The clinical and cost-effectiveness of a self-management intervention for patients with persistent depressive disorder and their partners/caregivers: study protocol of a multicenter pragmatic randomized controlled trial.

BACKGROUND: After regular treatment, patients with persistent depressive disorder (PDD) may remain in specialized psychiatric outpatient care without achieving remission. Lacking other options, these patients often receive long-term, non-protocolized care as usual (CAU) that does not involve the partner/caregiver of the patient. Although the revised depression treatment guidelines suggest focusing on psychiatric rehabilitation and self-management as the next treatment step for PDD, an evidence-based cost-effective self-management protocol for PDD is lacking. This study investigates the "Patient and Partner Education Program for All Chronic Illnesses" (PPEP4All) as a brief self-management protocol that could lead to lower costs, higher quality of life, and less disease burden in PDD patients and their partners/caregivers. METHODS: Presented is the rationale and methods of a multicenter pragmatic randomized controlled trial to evaluate the clinical efficacy and cost-effectiveness of PPEP4All for patients with PDD and their partners/caregivers. In accordance with current recommendations, a mixed methods research approach is used with both quantitative and qualitative data. A total of 178 eligible outpatients with PDD and their partners/caregivers are recruited and randomized to either PPEP4All or CAU. Those assigned to PPEP4All receive nine weekly self-management sessions with a trained PPEP4All therapist. Primary and secondary outcome measurements are at 0, 3, 6, and 12 months. DISCUSSION: This project will result in the implementation of a self-management intervention for patients with PDD, meeting an urgent need in mental healthcare. Using PPEP4All can optimize the quality and efficiency of care for both patients with PDD and their partners/caregivers. TRIAL REGISTRATION: Netherlands Trial Register Identifier NTR5973 . Registered on 20 July 2016.

Assessment of Factors Associated With Long-term Posttraumatic Stress Symptoms Among 56 388 First Responders After the 2011 Great East Japan Earthquake.

Importance: First responders are at risk for developing symptoms of posttraumatic stress disorder (PTSD). Little is known about the risk factors for developing PTSD during a years-long period after complex mass disasters. Objective: To explore the long-term course of PTSD symptoms and to identify risk factors and their relative association with PTSD among first responders dispatched to the 2011 Japanese earthquake, tsunami, and nuclear disaster. Design, Setting, and Participants: This 6-year, large, prospective cohort study was part of a continuous longitudinal study of Japan Ground Self-Defense Force first responders. The data were collected at 1, 6, 12, 24, 36, 48, 60, and 72 months after mission completion from 2011 to 2017. Of approximately 70 000 eligible participants, 56 388 were enrolled in this study. Data were analyzed from 2017 to 2020. Exposures: Stress exposures owing to personal or professional disaster experience (eg, duties with body recovery or radiation exposure risk) and working conditions (eg, deployment length, postdeployment overtime work). Main Outcomes and Measures: The Impact of Event Scale-Revised score assessed PTSD symptoms; scores of at least 25 were defined as probable PTSD. Cox proportional hazards regression models assessed the risk factors for incidence of probable PTSD. Results: Among the 56 388 participants, 97.1% were men, and the median age at enrollment was 34 (range, 18-63) years. A probable PTSD rate was 2.7% at 1 month and showed a downward trend in the first year and a subsequent plateau. The cumulative incidence of probable PTSD was 6.75%. The severity of PTSD symptoms demonstrated a high degree of rank-order stability over time. Rather than professional disaster experience, sociodemographic factors and working conditions were independently associated with the incidence of probable PTSD: personal experience of the disaster (hazard ratio [HR], 1.96; 95% CI, 1.72-2.24), deployment length of at least 3 months (HR vs <1 month, 1.75; 95% CI, 1.52-2.02), increased age (HR for ≥46 vs ≤25 years, 2.28; 95% CI, 1.79-2.92), and postdeployment overtime work of at least 3 months (HR vs little to none, 1.61; 95% CI, 1.39-1.87). Conclusions and Relevance: Given these findings, in the future, first responders' PTSD symptoms might be mitigated by shortening deployment length, avoiding postdeployment overtime work, and paying special attention to the needs of personnel with personal experience of the disaster or older age. Efforts to alleviate responders' initial symptoms will be required.

Reference values for mental health assessment instruments: objectives and methods of the Leiden Routine Outcome Monitoring Study.

RATIONALE, AIMS AND OBJECTIVES: Routine outcome monitoring (ROM) was developed to establish the outcome of psychotherapeutic and pharmacological treatments through repeated assessments before, during and after treatment. Although standardization of psychiatric assessments and their reference values are essential for patient care, for various ROM instruments reference values are not available. The aim of the Leiden ROM Study is to generate reference values for 22 ROM instruments, covering generic and specific mood, anxiety and somatoform (MAS) disorders, for the general population. This article describes the extensive process of recruitment, as well as baseline characteristics of patient versus non-patient groups. METHOD: Cross-sectional study in randomly selected participants aged 18-65 years from the Dutch population, included through general practitioners. RESULTS: Extensive demographic, psychosocial, mental health, and biological data from 1302 participants, recruited via general practitioners, were collected during a two-hour standardized assessment including observer-rated and self-report scales. These data will be compared with corresponding data from 7840 patients with psychopathology who were referred to secondary care. On-going quality control and calibration ensured maintenance of high quality during data collection. CONCLUSIONS: This reference group study for mental health assessments is the first study of this size carried out in the Netherlands. The results of this study are expected to be of value to secondary psychiatric care because they allow the indication of progress in health, treatment effect and possible termination of treatment. Additionally, the reference values can be used by primary care physicians as decision threshold for referral to specialized mental health care and vice versa.

Reliability and validity of the Global Assessment of Functioning Scale in clinical outpatients with depressive disorders.

RATIONALE, AIMS AND OBJECTIVES: The Global Assessment of Functioning Scale (GAF) is widely used to assess psychological, social and occupational functioning. The validity and reliability of the GAF in clinical practice have only scarcely been studied in naturalistic samples. METHODS: A total of 432 outpatients with a current major depressive disorder (MDD) were evaluated with routine outcome monitoring (ROM). At baseline the GAF score was assessed by the treating clinician and at ROM baseline and follow-up sessions also by a trained test nurse. Sociodemographic data, the Mini International Neuropsychiatric Interview Plus and scores on the Montgomery-Äsberg Depression Rating Scale, Beck Depression Inventory-revised, Brief Symptom Inventory and Short Form-36 were assessed. RESULTS: At baseline, the mean GAF score by the clinician was 54.8 (range 35-85), and this was systematically lower than the mean GAF score by the test nurse of 57.5 (range 31-88). GAF scores by the clinician and test nurse correlated weakly (r = 0.26). The GAF scores of the clinicians correlated strongly with disease severity, and social and physical functioning. CONCLUSION: The GAF showed rather poor inter-rater reliability as well as poor discriminant validity with disease severity and physical limitations in a large naturalistic sample of outpatients with MDD.

Vitality predicts level of guideline-concordant care in routine treatment of mood, anxiety and somatoform disorders.

OBJECTIVE: To examine the clinical and psychosocial correlates of adherence to treatment guidelines among outpatients with common mental disorders in a routine clinical setting. METHODS: In this retrospective cohort study, we analysed 192 patients who were treated for a mood, anxiety or somatoform disorder with pharmacotherapy, psychotherapy or a combination of both treatment modalities. Guideline adherence was assessed with a disorder independent set of quality indicators during up to 3 years of follow-up. At baseline, a standardized diagnostic interview, the Brief Symptom Inventory (BSI), the Short Form 36 (SF-36) and demographic variables were assessed. Using multivariable regression analysis we identified independent predictors associated with guideline adherence. RESULTS: Patients were aged 36.8 years (SD 11.6) on average. The majority of patients were treated with psychotherapy (47.4%), followed by pharmacotherapy (37.5%) and a combination of pharmacotherapy and psychotherapy (15.1%). Three adherence groups were defined: low (29.7%), intermediate (43.2%) and high (27.1%). Univariate predictors of low adherence were low scores on the subscales vitality and social functioning of the SF-36. In the multivariable model, low adherence was independently predicted by a score lower than 50 on the subscale vitality of the SF-36 (odds ratio per 10 units increase in vitality = 1.34, 95% confidence interval: 1.06-1.71). No significant differences were found within socio-demographic variables, co-morbidity and the scores on the BSI subscales between the adherence groups. CONCLUSIONS: We found that patients with low scores on the vitality subscale of the SF-36 were at the highest risk to receive low guideline-concordant care. Understanding factors that affect treatment adherence may help to prevent non-adherence and increase the quality of care as well as cost-effectiveness.

Routine outcome monitoring and feedback on physical or mental health status: evidence and theory.

OBJECTIVES: Routine Outcome Monitoring (ROM) is an important quality tool for measuring outcome of treatment in health care. The objective of this article is to summarize the evidence base that supports the provision of feedback on ROM results to (mental) health care professionals and patients. Also, some relevant theoretical aspects are considered. METHODS: Literature study (Pubmed, Medline, PsychINFO, Embase Psychiatry, 1975-2009) concerning randomized controlled trials (RTC's) of ROM and feedback on physical or mental health status of patients of all ages. Main search terms were routine outcome monitoring/measurement, feedback, health status measurement, patient reported outcome measures. RESULTS: Included were 52 RCT's concerning ROM and feedback with adult or older patients: of these seven RCT's were exclusively focused on physical health and 45 RCT's (also) on the mental health of the patient, although not always in a mental health care setting or as primary outcome measure. There appears to be a positive impact of ROM on diagnosis and monitoring of treatment, and on communication between patient and therapist. Other results were less clear. There were no published RCT's on this topic with children or adolescents. CONCLUSIONS: ROM appears especially effective for the monitoring of patients who are not doing well in therapy. Further research into this topic and the clinical-and cost-effectiveness of ROM is recommended, especially in mental health care for both adults and children. Also, more theory-driven research is needed with relevant conceptualizations such as Feedback Intervention Theory, Therapeutic Assessment.