Moderators Of Treatment Outcome Research Articles

Psychological intervention (ConquerFear) for treating fear of cancer recurrence: mediators and moderators of treatment efficacy.

ConquerFear is an efficacious intervention for fear of cancer recurrence (FCR) that demonstrated greater improvements than an attention control (relaxation training) in a randomized controlled trial. This study aimed to determine mediators and moderators of the relative treatment efficacy of ConquerFear versus relaxation. One hundred and fifty-two cancer survivors completed 5 therapy sessions and outcome measures before and after intervention and at 6months' follow-up. We examined theoretically relevant variables as potential mediators and moderators of treatment outcome. We hypothesized that metacognitions and intrusions would moderate and mediate the relationship between treatment group and FCR level at follow-up. Only total FCR score at baseline moderated treatment outcome. Participants with higher levels of FCR benefited more from ConquerFear relative to relaxation on the primary outcome. Changes in metacognitions and intrusive thoughts about cancer during treatment partially mediated the relationship between treatment group and FCR. These results show that ConquerFear is relatively more effective than relaxation for those with overall higher levels of FCR. The mediation analyses confirmed that the most likely mechanism of treatment efficacy was the reduction in unhelpful metacognitions and intrusive thoughts during treatment, consistent with the theoretical framework underpinning ConquerFear. ConquerFear is a brief, effective treatment for FCR in cancer survivors with early-stage disease. The treatment works by reducing intrusive thoughts about cancer and changing beliefs about worry and is particularly helpful for people with moderate to severe FCR.

Alcohol demand moderates brief motivational intervention outcomes in underage young adult drinkers

IntroductionThe Alcohol Purchase Task (APT), a behavioral economic measure of alcohol's reinforcing value (demand), has been used to predict the effects of Brief Motivational Intervention (BMI) on alcohol use outcomes. However, it is not known whether BMI may be more or less efficacious, relative to control, among those with different levels of alcohol demand prior to treatment. MethodsNon college-attending young adults (N = 150) reporting past-month heavy drinking were randomized to a single in-person session of BMI or a relaxation training control (REL). The BMI included delivery of personalized feedback and focused on developing discrepancy between the young adults' goals and their current pattern of alcohol use. At baseline, participants completed assessments of alcohol use and the APT. Drinking levels were re-assessed at 6 weeks and 3 months post-intervention. Demand indices derived from the APT were examined as moderators of treatment effects on follow-up drinking after covarying for baseline alcohol use. ResultsTwo of four APT demand indices – intensity and Omax - moderated treatment outcomes. Relative to REL, BMI led to greater reductions in total number of drinks consumed and drinks per drinking day among participants with higher baseline alcohol demand. This association was not observed among participants with lower levels of alcohol demand. ConclusionsThese results demonstrate that BMI may be particularly beneficial for those with a high reinforcing value of alcohol. The mechanism for this effect is unclear, and determining the process by which BMI confers increased benefit for these individuals is a fruitful area for future work.

Examining race as a predictor and moderator of treatment outcomes for binge-eating disorder: Analysis of aggregated randomized controlled trials.

To examine whether race predicted or moderated response to treatments for binge-eating disorder (BED). Participants were 592 adults (n = 113 Black; n = 479 White) with DSM-IV-defined BED who participated in randomized controlled trials (RCTs) at 1 medical center. Data were aggregated from RCTs for BED testing cognitive-behavioral therapy, behavioral weight loss, multimodal treatment, and/or control conditions. Participants had weight and height measured and were assessed using established interviews and self-report measures at baseline, throughout treatment, and post treatment. Race did not significantly moderate treatment outcomes. Mixed models revealed a main effect of race: Black participants had fewer binge-eating episodes and lower depression than White participants across time points. Race also had a main effect in generalized estimating equations with a significantly greater proportion of Black participants achieving binge-eating remission than White participants. Race did not predict percent weight loss, but a significantly lower proportion of Black participants attained 5% weight loss than White participants. Race did not significantly predict global eating-disorder severity. Despite disparities in treatment-seeking reported in epidemiological and RCT studies, Black individuals appear to have comparable or better treatment outcomes in BED treatment research compared with White individuals, except they were less likely to attain 5% weight loss at post treatment. This suggests that disseminating evidence-based treatments for BED among diverse populations holds promise and treatments may not require further adaptation prior to dissemination. Implementation research is needed to test treatment effectiveness across diverse providers, settings, and patient groups to improve understanding of potential predictors and moderators. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Do race/ethnicity and religious affiliation moderate treatment outcomes among individuals with co-occurring PTSD and substance use disorders?

The effect of race/ethnicity and religious affiliation on treatment outcomes among 107 individuals with co-occurring substance use disorder (SUD) and full or subthreshold posttraumatic stress disorder (PTSD) was examined in a secondary analysis. Participants were randomly assigned to one of three treatment conditions: dual-disorder treatment of PTSD and SUD using prolonged exposure; single-disorder relapse prevention treatment for SUD; or an active monitoring control group. Results revealed no significant interaction between race/ethnicity and treatment on PTSD and substance use frequency. However, compared to Whites, African Americans had significantly lower levels of PTSD over the course of treatment. Religious affiliation moderated the impact of treatment on substance use frequency and was a significant predictor of PTSD scores during treatment. Results highlight the need to explore factors associated with social identity variables such as race and religion that may enhance or attenuate the mechanisms of treatments for PTSD and SUD.

Moderators of Treatment Outcomes from Family Caregiver Skills Training: Secondary Analysis of a Randomized Controlled Trial

Background: Moderator analyses may be helpful for evaluating intervention effects. The objective of this study was to evaluate whether the effect of a caregiver skills training intervention – Helping Invested Families Improve Veterans' Experience Study (HI-FIVES) – on care recipient outcome and caregiver outcome is moderated by the veteran’s risk for hospitalization or level of functional impairment. Methods: Secondary data analysis of HI-FIVES. Outcomes included community days (cumulative days in the community at 12 months alive and not in the emergency department, hospital, or post-acute facility) and caregiver burden (Zarit Burden Interview at baseline, 3, 6, and 12 months). Moderators, risk for hospitalization and functional impairment, was assessed using their Care Assessment Need (CAN) score the Older Americans Resources and Services (OARS) Questionnaire, respectively. Negative binomial and linear mixed models were used to assess intervention effects on community days and caregiver burden, respectively. Results: Of 241 dyads, veteran (caregiver) mean age was 73 (61) years, 53% (54%) were Black, and 4% (89%) were female. Medium hospitalization-risk (91-98 CAN score) participants who received HI-FIVES had 3.75 times more community days vs. medium risk participants in the control group. By contrast, the high hospitalization-risk (99+ CAN score) participants who received HI-FIVES had 4.39 times fewer community days vs. high-risk participants in the control group. The CAN score did not have a significant moderating effect on caregiver burden. OARS did not have a significant moderating effect on community days or caregiver burden. Conclusions: Targeting the HI-FIVES based on hospitalization risk may be an effective strategy for keeping veterans in the community longer.

An examination of the moderating effects of neurophysiology on treatment outcomes from cognitive training in schizophrenia-spectrum disorders

BackgroundImpairments in neurocognition and community functioning are core features of schizophrenia and cognitive training techniques have been developed with the aim of improving these impairments. While cognitive training has produced reliable improvements in neurocognition and functioning, little is known about factors that moderate treatment response. Electroencephalographic (EEG) measures provide a neurophysiological indicator of cognitive functions that may moderate treatment outcomes from cognitive training. MethodsData from a clinical trial comparing two cognitive training approaches in schizophrenia-spectrum disorders were utilized in the current report. Cluster analysis was conducted to identify participant clusters based on baseline P300, mismatch negativity (MMN), and theta power during an n-back task, and the EEG measures were also examined as continuous predictors of treatment response. ResultsThree clusters were identified based on the baseline EEG variables; however, there were no significant differences in treatment response across the three clusters. Higher P300 amplitude and theta power during the n-back at baseline were significantly associated with greater improvements in a cognitive composite score post-treatment. None of the EEG measures were significantly associated with treatment outcomes in specific cognitive domains or community functioning. Change in EEG measures from baseline to post-treatment was not significantly associated with durability of cognitive or functional change at 12-week follow-up. ConclusionsClusters derived from the EEG measures were not significantly associated with either neurocognitive or functional outcomes. P300 and n-back theta power may be associated with learning-related processes, which are important for acquisition and retention of skills during cognitive training programs. Future research should aim to identify at an individual level who is likely to respond to specific forms of cognitive enhancement.

Acceptability and Efficacy of Group Behavioral Activation for Depression Among Adults: A Meta-Analysis

The evidence base for behavioral activation (BA) as a front-line treatment for depression is grounded in individual delivery. No valid previous meta-analytic reviews of BA delivered in groups have been conducted. This study therefore examined the efficacy and acceptability of group BA drawn from clinical trial evidence. Randomized controlled trials of group BA were identified using a comprehensive literature search. Depression outcomes at posttreatment/follow-up, recovery and dropout rates were extracted and analyzed using a random-effects meta-analysis. Treatment moderators were analyzed using meta-regression and subgroup analyses. Nineteen trials were quantitatively synthesized. Depression outcomes postgroup BA treatment were superior to controls (SMD 0.72, CI 0.34 to 1.10, k=13, N=461) and were equivalent to other active therapies (SMD 0.14, CI -0.18 to 0.46, k=15, N=526). Outcomes were maintained at follow-up for group BA and moderators of treatment outcome were limited. The dropout rate for group BA (14%) was no different from other active treatments for depression (17%). Further research is required to refine the conditions for optimum delivery of group BA and define robust moderators and mediators of outcome. However, BA delivered in groups produces a moderate to large effect on depressive symptoms and should be considered an appropriate front-line treatment option.

Effectiveness and treatment moderators of internet interventions for adult problem drinking: An individual patient data meta-analysis of 19 randomised controlled trials.

BackgroundFace-to-face brief interventions for problem drinking are effective, but they have found limited implementation in routine care and the community. Internet-based interventions could overcome this treatment gap. We investigated effectiveness and moderators of treatment outcomes in internet-based interventions for adult problem drinking (iAIs).Methods and findingsSystematic searches were performed in medical and psychological databases to 31 December 2016. A one-stage individual patient data meta-analysis (IPDMA) was conducted with a linear mixed model complete-case approach, using baseline and first follow-up data. The primary outcome measure was mean weekly alcohol consumption in standard units (SUs, 10 grams of ethanol). Secondary outcome was treatment response (TR), defined as less than 14/21 SUs for women/men weekly. Putative participant, intervention, and study moderators were included. Robustness was verified in three sensitivity analyses: a two-stage IPDMA, a one-stage IPDMA using multiple imputation, and a missing-not-at-random (MNAR) analysis. We obtained baseline data for 14,198 adult participants (19 randomised controlled trials [RCTs], mean age 40.7 [SD = 13.2], 47.6% women). Their baseline mean weekly alcohol consumption was 38.1 SUs (SD = 26.9). Most were regular problem drinkers (80.1%, SUs 44.7, SD = 26.4) and 19.9% (SUs 11.9, SD = 4.1) were binge-only drinkers. About one third were heavy drinkers, meaning that women/men consumed, respectively, more than 35/50 SUs of alcohol at baseline (34.2%, SUs 65.9, SD = 27.1). Post-intervention data were available for 8,095 participants. Compared with controls, iAI participants showed a greater mean weekly decrease at follow-up of 5.02 SUs (95% CI −7.57 to −2.48, p < 0.001) and a higher rate of TR (odds ratio [OR] 2.20, 95% CI 1.63–2.95, p < 0.001, number needed to treat [NNT] = 4.15, 95% CI 3.06–6.62). Persons above age 55 showed higher TR than their younger counterparts (OR = 1.66, 95% CI 1.21–2.27, p = 0.002). Drinking profiles were not significantly associated with treatment outcomes. Human-supported interventions were superior to fully automated ones on both outcome measures (comparative reduction: −6.78 SUs, 95% CI −12.11 to −1.45, p = 0.013; TR: OR = 2.23, 95% CI 1.22–4.08, p = 0.009). Participants treated in iAIs based on personalised normative feedback (PNF) alone were significantly less likely to sustain low-risk drinking at follow-up than those in iAIs based on integrated therapeutic principles (OR = 0.52, 95% CI 0.29–0.93, p = 0.029). The use of waitlist control in RCTs was associated with significantly better treatment outcomes than the use of other types of control (comparative reduction: −9.27 SUs, 95% CI −13.97 to −4.57, p < 0.001; TR: OR = 3.74, 95% CI 2.13–6.53, p < 0.001). The overall quality of the RCTs was high; a major limitation included high study dropout (43%). Sensitivity analyses confirmed the robustness of our primary analyses.ConclusionTo our knowledge, this is the first IPDMA on internet-based interventions that has shown them to be effective in curbing various patterns of adult problem drinking in both community and healthcare settings. Waitlist control may be conducive to inflation of treatment outcomes.

Perceived Psychotherapist's Empathy and Therapy Motivation as Determinants of Long-Term Therapy Success-Results of a Cohort Study of Short Term Psychodynamic Inpatient Psychotherapy.

Objective: Outcome predictors and determinants for treatment outcome of inpatient psychotherapy will be assessed in a follow-up-study. Sociodemographic factors and the level of depressiveness at admission, the perceived psychotherapist's empathy rated by patients and the therapy motivation as possible moderators of treatment outcome (reduction of depressive symptoms) are analyzed.Methods: In a cohort study, the outcome of inpatient multimodal psychotherapy was examined with Beck-Depression-Inventory (BDI) at admission (T1), discharge (T2) and at follow-up (1–3 years after treatment) (T3). Inclusion criteria were: Inpatient psychotherapy between 2007 and 2010 with a duration of at least 1 week and complete data set. The influence on therapy success of (1) sociodemographic factors, (2) the perceived psychotherapist's empathy rated by patients using the Consultation and Relational Empathy Measure (CARE), and (3) the therapy motivation of the patients rated by therapists are examined by means of correlation analysis, distribution comparisons and subsequently logistic regression.Results: Ninety-two (64 females, average age 39 yrs.) of 182 eligible patients participated in the follow-up survey. Duration of inpatient psychotherapy lasted 8.7 weeks ± 3.6 [min. 1, max. 33 weeks]. The perceived psychotherapist's empathy, therapy motivation, education level and depression at baseline had a significant impact on therapy success. Gender, age, and partnership were not significant. The length between discharge and follow-up had no influence on the results. Based on these variables a multiple logistic regression explained 42% of the variation (goodness-of-fit).Conclusion: Due to the shown relevance of the psychotherapist's empathy perceived by patients and the therapy motivation of patients for therapy success, both factors should be considered already at the beginning of the therapy. Consequently, they should be recognized in the context of postgraduate training and education.

Weight-related quality of life and temperament as predictors and moderators of outcomes among treatment-seeking, low-income, ethnically diverse children with obesity.

Within any childhood obesity treatment program, some children have better outcomes than others. Little is known about predictors or moderators of more positive outcomes. We aimed to identify whether child temperament and weight-related quality of life predict or moderate childhood obesity treatment outcomes at 6 months. From 2015 to 2016, children (n = 97) ages 5-11 years old with obesity were randomized to a clinic-community (Bull City Fit) or a clinic-only treatment program. Linear regression was used to explore whether dimensions of child temperament and weight-related quality of life predicted or moderated 6-month anthropometric and physical activity outcomes. Children who had more social avoidance due to their weight at baseline had significantly better improvements in body fat percent in the clinic-community model compared with the clinic-only model at 6 months. Across programs, better baseline social quality of life predicted greater increases in waist circumference; conversely, better physical quality of life predicted a decrease in percent of the 95th percentile. Also, children with longer attention spans had greater increases in physical activity. Our findings suggest that children who have social avoidance due to their weight may benefit most from comprehensive clinic-community treatment. Weight-related quality of life may influence outcomes across all treatments, and practitioners need to carefully counsel children experiencing weight negatively.

Cognitive Behavior Therapy and Metacognitive Therapy: Moderators of Treatment Outcomes for Children with Generalized Anxiety Disorder.

Although cognitive behavioral therapy (CBT) is effective for childhood anxiety disorders, approximately 40% of youth remain anxious after treatment. Metacognitive therapy (MCT-c) for children with generalized anxiety disorder (GAD) has shown promising effects. The present study aimed to examine if CBT and MCT-c show differential effects in children with primary GAD based on baseline characteristics, in a quasi-experimental design. To investigate which treatment is most beneficial for whom, three potential moderators: age, symptom severity, and comorbid social anxiety were examined. Sixty-three children aged 7-14 completed CBT or MCT-c. Participants were assessed before and after treatment. Both CBT and MCT-c were highly effective in treatment of childhood GAD. None of the selected variables significantly moderated treatment outcomes. Subgroups of children with high symptom severity and social anxiety comorbidity showed trends of responding better to CBT. Methodologically stronger studies are needed to facilitate a better adaptation of treatment for children with GAD.

Does the nicotine metabolite ratio moderate smoking cessation treatment outcomes in real-world settings? A prospective study.

Background and aimsIn smoking treatment trials comparing varenicline with transdermal nicotine replacement therapy (NRT), stratified by nicotine metabolite (3‐hydroxycotinine/cotinine) ratio (NMR), the relative benefit of varenicline is greater among normal rather than slow metabolizers. This study tested if the relative effectiveness of varenicline and NRT is associated with NMR status in a natural treatment setting. A secondary aim was to test if this relationship is moderated by behavioural support.DesignProspective observational multi‐centre study with 4‐week and 52‐week follow‐up.SettingNine English Stop Smoking Services (SSS).ParticipantsData came from 1556 smokers (aged ≥ 16 years) attending SSS between March 2012 and March 2013.InterventionsParticipants received pharmacotherapy together with behavioural support.MeasurementsThe primary outcome was carbon monoxide‐verified continuous abstinence at both follow‐up times. Main explanatory variables were (1) NMR status [slow (NMR < 0.31, n = 451) versus normal (NMR ≥ 0.31, n = 1105) metabolizers]; (2) pharmacotherapy (varenicline versus NRT) and (3) behavioural support (individual versus group‐based treatment). Analyses adjusted for baseline socio‐demographic, SSS, mental/physical health and smoking characteristics.FindingsOf participants, 44.2% [95% confidence interval (CI) = 41.7–46.6%] and 8.0% (95% CI = 6.8–9.5%) were continuously abstinent at 4 and 52 weeks. Varenicline was more effective than NRT at 4 weeks (P < 0.001) but only marginally so at 52 weeks (P = 0.061). There was no or inclusive evidence that NMR status moderated relative efficacy of varenicline and NRT at 4‐ [P = 0.60, Bayes factor (BF) = 0.25] or 52‐week follow‐ups (P = 0.74, BF = 0.73). However, this relationship was moderated by behavioural support (p = 0.012): the relative benefit of varenicline over NRT at 52‐week follow‐up was greater in slow, not normal, metabolizers receiving group rather than individual support (P = 0.012).ConclusionsIn a real‐world setting, the nicotine metabolite ratio status of treatment‐seeking smokers does not appear to contribute substantially to the differential effectiveness of varenicline and nicotine replacement therapy in Stop Smoking Services, when both pharmacotherapy and behavioural support are self‐selected.

Moderators of treatment outcomes in a partial hospitalization and intensive outpatient program for eating disorders

ABSTRACTEating disorders cause a number of severely impairing symptoms that may require more intensive intervention that is available through outpatient therapy services. The PHP/IOP level of care may be an effective mode of treatment in these cases, but few studies have examined overall outcomes or treatment moderators for this level of care. Using a large sample from a PHP/IOP specifically designed for the treatment of eating disorders, the current study examines a variety of symptoms (eating disorder severity, quality of life, depression, etc.) from admission to discharge, as well as potential moderators of treatment, including demographic and clinical factors. Overall, the PHP/IOP level of care was found to improve treatment outcomes. Age, race, gender, and depression were found to moderate the change in quality of life and functional impairment. Additionally, patients diagnosed with anorexia nervosa had significantly lowered quality of life and greater eating disorder symptomatology than all other diagnoses. The results of this study can help to inform clinical practice and help guide in treatment decisions at the partial hospitalization level of care.

A multicentre randomized controlled trial on trans-generational attention deficit/hyperactivity disorder (ADHD) in mothers and children (AIMAC): an exploratory analysis of predictors and moderators of treatment outcome

We examined predictors and moderators of treatment outcome in mothers and children diagnosed with ADHD in a large multicentre RCT. In total, 144 mother-child dyads with ADHD were randomly assigned to either a maternal ADHD treatment (group psychotherapy and open methylphenidate medication, TG) or to a control treatment (individual counselling without psycho- or pharmacotherapy, CG). After maternal ADHD treatment, parent-child training (PCT) for all mother-child dyads was added. The final analysis set was based on 123 dyads with completed primary outcome assessments (TG: n = 67, CG: n = 56). The primary outcome was the change in each child's externalizing symptoms. Multiple linear regression analyses were performed. The severity of the child's externalizing problem behaviour in the family at baseline predicted more externalizing symptoms in the child after PCT, independent of maternal treatment. When mothers had a comorbid depression, TG children showed more externalizing symptoms after PCT than CG children of depressive mothers. No differences between the treatment arms were seen in the mothers without comorbid depression. Severely impaired mothers with ADHD and depressive disorder are likely to need additional disorder-specific treatment for their comorbid psychiatric disorders to effectively transfer the contents of the PCT to the home situation (CCTISRCTN73911400).

Fractures of the lateral process of the talus-snowboarder's ankle

Fractures of the lateral tubercle of the talus (PLT) are rare. With the increasing popularity of the trend sport snowboarding, the incidence of PLT fractures has increased. The most common classification of PLT fractures is the Hawkins classification. The aim of this review was to raise awareness for the injury and discuss the current evidence. A literature search revealed eight studies, each including at least seven patients. Six out of the eight studies were descriptive, retrospective case series without predefined treatment concepts. These resulted in only moderate treatment outcomes. Due to the low number of patients, the lack of computed tomography (CT) or magnetic resonance imaging (MRI) and inconsistent treatment approaches, these studies do not allow to draw conclusions on atreatment concept for PLT fractures. The other two studies validated existing treatment regimens. Overall, surgical treatment of dislocated fractures and conservative treatment of non-dislocated fractures was carried out with satisfactory results. The outcome of conservative treatment of dislocated factures remains unclear. A reason for the inconsistent treatment results could be the observed concomitant injuries, including dislocation of the tendons of the peroneus muscles (46%), calcaneal chondral injuries (48%) and subluxation of the subtalar joint (7%). Based on the limited evidence available, the authors recommend the application of CT and MRI for PLT fractures to assess concomitant injuries, which are the primary indication for surgery. Dislocated typeI and II fractures (>2 mm) should be treated operatively, typeIII and non-dislocated typeI and II fractures can be treated conservatively by immobilization and partial weight-bearing for 6weeks.

Adiponectin moderates antidepressant treatment outcome in the combining medications to enhance depression outcomes randomized clinical trial

BackgroundMajor depressive disorder (MDD) is often comorbid with metabolic diseases such as obesity, cardiovascular disease, and type 2 diabetes. A potential link between these disorders is adiponectin, an adipocyte-derived circulating hormone with insulin-sensitizing, anti-inflammatory, and neuroplasticity effects. Reductions in plasma levels of adiponectin have been reported in both humans with depression and in the chronic-defeat mouse model of depression. However, the predictive value of adiponectin for treatment response to depression has not been determined. MethodsWe investigated the potential predictive effect of baseline adiponectin levels in patients who provided plasma and were undergoing one of three pharmacological treatments (escitalopram monotherapy; escitalopram plus bupropion; and venlafaxine plus mirtazapine) in the Combining Medications to Enhance Depression Outcomes clinical trial (n = 160). Specifically, we assessed whether adiponectin moderates—that is, differentially predicts—treatment response among the treatment arms. Improvements with treatment were assessed using change in the clinician-rated 30-item Inventory of Depressive Symptomatology (IDS-C) from baseline through week 12. Moderator effects were tested using separate pairwise repeated measures mixed-effects models with a treatment-arm-by-adiponectin interaction. ResultsBaseline adiponectin levels moderated treatment outcome between two combination therapies. Specifically, low adiponectin predicted better response to escitalopram plus bupropion compared to venlafaxine plus mirtazapine, whereas high adiponectin predicted better response to venlafaxine plus mirtazapine compared to escitalopram plus bupropion (F = 4.84, p = 0.03). Adiponectin levels did not correlate with baseline depression severity (r = −0.03, p = 0.59). ConclusionsAntidepressant selection for patients with MDD can be personalized using pre-treatment blood-based biomarkers, such as adiponectin, thereby improving treatment outcomes.

Severely Burdened Individuals Do Not Need to Be Excluded From Internet-Based and Mobile-Based Stress Management: Effect Modifiers of Treatment Outcomes From Three Randomized Controlled Trials.

BackgroundAlthough internet-based and mobile-based stress management interventions (iSMIs) may be a promising strategy to reach employees suffering from high chronic stress, it remains unknown whether participants with high symptom severity of depression or anxiety also benefit from iSMIs or should be excluded.ObjectiveThis study aimed to evaluate the efficacy of iSMIs in subgroups with high symptom severity and to test whether baseline symptom severity moderates treatment outcome.MethodsData from three randomized controlled trials (N=791) were pooled to identify effect modifiers and to evaluate efficacy in subgroups with different levels of initial symptom severity. The outcomes perceived stress (Perceived Stress Scale, PSS), depression severity (Center for Epidemiological Depression Scale, CES-D), and anxiety (Hospital Anxiety and Depression Scale, HADS) symptom severity were assessed at baseline, 7-week postassessment, and 6-month follow-up. Potential moderators were tested in predicting differences in the change of outcome in multiple moderation analyses. Simple slope analyses evaluated efficacy of the iSMI comparing the intervention group with the waitlist control group in subgroups with low, moderate, and severe initial symptomology based on means and SDs of the study population. In addition, subgroups with clinical values of depression (CES-D≥16) and anxiety (HADS≥8) at baseline were explored, and response rates (RRs; 50% symptom reduction) and symptom-free (SF) status (CES-D<16, HADS<8) were reported.ResultsIndividuals with high stress (PSS≥30), depression (CES-D≥33), anxiety (HADS≥15), and emotional exhaustion (MBI≥5.6) benefited significantly from the intervention with great reductions of stress (dpost=0.86-1.16, dFU=0.93-1.35), depression (dpost=0.69-1.08, dFU=0.91-1.19), and anxiety (dpost=0.79-1.19, dFU=1.06-1.21), and effects were sustained at 6-month follow-up. Symptom severity moderated treatment outcomes, as individuals with higher symptom severity at baseline benefited significantly more from the intervention than individuals with lower symptom severity. Furthermore, 82.9% (656/791) of individuals had clinical depression values at baseline, of which significantly more individuals in the intervention group reached at least 50% symptom reduction or fell under clinical cut-off (RR: 29.2%, 93/318; SF: 39.6%, 126/318) compared with the waitlist control group (RR: 8.0%, 27/338; SF: 18.6%, 63/338) at postassessment. Significantly more individuals with clinical anxiety values at baseline (HADS≥8, 85.3%, 675/791) in the intervention group achieved at least 50% symptom reduction or fell under clinical cut-off (RR: 27.7%, 94/339; SF: 39.8%, 135/339) compared with the WLC (RR: 4.8%, 16/336; SF: 15.5%, 52/336).ConclusionsHighly burdened individuals benefit greatly from iSMIs and therefore should not be excluded from participation. Stress management may be a valid entry point to reach highly burdened individuals who otherwise may not seek treatment.Trial Registration1) German Clinical Trials Register DRKS00005112; https://www.drks.de/DRKS00005112 (Archived by WebCite at http://www.webcitation.org/6zmIZwvdA); 2) German Clinical Trials Register DRKS00005384; https://www.drks.de/ DRKS00005384 (Archived by WebCite at http://www.webcitation.org/6zmIerdtr); and 3) German Clinical Trials Register DRKS00004749; https://www.drks.de/DRKS00004749 (Archived by WebCite at http://www.webcitation.org/6zmIjDQPx).

Emotional clarity and attention to emotions in cognitive behavioral group therapy and mindfulness-based stress reduction for social anxiety disorder

We examined (1) differences between controls and patients with social anxiety disorder (SAD) in emotional clarity and attention to emotions; (2) changes in emotional clarity and attention to emotions associated with cognitive-behavioral group therapy (CBGT), mindfulness-based stress reduction (MBSR), or a waitlist (WL) condition; and (3) whether emotional clarity and attention to emotions moderated changes in social anxiety across treatment. Participants were healthy controls (n = 37) and patients with SAD (n = 108) who were assigned to CBGT, MBSR, or WL in a randomized controlled trial. At pretreatment, posttreatment, and 12-month follow-up, patients with SAD completed measures of social anxiety, emotional clarity, and attention to emotions. Controls completed measures at baseline only. At pretreatment, patients with SAD had lower levels of emotional clarity than controls. Emotional clarity increased significantly among patients receiving CBGT, and changes were maintained at 12-month follow-up. Emotional clarity at posttreatment did not differ between CBGT and MBSR or between MBSR and WL. Changes in emotional clarity predicted changes in social anxiety, but emotional clarity did not moderate treatment outcome. Analyses of attention to emotions were not significant. Implications for the role of emotional clarity in the treatment of SAD are discussed.

Moderators of Treatment Outcomes After Telehealth Self-Management and Education in Adults With Multiple Sclerosis: A Secondary Analysis of a Randomized Controlled Trial

ObjectiveTo examine moderators of treatment effects in a randomized controlled trial comparing a telehealth self-management intervention with a telehealth multiple sclerosis (MS) education intervention for fatigue, pain, and mood in adults with MS. DesignSecondary analysis of a single-blind randomized controlled trial. SettingCommunity. ParticipantsAdults with MS and chronic fatigue, chronic pain, and/or moderate depressive symptoms (N=163) recruited from across the United States. InterventionsTwo 8-week, telephone-delivered symptom interventions delivered 1:1: a self-management intervention (n=75) and an MS education intervention (n=88). Main Outcome MeasuresOutcome measures were fatigue impact pain interference, and depressive symptom severity assessed at baseline and posttreatment. Potential moderators of treatment effects assessed at baseline were demographics (age, sex, and education), clinical characteristics (disease duration and disability severity), symptoms (perceived cognitive impairment and pain intensity), baseline levels of the treatment outcomes (pain interference, fatigue impact and depressive symptom severity), and cognitive behavioral factors (pain catastrophizing, fatigue catastrophizing, self-efficacy, and patient activation). ResultsModeration analyses found significant moderation for fatigue impact but not for pain intensity or depressive symptom severity. Baseline patient activation interacted with treatment group to predict fatigue impact at posttreatment (P=.049). Among participants with high baseline patient activation, the self-management group reported significantly less fatigue at posttreatment than the education group. No other variables moderated the study outcomes. ConclusionsAt the group level, participants responded to both interventions, regardless of disease characteristics, demographics, symptom levels, and cognitive behavioral factors. Self-management and education are both potentially beneficial symptom treatments that may be recommended to individuals with MS and chronic pain, fatigue, and/or depressive symptoms.

Residual anxiety may be associated with depressive relapse during continuation therapy of bipolar II depression

BackgroundAnxiety symptoms are common in bipolar disorder. We explored the effect of anxiety on the outcome of acute and continuation pharmacotherapy of bipolar II depression. MethodsData were derived from a randomized double-blind 12-week acute (N = 129) and 6-month continuation (N = 55) comparison of venlafaxine versus lithium monotherapy in bipolar II depression in adults. We distinguished between the items of the Hamilton Rating Scale for Depression (HRSD) that capture depression vs. anxiety (i.e., psychomotor agitation, psychic anxiety, somatic anxiety, hypochondriasis, and obsessive-compulsive concerns) and examined the effect of treatment on depression and anxiety. Additionally, we explored whether baseline anxiety or depression predicted changes over time in depression and anxiety ratings or moderated treatment outcomes. We also explored whether residual depressive and anxious symptoms predicted relapse during continuation therapy. ResultsVenlafaxine was superior to lithium in reducing both depression and anxiety, though its effects on anxiety were more modest than those on depression. Baseline anxiety predicted change over time in anxiety, but not depression. By contrast, baseline depression did not predict change over time in depression or anxiety. Residual anxiety, specifically uncontrollable worry, was a stronger predictor of relapse than residual depression. ConclusionSuccessful treatment of symptoms of anxiety in bipolar depression may protect against depressive relapse.