Designing individually randomized group treatment trials with repeated outcome measurements using generalized estimating equations.

Individually randomized group treatment (IRGT) trials, in which the clustering of outcome is induced by group-based treatment delivery, are increasingly popular in public health research. IRGT trials frequently incorporate longitudinal measurements, of which the proper sample size calculations should account for correlation structures reflecting both the treatment-induced clustering and repeated outcome measurements. Given the relatively sparse literature on designing longitudinal IRGT trials, we propose sample size procedures for continuous and binary outcomes based on the generalized estimating equations approach, employing the block exchangeable correlation structures with different correlation parameters for the treatment arm and for the control arm, and surveying five marginal mean models with different assumptions of time effect: no-time constant treatment effect, linear-time constant treatment effect, categorical-time constant treatment effect, linear time by treatment interaction, and categorical time by treatment interaction. Closed-form sample size formulas are derived for continuous outcomes, which depends on the eigenvalues of the correlation matrices; detailed numerical sample size procedures are proposed for binary outcomes. Through simulations, we demonstrate that the empirical power agrees well with the predicted power, for as few as eight groups formed in the treatment arm, when data are analyzed using the matrix-adjusted estimating equations for the correlation parameters with a bias-corrected sandwich variance estimator.

Concentrated transdiagnostic and cross-disciplinary micro-choice based group treatment for patients with depression and with anxiety leads to lasting improvements after 12 months: a pilot study.

BACKGROUND: A concentrated transdiagnostic and micro choice-based group treatment for patients with depression and anxiety has previously shown to yield significant reduction in symptoms and increased level of functioning from pre to 3-month follow-up. In the present study, we report the results after 12 months follow-up. METHODS: This was a non-randomized clinical intervention pilot study, conducted in line with a published protocol. Sixty-seven consecutively referred patients, aged 19-47 (mean age 32.5, SD = 8.0) were included and completed treatment. All had a severity of their problems that entitled them to care in the specialist public mental health care. Self-reported age at onset of symptoms was 17.6 (SD = 7.9) years. Mean number of prior treatment courses was 3.5 (SD = 3.3; range 0-20). The main objective was to assess the treatment effectiveness by questionnaires measuring relevant symptoms at pre-treatment, 7 days-, 3 months-, 6 months- and at 12-months follow-up. RESULTS: Validated measures of functional impairment (WSAS), depression (PHQ9), anxiety (GAD7), worry (PSWQ), fatigue (CFQ), insomnia (BIS) and illness perception (BIPQ) improved significantly (p < .0005) from before treatment to 12 months follow-up, yielding mostly large to extremely large effect sizes (0.89-3.68), whereas some moderate (0.60-0.76). After 12 months, 74% report an overall improvement in problems related to anxiety and depression. Utilization of specialist, public and private mental health care was reported as nonexistent or had decreased for 70% of the patients at 12-month follow up. CONCLUSIONS: The concentrated, micro-choice based group treatment approach yielded a highly clinically significant reduction in a wide range of symptoms already one week after treatment, and the positive results persisted at 12-month follow-up. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05234281, first posted date 10/02/2022.

The feasibility and acceptability of delivering a group trauma-focused intervention to children in care.

OBJECTIVE: Young people in care (i.e., in the child welfare system) are a group who have often experienced very high rates of potentially traumatic events, including maltreatment. It is well-documented that they have high rates of trauma-related mental health difficulties, such as posttraumatic stress. To address the needs of the large number of young people who may benefit from support, scalable interventions are crucial. But also important is that they are effective and deliverable - particularly given the complexity of this group and services. We assessed a five-session group CBT-based intervention for PTSD. The primary goal was to understand core procedural and protocol uncertainties to address prior to a definitive trial. METHODS: Participants were 34 10-17 year olds in care, with moderate to severe posttraumatic stress symptoms, and their caregiver. We ran seven groups (four online), delivered in social care and NHS-based mental health teams. Data were collected via pre-, post-, 3-month follow-up questionnaires and qualitative interviews. RESULTS: Of the 34 participants allocated to the intervention, 27 (80%) attended at least three of the five sessions (most attended all). Caregiver attendance was lower (50%). There was generally good completion of assessment measures. Qualitatively, most participants were positive about the intervention, and many reported improvements in areas such as coping, sleep, and willingness to talk about experiences. However, there were important concerns about the lack of ongoing support, given this was a low-intensity intervention for a group who often had complex needs. CONCLUSION: The intervention and research protocols were acceptable to most young people and carers. With modifications, a future definitive trial would likely be possible. However, key considerations include: how (and whether) to screen for PTSD; the trial design; and the option to embed high-intensity support (e.g., via assessing a stepped-care model).

Designing multicenter individually randomized group treatment trials.

In an individually randomized group treatment (IRGT) trial, participant outcomes can be positively correlated due to, for example, shared therapists in treatment delivery. Oftentimes, because of limited treatment resources or participants at one location, an IRGT trial can be carried out across multiple centers. This design can be subject to potential correlations in the participant outcomes between arms within the same center. While the design of a single-center IRGT trial has been studied, little is known about the planning of a multicenter IRGT trial. To address this gap, this paper provides analytical sample size formulas for designing multicenter IRGT trials with a continuous endpoint under the linear mixed model framework. We found that accounting for the additional center-level correlation at the design stage can lead to sample size reduction, and the magnitude of reduction depends on the amount of between-therapist correlation. However, if the variance components of therapist-level random effects are considered as input parameters in the design stage, accounting for the additional center-level variance component has no impact on the sample size estimation. We presented our findings through numeric illustrations and performed simulation studies to validate our sample size procedures under different scenarios. Optimal design configurations under the multicenter IRGT trials have also been discussed, and two real-world trial examples are drawn to illustrate the use of our method.

Outcomes of a Virtual 10-Week COVID-19 and Psychosis Program in an HMO: A Mixed Methods Quality Improvement Project.

Virtual clinical services became the primary treatment modality in a large U.S. HMO psychiatry department during the COVID-19 pandemic. A mixed methods quality improvement project was developed to address psychosis, severe anxiety, and stressors unique to COVID-19 and sheltering in place. The purpose was to determine if a virtual 10-week pilot program combining psychoeducation, skills-based training, experiential exercises using third-wave CBT, and process questions would decrease symptoms and hospitalization rates and improve quality of life. Pre- and postmeasure scores on pandemic-related stress (the PRSF), perceived stress (PSS), and general patient health (PHQ-9) were gathered from five patients in the Department of Psychiatry at Kaiser Permanente in Oakland, California. Qualitative interviews explored patients' perceptions of program benefits. Mean, median, and range on the pre- and postprogram assessments and paired samples t tests for means were calculated. Quantitative results were not statistically significant: p = 0.32 (Revised PRSF), p = 0.34 (PSS), p = 0.94 (PHQ-9). In interviews, most participants reported a decrease in pandemic-related stress. Half reported a decrease in general perceived stress. Half reported no change. Self-assessment reflected perceptions of benefits from this 10-week program, using words such as useful and important. The virtual program helped relieve pandemic-related stress and improved overall quality of life. The results show promise for expanding the program to other hospitals providing services for this diagnostic population.

Metacognitive therapy for generalized anxiety disorders in group: A case study.

OBJECTIVES: In Metacognitive therapy (MCT), homework is used, for example, to increase awareness of thoughts and thought processes, to challenge metacognitive beliefs in real-life situations, and to practice new ways of processing thoughts, feelings, and symptoms. All MCT treatment manuals include homework assignments to be given between each session. METHOD: The following study provides a detailed description of the implementation of homework in a group-based MCT treatment for generalized anxiety disorder (GAD) at an outpatient clinic in Norway. The treatment described in this case consisted of 10 weekly group sessions (7 patients) lasting two hours. RESULTS: This case study demonstrates that group-based MCT can be used to treat GAD and describes how the use of homework can facilitate therapeutic change. CONCLUSION: Overall, the effectiveness of MCT was found to be high. Homework gives patients the opportunity to take charge of their therapy and develop a sense of responsibility for their own progress, both during and after treatment.

Sample size considerations for assessing treatment effect heterogeneity in randomized trials with heterogeneous intracluster correlations and variances.

An important consideration in the design and analysis of randomized trials is the need to account for outcome observations being positively correlated within groups or clusters. Two notable types of designs with this consideration are individually randomized group treatment trials and cluster randomized trials. While sample size methods for testing the average treatment effect are available for both types of designs, methods for detecting treatment effect modification are relatively limited. In this article, we present new sample size formulas for testing treatment effect modification based on either a univariate or multivariate effect modifier in both individually randomized group treatment and cluster randomized trials with a continuous outcome but any types of effect modifier, while accounting for differences across study arms in the outcome variance, outcome intracluster correlation coefficient (ICC) and the cluster size. We consider cases where the effect modifier can be measured at either the individual level or cluster level, and with a univariate effect modifier, our closed-form sample size expressions provide insights into the optimal allocation of groups or clusters to maximize design efficiency. Overall, our results show that the required sample size for testing treatment effect heterogeneity with an individual-level effect modifier can be affected by unequal ICCs and variances between arms, and accounting for such between-arm heterogeneity can lead to more accurate sample size determination. We use simulations to validate our sample size formulas and illustrate their application in the context of two real trials: an individually randomized group treatment trial (the AWARE study) and a cluster randomized trial (the K-DPP study).

Qualitative risk assessment of homogeneity, stability, and residual concentrations of antimicrobials in medicated feed and drinking water in pig rearing.

BACKGROUND: Despite the common use of oral group treatment in pig rearing, the magnitude of the factors influencing the homogeneity and stability of antimicrobial drugs in medicated feed and medicated drinking water are largely unknown, as well as the residual concentrations of the drugs after the end of the treatment. RESULTS: This study presents a qualitative risk assessment to estimate the magnitude of the risks for reduced homogeneity and stability, and increased residual concentrations of antimicrobial drugs in medicated feed and drinking water on the farm. Risk assessment was done using a questionnaire and farm visits (n = 52), combined with a second questionnaire, and concentrations of amoxicillin and doxycycline measured in medicated feed and water samples, each collected on 10 farms. For medicated feed, the duration of storage in the silo did not show to influence the concentration levels in a consistent trend, while the treatment duration had a low to negligible effect. A moderate to high risk was found caused by human error when preparing the medicated feed on the farm. Purchased medicated feed greatly reduces the risk of human error and drugs remain stable during the duration of treatment, while the risk of residual concentrations after the end of the treatment was estimated to be low to moderate. The feed intake variability was identified as a moderate to high risk factor. For medicated drinking water, the type of dosing pump, age of pre-solution, and human errors during the preparation of the pre-solution present a moderate to high risk on homogeneity and stability. Precipitation of the active substance in the absence of a stirrer in a drinking water tank was shown to be a low to moderate risk factor for residues after treatment. Waterline length had a weak correlation with the concentrations of the antimicrobials, while a moderate to high influence was detected for the water intake by the pigs. CONCLUSIONS: A considerable variation in drug concentration in both medicated feed and medicated drinking water was detected depending on their preparation. Therefore, it is important to know which factors influence the homogeneity and stability, and the residual concentrations after treatment.

Partially clustered designs for clinical trials: Unifying existing designs using consistent terminology.

INTRODUCTION: Clinical trial designs based on the assumption of independent observations are well established. Clustered clinical trial designs, where all observational units belong to a cluster and outcomes within clusters are expected to be correlated, have also received considerable attention. However, many clinical trials involve partially clustered data, where only some observational units belong to a cluster. Examples of such trials occur in neonatology, where participants include infants from both singleton and multiple births, and ophthalmology, where one or two eyes per participant may need treatment. Partial clustering can also arise in trials of group-based treatments (e.g. group education or counselling sessions) or treatments administered individually by a discrete number of health care professionals (e.g. surgeons or physical therapists), when this is compared to an unclustered control arm. Trials involving partially clustered data have received limited attention in the literature and the current lack of standardised terminology may be hampering the development and dissemination of methods for designing and analysing these trials. METHODS AND EXAMPLES: In this article, we present an overarching definition of partially clustered trials, bringing together several existing trial designs including those for group-based treatments, clustering due to facilitator effects and the re-randomisation design. We define and describe four types of partially clustered trial designs, characterised by whether the clustering occurs pre-randomisation or post-randomisation and, in the case of pre-randomisation clustering, by the method of randomisation that is used for the clustered observations (individual randomisation, cluster randomisation or balanced randomisation within clusters). Real life examples are provided to highlight the occurrence of partially clustered trials across a variety of fields. To assess how partially clustered trials are currently reported, we review published reports of partially clustered trials. DISCUSSION: Our findings demonstrate that the description of these trials is often incomplete and the terminology used to describe the trial designs is inconsistent, restricting the ability to identify these trials in the literature. By adopting the definitions and terminology presented in this article, the reporting of partially clustered trials can be substantially improved, and we present several recommendations for reporting these trial designs in practice. Greater awareness of partially clustered trials will facilitate more methodological research into their design and analysis, ultimately improving the quality of these trials.

Exposure based cognitive behavioral group therapy for IBS at a gastroenterological clinic - a clinical effectiveness study.

BACKGROUND: Patients with irritable bowel syndrome (IBS) may benefit from psychological treatment when diet changes and medications do not sufficiently reduce symptoms. Our research team has developed an exposure based cognitive behavioral therapy protocol (ECBT), which has been shown to be effective in several randomized controlled trials. AIM: To investigate the effectiveness of ECBT in clinical routine care at a gastroenterological clinic in Stockholm and to find predictors for treatment outcome. METHOD: A ten session ECBT based on our protocol was given face to face by licensed psychologists in groups of 4-6 patients. A total of 129 patients provided information regarding IBS symptoms, quality of life, gastrointestinal symptom-specific anxiety (GSA), and depression pre and post-treatment. We used linear regression analyses to identify patient characteristics that predicted treatment outcome. RESULTS: The primary outcome was symptom severity measured with The Gastrointestinal Symptom Rating Scale for IBS (GSRS-IBS). Average pre-and post-treatment GSRS-IBS scores were 49.24 (SD = 11.54) and 37.03 (SD = 10.03), corresponding to a 34.0% reduction in symptom severity (p < .001). Reductions were also found in GSA, 43.9% (p < .001) and depression, 38.6% (p < .001). IBS-related quality of life was on average increased by 68.2% (p < .001). The effect sizes were large and varied between (Cohen's d) 0.95 and 1.84. None of the patients' pre-treatment characteristics predicted outcome. CONCLUSION: We conclude that ECBT for IBS delivered face-to-face in a group-format is very effective, also in a routine care setting. We did not find any reliable predictors for treatment outcome. The trial was registered at Clinicaltrials.gov with ID: NCT04756414.

Influential methods reports for group-randomized trials and related designs.

BACKGROUND: This article identifies the most influential methods reports for group-randomized trials and related designs published through 2020. Many interventions are delivered to participants in real or virtual groups or in groups defined by a shared interventionist so that there is an expectation for positive correlation among observations taken on participants in the same group. These interventions are typically evaluated using a group- or cluster-randomized trial, an individually randomized group treatment trial, or a stepped wedge group- or cluster-randomized trial. These trials face methodological issues beyond those encountered in the more familiar individually randomized controlled trial. METHODS: PubMed was searched to identify candidate methods reports; that search was supplemented by reports known to the author. Candidate reports were reviewed by the author to include only those focused on the designs of interest. Citation counts and the relative citation ratio, a new bibliometric tool developed at the National Institutes of Health, were used to identify influential reports. The relative citation ratio measures influence at the article level by comparing the citation rate of the reference article to the citation rates of the articles cited by other articles that also cite the reference article. RESULTS: In total, 1043 reports were identified that were published through 2020. However, 55 were deemed to be the most influential based on their relative citation ratio or their citation count using criteria specific to each of the three designs, with 32 group-randomized trial reports, 7 individually randomized group treatment trial reports, and 16 stepped wedge group-randomized trial reports. Many of the influential reports were early publications that drew attention to the issues that distinguish these designs from the more familiar individually randomized controlled trial. Others were textbooks that covered a wide range of issues for these designs. Others were "first reports" on analytic methods appropriate for a specific type of data (e.g. binary data, ordinal data), for features commonly encountered in these studies (e.g. unequal cluster size, attrition), or for important variations in study design (e.g. repeated measures, cohort versus cross-section). Many presented methods for sample size calculations. Others described how these designs could be applied to a new area (e.g. dissemination and implementation research). Among the reports with the highest relative citation ratios were the CONSORT statements for each design. CONCLUSIONS: Collectively, the influential reports address topics of great interest to investigators who might consider using one of these designs and need guidance on selecting the most appropriate design for their research question and on the best methods for design, analysis, and sample size.

Impact of complex, partially nested clustering in a three-arm individually randomized group treatment trial: A case study with the wHOPE trial.

BACKGROUND/AIMS: When participants in individually randomized group treatment trials are treated by multiple clinicians or in multiple group treatment sessions throughout the trial, this induces partially nested clusters which can affect the power of a trial. We investigate this issue in the Whole Health Options and Pain Education trial, a three-arm pragmatic, individually randomized clinical trial. We evaluate whether partial clusters due to multiple visits delivered by different clinicians in the Whole Health Team arm and dynamic participant groups due to changing group leaders and/or participants across treatment sessions during treatment delivery in the Primary Care Group Education arm may impact the power of the trial. We also present a Bayesian approach to estimate the intraclass correlation coefficients. METHODS: We present statistical models for each treatment arm of Whole Health Options and Pain Education trial in which power is estimated under different intraclass correlation coefficients and mapping matrices between participants and clinicians or treatment sessions. Power calculations are based on pairwise comparisons. In practice, sample size calculations depend on estimates of the intraclass correlation coefficients at the treatment sessions and clinician levels. To accommodate such complexities, we present a Bayesian framework for the estimation of intraclass correlation coefficients under different participant-to-session and participant-to-clinician mapping scenarios. We simulated continuous outcome data based on various clinical scenarios in Whole Health Options and Pain Education trial using a range of intraclass correlation coefficients and mapping matrices and used Gibbs samplers with conjugate priors to obtain posteriors of the intraclass correlation coefficients under those different scenarios. Posterior means and medians and their biases are calculated for the intraclass correlation coefficients to evaluate the operating characteristics of the Bayesian intraclass correlation coefficient estimators. RESULTS: Power for Whole Health Team versus Primary Care Group Education is sensitive to the intraclass correlation coefficient in the Whole Health Team arm. In these two arms, an increased number of clinicians, more evenly distributed workload of clinicians, or more homogeneous treatment group sizes leads to increased power. Our simulation study for the intraclass correlation coefficient estimation indicates that the posterior mean intraclass correlation coefficient estimator has less bias when the true intraclass correlation coefficients are large (i.e. 0.10), but when the intraclass correlation coefficient is small (i.e. 0.01), the posterior median intraclass correlation coefficient estimator is less biased. CONCLUSION: Knowledge of intraclass correlation coefficients and the structure of clustering are critical to the design of individually randomized group treatment trials with partially nested clusters. We demonstrate that the intraclass correlation coefficient of the Whole Health Team arm can affect power in the Whole Health Options and Pain Education trial. A Bayesian approach provides a flexible procedure for estimating the intraclass correlation coefficients under complex scenarios. More work is needed to educate the research community about the individually randomized group treatment design and encourage publication of intraclass correlation coefficients to help inform future trial designs.

Concentrated transdiagnostic and cross-disciplinary group treatment for patients with depression and with anxiety: a pilot study.

BACKGROUND: A number of treatment approaches have shown efficacy for depression and/or anxiety, yet there is a paucity of research on potentially cost-effective concentrated approaches. Based on our previous experience with concentrated treatment in disorders such as Obsessive-Compulsive Disorder and chronic fatigue, we proposed that this novel approach could be useful for other conditions, including depression and/or anxiety. As a pre-requisite for a future randomized controlled trial, the aim of this study was to investigate the acceptability, satisfaction and effectiveness of a transdiagnostic, interdisciplinary group treatment delivered during 5 consecutive days to groups of 6-10 patients with depression and/or anxiety. METHODS: This was a non-randomized clinical intervention pilot study in line with a published protocol. Forty-two consecutively referred patients, aged 19-47 (mean age 31.7, SD = 8.12) were included and completed treatment. All had a severity of their problems that entitled them to care in the specialist public mental health care. Self-reported age when the symptoms became a problem was 20.9 years. Mean number of prior treatment courses was 2.77 (SD = 2.19; range 0-8). Acceptability was defined as the proportion of eligible patients who accepted and completed the treatment. Satisfaction was evaluated by Client Satisfaction Questionnaire-8. Secondary objectives were to assess the treatment effectiveness by questionnaires at pre-treatment, seven days post-treatment and three months follow-up. RESULTS: The treatment was highly acceptable (91.3% accepted, all completed), and patients were highly satisfied with the treatment, including the amount. Functional impairment, as measured by Work and Social Adjustment Scale (WSAS) improved significantly (p < .0005) from "severe" (mean 25.4 SD = 6.59) to "less severe" (mean 13.37, SD = 9.43) at 3 months follow-up. Using the Generalized Anxiety Disorder Scale (GAD-7) and the Patient Health Questionnaire (PHQ-9), the effect sizes at 3 months follow-up were 1.21 for anxiety and 1.3 for depression. More than 80% reported reduced utilization of mental health care, and 67% had not used, or had used the family doctor less, for anxiety or depression. 52% had not used, or had reduced, medication for their disorder. CONCLUSIONS: The concentrated, interdisciplinary treatment approach yielded promising results. Long-term follow up is warranted. TRIAL REGISTRATION: This study is registered in Clinical Trials, identifier NCT05234281 and approval date 09/02/2022.

Correcting the reward imbalance in binge eating: A pilot randomized trial of reward re-training treatment.

Behavioral treatments for psychological disorders characterized by reward-driven maladaptive behaviors (e.g., substance use disorder, eating disorders, behavioral addictions) primarily seek to reduce hyper-reward response to disorder-specific stimuli. Suboptimal outcomes for these treatments highlight the need to also target hypo-reward response to day-to-day life activities. The present study sought to conduct an initial test of a novel behavioral treatment, Reward Re-Training (RRT) to target hyper- and hypo-reward response in individuals with binge eating. Individuals with binge eating (N = 23) were randomly assigned to either 10 weeks of outpatient, group-based RRT treatment or a waitlist control. RRT was found to be feasible and acceptable, demonstrated large impacts on both hypo- and hyper-reward response (measured by self-report (pre-to post-treatment ηp2 range 0.38-0.58) and neural activation via fMRI), and was efficacious in reducing eating disorder pathology (ηp2 range 0.40-0.64, including binge eating, ηp2 = 0.64) compared to waitlist control (ηp2 range 0.00-0.04). This pilot data provides preliminary support for the feasibility, acceptability, and effectiveness of a novel treatment targeting reward imbalance for individuals with binge eating. Future evaluations of RRT may benefit from an active treatment comparison condition and a follow-up assessment to examine persistence of positive outcomes.

Virtual INSIGHT: Improving natural social interaction: Group reHabilitation after traumatic brain injury.

BACKGROUND: There is a growing body of literature that indicates positive outcomes of group treatment approaches to intervention for communication difficulties in chronic traumatic brain injury (TBI). The published research to date examines face-to-face group intervention. AIM: This study draws on one of these approaches, 'Improving Natural Social Interaction: Group reHabilitation after Traumatic brain injury' (INSIGHT), and examines the adaptation of this program to a virtual setting. The principles underlying the program, which involved providing an authentic contextualised and natural environment for group interactions and enhancing opportunities for identity expression, were maintained. METHODS & PROCEDURES: Six participants with mild to severe TBI and cognitive communication difficulties participated in an 8-week pilot program of the virtual INSIGHT program. Goal Attainment Scaling (GAS) scores completed over the course of the intervention served as the primary outcome measure. Secondary outcomes measures included The Repeatable Battery for the Assessment of Neuropsychological Status Update, The Awareness of Social Inference Test-Revised, the La Trobe Communication Questionnaire and the Satisfaction with Life Scale. OUTCOMES & RESULTS: A mixed multilevel analysis revealed significant improvement in GAS scores. A Wilcoxon signed rank test revealed no significant changes in secondary measures. CONCLUSIONS & IMPLICATIONS: There is a growing potential for this group treatment approach, in an online medium, and progress towards individualised goals was clear. The data have implications for examining the assessment measures typically used to document functional outcomes in clinical intervention. Future directions indicate a need to pursue more ecologically valid assessment methods. WHAT THIS PAPER ADDS: What is already known on the subject Recent literature has focused on the benefits of group intervention for cognitive communication diffuclties after traumatic brain injury (TBI). However, research to date examines only face-to-face group rehabilitation. As there has been a demand for a shift in the way we communicate worldwide, we must make adaptations to current intervention procedures to continue to serve individuals with diverse communication needs. What this paper adds to existing knowledge This study contributes new information about the feasibility of a virtual communication skills group for individuals with TBI. This virtual INSIGHT (Improving Natural Social Interaction: Group ehabilitation after Traumatic brain injury) group intervention facilitates progress towards collaboratively set communication goals and the online setting has the potential to increase the accessibility of these services. What are the potential or actual clinical implications of this work? Progress towards cognitive and social communication goals can be facilitated by an online group intervention. However, this progress was not correlated with scores on standard assessments of cognitive communication, social communication and quality of life. This has implications for the evaluation of the assessments typically used and their ecological validity and applicability to the communication context.

An initial proof of concept: A replicated single-case study of a CBT group treatment with partner involvement for vulvodynia.

Vulvodynia is common and has an immense impact on affected women and their partners. Psychological factors have been found to contribute to pain maintenance and exacerbation, and treatments addressing psychological factors have yielded positive results. This study employed a replicated single-case experimental design to examine a cognitive behavioral therapy (CBT) group treatment with partner involvement in vulvodynia. Repeated measures of pain intensity related to pain-inflicting behaviors were collected weekly throughout baseline and treatment phases. Associated outcomes were measured pre-, post- and at two follow-up assessments. Participants were 18-45-year-old women, in a stable sexual relationship with a man, experiencing vulvodynia. Five women completed the treatment consisting of 10 group sessions and 3 couple sessions. Data were analyzed through visual inspection and supplementary nonparametric calculations. The study showed promising results of the CBT treatment in alleviating pain intensity in connection to specific pain-inflicting behavior since three out of five participants showed improvements. For the participants who improved, sexual function, pain catastrophizing, avoidance, and endurance behavior changed during treatment and were maintained at follow-ups. These results warrant further study of the CBT treatment, in larger, and controlled formats.

A clinical illustration of short-term mentalization-based therapy for borderline personality disorder.

OBJECTIVE: Mentalization-based therapy (MBT) is an evidence-supported, long-term psychotherapy program developed to treat borderline personality disorder (BPD). A short-term, 20-week adaptation to the original MBT format including case formulation, psychoeducation, and group and individual therapy has recently been proposed. The current case material will illustrate how the recent adaptation to the mentalization-based practice can enhance personality functioning using a short-term format. METHODS: Case material is presented to demonstrate the clinical application of short-term MBT in the treatment of a young woman diagnosed with BPD who has a history of failed treatment attempts and who showed signs of affective dysregulation, unstable relationships, and intense abandonment anxiety. RESULTS: The case illustration shows how short-term MBT can facilitate improvement in personality functioning, specifically targeting situations in which the patient lost her temper and became overwhelmed by abandonment anxiety. By continuously employing therapeutic shifts toward greater autonomy and agency, and by maintaining a balanced empathetic therapeutic stance, the therapists were able to enhance the patients mentalizing and personality functioning. CONCLUSIONS: Short-term MBT can be effectively implemented to enhance the mentalizing capacity and personality functioning in outpatients with BPD.

Metacognitive interpersonal group therapy for adolescents with avoidant personality disorder: The case of Sofia.

INTRODUCTION: Early intervention studies for adolescents and early adults are required to explore the acceptability and effectiveness of psychological therapies across the full range of personality disorders (PDs) beyond just borderline PD. The main aim of the current paper was to describe a Metacognitive Interpersonal Therapy group adaptation for adolescents (MIT-GA) presenting with PDs featuring overcontrol and social inhibition, and in particular Avoidant PD characteristics. METHODS: We report findings from a single case of a female adolescent diagnosed with Avoidant PD providing preliminary data on feasibility and the possible effectiveness of MIT-GA. RESULTS: Evidence of acceptability and meaningful clinical gains are described. CONCLUSIONS: Results suggest that MIT-GA could be a powerful treatment option in patients with generalized social avoidance who do not currently receive gold-standard psychotherapeutic treatments. This intervention also appears to be effective and cost-effective in initiating significant clinical changes in profiles of young patients with non-borderline PD symptoms.

The power of compassion in group psycotherapy.

Research has repeatedly demonstrated that individual and group psychotherapy are equally effective. Compassion-focused therapy (CFT) has been shown to be an effective approach to treating individuals with a wide range of presenting mental health concerns. In this study, we discuss the basic tenets of CFT and introduce a 12-module CFT group psychotherapy approach for college counseling centers. We use a clinical vignette to provide an example of how psychotherapists may implement this approach. We then discuss clinical applications, including strengths and limitations of this approach.

Dialectical Behavior Therapy: Effect on Emotion Regulation and Death Anxiety in Older Female Adults.

This study examined the effectiveness of dialectical behavior therapy intervention on emotion regulation and death anxiety in old women. This quasi-experimental study was conducted using a pretest-posttest design with a control group. The research population included elderly women aged 60-75 years who were members of the Tehran Municipality Retirees Association in 2020. A total of 30 women were assigned to intervention and control groups (15 persons in each group). The participants in the intervention group received the dialectical behavior therapy (DBT) intervention for 10 sessions while the participants in the control group did not receive any intervention. The results of the analysis of covariance (ANCOVA) showed that there was a significant difference between the women in the intervention and control groups in terms of cognitive emotion regulation and death anxiety on the posttest. This therapy can be used for the elderly living in nursing homes and aging associations and institutions.