Group schema therapy versus group cognitive behavioral therapy for patients with social anxiety disorder and comorbid avoidant personality disorder: A randomized controlled trial.

BACKGROUND: Patients with social anxiety (SAD) and comorbid avoidant personality disorder (AVPD) are severely impaired. Group cognitive behavioral therapy (GCBT) is considered an effective treatment for SAD. More knowledge on treatment of SAD with comorbid AVPD is needed. Schema therapy, developed for personality and chronic mental disorders, may be a promising treatment. METHODS: We conducted a randomized controlled trial in an outpatient population (n = 154) with both SAD and AVPD. Group Schema Therapy (GST) and GCBT were compared on SAD symptoms (Liebowitz Social Anxiety Scale) and manifestations of AVPD (Avoidant Personality Disorder Severity Index). RESULTS: Intention-to-treat analysis showed no significant differences between treatments at 3 months post-treatment and one-year follow-up. Both modalities led to significant and substantial improvements. No significant between-differences were found in depressive symptoms (Inventory of Depressive Symptoms) and quality of life (World Health Organization Quality of Life-BREF). Per-protocol analysis showed similar outcomes and no significant differences in recovery from SAD and AVPD. Significantly more patients completed GST. CONCLUSION: GST and GCBT are valuable treatments for SAD with comorbid AVPD. The higher treatment retention in ST indicates ST is more acceptable than GCBT. Future studies should focus on enhancing treatment effects and improving retention to GCBT.

Extending the PROMIS item bank "ability to participate in social roles and activities": a psychometric evaluation using IRT.

OBJECTIVE: Our objective was to explore whether the extension of the PROMIS item bank Ability to Participate in Social Roles and Activities (APSRA) with new items would result in more effective targeting (i.e., selecting items that are appropriate for each individual's trait level), and more reliable measurements across all latent trait levels. METHODS: A sample of 1,022 Dutch adults completed all 35 items of the original item bank plus 17 new items (in Dutch). The new items presented in this publication have been translated provisionally from Dutch into English for presentation purposes. We evaluated the basic IRT assumptions unidimensionality, local independence, and monotonicity. Furthermore, we examined the item parameters, and assessed differential item functioning (DIF) for sex, education, region, age, and ethnicity. In addition, we compared the test information functions, item parameters, and θ scores, for the original and extended item bank in order to assess whether the measurement range had improved. RESULTS: We found that the extended item bank was compatible with the basic IRT assumptions and showed good reliability. Moreover, the extended item bank improved the measurement in the lower trait range, which is important for reliably assessing functioning in clinical populations (i.e., persons reporting lower levels of participation). CONCLUSION: We extended the PROMIS-APSRA item bank and improved its psychometric quality. Our study contributes to PROMIS measurement innovation, which allows for the addition of new items to existing item banks, without changing the interpretation of the scores and while maintaining the comparability of the scores with other PROMIS instruments.

Personalized exposure and experience sampling method feedback versus exposure as usual for obsessive-compulsive disorder: a study protocol for a randomized controlled trial.

BACKGROUND: Patients with obsessive-compulsive disorder (OCD) suffer from repetitive fearful intrusions which they try to neutralize by performing compulsions. OCD is considered to be the most resistant anxiety disorder with a remission rate of only 53% after a year of an evidence-based treatment. Therefore, it remains an obligation to develop and investigate more effective treatment interventions. This study aims to compare personalized exposure with response prevention (ERP) using experience sampling methodology-based feedback to ERP as usual in patients with OCD. Personalized exposure will be provided screen-to-screen in an ecologically valid (real time and real place) context by means of a smartphone application. This app will also be used to collect both objective and subjective data by means of experience sampling methodology (ESM). This ESM data will be used to identify triggers and protective factors for symptom severity, provide personalized feedback and optimize the effect of ERP. The primary goal of this RCT is to compare the effectiveness of personalized ERP to ERP as usual in the traditional context of a therapist's room in patients with OCD in OCD symptom severity, as well as differences in quality of life, depressive symptoms and anxiety states. Since both self-efficacy and experiential avoidance are known to influence symptom severity in OCS, a secondary goal is to examine if a possible treatment effect is mediated by self-efficacy or experiential avoidance. METHODS: This study involves a randomized controlled trial with 20 weekly sessions by 2 groups (ERP as usual versus personalized ERP), repeated measurements at baseline (T0), 5 weeks of treatment (T1), 10 weeks of treatment (T2), 15 weeks of treatment (T3), posttest at 20 weeks (T4), 6 weeks follow-up (T5), 3 months follow-up (T6), 6 months follow-up (T7) and a year follow-up (T8). A hundred and sixty patients with an OCD diagnosis according to DSM-5 criteria will participate. Half of the group will receive exposure with response prevention as usual, the other half will receive personalized exposure with response prevention with a smartphone application and personalized feedback sessions based on experience sampling data. Multilevel mixed modelling analysis will be used to investigate differences in treatment effect, as well as differences in quality of life, depressive symptoms and anxiety states. We will use the macro of Preacher and Hayes and apply bootstrapping methods to assess the possible mediating effect of changes in self-efficacy and experiential avoidance on subsequent treatment effects. DISCUSSION: This randomized controlled trial is the first to assess the influence of delivering ERP through video-calling and the use of an ESM intervention on the symptom severity of OCD. Since the global pandemic COVID-19, the use of video-calling to deliver psychological treatments has become more common, increasing the relevance of this study. TRIAL REGISTRATION: ICTRP Trial NL8254. Registered on 2019-12-24.

A Guided, Internet-Based Stress Management Intervention for University Students With High Levels of Stress: Feasibility and Acceptability Study.

BACKGROUND: Transitioning to adulthood and challenges in university life can result in increased stress levels among university students. Chronic and severe stress is associated with deleterious psychological and physiological effects. Digital interventions could succeed in approaching and helping university students who might be at risk; however, the experiences of students with internet-based stress management interventions are insufficiently understood. OBJECTIVE: This study aims to explore the feasibility; acceptability; and changes in perceived stress, depressive symptoms, and quality of life from baseline to posttest assessment of a 5-session, internet-based stress management intervention guided by an e-coach, developed for university students experiencing high levels of stress. METHODS: A single-arm study was conducted. Students were recruited from different channels, mainly from a web survey. Students were eligible if they (1) scored ≥20 on the Perceived Stress Scale-10, (2) were aged ≥18 years, and (3) were studying at one of the participating universities. Feasibility and acceptability of the intervention were investigated using several indications, including satisfaction (Client Satisfaction Questionnaire-8) and usability (System Usability Scale-10). We also investigated the indicators of intervention adherence using use metrics (eg, the number of completed sessions). Our secondary goal was to explore the changes in perceived stress (Perceived Stress Scale-10), depressive symptoms (Patient Health Questionnaire-9), and quality of life (EQ-5D-5L scale) from baseline to posttest assessment. In addition, we conducted semistructured interviews with intervention completers and noncompleters to understand user experiences in depth. For all primary outcomes, descriptive statistics were calculated. Changes from baseline to posttest assessment were examined using 2-tailed paired sample t tests or the Wilcoxon signed rank test. Qualitative data were analyzed using thematic analysis. RESULTS: Of 436 eligible students, 307 (70.4%) students started using the intervention. Overall, 25.7% (79/307) completed the core sessions (ie, sessions 1-3) and posttest assessment. A substantial proportion of the students (228/307, 74.3%) did not complete the core sessions or the posttest assessment. Students who completed the core sessions reported high satisfaction (mean 25.78, SD 3.30) and high usability of the intervention (mean 86.01, SD 10.25). Moreover, this group showed large reductions in perceived stress (Cohen d=0.80) and moderate improvements in depression score (Cohen d=0.47) and quality of life (Cohen d=-0.35) from baseline to posttest assessment. Qualitative findings highlight that several personal and intervention-related factors play a role in user experience. CONCLUSIONS: The internet-based stress management intervention seems to be feasible, acceptable, and possibly effective for some university students with elevated stress levels. However, given the high dropout rate and qualitative findings, several adjustments in the content and features of the intervention are needed to maximize the user experience and the impact of the intervention. TRIAL REGISTRATION: Netherlands Trial Register 8686; https://onderzoekmetmensen.nl/nl/trial/20889. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1016/j.invent.2021.100369.

Predictors and moderators of three online interventions for eating disorder symptoms in a randomized controlled trial.

OBJECTIVE: To optimize treatment recommendations for eating disorders, it is important to investigate whether some individuals may benefit more (or less) from certain treatments. The current study explored predictors and moderators of an automated online self-help intervention "Featback" and online support from a recovered expert patient. METHODS: Data were used from a randomized controlled trial. For a period of 8 weeks, participants aged 16 or older with at least mild eating disorder symptoms were randomized to four conditions: (1) Featback, (2) chat or e-mail support from an expert patient, (3) Featback with expert-patient support, and (4) a waitlist. A mixed-effects partitioning method was used to see if age, educational level, BMI, motivation to change, treatment history, duration of eating disorder, number of binge eating episodes in the past month, eating disorder pathology, self-efficacy, anxiety and depression, social support, or self-esteem predicted or moderated intervention outcomes in terms of eating disorder symptoms (primary outcome), and symptoms of anxiety and depression (secondary outcome). RESULTS: Higher baseline social support predicted less eating disorder symptoms 8 weeks later, regardless of condition. No variables emerged as moderator for eating disorder symptoms. Participants in the three active conditions who had not received previous eating disorder treatment, experienced larger reductions in anxiety and depression symptoms. DISCUSSION: The investigated online low-threshold interventions were especially beneficial for treatment-naïve individuals, but only in terms of secondary outcomes, making them well-suited for early intervention. The study results also highlight the importance of a supportive environment for individuals with eating disorder symptoms. PUBLIC SIGNIFICANCE: To optimize treatment recommendations it is important to investigate what works for whom. For an internet-based intervention for eating disorders developed in the Netherlands, individuals who had never received eating disorder treatment seemed to benefit more from the intervention than those who had received eating disorder treatment, because they experienced larger reductions in symptoms of depression and anxiety. Stronger feelings of social support were related to less eating disorder symptoms in the future.

Differential Associations of Cognitive Emotion Regulation Strategies with Depression, Anxiety, and Insomnia in Adolescence and Early Adulthood.

While difficulties with emotion regulation (ER) are consistently linked to poor mental health in adulthood, findings in adolescence have been more mixed. Cognitive ER strategies, which involve the ability to manage emotions through mental processes, may be particularly important during different stages of development due to age-specific adjustments. We conducted two exploratory and cross-sectional studies to examine the relationships between cognitive ER strategies and mental health (i.e., depressive, anxiety, and insomnia symptoms) in two samples: 431 young adults (Mage = 20.66 ± 2.21; 70% women and 30% men) and 271 adolescents (Mage = 14.80 ± 0.0.59; 44.6% girls and 55.4% boys). The participants completed a group of questionnaires, including the Cognitive Emotion Regulation Questionnaire, the Insomnia Severity Index, the Beck Depression Inventory-II, the State-Trait Anxiety Inventory, and the Youth Self Report. We employed hierarchical multiple regressions to assess the unique contribution of cognitive ER strategies to mental health outcomes. Maladaptive strategies (such as rumination and catastrophizing) were consistently associated with impaired mental health in both samples, while adaptive strategies (such as positive refocusing and positive reappraisal) were only associated with better mental health in young adults. These findings support the importance of cognitive ER strategies as potential risk factors for psychopathology and suggest that interventions aimed at improving emotion regulation may be beneficial. The age-specific differences in the relationship between cognitive ER strategies and mental health may reflect the refinement of emotion regulation abilities across the lifespan.

Cost-effectiveness of Internet Interventions Compared With Treatment as Usual for People With Mental Disorders: Systematic Review and Meta-analysis of Randomized Controlled Trials.

BACKGROUND: The economic costs of mental disorders for society are huge. Internet-based interventions are often coined as cost-effective alternatives to usual care, but the evidence is mixed. OBJECTIVE: The aim was to review the literature on the cost-effectiveness of internet interventions for mental disorders compared with usual care and to provide an estimate of the monetary benefits of such interventions compared with usual care. METHODS: A systematic review and meta-analysis of randomized controlled trials was conducted, which included participants with symptoms of mental disorders; investigated a telephone- or internet-based intervention; included a control condition in the form of treatment as usual, psychological placebo, waiting list control, or bibliotherapy; reported outcomes on both quality of life and costs; and included articles published in English. Electronic databases such as PubMed (including MEDLINE), Embase, Emcare, PsycINFO, Web of Science, and the Cochrane Library were used. Data on risk of bias, quality of the economic evaluation, quality-adjusted life years, and costs were extracted from the included studies, and the incremental net benefit was calculated and pooled. RESULTS: The search yielded 6226 abstracts, and 37 studies with 14,946 participants were included. The quality of economic evaluations of the included studies was rated as moderate, and the risk of bias was high. A random-effects approach was maintained. Analyses suggested internet interventions were slightly more effective than usual care in terms of quality-adjusted life years gain (Hedges g=0.052, 95% CI 0.010-0.094; P=.02) and equally expensive (Hedges g=0.002, 95% CI -0.080 to 0.84; P=.96). The pooled incremental net benefit was US $255 (95% CI US $91 to US $419; P=.002), favoring internet interventions over usual care. The perspective of the economic evaluation and targeted mental disorder moderated the results. CONCLUSIONS: The findings indicate that the cost-effectiveness of internet interventions for mental disorders compared with a care-as-usual approach is likely, but generalizability to new studies is poor given the substantial heterogeneity. This is the first study in the field of mental health to pool cost-effectiveness outcomes in an aggregate data meta-analysis. TRIAL REGISTRATION: PROSPERO CRD42019141659; https://tinyurl.com/3cu99b34.

Effects up to 20-Year Follow-Up of Preventive Cognitive Therapy in Adults Remitted from Recurrent Depression: The DELTA Study.

INTRODUCTION: Major depressive disorder (MDD) is common, and recurrence rates are high. Preventive Cognitive Therapy (PCT), has been shown to prolong time to recurrence and reduce risk of recurrence(s) over 2-10 years in patients with recurrent depression. OBJECTIVE: The aim of the study was to examine the effectiveness of PCT over 20 years on time to first recurrence, cumulative proportion of first recurrences, percentage of depression-free time, mean severity of recurrences, and the number of recurrences within a patient. METHODS: Adults remitted from recurrent MDD were randomized to PCT or Treatment As Usual (TAU). Clinical outcomes were assessed using the SCID over 20 years. We used Cox regression analyses, Kaplan-Meier analyses, ANOVA, and negative binomial regression and tested for interaction with the number of previous episodes. RESULTS: There was a significant interaction effect for number of previous episodes with treatment condition on time to first recurrence (Wald[1, n = 172] = 8.840, p = 0.003). For participants with more than 3 previous episodes, the mean time to recurrence was 4.8 years for PCT versus 1.6 years for TAU; the cumulative proportion of first recurrences was 87.5% for PCT and 100% for TAU. For participants with more than 3 previous episodes, exploratory analyses suggest that PCT had 53% less recurrences and percentage of depression-free time was significantly higher compared to TAU. There were no significant effects on mean severity. CONCLUSIONS: Up to 20 years, for MDD patients with more than 3 previous episodes, those who received PCT had significantly longer time to a first recurrence and lower recurrence risk and may have less recurrences and more depression-free time compared to TAU. This suggests long term protective effects of PCT up to 20-years.

Long-Term Effectiveness of an Online Self-help Intervention for People with HIV and Depressive Symptoms.

The aim of this study was to investigate the long-term effectiveness (3-4 years later) of an online intervention that was previously found to effectively reduce depressive symptoms in people with HIV on the short term. Participants were people with HIV who had participated in the large RCT on the short-term effectiveness of the guided online intervention. The primary outcome measure was depressive symptoms [Patient Health Questionnaire-9 (PHQ-9)] and the secondary outcome measure was anxiety symptoms [Generalized Anxiety Disorder-2 (GAD-2) scale]. Forty-seven participants completed the long-term follow-up. PHQ-9 scores, previously found to have been significantly reduced on the short term, remained low on the long term. GAD-2 scores did not decrease significantly on the short term, however, on the long term, a significant decrease was found. The intervention may not only be effective in lowering depressive symptoms on the short term but also retain the results on the long term.Trial registration International Clinical Trials Registry Platform, NL8448, March 3, 2020.

Cognitive Emotion Regulation Questionnaire-Short: Reliability, Validity, and Measurement Invariance of the Italian Version.

OBJECTIVE: The Cognitive Emotion Regulation Questionnaire (CERQ) is a widely used instrument to assess cognitive emotion regulation strategies. The study aimed to test the psychometric properties of the Italian short version of the CERQ (CERQ-IS). METHODS: Two separate samples of 442 young adults (Mage = 21.12; SD = 3.69) and 256 adolescents (Mage = 14.81; SD = 0.59) completed the CERQ, the Emotional Regulation Questionnaire (ERQ) and the Multidimensional Perfectionism Scale (MPS). A confirmatory factor analysis (CFA) was performed to evaluate the dimensionality of the CERQ-IS. Internal consistency was analysed by calculating model-based composite reliability coefficients. Criterion and discriminant validity were gathered through the correlations with the ERQ and the MPS, respectively. Factorial invariances tests across gender and age were computed by means of multiple-group CFA. RESULTS: CFA confirmed the nine-factor structure showing an excellent fit to the data. Except for rumination which was minimally acceptable, all subscales had an acceptable to good reliability. Criterion validity was supported by significant correlations between CERQ-IS and ERQ subscales. Discriminant validity was confirmed by meaningless correlations with the MPS facets. Configural, metric and scalar invariance were established across both grouping variables. CONCLUSIONS: The brevity of this tool and its good psychometric properties suggest that CERQ-IS could be a useful screening tool in both clinical and research practice in adolescence and young adulthood.

Mindfulness-based cognitive group therapy for treatment-refractory anxiety disorder: A pragmatic randomized controlled trial.

BACKGROUND: This study aimed: (a) to examine the effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) for patients with a treatment-refractory anxiety disorders compared to Relapse Prevention-Cognitive Behavioral Therapy (CBT-RP); and (b) to explore candidate mediating variables. METHODS: We conducted a pragmatic randomized controlled trial comparing MBCT with CBT-RP in a group format for 136 outpatients with treatment-refractory DSM-IV defined anxiety disorder, who insufficiently responded to first-line psychological treatment. RESULTS: At post-treatment, the MBCT group showed a significantly larger decrease in self-reported anxiety (Beck Anxiety Inventory), avoidance (Fear Questionnaire), difficulties in emotion regulation (Difficulties in Emotion Regulation Strategies), and worry (Penn State Worry Questionnaire), as well as a significantly larger increase in mindfulness skills (Five Facet Mindfulness Questionnaire). After a 6-month follow-up treatment gains were somewhat diminished. Effects of MBCT on anxiety at post-treatment did not prove to be mediated by mindfulness skills, difficulties in emotion regulation strategies, worry, or rumination (Rumination on Sadness Scales) at mid-treatment. CONCLUSIONS: MBCT seems to be a promising intervention in routine clinical care for persons with an anxiety disorder who insufficiently responded to first-line psychological treatment. Future research in larger samples assessing long-term effects and using intensive longitudinal designs to identify possible working mechanisms is called for.

Effectiveness of an online self-help program, expert-patient support, and their combination for eating disorders: Results from a randomized controlled trial.

OBJECTIVE: Many individuals with an eating disorder do not receive appropriate care. Low-threshold interventions could help bridge this treatment gap. The study aim was to evaluate the effectiveness of Featback, a fully automated online self-help intervention, online expert-patient support and their combination. METHOD: A randomized controlled trial with a 12-month follow-up period was conducted. Participants aged 16 or older with at least mild eating disorder symptoms were randomized to four conditions: (1) Featback, a fully automated online self-help intervention, (2) chat or email support from a recovered expert patient, (3) Featback with expert-patient support and (4) a waiting list control condition. The intervention period was 8 weeks and there was a total of six online assessments. The main outcome constituted reduction of eating disorder symptoms over time. RESULTS: Three hundred fifty five participants, of whom 43% had never received eating disorder treatment, were randomized. The three active interventions were superior to a waitlist in reducing eating disorder symptoms (d = -0.38), with no significant difference in effectiveness between the three interventions. Participants in conditions with expert-patient support were more satisfied with the intervention. DISCUSSION: Internet-based self-help, expert-patient support and their combination were effective in reducing eating disorder symptoms compared to a waiting list control condition. Guidance improved satisfaction with the internet intervention but not its effectiveness. Low-threshold interventions such as Featback and expert-patient support can reduce eating disorder symptoms and reach the large group of underserved individuals, complementing existing forms of eating disorder treatment. PUBLIC SIGNIFICANCE STATEMENT: Individuals with eating-related problems who received (1) a fully automated internet-based intervention, (2) chat and e-mail support by a recovered individual or (3) their combination, experienced stronger reductions in eating disorder symptoms than those who received (4) usual care. Such brief and easy-access interventions play an important role in reaching individuals who are currently not reached by other forms of treatment.

Cost-effectiveness of three internet-based interventions for eating disorders: A randomized controlled trial.

OBJECTIVE: The primary aim was assessing the cost-effectiveness of an internet-based self-help program, expert-patient support, and the combination of both compared to a care-as-usual condition. METHOD: An economic evaluation from a societal perspective was conducted alongside a randomized controlled trial. Participants aged 16 or older with at least mild eating disorder symptoms were randomly assigned to four conditions: (1) Featback, an online unguided self-help program, (2) chat or e-mail support from a recovered expert patient, (3) Featback with expert-patient support, and (4) care-as-usual. After a baseline assessment and intervention period of 8 weeks, five online assessments were conducted over 12 months of follow-up. The main result constituted cost-utility acceptability curves with quality-of-life adjusted life years (QALYs) and societal costs over the entire study duration. RESULTS: No significant differences between the conditions were found regarding QALYs, health care costs and societal costs. Nonsignificant differences in QALYs were in favor of the Featback conditions and the lowest societal costs per participant were observed in the Featback only condition (€16,741) while the highest costs were seen in the care-as-usual condition (€28,479). The Featback only condition had the highest probability of being efficient compared to the alternatives for all acceptable willingness-to-pay values. DISCUSSION: Featback, an internet-based unguided self-help intervention, was likely to be efficient compared to Featback with guidance from an expert patient, guidance alone and a care-as-usual condition. Results suggest that scalable interventions such as Featback may reduce health care costs and help individuals with eating disorders that are currently not reached by other forms of treatment. PUBLIC SIGNIFICANCE STATEMENT: Internet-based interventions for eating disorders might reach individuals in society who currently do not receive appropriate treatment at low costs. Featback, an online automated self-help program for eating disorders, was found to improve quality of life slightly while reducing costs for society, compared to a do-nothing approach. Consequently, implementing internet-based interventions such as Featback likely benefits both individuals suffering from an eating disorder and society as a whole.

Prognostic Value of Pathological Personality Traits for Treatment Outcome in Anxiety and Depressive Disorders: The Leiden Routine Outcome Monitoring Study.

ABSTRACT: Previous studies have failed to take baseline severity into account when assessing the effects of pathological personality traits (PPT) on treatment outcome. This study assessed the prognostic value of PPT (Dimensional Assessment of Personality Pathology-Short Form) on treatment outcome (Brief Symptom Inventory [BSI-posttreatment]) among patients with depressive and/or anxiety disorders ( N = 5689). Baseline symptom level (BSI-pretreatment) was taken into account as a mediator or moderator variable. Results showed significant effects of PPT on outcome, of which Emotional Dysregulation demonstrated the largest association ( ß = 0.43, p < 0.001). When including baseline BSI score as a mediator variable, a direct effect ( ß = 0.11, p < 0.001) remained approximately one-third of the total effect. The effects of Emotional Dysregulation (interaction effect ß = 0.061, p < 0.001) and Inhibition (interaction effect ß = 0.062, p < 0.001), but not Compulsivity or Dissocial Behavior, were moderated by the baseline symptom level. PPT predicts higher symptom levels, both before and after treatment, but yields relatively small direct effects on symptom decline when the effect of pretreatment severity is taken into account.

Cost-effectiveness and cost-utility of an Acceptance and Commitment Therapy intervention vs. a Cognitive Behavioral Therapy intervention for older adults with anxiety symptoms: A randomized controlled trial.

BACKGROUND: A previous randomized controlled trial in older adults with anxiety symptoms found no differences between a brief blended Acceptance and Commitment Therapy (ACT) intervention and brief face-to-face Cognitive Behavior Therapy (CBT) regarding anxiety symptom severity at posttreatment and 12-month follow-up. A health-economic evaluation comparing these interventions has not yet been conducted. OBJECTIVE: This study examined the one-year cost-effectiveness and cost-utility of blended ACT compared to face-to-face CBT for older adults with anxiety symptoms. METHODS: The economic evaluation was embedded in a randomized controlled trial comparing blended ACT to CBT in 314 older adults with mild to moderately severe anxiety symptoms. Data were collected at baseline and 3, 6 and 12 months post baseline. For the cost-effectiveness analysis, treatment response was defined as a reliable improvement in anxiety symptom severity (measured with the Generalized Anxiety Disorder-7) between baseline and 12-month follow-up. To assess cost-utility, quality-adjusted life years (QALYs) were computed using EuroQol-5 Dimensions-5 Levels-5 utility scores. Analyses took the societal perspective, including both healthcare costs and productivity costs. Incremental cost-effectiveness ratios were calculated using 2500 bootstraps of seemingly unrelated regression equations of costs and effects. Sensitivity analyses were performed to assess the robustness of the findings. RESULTS: Differences between the blended ACT group and CBT group in treatment response and QALYs were statistically insignificant and clinically irrelevant. The ACT intervention was associated with an average per-participant cost reduction of €466 ($593) compared to CBT, which resulted from lower productivity costs in the blended ACT group. From a healthcare perspective, the ACT intervention was associated with higher costs (by €71 ($90)) than CBT. CONCLUSIONS: The results do not indicate that from a health-economic perspective blended ACT should be preferred over CBT in the treatment of older adults with anxiety symptoms. The findings support a model of shared decision making, where clinicians and patients collaboratively decide on the preferred intervention, based on ethical-medical, practical and personal considerations. TRIAL REGISTRATION: Netherlands Trial Register: TRIAL NL6131 (NTR6270); https://www.trialregister.nl/trial/6131.

Quality of life and well-being problems in secondary schoolgirls in Kenya: Prevalence, associated characteristics, and course predictors.

BACKGROUND: Adolescents in sub-Saharan Africa often report low levels of quality of life (QoL) and well-being, but reliable data are limited. This study examines which sociodemographic, health, and behavioral risk factors and adverse adolescent experiences are associated with, and predictive of, QoL in Kenyan secondary schoolgirls. METHODS AND FINDINGS: 3,998 girls at baseline in a randomised controlled trial in Siaya County, western Kenya were median age 17.1 years. Subjectively perceived physical, emotional, social and school functioning was assessed using the Pediatric Quality of Life (QoL) Inventory-23. Laboratory-confirmed and survey data were utilized to assess sociodemographic, health and behavioral characteristics, and adverse adolescent experiences. We identified a group of girls with Low QoL (n = 1126; 28.2%), Average QoL (n = 1445; 36.1%); and High QoL (n = 1427; 35.7%). Significantly higher scores on all well-being indicators in the LQoL compared with HQoL group indicated good construct validity (Odds Ratio's (ORs) varying from 3.31 (95% CI:2.41-4.54, p < .001) for feeling unhappy at home to 11.88 (95%CI:7.96-17.74, p< .001) for PHQ9 defined possible caseness (probable diagnosis) of depression. Adverse adolescent experiences were independently statistically significant in the LQoL compared to the HQoL group for threats of family being hurt (aOR = 1.35,1.08-1.68, p = .008), sexual harassment out of school (aOR = 2.17,1.79-2.64, p < .001), and for menstrual problems like unavailability of sanitary pads (aOR = 1.23,1.05-1.44, p = .008) and stopping activities due to menstruation (aOR = 1.77,1.41-2.24, p < .001). After 2-years follow-up of 906 girls in the LQoL group, 22.7% persisted with LQoL. Forced sex (aOR = 1.56,1.05-2.32, p = .028) and threats of family being hurt (aOR = 1.98,1.38-2.82, p < .001) were independent predictors of persistent LQoL problems. CONCLUSIONS: Persistent QoL problems in Kenyan adolescent girls are associated with adverse physical, sexual and emotional experiences and problems with coping with their monthly menstruation. A multi-factorial integral approach to reduce the rate of adverse adolescent experiences is needed, including provision of menstrual hygiene products. TRIAL REGISTRATION: ClinicalTrials.gov:NCT03051789.

The ICECAP-A instrument for capabilities: assessment of construct validity and test-retest reliability in a general Dutch population.

PURPOSE: The ICEpop CAPability measure for Adults (ICECAP-A) assesses five capabilities that are important to one's well-being. The instrument might be an important addition to generic health questionnaires when evaluating quality of life extending beyond health. This study aimed to conduct a psychometric assessment of the Dutch translation of the ICECAP-A. METHODS: Construct validity of the instrument was assessed in two ways. First, by measuring correlations with the EQ-5D-5L questionnaire and a measure of self-efficacy and, second, by investigating the ability to distinguish between groups known to differ on the construct the ICECAP-A means to capture. Additionally, test-retest reliability was evaluated. RESULTS: In total, 1002 participants representative of the general Dutch population completed an online survey. For test-retest reliability, 252 participants completed the same questionnaire 2 weeks later. The ICECAP-A indicated moderate to strong correlations with the EQ-5D-5L and a strong correlation with self-efficacy. Furthermore, it was capable of differentiating known groups. Moreover, results indicated adequate test-retest reliability with an intraclass correlation coefficient of 0.79. CONCLUSION: In summary, results suggest adequate test-retest reliability and construct validity and indicate that the ICECAP-A might be of added value, especially when considering areas outside of the traditional health intervention model.

Construct validity, responsiveness, and utility of change indicators of the Dutch-Flemish PROMIS item banks for depression and anxiety administered as computerized adaptive test (CAT): A comparison with the Brief Symptom Inventory (BSI).

We evaluated construct validity, responsiveness, and utility of change indicators of the Dutch-Flemish PROMIS adult v1.0 item banks for Depression and Anxiety administered as computerized adaptive test (CAT). Specifically, the CATs were compared to the Brief Symptom Inventory (BSI) using pre- and re-test data of adult patients treated for common mental disorders (N = 400; median pre-to-re-test interval = 215 days). Construct validity was evaluated with Pearson's correlations and Cohen's ds; responsiveness with Pearson's correlations and pre-post effect sizes (ES); utility of change indicators with kappa coefficients and percentages of (dis)agreement. The results showed that the PROMIS CATs measure similar constructs as matching BSI scales. Under the assumption of measuring similar constructs, the CAT and BSI Depression scales were similarly responsive. For the Anxiety scales, we found a higher responsiveness for CAT (ES = 0.64) compared to the BSI (ES = 0.50). Finally, both CATs categorized the change scores of more patients as changed compared to matching BSI scales, indicating that the PROMIS CATs may be more able to detect actual change than the BSI. Based on these findings, the PROMIS CATs may be considered a modest improvement over matching BSI scales as tools for reviewing treatment progress with patients. We discuss several additional differences between the PROMIS CATs and the BSI to help test users choose instruments. These differences include the adopted measurement theory (Item Response Theory vs. Classical Test Theory), the mode of administration (CAT vs. fixed items), and the area of application (universal vs. predominantly clinical). (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Factors associated with relapse and recurrence of major depressive disorder in patients starting mindfulness-based cognitive therapy.

BACKGROUND: Mindfulness-based cognitive therapy (MBCT) is effective for relapse prevention in major depressive disorder (MDD). It reduces cognitive reactivity (CR) and rumination, and enhances self-compassion and mindfulness. Although rumination and mindfulness after MBCT are associated with relapse, the association of CR, rumination, self-compassion, and mindfulness with relapse before initiation of MBCT has never been investigated. METHODS: Data were drawn from two randomized controlled trials, including a total of 282 remitted MDD participants (≥3 depressive episodes) who had been using maintenance antidepressant medication (mADM) for at least 6 months before baseline. All participants were offered MBCT while either their mADM was maintained or discontinued after MBCT. CR, rumination, self-compassion, and mindfulness were assessed at baseline by self-rated questionnaires and were used in Cox proportional hazards regression models to investigate their association with relapse. RESULTS: CR and mindfulness were associated with relapse, independent of residual symptoms, previous depressive episodes, and mADM-use. Higher CR and lower mindfulness increased the risk of relapse. Self-compassion was not associated with relapse. For rumination, a significant interaction with mADM-use was found. Rumination was associated with relapse in patients who discontinued their mADM, while this effect was absent if patients continued mADM. CONCLUSIONS: These results show that CR, rumination, and mindfulness are associated with relapse in remitted MDD-patients before initiation of MBCT, independent of residual symptoms and previous depressive episodes. This information could improve decisions in treatment planning in remitted individuals with a history of depression.