Utility of the Work and Social Adjustment Scale (WSAS) in predicting long-term sick-leave in Danish patients with emotional disorders.

BACKGROUND: The Work and Social Adjustment Scale (WSAS) is a self-administered measure designed to assess the level of inability to function socially as a consequence of a defined problem or disorder. METHODS: A total of 230 patients with emotional disorders completed the Danish translation of the WSAS, measures of anxiety and depression, the Level of Personality Functioning Brief Form, the Personality Inventory for DSM-5 Short Form, and the World Health Organization Five-Item Well-Being Index (WHO-5). We conducted a confirmatory factor analysis of the previously suggested factor structure of the instrument. We furthermore evaluated the construct validity of the WSAS by means of its relationship with depression, anxiety, personality functioning, and overall well-being. Finally, we evaluated the utility of the WSAS to identify those on long-term sick-leave by conducting receiver operating characteristic (ROC) curves. RESULTS: The instrument had a poor to average fit with the previously reported single-factor structure, but a better fit to a modified single-factor structure. Cronbach's alpha and McDonald's omega showed good internal scale reliability (α = .79, ωtotal = .85). WSAS was positively correlated with measures of anxiety (r = .33), depression (r = .44), and personality functioning (r = .23 and r = .20), and negatively correlated with WHO-5 wellbeing (r = -.57). The optimal cut-off point in the ROC-analyses was 23, which yielded a sensitivity of 74% and a specificity of 55% in the prediction of sick-leave status. DISCUSSION: The Danish WSAS shows promising psychometric properties, but has limited external validity insofar as predicting long-term sick leave in psychiatric patients with emotional disorders.

Validation of the Danish Version of the Overall Depression Severity and Impairment Scale (ODSIS): A Reliable Instrument for Assessing Depression Symptoms and Functional Impairment.

INTRODUCTION: In psychotherapy, having a reliable tracking tool is vital for effective treatment. We have validated the Danish version of the 'Overall Depression Severity and Impairment Scale' (ODSIS), which is used in the Unified Protocol for Emotional Disorders (UP) and other cognitive behavioural therapies. This five-item self-rating scale is expected to correspond closely to the gold-standard Beck Depression Inventory-II (BDI-II), but also to self-rating scales addressing daily functioning and well-being. METHODS: Internal consistency is assessed using Cronbach's alpha and McDonald's omega. Criterion validity is explored through Pearson's correlation coefficient with BDI-II, the Work and Social Adjustment Scale (WSAS), the Five-Item World Health Organization Well-Being Index (WHO-5) and scatter plots, and an optimal cut-off score is determined using a receiver operating characteristic curve. The study included 340 respondents: 234 from a recent clinical trial, 56 psychiatric patients from inpatient/outpatient units and 50 healthy volunteers. RESULTS: ODSIS demonstrates strong internal consistency (Cronbach's alpha: 0.887-0.956, McDonald's omega: 0.888-0.957). Correlations with BDI-II, WSAS and WHO-5 highlight its strong criterion validity (BDI-II: 0.847, WSAS: 0.751, WHO-5: 0.771). The optimal cut-off score (> 7.5) for detecting depression shows great sensitivity (0.862) and specificity (0.731). CONCLUSION: The Danish version of ODSIS proves to be a reliable instrument for quantification of a combination of depression level and functional impairment from the symptoms. Its high correlation with established BDI-II makes it a brief and handy tool for repeated measurement in clinical and research settings.

Emotion Regulation and Mentalization in Patients With Depression and Anxiety.

OBJECTIVE: Theoretical conceptualizations of emotion and affect regulation have a considerable common ground. However, mentalization theory considers the ability to regulate affects as being contingent on the ability to mentalize. The aim of the present study is to examine the association between emotion regulation and mentalization, operationalized as reflective functioning, in a sample of patients with depression and/or anxiety. METHODS: The study used data from the TRAns-diagnostic Cognitive behavioural Therapy versus standard cognitive behavioural therapy (TRACT-RCT) trial. Patients with depression and/or anxiety (N = 291; 64.4% female; Mage = 32.2; SD = 11.0) completed the Emotion Regulation Strategies Questionnaire (ERSQ) and the Reflective Functioning Questionnaire (RFQ-6). Correlation and regression analyses were performed to determine associations of the measures of ERSQ and RFQ-6 in relation to the outcome variables, global well-being (World Health Organization Well-being Index; WHO-5) and social functioning (Work and Social Adjustment Scale; WSAS). RESULTS: Overall, the patients had a reduced level of emotion regulation (MERSQ_Total = 1.77; SD = 0.59). However, only mildly impaired reflective functioning was found (MRFQ-6 = 3.57; SD = 1.26). ERSQ correlated significantly with RFQ-6 (r = -0.31), that is, more frequent use of emotion regulation strategies was associated with less hypomentalization. ERSQ was a stronger predictor of well-being and social function than RFQ-6. CONCLUSION: In patients with anxiety and/or depression, hypomentalization as measured by the RFQ-6 is not a major problem, but emotion regulation is. It seems that these two, theoretically related constructs, do not necessarily co-occur. Alternatively, the RFQ-6 scale might not capture the mentalization construct in a valid way. Emotion regulation strategies are highly related to symptomatology; therefore, they are likely to be an important target for psychotherapy.

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.

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.

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.

Rumination-focused cognitive behaviour therapy for non-responsive chronic depression: an uncontrolled group study.

BACKGROUND: One-third of patients with depression do not respond satisfactorily to treatment, and approximately 20% of all patients treated for depression develop a chronic depression. One approach to more effective treatment of chronic and treatment-resistant depression is to target rumination - an underlying mechanism implicated in the development and maintenance of depression. AIM: The purpose of this uncontrolled group study was to investigate the feasibility of individual rumination-focused cognitive behavioural therapy (RfCBT) for patients with chronic and treatment-resistant depression. METHOD: A total of 10 patients with chronic and treatment-resistant depression were offered 12-16 individual sessions of RfCBT. The primary outcome was depressive symptoms as measured by Hamilton Depression Scale at pre-, post- and 3-month follow-up. Secondary symptoms measured included self-reported rumination and worry. RESULTS: There was a significant reduction in depressive symptoms (p < 0.05), rumination (p < 0.01) and worry (p < 0.5) from pre- to post-treatment. Half of the participants (n = 5) showed significant reliable change on levels of depressive symptoms post-treatment. The reduction in depressive symptoms, rumination and worry were maintained at follow-up. CONCLUSIONS: RfCBT was associated with significant reductions in depressive symptoms in a small sample with chronic and treatment-resistant depression. Despite limitations of being a small uncontrolled study with limited follow-up, these results are promising in a difficult to treat population. RfCBT warrants further systematic evaluation.

Transdiagnostic group CBT vs. standard group CBT for depression, social anxiety disorder and agoraphobia/panic disorder: Study protocol for a pragmatic, multicenter non-inferiority randomized controlled trial.

BACKGROUND: Transdiagnostic Cognitive Behavior Therapy (TCBT) manuals delivered in individual format have been reported to be just as effective as traditional diagnosis specific CBT manuals. We have translated and modified the "The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders" (UP-CBT) for group delivery in Mental Health Service (MHS), and shown effects comparable to traditional CBT in a naturalistic study. As the use of one manual instead of several diagnosis-specific manuals could simplify logistics, reduce waiting time, and increase therapist expertise compared to diagnosis specific CBT, we aim to test the relative efficacy of group UP-CBT and diagnosis specific group CBT. METHODS/DESIGN: The study is a partially blinded, pragmatic, non-inferiority, parallel, multi-center randomized controlled trial (RCT) of UP-CBT vs diagnosis specific CBT for Unipolar Depression, Social Anxiety Disorder and Agoraphobia/Panic Disorder. In total, 248 patients are recruited from three regional MHS centers across Denmark and included in two intervention arms. The primary outcome is patient-ratings of well-being (WHO Well-being Index, WHO-5), secondary outcomes include level of depressive and anxious symptoms, personality variables, emotion regulation, reflective functioning, and social adjustment. Assessments are conducted before and after therapy and at 6 months follow-up. Weekly patient-rated outcomes and group evaluations are collected for every session. Outcome assessors, blind to treatment allocation, will perform the observer-based symptom ratings, and fidelity assessors will monitor manual adherence. DISCUSSION: The current study will be the first RCT investigating the dissemination of the UP in a MHS setting, the UP delivered in groups, and with depressive patients included. Hence the results are expected to add substantially to the evidence base for rational group psychotherapy in MHS. The planned moderator and mediator analyses could spur new hypotheses about mechanisms of change in psychotherapy and the association between patient characteristics and treatment effect. TRIAL REGISTRATION: Clinicaltrials.gov NCT02954731 . Registered 25 October 2016.

Interventions promoting recovery from depression for patients transitioning from outpatient mental health services to primary care: Protocol for a scoping review.

INTRODUCTION: Patients with severe Major Depressive Disorder (MDD) have an increasing risk of new psychiatric hospitalizations following each new episode of depression highlighting the recurrent nature of the disorder. Furthermore, patients are not fully recovered at the end of their treatment in outpatient mental health services, and residual symptoms of depression might explain why patients with MDD have a high risk of relapse. However, evidence of methods to promote recovery after discharge from outpatient mental health services is lacking. The proposed scoping review aims to systematically scope, map and identify the evidence and knowledge gaps on interventions that aims to promote recovery from MDD for patients transitioning from outpatient mental health services to primary care. MATERIALS AND METHODS: The proposed scoping review will follow the latest methodological guidance by the Joanna Briggs Institute (JBI) in tandem with the Preferred Reporting Items for Systematic reviews and Meta-Analysis-extension for Scoping Reviews (PRISMA-ScR) checklist. The review is ongoing. Four electronic databases (Medline via PubMed, PsycINFO, CINAHL, and Sociological Abstracts) were systematically searched from 20 January 2022 till 29 March 2022 using keywords and text words. The review team consists of three independent screeners. Two screeners have completed the initial title and abstract screening for all studies retrieved by the search strategy. Currently, we are in the full text screening phase. Reference lists of included studies will be screened, and data will be independently extracted by the review team. Results will be analyzed qualitatively and quantitatively. DISCUSSION: The chosen methodology is based on the use of publicly available information and does not require ethical approval. Results will be published in an international peer reviewed scientific journal, at national and international conferences and shared with relevant authorities. REGISTRATION: A pre-print has been registered at the medRxiv preprint server for health sciences (doi.org/10.1101/2022.10.06.22280499).

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.

"Despite the Differences, We Were All the Same". Group Cohesion in Diagnosis-Specific and Transdiagnostic CBT Groups for Anxiety and Depression: A Qualitative Study.

Group cohesion refers to a sense of belonging, mutual support and identification with other group members. Group cohesion has been associated with better outcomes, lower drop-out rates, more interpersonal support and better participation in psychotherapy. Nevertheless, the role of group cohesion in CBT has not yet received much attention. The rationale for delivering CBT in groups is that patients can model themselves through each other due to their similarities in symptoms. However, there has recently been a shift towards transdiagnostic CBT protocols, in which patients with varied diagnoses participate in the same groups. This shift challenges the rationale of delivering CBT in groups, and it is therefore highly important to understand if and how group cohesion develops in mixed diagnoses CBT groups. The current study used a qualitative comparative framework to investigate the patients' experiences of group cohesion in diagnosis-specific versus transdiagnostic CBT groups. Twenty-three patients were interviewed with semi-structured interviews upon completion of the treatment. Participants had a primary diagnosis of MDD, panic disorder, agoraphobia or social anxiety disorder. A comparative thematic analysis was carried out. Three themes were found: the move from differences to similarities, the role of group cohesion in group CBT and factors helpful and hindering to group cohesion. Group cohesion developed across groups and was considered highly important in both diagnosis-specific and transdiagnostic CBT groups.

Rumination-focused cognitive behaviour therapy vs. cognitive behaviour therapy for depression: study protocol for a randomised controlled superiority trial.

BACKGROUND: Cognitive behavioural therapy is an effective treatment for depression. However, one third of the patients do not respond satisfactorily, and relapse rates of around 30 % within the first post-treatment year were reported in a recent meta-analysis. In total, 30-50 % of remitted patients present with residual symptoms by the end of treatment. A common residual symptom is rumination, a process of recurrent negative thinking and dwelling on negative affect. Rumination has been demonstrated as a major factor in vulnerability to depression, predicting the onset, severity, and duration of future depression. Rumination-focused cognitive behavioural therapy is a psychotherapeutic treatment targeting rumination. Because rumination plays a major role in the initiation and maintenance of depression, targeting rumination with rumination-focused cognitive behavioural therapy may be more effective in treating depression and reducing relapse than standard cognitive behavioural therapy. METHOD/DESIGN: This study is a two-arm pragmatic randomised controlled superiority trial comparing the effectiveness of group-based rumination-focused cognitive behaviour therapy with the effectiveness of group-based cognitive behavioural therapy for treatment of depression. One hundred twenty-eight patients with depression will be recruited from and given treatment in an outpatient service at a psychiatric hospital in Denmark. Our primary outcome will be severity of depressive symptoms (Hamilton Rating Scale for Depression) at completion of treatment. Secondary outcomes will be level of rumination, worry, anxiety, quality of life, behavioural activation, experimental measures of cognitive flexibility, and emotional attentional bias. A 6-month follow-up is planned and will include the primary outcome measure and assessment of relapse. DISCUSSION: The clinical outcome of this trial may guide clinicians to decide on the merits of including rumination-focused cognitive behavioural therapy in the treatment of depression in outpatient services. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02278224 , registered 28 Oct. 2014.