Schema therapy versus treatment as usual for outpatients with difficult-to-treat depression: study protocol for a parallel group randomized clinical trial (DEPRE-ST).

BACKGROUND: About one third of patients with depression are in a condition that can be termed as "difficult-to-treat". Some evidence suggests that difficult-to-treat depression is associated with a higher frequency of childhood trauma and comorbid personality disorders or accentuated features. However, the condition is understudied, and the effects of psychotherapy for difficult-to-treat depression are currently uncertain. The aim of this trial is to investigate the beneficial and harmful effects of 30 sessions of individual schema therapy versus treatment as usual for difficult-to-treat depression in the Danish secondary, public mental health sector. METHODS: In this randomized, multi-centre, parallel-group, superiority clinical trial, 129 outpatients with difficult-to-treat depression will be randomized (1:1) to 30 sessions of individual schema therapy or treatment as usual; in this context mainly group-based, short-term cognitive behaviour or psychodynamic therapy. The primary outcome is the change from baseline in depressive symptoms 12 months after randomization, measured on the observer-rated 6-item Hamilton Rating Scale for Depression. The secondary outcomes are health-related quality of life assessed with the European Quality of Life 5 Dimensions 5 Level Version, functional impairment assessed with the Work and Social Adjustment Scale, psychological wellbeing assessed with the WHO-5 Well-being Index, and negative effects of treatment assessed with the Negative Effects Questionnaire. Exploratory outcomes are improvement on patient self-defined outcomes, personal recovery, anxiety symptoms, anger reactions, metacognitive beliefs about anger, and perseverative negative thinking. Outcomes will be assessed at 6, 12, and 24 months after randomization; the 12-month time-point being the primary time-point of interest. Outcome assessors performing the depression-rating, data managers, statisticians, the data safety and monitoring committee, and conclusion makers for the outcome article will be blinded to treatment allocation and results. To assess cost-effectiveness of the intervention, a health economic analysis will be performed. DISCUSSION: This trial will provide evidence on the beneficial and harmful effects, as well as the cost-effectiveness of schema therapy versus treatment as usual for outpatients with difficult-to-treat depression. The results can potentially improve treatment for a large and understudied patient group. TRIAL REGISTRATION: ClinicalTrials.gov NCT05833087. Registered on 15th April 2023 (approved without prompts for revision on 27th April 2023).

Cross-cultural validity of the WHO-5 Well-Being Index and Euthymia Scale: A clinimetric analysis.

BACKGROUND: The assessment of psychological well-being and euthymia represents an emerging issue in clinical psychology and psychiatry. Rating scales and indices such as the 5-item version of the World Health Organization Well-Being Index (WHO-5) and the Euthymia Scale (ES) were developed but insufficient attention has been devoted to the evaluation of their cross-cultural validity. This is the first study using Clinimetric Patient-Reported Outcome Measures (CLIPROM) criteria to assess cross-cultural validity and sensitivity of five different versions of the WHO-5 and ES. METHODS: A multicenter cross-sectional study involving a total of 3762 adult participants from different European (i.e., Italy, Poland, Denmark) and non-European (i.e., China, Japan) countries was conducted. Item Response Theory models (Mokken and Rasch analyses) were applied. RESULTS: Mokken coefficients of scalability were found to range from 0.42 to 0.84. The majority of the versions of the WHO-5 fitted the Rasch model expectations. Paired t-tests revealed that the Italian and Danish WHO-5 versions were unidimensional. Person Separation Reliability indices showed that the Polish, Danish, and Japanese ES versions could reliably discriminate between subjects with different levels of euthymia. LIMITATIONS: A convenience sampling was used, thus limiting the generalizability of study findings. In addition, no measures of negative mental health were administered. CONCLUSIONS: WHO-5 can be used in international studies for cross-cultural comparisons since it covers transcultural components of subjective well-being. Findings also suggest that the ES can be used as a cross-cultural screening tool since it entailed the clinimetric property of sensitivity.

Evaluation of a standardized posttraumatic stress disorder treatment framework in routine mental health care: Effectiveness and predictors of treatment outcome in a consecutive sample.

The primary aim of the present study was to evaluate the effectiveness of standardized care package (CP) treatment for posttraumatic stress disorder (PTSD) in a Danish sample of adult psychiatric outpatients (N = 948). Secondary aims were to identify baseline predictors of treatment outcomes and investigate between-group differences in outcomes with regard to sex and treatment modality (i.e., group vs. individual therapy). The naturalistic, nonrandomized study followed a pre-post design. Patient data from five psychiatric outpatient clinics were collected between March 2011 and November 2017. Data were drawn from self-report questionnaires (i.e., SCL-90-R, WHO-5, BHS) and therapist-reported measures (i.e., GAF-S, GAF-F) administered at baseline and posttreatment. Between-group effects for sex and therapy modality (group vs. individual) were analyzed using analyses of variance, and possible predictors of outcomes were selected through LASSO regression and analyzed via hierarchical regression. Pre-post effects were small to moderate, ds = 0.39-0.69. No differences emerged regarding treatment modality, but women had significantly better outcomes than men. Aside from sex, only baseline symptom severity predicted outcomes. The effectiveness of the CP treatment was generally limited, indicating the need to implement improved therapeutic practices, such as the use of evidence-based treatments, and to provide better training to mental health clinicians. The findings underscore the need for further comparisons of group and individual treatment modalities using evidence-based therapies as well as the need to investigate factors that may affect treatment outcome.

The Short Version of the Metacognitive Anger Processing Scale (MAP-SV) - initial psychometric testing.

BACKGROUND: The 26-item version of the Metacognitive Anger Processing Scale (MAP) has shown good psychometric properties in previous studies. However, there is a need for a shorter version of the scale. AIMS: The aim of the present study is to psychometrically evaluate the 9-item Metacognitive Anger Processing Scale - Short Version (MAP-SV) in comparison with the original, 26-item version. METHOD: The 26-item MAP includes three subscales: rumination, positive beliefs and negative beliefs. Three items from each subscale were selected based on clinical validity to constitute the 9-item MAP-SV. A previous sample used for validation of the 26-item MAP was used for clinimetric testing. The sample included psychiatric patients (n = 88) and male forensic inpatients (n = 54). The MAP-SV was assessed according to scalability, convergent validity with general metacognition, and concurrent validity with anger measures. RESULTS: The scalability of the 9-item MAP-SV was comparable to that of the original 26-item MAP in most psychometric tests. The Loevinger's coefficient of homogeneity for the total score of the MAP-SV items was 0.29 for the combined sample compared with 0.36 in the original MAP, indicating close to acceptable scalability. The alpha coefficient for the MAP-SV total score was 0.79. For the combined sample, Pearson inter-correlations between the subscales of the MAP-SV were highly correlated with the MAP-SV total score (ranging from .66 to .84). CONCLUSIONS: The 9-item MAP-SV showed good psychometric properties and can be used as a reliable tool for assessing self-reported metacognitive anger processing.

Patients' Experiences of Using a Self-help App for Posttraumatic Stress Disorder: Qualitative Study.

BACKGROUND: Posttraumatic stress disorder (PTSD) is a common disorder that requires more treatment options. Mobile health (mHealth) app interventions are promising for patients with PTSD, as they can provide easily accessible support, strategies, and information. However, knowledge about mHealth interventions is sparse and primarily based on quantitative studies. OBJECTIVE: The aim of this study is to qualitatively explore the experiences of patients with PTSD with regard to using an mHealth app as a stand-alone intervention before commencing psychotherapeutic treatment. METHODS: We conducted semistructured interviews with 14 participants 6 weeks after they received the app. The participants were all referred to PTSD treatment and were waiting to commence psychotherapeutic treatment. During this waiting time, the participants had no contact with the health staff. Interviews were transcribed and were analyzed using thematic analysis. RESULTS: A total of 3 themes were identified-the use of app, being a patient, and the overall evaluation of the app. The use of the app was described with the subtheme of habits, and the theme of being a patient included the subthemes of having negative experiences with the app and being a part of a research project. The use of the app encompassed how psychological factors and technical problems could interfere with the use of the app. The theme of being a patient depicted that the waiting time before starting treatment was long, and a subgroup of patients experienced feeling worse during this time, which they partly attributed to using the app. Several suggestions for change have been described in the overall evaluation of the app. CONCLUSIONS: The findings in this study revealed that emotional arousal influenced the use of the app and that it was difficult for participants to establish a habit of using the app, thus reflecting the importance of supporting habit formation when implementing an mHealth app in mental health care services. This study makes an important contribution to the field of mHealth research, as it revealed that some participants had negative experiences resulting from using the app, thus reflecting the potential harm of having an mHealth app without the support of a clinician. It is therefore recommended to use a blended care treatment or an approach in which mental health care professionals prescribe an mHealth app for relevant patients to avoid increased suicidal risk.