Development and Validation of a Psoriasis Treatment Acceptability Measure through Group Concept Mapping

Background: Psoriasis is a common autoimmune dermatologic condition which has a pronounced negative impact on patient quality of life and disease burden. Currently, there are a number of treatments available for psoriasis, with differences in efficacy, mechanism of action, mode of administration, adverse effects, and tolerability. However, a reliable, validated patient-reported instrument to address patient expectations and of psoriasis treatment has not been developed. This project was undertaken with the aim of developing a fit-for-purpose self-reported instrument to inform patient expectations and preferences of psoriasis treatments.Methods: Two studies, both utilizing qualitative and quantitative methods, were conducted in patients within the entire spectrum of psoriasis severity. In Study 1, a group concept mapping (GCM) exercise was conducted with dermatologists and moderate-to-severe psoriasis patients to identify concepts important in the treatment of psoriasis. In Study 2, a preliminary Treatment Acceptability Questionnaire (TAQ) was developed using GCM-derived concepts from Studies 1 and 2, followed by cognitive debriefing (CD) telephone interviews of the preliminary TAQ. In Study 2, another GCM exercise was conducted with mild and newly diagnosed psoriasis patients. Psychometric analyses were performed on the TAQ to evaluate validity and reliability.Results: The Study 1 GCM exercise generated 43 concepts from moderate-to-severe psoriasis patients (n=20) and dermatologists (n=10). In Study 2, 37 GCM concepts were generated from mild and newly diagnosed psoriasis patients (n=20). From the 2 GCM exercises, 28 concepts were selected to form the preliminary TAQ; CD interviews indicated strong understanding and relevance of TAQ items among patients with disease ranging from mild to severe. The final TAQ consisted of 20 items; psychometric analysis demonstrated strong validity and reliability of the TAQ. Conclusions: The TAQ is a novel psychometrically validated fit-for-purpose patient-reported instrument to inform healthcare providers of patients’ expectations of and preferences for treatment of their psoriasis and can help in shared decision making between patients and physicians.

App-Based Mindfulness for People of Color Who Experience Race-Related Stress: Protocol for a Randomized Controlled Trial (Preprint)

BACKGROUND People of color (POC) who experience race-related stress are at risk of developing mental health problems, including high levels of stress, anxiety, and depression. Mindfulness meditation (MM) may be especially well suited to help POC cope, given their emphasis on gaining awareness and acceptance of emotions associated with discriminatory treatment. However, MM rarely reaches POC, and the use of digital approaches could reduce this treatment gap by addressing traditional barriers to care. OBJECTIVE The current study will test the effectiveness of a self-directed app-based mindfulness meditation program among POC who experience elevated levels of race-related stress. Similarly, important implementation outcomes, including treatment acceptability, adherence, and satisfaction will be examined. METHODS Participants (n = 80) will be recruited online, sending emails to relevant listservs, and posting fliers in communities of color. Eligible participants will be block randomized to either 1) the intervention group (n = 40) where they will complete a self-directed 4-week MM program, or 2) a wait-list control condition (n = 40) that will receive access to the app after study completion. All participants will complete measures at baseline, mid-, and post-treatment. Primary outcomes include changes in stress, anxiety, and depression. Secondary outcomes include changes in mindfulness, self-compassion, rumination, emotion suppression, and experiential avoidance. Exploratory analyses will examine whether changes in primary outcomes are mediated by changes in the secondary outcomes. Finally, treatment acceptability, adherence, and satisfaction will be examined descriptively. RESULTS Recruitment began in October 2021. Data will be analyzed using multilevel modeling, a statistical methodology that accounts for the dependence among repeated observations. Considering issues of attrition in self-directed digital interventions and their potential effects on statistical significance and treatment effect sizes, we will examine data using both intention-to-treat and per-protocol analyses. CONCLUSIONS To our knowledge, this will be the first study to provide data on the effectiveness of an app-based mindfulness program for POC recruited based on elevated race-related stress, a high-risk population. Findings will also provide important information regarding whether a self-directed app-based MM interventions are an acceptable treatment among this underserved population. CLINICALTRIAL ClinicalTrials.gov NCT05027113; https://clinicaltrials.gov/ct2/show/NCT05027113

Treatment Intensity: Considering Persons with Autism Spectrum Disorder and Intellectual Disability Who Have Complex Communication Needs

Treatment intensity is an aspect of communication intervention that has received limited empirical attention. In this article, we discuss key parameters of treatment intensity related to individuals with complex communication needs who use augmentative and alternative communication. We advocate for an examination of treatment intensity along with learner and intervention characteristics that may moderate or mediate treatment intensity. In addition, we discuss the influence that contextual fit/treatment acceptability may have on intervention success. We also discuss the challenges created by a number of interacting variables that make determining optimal dosage for groups of individuals difficult. Finally, treatment intensity is briefly discussed in terms of its possible influence on maintenance and generalization.

Mindfulness-Based Cognitive Therapy for Unmedicated Obsessive-Compulsive Disorder: A Randomized Controlled Trial With 6-Month Follow-Up

Background: This was the first randomized controlled trial (RCT) designed to compare the efficacy of mindfulness-based cognitive therapy (MBCT) on unmedicated obsessive-compulsive disorder with that of the first-line treatment for OCD (SSRIs) or a placebo, as well as to analyze the treatment acceptability and safety of MBCT.Methods: A total of 123 unmedicated OCD patients with mild to moderate symptoms were randomly assigned into selective serotonin reuptake inhibitors group (SSRIs group), MBCT group or psycho-education group (PE group), respectively. They were intervened for 10 weeks. The Yale–Brown Obsessive-Compulsive Scale (Y-BOCS) grade was the primary outcome, and Hamilton Depression Scale-24 (HAMD-24) and Hamilton Anxiety Scale (HAMA) grades were secondary outcomes to be measured at baseline, mid-intervention, post-intervention and 14, 22, and 34 weeks of follow-up. The Five Facet Mindfulness Questionnaire (FFMQ) and Sheehan Disability Scale (SDS) were used to assess mindfulness and social functions, respectively. In addition, treatment acceptability (dropout rate and frequency of occurrence) and safety [adverse event (AE)] of MBCT were investigated.Results: Significant differences were detected in the treatment responses among SSRIs group, MBCT group and PE group. Notably, treatment responses were significantly better in the former two groups than that of PE group (χ2 = 6.448, p = 0.04), although we did not identify significant differences between SSRIs group and MBCT group (χ2 = 1.220, p = 0.543). Observed until 6 months of follow-up, there were no significant differences in treatment response among three groups. No AE was recorded in MBCT group.Conclusion: MBCT is effective in the treatment of unmedicated OCD with mild to moderate symptoms comparable to that of SSRIs, which contributes to maintain the treatment outcomes at follow-up. Besides, MBCT is safe with a good clinical compliance.

Differential Effects of Mindful Breathing and Loving Kindness Meditations: A Component Analysis Pilot Study

Objectives: Mindful breathing meditation (MBM) and loving-kindness meditation (LKM) are common components of effective mindfulness-based interventions (MBIs). This pilot study examined the differential effects of MBM and LKM on purported therapeutic process variables and mental health outcomes via component analysis. Methods: The research design was a randomized controlled trial with four conditions: MBM, LKM, combined (MBM+LKM), and a relaxation control. Participants were college undergraduates. Condition effects were analyzed across seven therapeutic process variables and three mental health outcomes. Treatment integrity and treatment acceptability data were also collected.Results: Findings indicated statistically significant and very large main effects of time, regardless of condition. Statistically significant time by condition interactions were only observed for one process variable and one mental health outcome. Follow-up descriptive evaluation of between-group effect sizes indicated patterns of favorable effects for MBM and LKM over the combined and relaxation control conditions. Treatment integrity and treatment acceptability data indicated very favorable social validity across conditions. Conclusion: We conclude that the findings make a modest yet value-added contribution to the MBI component analysis literature, suggesting differentiated performance among isolated MBM and LKM exercises compared to combined and control conditions. Yet further research is warranted to improve upon the limitations of this study.

Differential Effects of Mindful Breathing and Loving Kindness Meditations: A Component Analysis Pilot Study

Objectives: Mindful breathing meditation (MBM) and loving-kindness meditation (LKM) are common components of effective mindfulness-based interventions (MBIs). This pilot study examined the differential effects of MBM and LKM on purported therapeutic process variables and mental health outcomes via component analysis. Methods: The research design was a randomized controlled trial with four conditions: MBM, LKM, combined (MBM+LKM), and a relaxation control. Participants were college undergraduates. Condition effects were analyzed across seven therapeutic process variables and three mental health outcomes. Treatment integrity and treatment acceptability data were also collected.Results: Findings indicated statistically significant and very large main effects of time, regardless of condition. Statistically significant time by condition interactions were only observed for one process variable and one mental health outcome. Follow-up descriptive evaluation of between-group effect sizes indicated patterns of favorable effects for MBM and LKM over the combined and relaxation control conditions. Treatment integrity and treatment acceptability data indicated very favorable social validity across conditions. Conclusion: We conclude that the findings make a modest yet value-added contribution to the MBI component analysis literature, suggesting differentiated performance among isolated MBM and LKM exercises compared to combined and control conditions. Yet further research is warranted to improve upon the limitations of this study.