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.

Validation of the Danish Translation of the Revised Mystical Experience Questionnaire (MEQ30) and Possible Impact of Setting, Dose and Intention.

Research suggests positive changes in both well-being and psychiatric symptoms following a psychedelic experience. One explanation may be the ability of psychedelic compounds to occasion mystical-type experiences. The Revised Mystical Experiences Questionnaire (MEQ30) is designed to assess the intensity and quality of such experiences. We examined the validity, reliability, and factor structure of a Danish translation of the MEQ30 in one sample of healthy volunteers receiving psilocybin in a laboratory setting (N = 47) and two samples of recreative users of psychedelics, in which MEQ30 was reported retrospectively through an online survey based on their most recent experience with psilocybin (N = 834) or their most memorable experience with any psychedelic (N = 500). We conducted a confirmatory factor analysis of the previously suggested factor structures, calculated alpha and omega, and tested the associations between MEQ30 total score and setting, intention and dose. We found excellent internal reliability estimates across all samples, and confirmatory factor analysis showed that a four-factor structure, had the best, fair fit to the data. We further found that the MEQ30 total score was correlated with dose and a spiritual/religious intention, but not with setting. The Danish MEQ30 seems to be a valid tool for accessing mystical-type experiences among Danish-speaking individuals.

Assessment of the acute subjective psychedelic experience: A review of patient-reported outcome measures in clinical research on classical psychedelics.

BACKGROUND: The classical psychedelics psilocybin, peyote, ayahuasca/ N, N-dimethyltryptamine, and lysergic acid diethylamide can temporarily produce altered states of consciousness, characterized by changes in sensory perception, thought, mood, and the sense of self-reality and meaning. It is important to have reliable instruments for quantifying these altered states in trials, due to a plausible link between the acute subjective experience and treatment outcome. METHODS: We conducted a review of outcome measures applied in research on classical psychedelics to assess one or more dimensions of the acute subjective psychedelic experience. Three relevant databases were searched electronically. Two reviewers independently conducted article selection and data extraction regarding the instruments, dimensions, geography, population, and psychedelic substance investigated in the included studies. We identified the five most utilized instruments for the most recent 6 years, as well as the five most utilized instruments for each psychedelic. RESULTS: We included 93 papers, which reported on 93 unique trials and utilized 17 different rating scales. Of these, the most utilized were the Five-Dimensional Altered States of Consciousness Questionnaire, visual analog or Likert scales specially developed for the trials, the Hallucinogen Rating Scale, the States of Consciousness Questionnaire, and the Abnormer Psychischer Zustand. DISCUSSION: Considerable variability was found in the instruments utilized in clinical trials on classical psychedelics. We advise and encourage the development of a core outcome set for psychedelic research to enable altered state comparisons across compounds, participants, and settings. We further advise that instruments be designed to assess the "setting" of a psychedelic experience.

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.

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.

Psychotherapy for patients with schizotypal personality disorder: A scoping review.

BACKGROUND: Treatment of schizotypal personality disorder is complex. Currently, there are no clear evidence-based recommendations for use of psychotherapy for individuals suffering from this mental illness, and studies are sparse. Our aim in this review is to map and describe the existing research and to answer the research question: What do we know about the use of psychotherapy for people with schizotypal personality disorder? METHODS: We conducted a scoping review using systematic searches in the Embase, MEDLINE and PsycINFO databases. Two reviewers screened possible studies and extracted data on subject samples, type of psychotherapy, outcomes and suggested mechanisms of change. The review is based on the PRISMA checklist for scoping reviews. RESULTS: Twenty-three papers were included, and we found a wide variety of study types, psychotherapeutic orientations and outcomes. Few studies emerged that focused solely on schizotypal personality disorder. CONCLUSION: Psychotherapy as a treatment for schizotypal personality disorder is understudied compared with diagnoses such as schizophrenia and borderline personality disorder. Our results included two randomized controlled studies, as well as mainly smaller studies with different approaches to diagnostic criteria, psychotherapeutic orientation and outcome measures. The findings are too sparse and too diverse to make any evidence-based recommendations. We found some indications that psychotherapy may support and assist individuals with schizotypal personality disorder.

Risk of bias in randomized clinical trials on psychedelic medicine: A systematic review.

BACKGROUND: The classical psychedelics, psilocybin, peyote, ayahuasca/N,N-dimethyltryptamine, and lysergic acid diethylamide are considered promising new treatments for psychiatric illnesses, such as depression, anxiety, addiction, and obsessive-compulsive disorders. However, their profound and characteristic subjective effects raise concern for distinctive biases in randomized clinical trials. METHODS: We performed a systematic literature search to identify all clinical trials on classical psychedelics with patient populations to examine descriptive data and determine the risk of bias. Two independent reviewers searched three databases (PubMed, Embase, and APA PsycNet) and extracted information on study design, study population, use of active or inactive placebo, dropouts, evaluation of blinding of intervention, and reporting of expectancy and therapeutic alliance. RESULTS: We included 10 papers reporting on 10 unique trials. The trials generally included populations that were predominantly white and highly educated. The trials had small samples and considerable dropout. Blinding was either unsuccessful or not reported regardless of type of placebo. Few trials published protocols, statistical analysis plans (SAPs), and outcomes relating to psychotherapy fidelity. All trials but one were rated as high risk of bias. CONCLUSION: Successful blinding of intervention is a significant challenge in this field. To better accommodate this, we suggest that future trials use a parallel-group design and utilize an active placebo on a psychedelic-naïve population. Future trials should publish trial protocol and SAPs, use clinician-rated outcomes accessed by a blinded rater, evaluate blinding of intervention, and consider measuring expectancy and therapeutic fidelity.

Social phobia and evasiveness: trial protocol for a randomized controlled feasibility and superiority trial of the effect of Modified Collaborative Assessment vs. standard assessment on patients' readiness for psychotherapy (CO-ASSM-RCT).

BACKGROUND: Evasive personality disorder (AvPD) and social phobia (SP) have substantial costs for patients and their families and great economic costs to the society. While psychotherapy can be an efficacious treatment, many patients drop out during treatment. Increased knowledge on how to decrease dropout from psychotherapy is warranted, including how to increase a patient's readiness for psychotherapy. METHODS: We describe a randomized controlled feasibility and superiority trial of 42 individuals with a clinical diagnosis of either SP or AvPD, who are to initiate psychotherapeutic treatment in Danish outpatient mental health services. They will be randomized in a 1:1 ratio to either assessment-as-usual and receive no further assessment or to a Modified Collaborative Assessment (MCA) provided as a pre-treatment intervention before psychotherapy initiation. MCA will include a battery of psychological tests designed to thoroughly assess the patients' psychopathology. The tests are administered in collaboration with the patient, including detailed oral and written feedback. We hypothesize that the intervention is feasible regarding patient's acceptance and adherence. We further hypothesize that patients randomized to MCA will reach higher levels of readiness for psychotherapy as assessed with the University of Rhode Island Change Assessment Scale (URICA). DISCUSSION: This protocol assesses the feasibility, efficacy, acceptability, and safety of an intervention aimed at changing the readiness for participation in psychotherapy of patients with SP and AvPD. Results from this feasibility study could guide the development of future large-scale trials of MCA and procedures for MCA treatment fidelity assessment. TRIAL REGISTRATION: NCT2021001.

What is the effect of using collaborative assessment on symptomatology as an intervention in the treatment of mental illness? A systematic review and meta-analysis protocol.

BACKGROUND: Clinicians usually conduct diagnostic assessments in order to establish a diagnosis or to evaluate the effect of treatment. Two meta-analyses suggest that diagnostic assessment administered in collaboration with the patient and personalized feedback might have a therapeutic effect. METHODS: We aim to conduct a systematic review and meta-analysis of the effect on symptomatology when using assessment as a therapeutic intervention for patients with psychiatric illnesses. We will search in five relevant electronic databases. Two reviewers will independently select papers following pre-defined eligibility criteria, extract data, and assess the quality of included studies. Randomized controlled trials comparing the effect of psychological assessment with other psychotherapeutic interventions in populations of patients will be included in the meta-analysis. We will extract data on symptom-related outcomes, quality of life, dropout, and re-diagnosis and use meta-analysis techniques to compute the effect size of interventions using assessment as a psychotherapeutic intervention. The review will be conducted and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement. Risk of bias will be assessed by using the Risk of Bias tool RoB 2.0 of the Cochrane Collaboration, and the certainty of the body of evidence will be assessed with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. DISCUSSION: THE RESULTS WILL BE ABLE TO INFORM CLINICIANS AND POLICYMAKERS ON THE EFFECT OF ASSESSMENT AND, DEPENDING ON THE RESULTS, COULD LEAD TO A RECOMMENDATION FOR MODIFIED ASSESSMENT PROCEDURES AND APPROACHES IN MENTAL HEALTH SERVICES. ULTIMATELY, IT MIGHT IMPROVE THE TREATMENT OUTCOME IN MENTAL HEALTH SERVICES.: SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42021270567.