Between-group Effect Sizes Research Articles

How should the margin of stability during walking be expressed to account for body size?

When expressing the margin of stability as a distance, it does not directly estimate the perturbation magnitude needed to change stability states. Additionally, it is unknown how body size may influence this measure. Therefore, we propose other expressions of stability margins, including that of an impulse, a change in center of mass velocity, and a scaled, unitless impulse. The purpose of this study was to determine the influence of body size on these margin expressions using walking data from children and adults. We anticipated that margins expressed as an impulse would have strong correlations with body mass and height, as well as large between-group differences. We predicted that scaling this impulse value would result in small correlations and between-group effect sizes. We calculated each stability margin at minimum lateral values and in the anteroposterior directions at mid-swing and foot strike. In the lateral direction, margins expressed as an impulse had strong correlations with body size (r≥0.58, p<0.01) and large between-group differences (|d|≥1.07, p<0.01). The other expressions did not have strong positive correlations (|r|≤0.20) or large between-group effects (|d|≤0.44). In the anteroposterior directions, impulse margins had strong correlations with body size (|r|≥0.83, p<0.01) and large between-group differences (|d|≥1.74, p<0.01). The scaled, unitless impulse margin was the only variable that resulted in small, non-significant differences (|r|≤0.22, p≥0.24) as well as small between-group effect sizes (|d|≤0.46, p≥0.22). We propose expressing stability margins as an impulse. If scaling is needed, we encourage using the scaled, unitless impulse.

At-Home use of App-Based Mindfulness for Children: A Randomized Active-Controlled Trial

ObjectivesSchool-based mindfulness interventions in children have shown benefits to child well-being. Here, we investigated the effectiveness of a remote, app-based mindfulness intervention for promoting well-being in children.MethodWe conducted a randomized controlled trial (RCT) with two control groups to examine the effects of an 8-week mindfulness intervention in U.S. children ages 8–10. We compared pre-post effects between a mindfulness intervention using the Inner Explorer app, and two audiobook control interventions. The 279 children who participated in the interventions were assessed on self-report measures of anxiety and depression symptoms, perceived stress and trait mindfulness and we also collected parental reports.ResultsOver 80% of children completed the intervention in each condition. There was evidence for reduced self-perceived stress in children and reduced negative affect in children by parental reports using the mindfulness app, but no significant reduction for anxiety or depression symptoms. In general, between-group effect sizes were small (d < 0.45). Regular use, defined as at least 30 days of mindfulness practice within the study period, was associated with reduced child negative affect by parental reports, as well as reduced parental stress and child self-perceived stress.ConclusionsThese findings suggest that home use of a mindfulness app in young children can have a positive impact on children’s emotional well-being if the app is used regularly, specifically for at least 30 days in the 8-week study period. Strategies aimed at promoting regular use of the mindfulness app at home could lead to even better outcomes for children.PreregistrationPreregistered on OSF at https://osf.io/23vax

Increasing the accessibility to internet-based cognitive behavioural therapy for depression: A single-blind randomized controlled trial of condensed versus full-text versions

BackgroundResearch shows that internet-based cognitive behavioural therapy (iCBT) is an effective treatment for depression. However, little is known about how the length of the text material in iCBT affects outcomes. ObjectiveThe aim of this study was to test whether a condensed iCBT version for depression would be non-inferior to the existing full-text version in reducing depressive symptoms at post-treatment. We also wanted to test non-inferiority for secondary outcomes and explore reading speed and ADHD symptoms as potential moderators. MethodA single-blind randomized controlled trial was conducted (N = 267) comparing two versions of guided iCBT for depression; full-text (around 60,000 words) and condensed (around 30,000 words, with the option to listen to the text). Estimated between-group effect sizes and their confidence intervals for depression, anxiety and quality of life, were compared to a pre-determined non-inferiority margin (ES = 0.4). Moderation analyses of reading speed and ADHD symptoms were conducted. ResultsThe condensed version of iCBT was non-inferior to the full-text version on post-treatment measures for depressive symptoms (95 % CI = −0.42–0.24), anxiety symptoms (95 % CI = −0.24–0.32), and quality of life (95 % CI = −0.09–0.49). Non-inferiority was inconclusive for depressive symptoms at the one-year follow-up (95 % CI = −0.60–0.47). There was no significant moderation effects of reading speed (p = 0.06) or ADHD symptoms (p = 0.11) on depressive symptoms. ConclusionThese results indicate that a condensed version of iCBT for depression is as effective at treating depression as the full-text version. By shortening texts, iCBT may be made available to more people. Due to unequal dropout rates between the groups, these results are preliminary and need to be replicated.

Empowering self-critical perfectionistic students: A waitlist controlled feasibility trial of an explanatory feedback intervention on daily coping processes.

This study of 176 university students tested a single-session explanatory feedback intervention (EFI), derived from the perfectionism coping processes model. Participants with higher self-critical perfectionism completed daily measures of stress appraisals, coping, and affect for 7 days. A randomized control design was used to compare an EFI condition with a waitlist control condition over 4 weeks with individualized feedback delivered one-on-one by student trainees in-person or remotely through videoconferencing. The feasibility of the individualized analyses of each participant's daily data was supported by identifying daily trigger patterns, maintenance tendencies, strengths, common triggers, and best targets for reducing negative mood and increasing positive mood across several stressors for each participant. Participant ratings indicated that the comprehensive feedback was coherent and functional. Participants in the EFI condition, compared to those in the control condition, reported increases in empowerment, coping self-efficacy, and problem-focused coping, as well as decreases in depressive and anxious symptoms. Between-group effect sizes were moderate-to-large. There were reliable improvements in empowerment and depressive symptoms for 56% and 36%, respectively, of participants in the EFI condition. These findings demonstrate the broad applicability, conceptual utility, and effectiveness of the EFI for self-critical perfectionistic individuals. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Scheduled Support Versus Support on Demand in Internet-Delivered Cognitive Behavioral Therapy for Social Anxiety Disorder: Randomized Controlled Trial.

Clinician-supported internet-delivered cognitive behavioral therapy (ICBT) can be an effective treatment option when treating social anxiety disorder (SAD). Unguided ICBT is often found to be less effective. One possible solution to reduce the costs of clinician support is to provide support on demand. In this format of guidance, participants have the option to contact their clinician if needed. In a few studies, this mode of support has been compared favorably to scheduled support. Participants in a previously reported controlled trial on SAD who had been in a waitlist control group were randomly allocated to ICBT with either on-demand guidance or scheduled weekly therapist guidance. A total of 99 participants were included. Data were collected weekly on the primary outcome measure, the Liebowitz Social Anxiety Scale self-report (LSAS-SR), and at pre- and post-treatment for secondary measures. Data were analyzed in accordance with the intention-to-treat principle using mixed-effects models. Both groups improved significantly during the treatment according to the LSAS-SR ratings. The groups did not differ in their estimated change during the treatment period, with a between-group effect of d = 0.02, 95% CI [-0.37, 0.43]. Both groups experienced similar improvement also on the secondary outcome measures, with small between-group effect sizes on all outcomes. The findings indicate that support on demand can be an effective way of providing guidance in ICBT for SAD, although more research on this topic is needed. A limitation of the study is that it was conducted in 2009, and the findings were in the file drawer. Subsequent published studies support our initial findings, but more research is needed.

170 Improving illness collaboration, communication and confidence in adults with heart failure and their spouse/partners: results from an early-phase intervention

Abstract Background Older adults with Heart Failure (HF) and their spouse/partner experience significant negative impact on their health and relationship. Yet, few interventions focus on the HF couple. Informed by the Theory of Dyadic Illness Management, the Taking Care of Us© (TCU) intervention was designed to improve illness collaboration, communication, and confidence within older couples living with HF. Methods A randomised controlled trial was used to explore this early-phase psychosocial intervention in comparison to an education attention-control condition. Both programs were delivered virtually over two months to couples in the United States. Thirty seven couples (adults with heart failure [AwHF] and their spouse/partners) were randomised (18 to TCU and 19 to attention-control) with 24 couples completing the follow-up assessment (12 couples per condition). AwHF were on average 69.9 (SD = 9.6) years of age, predominantly male (70%) and reported being in NYHA Stage II/III (73%). Between-group effect sizes are reported due to small sample. Results At follow-up, TCU AwHF reported bigger declines in dyspnoea (d = 0.66), pain interference (d = 1.23) and fatigue (d = 0.18) than the educational condition. Additionally, TCU couples reported greater improvements in collaborative HF management (d = 0.17 for AwHF; d = 0.40 for spouses), collaborative coping (d = 0.68 for AwHF; d = 0.49 for spouses), shared physical activity (d = 0.72 for AwHF), shared fun activities (d = 0.70 for AwHF; d = 0.52 for spouses), and communication as a couple (d = 0.38 for AwHF; d = 0.20 for spouses). TCU AwHF reported being more likely to reduce fluid (d = 0.35) and take a diuretic (d = 0.22) when needed; TCU spouses reported being more likely to recommend reducing salt (d = 0.37), fluid (d = 0.16), and taking a diuretic (d = 0.54) when needed. Finally, AwHF in the attention-control condition reported bigger improvements in confidence to manage HF (d = 0.18) than TCU AwHF. Conclusion Preliminary data of the TCU© program shows promise for improving collaboration, communication, and health in older couples with HF.

Long-term outcomes of once weekly v. twice weekly sessions of cognitive behavioral therapy and interpersonal psychotherapy for depression.

Twice weekly sessions of cognitive behavioral therapy (CBT) and interpersonal psychotherapy (IPT) for major depressive disorder (MDD) lead to less drop-out and quicker and better response compared to once weekly sessions at posttreatment, but it is unclear whether these effects hold over the long run. Compare the effects of twice weekly v. weekly sessions of CBT and IPT for depression up to 24 months since the start of treatment. Using a 2 × 2 factorial design, this multicentre study randomized 200 adults with MDD to once or twice weekly sessions of CBT or IPT over 16-24 weeks, up to a maximum of 20 sessions. Main outcome measures were depression severity, measured with the Beck Depression Inventory-II and the Longitudinal Interval Follow-up Evaluation. Intention-to-treat analyses were conducted. Compared with patients who received once weekly sessions, patients who received twice weekly sessions showed a significant decrease in depressive symptoms up through month 9, but this effect was no longer apparent at month 24. Patients who received CBT showed a significantly larger decrease in depressive symptoms up to month 24 compared to patients who received IPT, but the between-group effect size at month 24 was small. No differential effects between session frequencies or treatment modalities were found in response or relapse rates. Although a higher session frequency leads to better outcomes in the acute phase of treatment, the difference in depression severity dissipated over time and there was no significant difference in relapse.

Aerobic Exercise, Training Dose, and Cardiorespiratory Fitness: Effects and Relationships with Resting Plasma Neurotrophic Factors in Alzheimer's Dementia.

Vascular health is increasingly recognized for its roles in the pathogenesis and progression of Alzheimer's disease (AD). The objective of this study was to investigate effects of exercise training, dose, and cardiorespiratory fitness (CRF) on neurotrophic factors in community-dwelling, older adults with mild-to-moderate AD dementia. This was a pilot blood ancillary study of the FIT-AD trial. Participants in the parent study were randomized to 6-month aerobic exercise (AEx) or stretching control. For this ancillary study, resting plasma brain-derived neurotrophic factor (BDNF), irisin, fibroblast growth factor-21 (FGF-21), and insulin-like growth factor-1 (IGF-1) biomarkers were assessed at baseline, 3, and 6 months. Estimates of within- and between-group effect sizes were calculated (Cohen's d). Relationships of biomarker change with dose and CRF change were explored with multivariable linear regression and repeated measures correlations. The sample (n = 26, 18 AEx/8 stretching) averaged 77.6 ± 6.9 years old, with the majority being male (65.4%), and non-Hispanic White (92.3%); between-group effect sizes were generally small except for irisin (d = -0.44)), AEx group relative to stretching group. Associations of dose and changes in CRF with changes in neurotrophic biomarker were weak (r2 ≤ 0.025). The effects of exercise on BDNF, irisin, IGF-1, and FGF-21 were heterogeneous in AD. Our findings need validation in future, adequately powered exercise studies in AD.

The Role of Systemic Steroids in Sciatica Due to Herniated Lumbar Disc: A Systematic Review and Meta-analysis.

Systematic review and meta-analysis. Evaluate the role of systemic steroids in treating patients with sciatica due to lumbar disc herniation (LDH). The association between LDH and sciatica has been well described. Use of steroids seems logical in this context; however, their efficacy is not well described and use remains controversial. A comprehensive search on PubMed, EMBASE and Scopus databases (up to 15, February 2022) was performed to identify randomized clinical trials that included patients with symptoms of sciatica due to LDH that were treated with systemic steroids. Risk of bias was judged using the Cochrane RoB2 tool. Meta-analysis was conducted using random effects model to estimate the between-group effect size for pain and functional outcomes. The risk of developing adverse events (AE) was computed using relative risks (RR). All pooled results are reported with their 95% confidence interval (CI) and certainty of evidence analyzed using the GRADE framework. Ten studies met inclusion criteria, comprising a total of 1,017 participants: 540 in the treatment group and 477 in the control group. Steroid treatment was associated with a significant superior reduction of pain (SMD = -0.42, 95% CI -0.76 to -0.08, weak effect, very-low certainty) and reduction in disability (SMD = -0.30, 95% CI -0.51 to -0.10, weak effect, very-low certainty). Corticosteroid administration was associated with significant increased risk of developing an AE (RR = 2.00, 95% CI 1.40 to 2.85, low certainty). The use of systemic steroids in the treatment of sciatica due to LDH seems reasonable despite a two-fold higher risk for developing mild AEs. However, the effect size is small for reducing pain in the short-term and improving functional outcomes at long-term follow-up.

Autism Spectrum Disorders in forensic psychiatric investigations-patterns of comorbidity and criminality.

There are contradictory research findings regarding whether individuals with Autism Spectrum Disorders (ASDs) are more or less likely to commit crimes. The aims of the current study were to: (1) Describe psychiatric and crime-related characteristics of a large group of offenders with ASD who had undergone a Forensic Psychiatric Investigation (FPI). (2) Identify clinical subgroups among this group of offenders. (3) Investigate associations between the identified clinical subgroups and (a) psychiatric comorbidity (b) types of crimes and (c) criminal responsibility. The study cohort consists of all subjects (n = 831) who received an ASD-diagnosis at an FPI between 2002 and 2018 in Sweden. Descriptive and clinical, as well as crime related variables were obtained from the FPIs. Non-parametric (Pearson χ2, Fisher's exact and Mann-Whitney U-test) inferential statistics were used for analyses of between-group differences and effect sizes were reported. A Latent Class Analysis was used to identify homogeneous subgroups (or classes) from categorical characteristics. The cohort consisted of 708 men and 123 women, aged 18 to 74 yrs. Two-thirds (66.7%) of the cohort had at least one other psychiatric diagnosis, the most prevalent was substance use disorder (SUD). A severe mental disorder, equivalent to lack of criminal responsibility, was most often reported among offenders with a comorbid diagnosis of schizophrenia spectrum disorder. The most common type of crime was violent crime. Three person-oriented clinical subgroups were identified; (1) ASD with few other diagnoses; (2) ASD and very high levels of SUDs, plus moderate levels of other externalizing disorders and psychotic psychopathology and (3) ASD and moderate to high levels of personality disorders (other than ASPD) and SUDs. Our results highlight the importance of all parts of the CJS to be prepared to handle offenders with ASD, often with high levels of additional psychiatric problems. Traditional approaches in treatment or other psychosocial interventions for ASD may need to be adapted to at least three general clinical profiles- one with mainly neurodevelopmental problems, one with a spectrum of externalizing problems and one with complex personality related difficulties.

Altered Joint Angle Strategy for Sprinting in Elite Sprinters with Chronic Ankle Instability

OBJECTIVES Individuals with chronic ankle instability (CAI) demonstrated altered not only ankle but also lower extremity joint angle during numerous dynamic movements compared to healthy controls. However, little is known about joint angles during sprinting, which is the most essential movement during explosive sports. We, therefore, investigated the lower extremity joint angle during sprinting between elite sprinters with CAI and healthy controls.METHODS Fourteen male college sprinters participated in this study, seven with CAI and seven healthy controls. Five-second steady speed running was performed on a treadmill at 7.5 m/s. Mean lower extremity joint angles were compared applying the statistical parametric mapping method.RESULTS The CAI patients demonstrated significantly higher ankle dorsiflexion and knee flexion angles during the stance phase. Additionally, large between-group effect sizes would demonstrate higher ankle dorsiflexion and knee and hip flexion angle from the late swing phase to the late stance phase.CONCLUSIONS The altered lower extremity joint angles from the late swing phase to the late stance phase in CAI patients suggest greater joint stability for large external loads with feed-forward motor control programs.

The effect of internet-delivered cognitive behavioral therapy for depression and anxiety on quality of life: A meta-analysis of randomized controlled trials

Although numerous studies have examined the effects of internet-delivered cognitive behavioral therapy (iCBT) for depression and anxiety on quality of life, no meta-analysis has yet been conducted to integrate the results of these studies. We conducted systematic searches in PubMed, Cochrane, and PsycInfo, which included terms for treatment type, modality of delivery, condition, and main outcome. We included studies that met the following inclusion criteria: (a) randomized controlled trials, (b) patients allocated to some form of the control condition, (c) patients receiving some type of treatment of anxiety and/or depression involving Internet-delivered Cognitive Behavioral Therapy, (d) use of a validated outcome measure assessing the level of quality of life, (e) conducted with adult participants diagnosed with anxiety disorder and/or unipolar depression, (f) papers written in English. We analyzed 40 randomized controlled trials with a total of 4289 participants that met inclusion criteria. The pooled between-group effect size for the quality of life overall score was small (g = 0.35, 95 % CI: 0.26–0.44, p = .0001), favoring iCBT over the control conditions. Regarding the distinct quality of life domains measured by the World Health Organization Quality of Life Assessment, a statistically significant difference between iCBT and control conditions was found only for the physical health domain (g = 0.56, 95 % CI: 0.06–1.07, p = .029), in favor of iCBT. In both cases, heterogeneity was moderate. While the effect on the quality of life is small (the overall quality of life score) to moderate (the physical health domain score), we conclude that iCBT for depression and anxiety may be a promising approach for improving the quality of life of patients.

Blending an internet-based emotion regulation intervention with face-to-face psychotherapy: Findings from a pilot randomized controlled trial

BackgroundTransdiagnostic interventions targeting shared mechanisms may improve treatment of mental health disorders. One way of providing such interventions is through blended treatment. This study examined the addition of an internet-based emotion regulation intervention to face-to-face psychotherapy in an outpatient setting. MethodsIn a pilot randomized controlled trial, 70 patients with a range of diagnoses were assigned to an internet-based program targeting emotion regulation + treatment as usual (face-to-face psychotherapy; TAU) (n = 35) or TAU (n = 35). Assessments occurred at baseline, after six, and after 12 weeks and included measures of symptom severity, emotion regulation, and various intervention feasibility parameters. ResultsITT-analyses revealed no significant group-by-time interaction for the primary and almost all secondary outcomes. Descriptively, between-group effect sizes were in favor of the intervention group for almost all outcomes. Sensitivity analysis with patients who completed a minimum of three modules of the internet-based program showed a significant group-by-time interaction for the Difficulties in Emotion Regulation Scale in favor of the intervention group. The internet-based intervention showed good satisfaction ratings, user experience and usability. Findings from therapist measures complemented patient measures. ConclusionPreliminary results show that an internet-based emotion regulation intervention added to psychotherapy may not reduce symptom severity compared to psychotherapy alone. The intervention was rated positively by patients and therapists regarding several parameters, but certain features still need to be improved. An RCT powered to detect small between-group effect-sizes is necessary to consolidate findings.

Effectiveness of an integrated motivational cognitive-behavioral group intervention for adolescents with gaming disorder: a randomized controlled trial.

The aim of this study was to test the efficacy of the integrated cognitive-behavioral therapy with a strength-based motivational approach [integrated cognitive-behavioral therapy (ICBT)] intervention to change gaming disorder (GD) symptoms and other outcomes and to study the therapeutic mechanism. A two-arm parallel randomized waiting-list controlled trial with 3- and 6-month follow-ups were conducted in a secondary vocational school in mainland China. Participants comprised 77 Chinese adolescents with GD symptoms with a mean age of 16.36 years [standard deviation (SD) = 0.93]; 88.3% were male INTERVENTIONS: Participants were randomized into an ICBT group (n = 38) and a waiting-list control (WLC, n = 39) group. ICBT intervention comprised eight weekly sessions to encourage participants to identify their interests and strengths and set goals for developing personally meaningful real-life activities. The outcomes were measured at pre-treatment (t0 ), post-treatment (t1 ), 3-month (t2 ) and 6-month (t3 ) follow-ups. The primary outcome was GD symptoms at t3. Secondary outcomes included GD symptoms at t1 and t2 , and gaming motivation, maladaptive gaming cognition, depression and anxiety symptoms at t1 , t2 and t3 . With the intention-to-treat principle, the GD scores at t3 were significantly different between the CBT and WLC groups [mean difference 62.08 (SD = 10.48) versus 73.64 (SD = 11.70); Hedges' g = 1.15, 95% confidence interval = 0.67-1.62]. Linear mixed-effects modeling showed significant group × time interaction for the secondary outcomes (P < 0.01), with a moderate to strong between-group effect size in the reduction in depression symptoms (g = 0.67-0.84) and anxiety symptoms (g = 0.6-0.64). Path analysis shows ICBT leads to GD reduction through reducing gaming motivation and maladaptive gaming cognition. An integrated cognitive-behavioral therapy with strength-based motivational approach intervention reduced gaming disorder symptoms and time spent gaming over a 6-month period by decreasing maladaptive gaming motivation and cognition.

Effectiveness of and processes related to internet-delivered acceptance and commitment therapy for adolescents with anxiety disorders: a randomized controlled trial.

Early access to evidence-based help is crucial for adolescents with anxiety disorders. Internet-delivered acceptance and commitment therapy (iACT) may offer adolescents increased access to care and more flexibility in engaging with treatment when and how they prefer. Process-based therapies, such as ACT, focus on theoretically derived and empirically tested key mechanisms in treatment that enable change. This study aimed to investigate the effectiveness of iACT for adolescents with anxiety disorders. The study also assessed the relationship between psychological flexibility and treatment outcomes and the relationship between participating adolescents' and therapists' perceived alliance and treatment outcomes. This was a randomized controlled trial comparing a 10-week intervention group with a wait-list control group. The 52 participants, aged 15 to 19, were recruited from all over Sweden. The treatment was effective in increasing quality of life and psychological flexibility, with moderate between-group effect sizes based on observed values. Changes in psychological flexibility was associated with changes in anxiety symptoms. The results further showed a statistically significant between-group difference in post-treatment diagnoses. No significant time per group interaction was found for anxiety symptoms, as both groups improved. Working alliance was rated as high by both participating adolescents and therapists but showed no significant relationship with treatment outcomes. Participants found the treatment an acceptable intervention. This study shows promising results for iACT in treating adolescents with anxiety disorders. The results suggest the model of psychological flexibility as an important process of change in treatment outcomes. Future research should validate these findings in larger samples and clinical contexts.

Behavioural Activation versus Treatment as Usual for Depressed Older Adults in Primary Care: A Pragmatic Cluster-Randomised Controlled Trial

Introduction: Effective non-pharmacological treatment options for depression in older adults are lacking. Objective: The effectiveness of behavioural activation (BA) by mental health nurses (MHNs) for depressed older adults in primary care compared with treatment as usual (TAU) was evaluated. Methods: In this multicentre cluster-randomised controlled trial, 59 primary care centres (PCCs) were randomised to BA and TAU. Consenting older (≥65 years) adults (n = 161) with clinically relevant symptoms of depression (PHQ-9 ≥ 10) participated. Interventions were an 8-week individual MHN-led BA programme and unrestricted TAU in which general practitioners followed national guidelines. The primary outcome was self-reported depression (QIDS-SR16) at 9 weeks and 3, 6, 9, and 12-month follow-up. Results: Data of 96 participants from 21 PCCs in BA and 65 participants from 16 PCCs in TAU, recruited between July 4, 2016, and September 21, 2020, were included in the intention-to-treat analyses. At post-treatment, BA participants reported significantly lower severity of depressive symptoms than TAU participants (QIDS-SR16 difference = −2.77, 95% CI = −4.19 to −1.35), p < 0.001; between-group effect size = 0.90; 95% CI = 0.42–1.38). This difference persisted up to the 3-month follow-up (QIDS-SR16 difference = −1.53, 95% CI = −2.81 to −0.26, p = 0.02; between-group effect size = 0.50; 95% CI = 0.07–0.92) but not up to the 12-month follow-up [QIDS-SR16 difference = −0.89 (−2.49 to 0.71)], p = 0.28; between-group effect size = 0.29 (95% CI = −0.82 to 0.24). Conclusions: BA led to a greater symptom reduction of depressive symptoms in older adults, compared to TAU in primary care, at post-treatment and 3-month follow-up, but not at 6- to 12-month follow-up.

Intolerance-of-uncertainty therapy versus metacognitive therapy for generalized anxiety disorder in primary health care: A randomized controlled pilot trial.

This randomized controlled pilot study investigated the feasibility of a future full-scale RCT to compare the effects of intolerance-of-uncertainty therapy (IUT) and metacognitive therapy (MCT) in primary health care patients with generalized anxiety disorder (GAD). Preliminary treatment effects were also evaluated. 64 patients with GAD at a large primary health care center in Stockholm, Sweden, were randomized to IUT or MCT. Feasibility outcomes included participant recruitment and retention, willingness to receive psychological treatment, and therapists' competence in and adherence to treatment protocols. Self-reported scales were used to assess treatment outcomes, including worry, depression, functional impairment, and quality of life. Recruitment was satisfactory, and dropout was low. On a scale from 0 to 6, participants were satisfied with participating in the study (M = 5.17, SD = 1.09). Following brief training, therapists' competence was rated as moderate, and adherence was rated as weak to moderate. From pre- to post-treatment, reductions on the primary treatment outcome measure of worry were of a large effect size and statistically significant in both the IUT and MCT conditions (Cohen's d for IUT = -2.69, 95% confidence interval [-3.63, -1.76] and d for MCT = -3.78 [-4.68, -2.90]). The between-group effect size from pre- to post-treatment was large and statistically significant (d = -2.03 [-3.31, -0.75]), in favor of the MCT condition. It is feasible to carry out a full-scale RCT to compare the effects of IUT to MCT for patients with GAD in primary health care. Both protocols seem effective, and MCT seems superior to IUT, but a full-scale RCT is needed to confirm these conclusions. ClinicalTrials.gov (no. NCT03621371).

Efficacy of Web-Based, Guided Self-help Cognitive Behavioral Therapy–Enhanced for Binge Eating Disorder: Randomized Controlled Trial

Owing to the gap between treatment supply and demand, there are long waiting periods for patients with binge eating disorder, and there is an urgent need to increase their access to specialized treatment. Guided self-help cognitive behavioral therapy-enhanced (CBT-E) may have great advantages for patients if its efficacy can be established. The aim of this study was to examine the efficacy of guided self-help CBT-E compared with that of a delayed-treatment control condition. A single-blind 2-arm randomized controlled trial was designed to evaluate guided self-help CBT-E according to an intention-to-treat analysis. A total of 180 patients were randomly assigned to guided self-help CBT-E (n=90, 50%) or the delayed-treatment control condition (n=90, 50%) for which guided self-help CBT-E was provided after the initial 12-week delay. The primary outcome was reduction in binges. The secondary outcome was full recovery at the end of treatment, as measured using the Eating Disorder Examination during the last 4 weeks of treatment. A linear mixed model analysis was performed to compare treatment outcomes at the end of treatment. A second linear mixed model analysis was performed to measure between- and within-group effects for up to 24 weeks of follow-up. The Eating Disorder Examination-Questionnaire and clinical impairment assessment were conducted before and after treatment and during follow-up. In addition, dropout rates were assessed in both conditions. During the last 4 weeks of treatment, objective binges reduced from an average of 19 (SD 16) to 3 (SD 5) binges, and 40% (36/90) showed full recovery in the guided self-help CBT-E group. Between-group effect size (Cohen d) was 1.0 for objective binges. At follow-up, after both groups received treatment, there was no longer a difference between the groups. Of the 180 participants, 142 (78.9%) completed treatment. The overall treatment dropout appeared to be associated with gender, level of education, and number of objective binges at baseline but not with treatment condition. This is the first study to investigate the efficacy of guided self-help CBT-E. Guided self-help CBT-E appeared to be an efficacious treatment. This study's findings underscore the international guidelines recommending this type of treatment for binge eating disorder. Netherlands Trial Registry (NTR) NL7994; https://trialsearch.who.int/Trial2.aspx?TrialID=NL7994. RR2-10.1186/s12888-020-02604-1.

Depression trial results: A cross-sectional study of ClinicalTrials.gov

Published clinical trials represent a subsample of the objective information needed to appraise treatments for depression. We characterize the extent of selective and delayed reporting in a systematic review (PROSPERO #CRD42020173606) of depression trial results registered on ClinicalTrials.gov. Inclusion criteria were studies registered on ClinicalTrials.gov with depression as the condition, had enrolled ages 18 and over, were completed between January 1, 2008 and May 1, 2019, and had posted results by February 1, 2022. Cox regression analyses of time to result posting from registration and from study completion included enrollment as a covariate. Among 442 protocols, median result posting occurred over two years after study completion and five years after registration. Among protocols with incomplete results, effect sizes (d or W) were calculated for 134 protocols. Median effect sizes for protocols with incomplete results were small (0.16, 95% CI 0.08, 0.21). For 28% of protocols, observed effects were contrary to the expected direction. Between-group effect size calculations were based on post-treatment data as pre-treatment data were inconsistently provided. Although drug and device trials in the U.S. are required to register on ClinicalTrials.gov, compliance is imperfect, and submissions are not peer reviewed. For depression treatment trials, long intervals between study completion and posting of results are common. Further, investigators often fail to report the results of statistical tests. Failure to post trial results in a timely manner and omission of statistical test reporting may lead to overestimates of treatment effects in systematic literature reviews.

Effects of a culturally tailored, family-support, community-based self-management education and support programme on clinical outcomes amongst adults with type 2 diabetes in Western Ethiopia: A pilot randomised controlled trial.

To examine the preliminary effects of a culturally tailored, family-supported, community-based diabetes self-management education and support (DSMES) programme for Ethiopian people with type 2 diabetes on glycosylated haemoglobulin (HbA1c), blood pressure, body mass index and lipid profiles. A two-arm pilot randomised controlled trial (RCT) was conducted involving 76 patient-caregiver dyads from Western Ethiopia, which were randomly allocated to the intervention arm to receive 12 hours of DSMES intervention guided by social cognitive theory on top of usual care, or to the control group, which received usual care. Whilst HbA1c was a primary outcome, the blood pressure, body mass index and lipid profiles were secondary outcomes. Primary outcome was the change in HbA1c between baseline and 2-month follow-up between the groups. Generalised estimating equations was used to test the preliminary effect of the DSMES programme on the outcomes at baseline, post-intervention and at 2-month follow-up for secondary outcomes. Cohen's d was used to estimate the between-group effect sizes of the intervention. The DSMES produced significant improvement in HbA1c with large effect size (β = -1.667, p < 0.001, d = -0.81) and triglycerides with medium effect size (d = -0.50). HbA1c in the intervention group was decreased by 12 mmol/mol (1.1%). Although non-significant, the DSMES also had small to moderate effects (d = -0.123 to 0.34) on blood pressure, body mass index, total cholesterol, low-density and high-density lipoproteins when compared with usual care. A culturally tailored, social-cognitive theory guided, family-supported, community based DSME programme could have a benefit on HbA1c and triglycerides. A full RCT is warranted to test the effectiveness of the DSMES programme.