being both discreet and anonymous, the app might be an appealing option for support. In addition, people with current or former NSSI were involved in the development of the app. The app was developed with a focus on minimizing harm, not to end NSSI, which might also make the app appealing for a broader group of users.Trial registration: ClinicalTrials.gov, NCT04463654. Registered on 7 June 2020

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.

Background: Recovery-oriented intersectoral care is described as an aim in mental healthcare to create a holistic framework for planning that provides integration of treatment and rehabilitation. Existing studies show that nurses and other professionals do not take responsibility for the collaborative element of intersectoral care between mental health hospitals and community mental health services. The users of mental healthcare do not experience their patient journey as a cohesive process when they are discharged from a mental health hospital to community mental health services. Aim: The integrative review aims to examine the professionals’ experience with recovery-oriented intersectoral care between mental health hospitals and community mental health services. Design: Since the aim was to review user experience, we chose an integrative review as an obvious choice for design. Ethical approval: Not applicable. Findings: Seven studies met the inclusion criteria. The interactive inductive and deductive analysis generated four themes, which clarify the experience of professionals with recovery-oriented intersectoral care between the mental health hospitals and community mental health services, namely ‘structurally routine care’, ‘unequal balance of power between the sectors’, ‘bureaucracy as a barrier to recovery-oriented intersectoral care’ and ‘flexible mental healthcare approaches’. Conclusion: This review achieves specific knowledge of recovery-oriented intersectoral care. The studies included show that recovery-oriented intersectoral care is not clearly defined. It is challenging to transfer intersectoral care to an organisation with different structural and linguistic barriers.

Aims and objectives: In the medical field, we lack knowledge on how interprofessional collaboration across sectors is carried out. This paper explores how healthcare professionals and users perceive recovery-oriented cross-sectoral discharge network meetings between mental health hospital professionals and community mental health professionals and which discourses manifest themselves within the field of mental healthcare. Method: Ten professionals from a mental health hospital and eight community mental health professionals participated. In addition, five users with experience in mental health services in both sectors participated. Fairclough’s discourse analysis framework was used to explore their experiences. The study was designed following the ethical principles of the Helsinki Declaration and Danish law. Each study participant in the two intersectoral sectors gave their informed consent after verbal and written information was provided. The Consolidated Criteria for Reporting Qualitative Research checklist was used as a guideline to secure accurate and complete reporting of the study). Results: The healthcare professionals in both sectors are governed by steering tools, legislation and a strong biomedical tradition to solve illness-related problems, such that users must be offered treatment and support to achieve self-care as soon as possible. This can be seen as a reflection of, and a driving force in, a change in the wider social practice that Fairclough terms the ‘marketisation of discourse’—a social development in late modernity, whereby market discourse colonises the discursive practices of public institutions. The user of psychiatric and social services experiences a structured system that does not offer the necessary time for deep conversations. Users do not consider recovery as something that is only seen in relation to the efforts of the professionals, as recovery largely takes place independently of professionals. Recovery depends on users’ internal resources and a strong network that can support them on the journey. Conclusion: Healthcare professionals perceive recovery-oriented cross-sectoral discharge network meetings to reflect paternalistic and biomedical discourses. Users want to be seen more as whole persons and did not experience sufficient involvement in the intersectoral care. Relevance to clinical practice: Healthcare professionals need to be supported to seek clarity in the understanding and operationalisation of a recovery-oriented approach, if the agenda is to be truly adopted and strengthened.

Recovery-oriented cross-sectoral collaboration is a cornerstone of the debate concerning health professionals and users of mental health services and constitutes an objective in government health policy in Scandinavia and other Western countries. Users do not find that professionals communicate with each other across specific sectors regarding plans that have been prepared. They often experience that they have to start over again every time they switch between treatment locations. The aim of this study is to develop a recovery-oriented model for network meetings. Health professionals and users with experience from mental health services participated in three workshops to discuss and achieve a plan for recovery-oriented network meetings. Knowledge was generated in dynamic research cycles that were experiential, presentational, propositional, and practical. Themes were developed and framed by a content analysis.Recommendations are presented as a narrative from all the participants involved. The overall theme was 'more focus on personal recovery' with subthemes such as 'CHIME as a recovery-oriented approach'. In addition, other themes were generated such as 'open dialogical meetings', with subthemes such as 'meeting structures' and 'open dialogues'. This study concludes recommendations to promote a recovery-oriented approach in cross-sectoral network meetings inspired by theoretical perspectives along with the experiences and knowledge of co-researchers.

Introduction: This study aimed to explore how healthcare professionals and users could perceive user involvement in the handover between mental health hospitals and community mental healthcare, drawing on the discourse analysis framework from Fairclough. Methods: A qualitative research design with purposive sampling was adopted. Five audio-recorded focus group interviews with nurses, users and other health professionals were explored using Fairclough’s discourse analysis framework. Ethical approval: The study was designed following the ethical principles of the Helsinki Declaration and Danish Law. Each study participant in the two intersectoral sectors gave their informed consent after verbal and written information was provided. Results: This study has shown how users can be subject to paternalistic control despite the official aims that user involvement should be an integral part of the care and treatment offered. As evidenced in discussions by both health professionals and the users themselves, the users were involved in plans with the handover on conditions determined by the health professionals who were predominantly focused on treating diseases and enabling the users to live a life independent of professional help. Conclusions: Our results can contribute to dealing with the challenges of incorporating user involvement as an ideology in the handover between mental health hospitals and community mental health. There is a need to start forming a common language across sectors and, jointly, for professionals and users to draw up plans for intersectoral care.

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.

This study aimed to explore how mental health professionals and users perceive recovery-oriented intersectoral care when comparing mental health hospitals and community mental healthcare. Methodological design: Five audio-recorded focus group interviews of nurses, other health professionals and users were explored using manifest and latent content analysis. Ethical issues and approval: The study was designed in accordance with the ethical principles of the Helsinki Declaration and Danish law. Each study participant in the two intersectoral sectors gave their informed consent after verbal and written information was provided. Findings: From the health professionals&rsquo, perspective, the main theme informed by subthemes and categories was formulated: &lsquo, Recovery-oriented intersectoral care requires more coordination and desire for collaboration&rsquo, Two subthemes were subsequently formulated: &lsquo, The users&acute, perspective of the centre&rsquo, and &lsquo, Need for a common agenda and understanding of recovery-oriented intersectoral care&rsquo, From the users&acute, perspective, the main theme was formulated as: &lsquo, Recovery-oriented intersectoral care in tension between medical- and holistically oriented care&rsquo, This theme was informed by two subthemes: &lsquo, perspective is not in focus&rsquo, A trusting relationship and a holistic approach brings coherence&rsquo, Conclusions: This study reveals that health professionals want to work in a recovery-oriented manner in intersectoral care, but several challenges appear which make achieving this aim difficult. A common understanding of recovery and how it should be carried out in intersectoral care does not exist. Care decisions are primarily made paternalistically, where the users&rsquo, and relatives&rsquo, voices are ignored. In an attempt to create coherence across sectors, intersectoral network meetings have been established with health professionals from both sectors. However, the meetings are characterised by a lack of a clear purpose regarding the meeting structure and content, and users are only minimally involved. Our results can contribute to dealing with the challenges of incorporating recovery-oriented intersectoral care as an ideology in all psychiatric and municipal contexts and is, therefore, important for health professionals and users.

The objective of this study was to explore different stakeholder perspectives on the MYPLAN app for suicide prevention safety planning. The study was a comparative analysis of 4 focus groups with Danish MYPLAN stakeholders, young users, adult users, relatives, and clinicians. The focus groups were audio recorded, transcribed, and subjected to a thematic analysis. The analysis contextualized the participants’ experiences of the benefits and limitations of MYPLAN. While participants believed that MYPLAN could potentially interrupt early stages of a suicidal process, clinicians’ involvement in safety planning was considered important. MYPLAN could potentially give users a sense of increased personal control but learning how to effectively safety plan was not perceived to be simple and additional support should be considered for MYPLAN users.

Background The effect of safety planning for people in suicidal crisis is not yet determined, but using safety plans to mitigate acute psychological crisis is regarded as best practice. Between 2016 and 2017, Australian and Danish stakeholders were involved in revising and updating the Danish MYPLAN mobile phone safety plan and translating the app into a culturally appropriate version for Australia. Objective The objective of this study was to examine the negotiation of stakeholders’ suggestions and contributions to the design, function, and content of the MYPLAN app and to characterize significant developments in the emerging user-involving processes. Methods We utilized a case study design where 4 focus groups and 5 user-involving workshops in Denmark and Australia were subjected to thematic analysis. Results The analyses identified 3 consecutive phases in the extensive development of the app: from phase 1, Suggesting core functions, through phase 2, Refining functions, to phase 3, Negotiating the finish. The user-involving processes continued to prevent closure and challenged researchers and software developers to repeatedly reconsider the app’s basic user interface and functionality. It was a limitation that the analysis did not include potentially determinative backstage dimensions of the decision-making process. Conclusions The extended user involvement prolonged the development process, but it also allowed for an extensive exploration of different user perspectives and needs.

Background Many psychological treatments have shown effect on reducing self-harm in adults with borderline personality disorder. There is a need of brief psychotherapeutical treatment alternative for suicide prevention in specialized outpatient clinics. Methods/Design The DiaS trial was designed as a pragmatic single-center, two-armed, parallel-group observer-blinded, randomized clinical superiority trial. The participants had at least two criteria from the borderline personality disorder diagnosis and a recent suicide attempt (within a month). The participants were offered 16 weeks of dialectical behavior therapy (DBT) versus up to 16 weeks of collaborative assessment and management of suicidality (CAMS) treatment. The primary composite outcome was the number of participants with a new self-harm (nonsuicidal self-injury [NSSI] or suicide attempt) at week 28 from baseline. Other exploratory outcomes were: severity of borderline symptoms, depressive symptoms, hopelessness, suicide ideation, and self-esteem. Results At 28 weeks, the number of participants with new self-harm in the DBT group was 21 of 57 (36.8%) versus 12 of 51 (23.5%) in the CAMS treatment (OR: 1.90; 95% CI: 0.80–4.40; P = .14). When assessing the effect of DBT versus CAMS treatment on the individual components of the primary outcome, we observed no significant differences in the number of NSSI (OR: 1.60; 95% CI: 0.70–3.90; P = .31) or number of attempted suicides (OR: 2.24; 95% CI: 0.80–7.50; P = .12). Conclusion In adults with borderline personality traits and disorder and a recent suicide attempt, DBT does not seem superior compared with CAMS for reduction of number of self-harm or suicide attempts. However, further randomized clinical trials may be needed.

BACKGROUND The effect of safety planning for people in suicidal crisis is not yet determined, but using safety plans to mitigate acute psychological crisis is regarded as best practice. Between 2016 and 2017, Australian and Danish stakeholders were involved in revising and updating the Danish MYPLAN mobile phone safety plan and translating the app into a culturally appropriate version for Australia. OBJECTIVE The objective of this study was to examine the negotiation of stakeholders’ suggestions and contributions to the design, function, and content of the MYPLAN app and to characterize significant developments in the emerging user-involving processes. METHODS We utilized a case study design where 4 focus groups and 5 user-involving workshops in Denmark and Australia were subjected to thematic analysis. RESULTS The analyses identified 3 consecutive phases in the extensive development of the app: from phase 1, Suggesting core functions, through phase 2, Refining functions, to phase 3, Negotiating the finish. The user-involving processes continued to prevent closure and challenged researchers and software developers to repeatedly reconsider the app’s basic user interface and functionality. It was a limitation that the analysis did not include potentially determinative backstage dimensions of the decision-making process. CONCLUSIONS The extended user involvement prolonged the development process, but it also allowed for an extensive exploration of different user perspectives and needs.

BACKGROUND: Persons with a past episode of self-harm or severe suicidal ideation are at elevated risk of self-harm as well as dying by suicide. It is well established that suicidal ideation fluctuates over time. Previous studies have shown that a personal safety plan can assist in providing support, when a person experiences suicide ideation, and help seeking professional assistance if needed. The aim of the trial is to determine whether a newly developed safety mobile app is more effective in reducing suicide ideation and other symptoms, compared to a safety plan on paper.METHODS/DESIGN: The trial is designed as a two-arm, observer-blinded, parallel-group randomized clinical superiority trial, where participants will either receive: (1) Experimental intervention: the safety plan provided as the app MyPlan, or (2) Treatment as Usual: the safety plan in the original paper format. Based on a power calculation, a total of 546 participants, 273 in each arm will be included. They will be recruited from Danish Suicide Prevention Clinics. Both groups will receive standard psychosocial therapeutic care, up to 8-10 sessions of supportive psychotherapy. Primary outcome will be reduction in suicide ideation after 12 months. Follow-up interviews will be conducted at 3, 6, 9, and 12 months after date of inclusion.DISCUSSION: A safety plan is a mandatory part of the treatment in the Suicide Prevention Clinics in Demark. There are no studies investigating the effectiveness of a safety plan app compared to a safety plan on paper on reducing suicide ideation in patients with suicide ideation and suicidal behavior. The trial will gain new knowledge of whether modern technology can augment the effects of traditional personalized safety planning.TRIAL REGISTRATION: ClinicalTrials.gov, NCT02877316 . Registered on 19 August 2016.

Our objective was to validate the different versions of the Hamilton Depression Scale (HAM-D) both psychometrically (scalability) and clinically in discriminating antidepressants from placebo in terms of remission rates in an 8-week clinical trial in the acute treatment of major depression. The traditional HAM-D17 version was compared with the shorter HAM-D6 and the longer HAM-D21 or HAM-D24 in a fixed-dose placebo-controlled vortioxetine study. Clinical Global Impression of Severity scores were used to establish standardized cutoff scores for remission across each scale. Using these cutoff scores, we compared the ability of each scale to separate drug-placebo remission rates, evaluated by the number needed to treat for clinical evidence. The HAM-D6 was superior to HAM-D17 in separating drug-placebo remission rates at the end point, defined as number needed to treat of less than 10. More items in the longer HAM-D versions indicated smaller discriminating validity over placebo. The HAM-D6 indicated a dose effect on remission for vortioxetine in both moderate and severe major depression. The brief HAM-D6 was thus found superior to HAM-D17, HAM-D21, and HAM-D24 both in terms of scalability and in discriminating antidepressants from placebo.

Background Mental pain, defined as a subjective experience characterized by perception of strong negative feelings and changes in the self and its function, is no less real than other types of grief. Mental pain has been considered to be a distinct entity from depression. We have performed a systematic review analyzing the relationship between mental pain and suicide by providing a qualitative data synthesis of the studies. Methods We have conducted, in accordance with PRISMA guidelines, a systematic search for the literature in PubMed, Web Of Science, and Scopus. Search terms were “mental pain” “OR” “psychological pain” OR “psychache” combined with the Boolean “AND” operator with “suicid*.” In addition, a manual search of the literature, only including the term “psychache,” was performed on Google Scholar for further studies not yet identified. Results Initial search identified 1450 citations. A total of 42 research reports met the predefined inclusion criteria and were analyzed. Mental pain was found to be a significant predictive factor of suicide risk, even in the absence of a diagnosed mental disorder. Specifically, mental pain is a stronger factor of vulnerability of suicidal ideation than depression. Conclusion Mental pain is a core clinical factor for understanding suicide, both in the context of mood disorders and independently from depression. Health care professionals need to be aware of the higher suicidal risk in patients reporting mental pain. In this regard, psychological assessment should include a clinimetric evaluation of mental pain in order to further detect its contribution to suicidal tendency.

Bech P, Tanghoj P, Andreasson K, Overo KF. Dose–response relationship of sertindole and haloperidol using the pharmacopsychometric triangle. Objective: Renewed insight into dose-related effects of sertindole and haloperidol was sought by re-analysing published data for antipsychotic effect, extrapyramidal effect, and patient wellbeing – i.e., the important pharmacopsychometric triangle domains. Method: Selected Positive and Negative Syndrome Scale (PANSS) subscales and the Simpson–Angus scale were tested for validity. Standardized effect sizes [last observation carried forward (LOCF)] at endpoint were calculated. Results: The scales were found to be valid instruments. The PANSS11 psychotic subscale showed clinically significant effect sizes for all doses of sertindole (12, 20, and 24 mg) and haloperidol (4, 8, and 16 mg). Extrapyramidal effects were evident for all doses of haloperidol, but absent for the lower doses of sertindole. The PANSS6 depression subscale, a proxy measure of quality of life, showed a clinically significant effect for sertindole 20 mg and no effect for haloperidol. Conclusion: This re-analysis confirmed the antipsychotic effect and absence of extrapyramidal effects for sertindole and, in addition, showed a clinically significant antidepressant effect. A profile for bipolar states emerged.

Introduction Attempts to identify the factor structure in patients with treatment-resistant depression have been very limited. Methods Principal component analysis was performed using the baseline datasets from 3 add-on studies [2 with repetitive transcranial magnetic stimulation and one with transcranial pulsed electromagnetic fields (T-PEMF)], in which the relative effect as percentage of improvement during the treatment period was analysed. Results We identified 2 major factors, the first of which was a general factor. The second was a dual factor consisting of a depression subscale comprising the negatively loaded items (covering the pure depression items) and a treatment resistant subscale comprising the positively loaded items (covering lassitude, concentration difficulties and sleep problems). These 2 dual subscales were used as outcome measures. Improvement on the treatment resistant subscale was 40% in the active treatment group compared to 17-30% improvement in the sham treatments. Discussion It is possible to describe patients with therapy-resistant depression by a factor structure. Both rTMS and T-PEMF had a clinical effect on the factor-derived scales when compared to sham treatment.

Patients with borderline personality disorder (BPD) have a 10% lifetime risk of death by suicide.1 Therefore, prevention of self-harm is an important target for treatment in this population. A recent Cochrane review2 concludes that dialectical behaviour therapy (DBT) is the most studied psychotherapeutic treatment for patients with BPD. The authors found that there were indications of beneficial effects for many psychotherapies, including DBT, for the BPD core symptoms and reduction of self-harm. One of the meta-analyses conducted regarding DBT compared with treatment as usual (TAU) showed a moderate statistically significant effect, indicating a beneficial effect in favour of DBT.2 Owing to the multicomponent nature of DBT treatment, Linehan and colleagues made an important study to compare DBT skills training with other DBT components, and tried to identify what is needed to obtain a positive outcome. The study was designed as a three arm, single-blinded randomised …

In Denmark 8,000 to 10,000 people will attempt suicide each year. The Centre of Excellence in Suicide Prevention in the Capital Region of Denmark is treating patients with suicidal behavior, and a recent survey has shown that 30% of the patients are suffering from borderline personality disorder. The majority of patients (70% to 75%) with borderline personality disorder have a history of deliberate self-harm and 10% have a lifetime risk to die by suicide. The DiaS trial is comparing dialectical behavior therapy with collaborative assessment and management of suicidality-informed supportive psychotherapy, for the risk of repetition of deliberate self-harm in patients with a recent suicide attempt and personality traits within the spectrum of borderline personality disorder. Both treatments have previously shown effects in this group of patients on suicide ideation and self-harm compared with treatment as usual. The trial is designed as a single-center, two-armed, parallel-group observer-blinded randomized clinical superiority trial. We will recruit 160 participants with a recent suicide attempt and at least two traits of the borderline personality disorder from the Centre of Excellence in Suicide Prevention, Capital Region of Denmark. Randomization will be performed though a centralized and computer-generated approach that conceals the randomization sequence. The interventions that are offered are a modified version of a dialectical behavior therapy program lasting 16 weeks versus collaborative assessment and management of suicidality-informed supportive psychotherapy, where the duration treatment will vary in accordance with established methods up to 16 weeks. The primary outcome measure is the ratio of deliberate self-harming acts including suicide attempts measured at week 28. Other exploratory outcomes are included such as severity of symptoms, suicide intention and ideation, depression, hopelessness, self-esteem, impulsivity, anger, and duration of respective treatments. Clinical Trial.gov: NCT01512602 .