Let's get aligned! Developing a core outcome set for clinical trials in eating disorders.

OBJECTIVE: Our study aimed to review the outcome measures/assessment instruments used and to assess their heterogeneity/homogeneity in eating disorders (EDs) randomised controlled trials. METHODS: APA PsycInfo, PubMed, and Embase were searched in December 2022 to identify studies published between and inclusive of January 2012 and December 2022. Inclusion/exclusion criteria were: (1) complete articles published in peer-reviewed scientific journals, which were: (2) randomised trials, (3) in a clinical setting (4) with human subjects, (5) with an ICD or DSM diagnosis of Anorexia Nervosa, Binge Eating Disorder, or Bulimia Nervosa. The selected papers also: (6) used one or more standardised instruments designed to measure one or more psychometric characteristics associated with ED as a primary or secondary outcome, as judged by the authors of this systematic review, and (7) were published in English or Danish. RESULTS: Ninety one articles were included, and a total of 196 outcome measures were collected. DISCUSSION: The diversity of outcome measures in ED trials hampers result comparability and data integration. We suggest creating a core outcome measure set using the Delphi method, including clinician and patient-reported ED assessments, along with relevant comorbidity scales.

Affectivity in danish patients with emotional disorders: assessing the validity of the Positive and Negative Affect Schedule (PANAS).

BACKGROUND: The Positive and Negative Affect Schedule (PANAS) was designed to measure trait positive affect (PA) and trait negative affect (NA). METHODS: The Danish PANAS was administered to outpatients with depression and anxiety disorders. Internal consistency was assessed using Cronbach's alpha and McDonald's omega and factorial structure was evaluated using confirmatory factor analysis (CFA). Convergent validity was evaluated by means of correlations with the negative affectivity and the detachment domain of the Personality Inventory for DSM-5 Short Form (PID-5-SF), the Hamilton Anxiety Rating Scale 6 (HARS-6) and the Hamilton Depression Rating Scale 6 (HDRS-6). RESULTS: PANAS Scores of 256 patients were analyzed. Cronbach's alpha and McDonald's omega showed good internal consistency for both the PA score (alpha = .84 and omega = .89) and the NA score (alpha = .86 and omega = .90). CFA analysis confirmed a structure with two factors corresponding to the PA and NA factors. PA was negatively correlated with the detachment domain of PID-5 (r = -.47), HARS-6 (r = -.15) and HDRS-6 (r = -.37). NA was positively correlated with PID-5-SF negative affectivity domain (r = .43), HARS-6 (r = .51) and HDRS-6 (r = .52). DISCUSSION: The Danish PANAS has promising internal consistency and construct validity, which are comparable to other studies of the instrument.

Patient-reported outcome measures in depression.

AIM: Patient-reported outcome measures (PROMs) are increasingly important as a mean for quality assurance. Feasible estimates of recovery can be achieved through the application of Jacobson plots, which is a simple demonstration of the outcome of each case, recommended for clinical use. We applied this approach with PROMs collected regarding group psychotherapy in a mental health service (MHS) setting. We hypothesized a recovery rate of above 50% of all cases, expecting a lower recovery rate amongst patients with severe depression. METHODS: We made a secondary sub-sample analysis of data from patients with unipolar depression (N = 171) within a pragmatic, non-inferiority, randomized controlled clinical trial comparing two cognitive behavior therapy (CBT) group interventions. The treatment consisted of 14 2-hours weekly group CBT sessions. We collected depression PROMs with the Becks Depression Inventory-II and functional levels PROMs with the Work and Social Adjustment Scale at baseline, end-of-treatment, and at a 6-months follow-up. RESULTS: At follow-up, 35% (N = 43/123) of cases with moderate or severe depression (BDI > 19) at baseline reached scores below the cut-off for moderate depression. Recovery rates in severe cases were significantly lower (26.5 vs 52.5%; p = 0.0004). We observed severe functional impairment in 36% of the patients at baseline (52/144) and observed no changes or worsening in scores at a 6-months follow-up in 44% of the patients (64/144). CONCLUSION: We achieved satisfactory remission rates for patients with moderate depression. Patients with severe depression and patients with functional impairment reached recovery rates below the standard of comparable MHSs. Improved MHSs for these patients are needed.

Trait and symptom change in group cognitive behaviour therapy for anxiety and depression.

Personality traits underlying both anxiety disorders and depression are more malleable than previously presumed. This study examined associations between changes in personality traits (i.e. negative affectivity and detachment) and alleviation of anxiety and depression symptoms following cognitive behaviour therapy (CBT). We hypothesized that decreases in negative affectivity would predict alleviation of depression and anxiety symptoms and decreases in detachment would predict decreases in depression and, to a lesser degree, anxiety symptoms. Data (N = 156) were collected in a randomized controlled trial comparing transdiagnostic and diagnosis-specific group CBT for patients with major depressive disorder, social anxiety disorder, panic disorder or agoraphobia. We assessed personality traits using the Personality Inventory for DSM-5 (PID-5) and symptoms with the Hopkins Symptom Checklist 25-item scale (SCL). Prediction was based on regression analyses. We found that decreases in negative affectivity predicted lower levels of depression and anxiety symptoms while decreases in detachment only predicted lower levels of depression symptoms. The findings substantiate current efforts to explicate the dynamic interplay between personality traits and symptoms and support the existing focus on targeting negative affectivity and detachment in therapy for anxiety disorders and depression. The trial is registered at clinicaltrials.gov (ID NCT02954731).

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.

"The Depressed" and "People with Anxiety" therapists' discursive representations of patients with depression and anxiety in Danish Psychiatry.

Stigmatization within mental health care has previously been identified, and some diagnoses have been shown to be particularly exposed to negative attitudes and stigma. However, no previous studies have explored practitioners' discursive construction of patients with different diagnoses within a transdiagnostic group context. We performed discourse analysis on 12 interviews with Danish mental health practitioners, who had been conducting either transdiagnostic psychotherapy (The Unified Protocol) or standard group cognitive behavioral therapy (CBT) with patients treated for anxiety disorders or major depressive disorder. The purpose of this study was to identify how patients with anxiety and depression were represented by therapists. We identified a "training discourse," within which patients were evaluated through perceived motivation, responsibility, active participation, and progression. We argue that this training discourse can be related to a broader neoliberal order of discourse valuing efficiency and agency. The analysis indicated that patients with anxiety were sometimes "favorized" over patients with depression, and it is argued that the neoliberal order of discourse and pre-assumptions related to the diagnoses are contributing to this. The interviews indicate that multiple discourses were applied when describing patients, and ambivalence was often detectable. We discuss the findings of the analysis in relation to therapists' general critical attitudes toward the psychiatric system and in relation to broader societal tendencies.

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.