Between-group Effect Sizes Research Articles

Confirmatory Efficacy of Cognitive Enhancement Therapy for Early Schizophrenia: Results From a Multisite Randomized Trial.

Cognitive enhancement therapy (CET) is an 18-month comprehensive cognitive remediation intervention designed to improve cognition and functioning among patients with schizophrenia. The current study sought to confirm previously observed benefits of CET on cognitive and behavioral outcomes in the early course of the condition in a large multisite trial. Overall, 102 outpatients with early-course schizophrenia were randomly assigned to 18 months of CET (N=58) or enriched supportive therapy (EST; N=44). Participants completed cognitive, social adjustment, and symptom assessments at baseline and at 9 and 18 months. Composite indices were calculated for these outcomes. Mixed-effects models investigated differential changes in outcomes between CET and EST. Because of a high attrition rate, sensitivity analyses of data from treatment completers (N=49) were conducted. The effects of CET on improved overall cognition were confirmed and tentatively confirmed for social cognition in both intent-to-treat and completer analyses, and beneficial effects on attention/vigilance were also observed. An effect of CET on social adjustment was not confirmed in the analyses, because both CET and EST groups had considerably improved social adjustment. Although not statistically significant, the between-group effect size for CET's effect on social adjustment doubled from the intent-to-treat (Cohen's d=0.23) to completer analyses (Cohen's d=0.51) (p=0.057). Both groups displayed similar symptom improvements. CET effectively improved cognition among patients with early-course schizophrenia. The functional benefits of CET appeared to increase with treatment retention. Further research is needed to understand predictors of attrition and mechanisms of change during CET for this population.

Effectiveness and safety of the adjunctive use of an internet-based self-management intervention for borderline personality disorder in addition to care as usual: results from a randomised controlled trial

ImportanceBorderline personality disorder (BPD) is a severe mental disorder that is often inadequately treated.ObjectiveTo determine if adding a self-management intervention to care as usual (CAU) is effective and safe.DesignRandomised, controlled,...

A pilot randomized clinical trial of a teamwork intervention for heart failure care dyads

BackgroundDyadic heart failure (HF) management can improve outcomes for patients and caregivers and can be enhanced through eHealth interventions. ObjectiveTo evaluate the feasibility, acceptability, and preliminary efficacy of an eHealth dyadic teamwork intervention, compared to an attention control condition. MethodsWe recruited 29 HF patient-caregiver dyads from inpatient units and randomized dyads to an intervention or a control group. We calculated enrollment and retention rates, described acceptability using interview and questionnaire data, and computed intervention effect sizes. Results37% of eligible dyads agreed to participate and 93% of randomized participants completed follow-up questionnaires. Participants found both study conditions to be acceptable. Between-group effect sizes suggested that the intervention led to improvements in relationship quality, self-efficacy, and quality of life for patients and caregivers. ConclusionsDyadic recruitment from acute care settings is challenging. Findings provide initial evidence that our intervention can contribute to better health outcomes for HF dyads.

Effect of interventions for the well-being, satisfaction and flourishing of general practitioners—a systematic review

ObjectivesClinician well-being has been recognised as an important pillar of healthcare. However, research mainly addresses mitigating the negative aspects of stress or burnout, rather than enabling positive aspects. With the...

Fighting Hypertension In The Digital Age - A Lifestyle Intervention To Promote Physical Activity

PURPOSE: Although activity trackers are widely utilized, little is known about the effectiveness of activity trackers alone or combined with additional behavior change strategies to promote healthy lifestyles in individuals with pre-hypertension or hypertension. The purpose of the study was to determine the effectiveness of wearable activity trackers alone or in combination with behavior change strategies for promoting physical activity (PA) among individuals with pre-hypertension or hypertension. METHODS: A sample of 44 adults with pre-hypertension or hypertension (68% female) were randomized to receive either a Fitbit Charge HR 3 alone (FB) or the Fitbit in combination with behavior change strategies delivered by a trained health coach (FB+) for 12 weeks. Activity behaviors were assessed using ActiGraph wGT3X-BT, and psychological measures of social support, self-efficacy, self-regulation, and self-motivation were assessed using validated questionnaires. Compliance of wear time and daily activity data were tracked by Fitbit. The within-group and between-group effect size of Cohen’s d for change scores were calculated in the PA outcomes and psychological measures. The effect of the intervention on change in PA was tested with multiple linear regression controlling for demographic variables. RESULTS: Participants in FB+ had higher adherence with an average of 70.4 valid days (at least 10 h/day) out of 84 days in total compared to FB (65.0 days). The FB+ group showed significant increases in daily steps (+1854 steps/day, p < .01), moderate and vigorous physical activity (MVPA; +26 mins/day, p < .05), and decreases in sedentary time (-63 mins/day, p < .01). A similar pattern was found in participants from the FB but with smaller change from baseline to post-intervention (steps: +764/day, p < .1; MVPA: +10 mins/day, p < .05; sedentary time: -89 mins/day, p < .01). Participants from FB+ had significantly greater increases in MVPA/day compared to FB only group with a between-group effect size of 0.6 (p < .05). CONCLUSIONS: The study indicated that the usage of Fitbit for self-monitoring is effective in increasing PA and reducing sedentary time among pre-hypertensive and hypertensive participants. Additional behavior change support amplified the intervention effectiveness for promoting MVPA.

Randomized Controlled Trial of Solution-Focused Brief Therapy for Substance-Use-Disorder-Affected Parents Involved in the Child Welfare System

Objective: Solution-focused brief therapy (SFBT) has shown promise as an effective intervention with substance-abusing adults. This study expands on a preliminary study by Kim et al. (2018) by examining the results from the complete sample on substance abuse and trauma-related problems. Method: Child-welfare-involved parents were randomly assigned to either the SFBT (N = 90) or treatment-as-usual (N = 89) control group. Mixed linear models tested changes using intent-to-treat analysis, and effect sizes examined the magnitude of treatment effects. Results: Both the SFBT and control groups decreased on most of the Addiction Severity Index-SR (ASI-SR) measures and on all Trauma Symptom Checklist-40 (TSC-40) measures, indicating improvements. Between-group effect sizes favored the control group for two ASI-SR subscales—medical status and drug use—and favored SFBT for the TSC-40 subscale measures, although none was statistically significant except for the TSC-40 depression subscale. Conclusions: Further exploration of SFBT as an intervention to treat substance abuse and trauma among parents involved in the child welfare system is warranted.

Lifestyle Interventions in the Treatment of Obsessive-Compulsive and Related Disorders: A Systematic Review.

Lifestyle medicine is increasingly important in psychiatry for its efficacy as a transdiagnostic treatment, its preventative potential, and its increased tolerability compared with first-line strategies. Although the impact of lifestyle medicine is strong across many psychiatric illnesses, our understanding of the effectiveness of lifestyle interventions in treating obsessive-compulsive and related disorders (OCRDs) is minimal. We aimed to conduct a systematic review examining the effect of lifestyle interventions (targeting diet, exercise, sleep, stress management, and tobacco/alcohol use) on OCRD symptoms. We systematically searched four electronic databases for published randomized controlled trials reporting on lifestyle interventions for OCRDs. We qualitatively synthesized results of eligible studies and calculated mean changes in symptom severity from baseline to end point and standardized between-group effect sizes. We identified 33 eligible studies. Poor efficacy was noted across a number of rigorous dietary supplement interventions with some promising data in four (of six) studies regarding N-acetylcysteine for trichotillomania, skin picking, and obsessive-compulsive disorder. Stress management interventions, generally characterized by high risk of bias, reported mild effectiveness with greater effects noted for mind-body exercises (yoga) for obsessive-compulsive disorder. Greater improvements may be achieved when lifestyle intervention is adjunct to first-line treatments and delivered by facilitators. Diet (particularly N-acetylcysteine) and stress management interventions seem promising avenues for OCRDs treatment. We present an action plan to move the lifestyle interventions for OCRDs field forward. Further high-quality lifestyle interventions are required to improve the certainty of findings and to inform clinical treatment guidelines.Review Registration Number: CRD42020151407.

New Evidence in the Booming Field of Online Mindfulness: An Updated Meta-analysis of Randomized Controlled Trials.

BackgroundThere is a need to regularly update the evidence base on the effectiveness of online mindfulness-based interventions (MBIs), especially considering how fast this field is growing and developing.ObjectiveThis study presents an updated meta-analysis of randomized controlled trials assessing the effects of online MBIs on mental health and the potential moderators of these effects.MethodsWe conducted a systematic literature search in PsycINFO, PubMed, and Web of Science up to December 4, 2020, and included 97 trials, totaling 125 comparisons. Pre-to-post and pre-to-follow-up between-group effect sizes (Hedges g) were calculated for depression, anxiety, stress, well-being, and mindfulness using a random effects model.ResultsThe findings revealed statistically significant moderate pre-to-post effects on depression (g=0.34, 95% CI 0.18-0.50; P<.001), stress (g=0.44, 95% CI 0.32-0.55; P<.001), and mindfulness (g=0.40, 95% CI 0.30-0.50; P<.001) and small effects on anxiety (g=0.26, 95% CI 0.18-0.33; P<.001). For well-being, a significant small effect was found only when omitting outliers (g=0.22, 95% CI 0.15-0.29; P<.001) or low-quality studies (g=0.26, 95% CI 0.12-0.41; P<.001). Significant but small follow-up effects were found for depression (g=0.25, 95% CI 0.12-0.38) and anxiety (g=0.23, 95% CI 0.13-0.32). Subgroup analyses revealed that online MBIs resulted in higher effect sizes for stress when offered with guidance. In terms of stress and mindfulness, studies that used inactive control conditions yielded larger effects. For anxiety, populations with psychological symptoms had higher effect sizes. Adherence rates for the interventions ranged from 35% to 92%, but most studies lacked clear definitions or cut-offs.ConclusionsOur findings not only demonstrate that online MBIs are booming but also corroborate previous findings that online MBIs are beneficial for improving mental health outcomes in a broad range of populations. To advance the field of online MBIs, future trials should pay specific attention to methodological quality, adherence, and long-term follow-up measurements.

Combining Frontal Transcranial Direct Current Stimulation With Walking Rehabilitation to Enhance Mobility and Executive Function: A Pilot Clinical Trial

This pilot study assessed whether frontal lobe transcranial direct current stimulation (tDCS) combined with complex walking rehabilitation is feasible, safe, and shows preliminary efficacy for improving walking and executive function. Participants were randomized to one of the following 18-session interventions: active tDCS and rehabilitation with complex walking tasks (Active/Complex); sham tDCS and rehabilitation with complex walking tasks (Sham/Complex); or sham tDCS and rehabilitation with typical walking (Sham/Typical). Active tDCS was delivered over F3 (cathode) and F4 (anode) scalp locations for 20 min at 2mA intensity. Outcome measures included tests of walking function, executive function, and prefrontal activity measured by functional near infrared spectroscopy. Ninety percent of participants completed the intervention protocol successfully. tDCS side effects of tingling or burning sensations were low (average rating less than two out of 10). All groups demonstrated gains in walking performance based on within-group effect sizes (d ≥ 0.50) for one or more assessments. The Sham/Typical group showed the greatest gains for walking based on between-group effect sizes. For executive function, the Active/Complex group showed the greatest gains based on moderate to large between-group effect sizes (d=0.52-1.11). Functional near-infrared spectroscopy (fNIRS) findings suggest improved prefrontal cortical activity during walking. Eighteen sessions of walking rehabilitation combined with tDCS is a feasible and safe intervention for older adults. Preliminary effects size data indicate a potential improvement in executive function by adding frontal tDCS to walking rehabilitation. This study justifies future larger clinical trials to better understand the benefits of combining tDCS with walking rehabilitation.

A Meta-Analysis of Group Interventions for Trauma and Depression Among Immigrant and Refugee Children

Purpose: A meta-analysis of group interventions to reduce post-traumatic stress symptoms (PTSS) and/or depression among refugee and immigrant children and adolescents. Methods: A systematic search was followed by independent reviews of each study for risk of bias. The meta-analysis pooled between- and within-condition effect sizes on PTSS and depression across studies using a random effects model. Results: The search yielded 16 studies utilizing eight interventions involving 976 participants. For all studies, within conditions, there were good effects on PTSS ( d = −0.66, 95% CI [−0.86, −0.46]) and depression ( d = −0.51, 95% CI [−0.79, −0.23]) with substantial heterogeneity. For studies with control groups, the between-group effect sizes yielded a small effect on PTSS ( d = −0.31, 95% CI [−0.65, 0.03]) with no significant effect on depression. Conclusions: The interventions helped to reduce PTSS and depression. Most studies lacked rigorous designs and provided little information on group variables needed for replication.

Long-term Exercise After Pulmonary Rehabilitation (LEAP): a pilot randomised controlled trial of Tai Chi in COPD.

Mind–body modalities are promising strategies to maintain the benefits gained after completion of conventional pulmonary rehabilitation in persons with COPD.In this pilot randomised controlled study we examined Tai Chi in persons with COPD after completing pulmonary rehabilitation. Participants were randomised 2:2:1 to Tai Chi (TC), usual care (UC) or group walking (GW) for 24 weeks. We assessed feasibility; primary outcome was exercise capacity measured by 6-min walk test (6MWT) distance at 24 weeks. Secondary outcomes included health-related quality of life measured by Chronic Respiratory Questionnaire (CRQ), dyspnoea, mood, stress, social support, self-efficacy, physical activity and exercise engagement. Effect size estimates and estimates from generalised estimating equations were calculated.Ninety-one persons (36 TC, 37 UC, 18 GW) were enrolled, with mean age 69±6 years, 59% male, and forced expiratory volume in 1 s % predicted (FEV1 % pred) 48±19%. There was no difference in adherence and adverse events between groups. There was a small between-group effect size (ES=0.25) in change in 6MWT distance favouring TC compared to UC; 24-week comparison was nonsignificant (p=0.10). There were no differences in secondary outcomes. In exploratory analyses, there was a greater percentage of participants in TC who improved 6MWT distance at 24 weeks, compared to UC, 64% versus 39%, p=0.05. There were higher percentages of participants in TC who improved CRQ Fatigue (59% versus 31%, p=0.02) and CRQ Mastery (47% versus 20%, p=0.01) domain scores, compared to UC. For GW, there were no differences compared with TC.Tai Chi may be a feasible option to maintain the benefits gained after completing conventional pulmonary rehabilitation.

Therapist-Guided Internet-Delivered Cognitive Behavioral Therapy vs Internet-Delivered Supportive Therapy for Children and Adolescents With Social Anxiety Disorder

Social anxiety disorder (SAD) is a prevalent childhood-onset disorder associated with lifelong adversity and high costs for the individual and society at large. Cognitive behavioral therapy (CBT) is an established evidence-based treatment for SAD, but its availability is limited. To assess the efficacy and cost-effectiveness of therapist-guided internet-delivered cognitive behavioral therapy (ICBT) for SAD in youths vs an active comparator, internet-delivered supportive therapy (ISUPPORT). This single-masked, superiority randomized clinical trial enrolled participants at a clinical research unit integrated within the child and adolescent mental health services in Stockholm, Sweden, from September 1, 2017, to October 31, 2018. The final participant reached the 3-month follow-up (primary end point) in May 2019. Children and adolescents 10 to 17 years of age with a principal diagnosis of SAD and their parents were included in the study. ICBT and ISUPPORT, both including 10 online modules, 5 separate parental modules, and 3 video call sessions with a therapist. The Clinician Severity Rating (CSR), derived from the Anxiety Disorder Interview Schedule, rated by masked assessors 3 months after the end of treatment. The CSR ranges from 0 to 8, with scores of 4 or higher indicating caseness. Secondary outcomes included masked assessor-rated diagnostic status of SAD and global functioning, child- and parent-reported social anxiety and depressive symptoms, and health-related costs. Of the 307 youths assessed for eligibility, 103 were randomized to 10 weeks of therapist-guided ICBT (n = 51) or therapist-guided ISUPPORT (n = 52) for SAD. The sample consisted of 103 youths (mean [SD] age, 14.1 [2.1] years; 79 [77%] female). Internet-delivered cognitive behavioral therapy was significantly more efficacious than ISUPPORT in reducing the severity of SAD symptoms. Mean (SD) CSR scores for ICBT at baseline and at the 3-month follow-up were 5.06 (0.95) and 3.96 (1.46), respectively, compared with 4.94 (0.94) and 4.48 (1.30) for ISUPPORT. There was a significant between-group effect size of d = 0.67 (95% CI, 0.21-1.12) at the 3-month follow-up. Similarly, all of the secondary outcome measures demonstrated significant differences with small to large effect sizes, except for child-rated quality of life (nonsignificant). The cost-effectiveness analyses indicated cost savings associated with ICBT compared with ISUPPORT, with the main drivers of the savings being lower medication costs (z = 2.38, P = .02) and increased school productivity (z = 1.99, P = .047) in the ICBT group. There was 1 suicide attempt in the ISUPPORT group; no other serious adverse events occurred in either group. In this randomized clinical trial, internet-delivered cognitive behavioral therapy was an efficacious and cost-effective intervention for children and adolescents with SAD. Implementation in clinical practice could markedly increase the availability of effective interventions for SAD. ClinicalTrials.gov Identifier: NCT03247075.

The effect of sleep-wake intraindividual variability in digital cognitive behavioral therapy for insomnia: a mediation analysis of a large-scale RCT.

Study ObjectivesDigital cognitive behavioral therapy for insomnia (dCBT-I) is an effective treatment for insomnia. However, less is known about mediators of its benefits. The aim of the present study was to test if intraindividual variability in sleep (IIV) was reduced with dCBT-I, and whether any identified reduction was a mediator of dCBT-I on insomnia severity and psychological distress.MethodsIn a two-arm randomized controlled trial (RCT), 1720 adults with insomnia (dCBT-I = 867; patient education about sleep = 853) completed the Insomnia Severity Index (ISI), the Hospital Anxiety and Depression Scale (HADS) and sleep diaries, at baseline and 9-week follow-up. Changes in IIV were analyzed using linear mixed modeling followed by mediation analyses of ISI, HADS, and IIV in singular sleep metrics and composite measures (behavioral indices (BI-Z) and sleep disturbance indices (SI-Z)).ResultsdCBT-I was associated with reduced IIV across all singular sleep metrics, with the largest between-group effect sizes observed for sleep onset latency (SOL). Reduced IIV for SOL and wake after sleep onset had the overall greatest singular mediating effect. For composite measures, SI-Z mediated change in ISI (b = −0.74; 95% confidence interval (CI) −1.04 to −0.52; 13.3%) and HADS (b = −0.40; 95% CI −0.73 to −0.18; 29.2%), while BI-Z mediated minor changes.ConclusionReductions in IIV in key sleep metrics mediate significant changes in insomnia severity and especially psychological distress when using dCBT-I. These findings offer important evidence regarding the therapeutic action of dCBT-I and may guide the future development of this intervention.Clinical trials Name: Overcoming Insomnia: Impact on Sleep, Health and Work of Online CBT-I Registration number: NCT02558647 URL: https://clinicaltrials.gov/ct2/show/NCT02558647?cond=NCT02558647&draw=2&rank=1

Effectiveness of a Guided Web-Based Intervention to Reduce Depressive Symptoms before Outpatient Psychotherapy: A Pragmatic Randomized Controlled Trial

Introduction: Psychotherapy is a first-line treatment for depression. However, capacities are limited, leading to long waiting times for outpatient psychotherapy in health care systems. Web-based interventions (WBI) could help to bridge this treatment gap. Objective: This study investigates the effectiveness of a guided cognitive-behavioral WBI in depressive patients seeking face-to-face psychotherapy. Methods: A 2-arm randomized controlled trial was conducted. Depressive patients (n = 136) recruited from the waiting lists of outpatient clinics were randomly assigned to an intervention group (IG; treatment as usual [TAU] + immediate access to WBI) or a control group (CG; TAU + access to WBI after follow-up). Depressive symptoms and secondary outcomes were assessed at baseline, 7 weeks, and 5 months after randomization. Results: Mixed-model analyses revealed a significant group × time interaction effect on depressive symptoms (F_{2, 121.5} = 3.91; p < 0.05). Between-group effect sizes were d = 0.55 at 7 weeks and d = 0.52 at 5 months. The IG was superior regarding psychological symptoms and mental health quality of life but not on physical health quality of life, attitudes, motivation for psychotherapy, or subjective need and uptake of psychotherapy. Conclusions: Patients waiting for face-to-face psychotherapy can benefit from a WBI when compared to TAU. Despite the reduction of depressive symptoms in the IG, the uptake of subsequent psychotherapy was still high in both groups. The effects remained stable at the 5-month follow-up. However, this study could not determine the proportion of specific intervention effects vs. nonspecific effects, such as positive outcome expectations or attention. Future research should focus on the long-term effects and cost-effectiveness of WBI before psychotherapy.

Treatment of chronic primary sleep onset insomnia with Kundalini yoga: a randomized controlled trial with active sleep hygiene comparison.

Prior studies have suggested a benefit of yoga for alleviating sleep disturbance; however, many studies have had methodological limitations. This trial study aimed to extend that literature by including an active sleep hygiene comparison. Participants aged 25-59 years with a primary complaint of sleep onset insomnia lasting at least 6 months were block randomized to an 8-week Kundalini yoga or sleep hygiene intervention, both consisting of initial 60-minute instruction and weekly check-ins. Daily sleep diaries and questionnaires were collected at baseline, throughout the intervention, and at 6-month follow-up. Data were analyzed using linear mixed models (n = 20 in each group). Participant ratings of the interventions did not significantly differ. Sleep hygiene improved several diary and questionnaire outcomes, however, yoga resulted in even greater improvements corresponding to medium-to-large between-group effect sizes. Total sleep time increased progressively across yoga treatment (d = 0.95, P = .002), concurrent with increased sleep efficiency (d = 1.36, P < .001) and decreased sleep onset latency (d = -1.16, P < .001), but without changes in pre-sleep arousal (d =-0.30, P = .59). Remission rates were also higher for yoga compared to sleep hygiene, with ≥ 80% of yoga participants reporting average sleep onset latency < 30 minutes and sleep efficiency > 80% at 6-month follow-up. For over 50% of yoga participants, the insomnia severity index decreased by at least 8 points at end of treatment and follow-up. Yoga, taught in a self-care framework with minimal instructor burden, was associated with self-reported improvements above and beyond an active sleep hygiene comparison, sustained at 6-month follow-up. Follow-up studies are needed to assess actigraphy and polysomnography outcomes, as well as possible mechanisms of change. Registry: ClinicalTrials.gov; Name: Yoga as a Treatment for Insomnia; URL: https://clinicaltrials.gov/ct2/show/NCT00033865; Identifier: NCT00033865. Khalsa SBS, Goldstein MR. Treatment of chronic primary sleep onset insomnia with Kundalini yoga: a randomized controlled trial with active sleep hygiene comparison. J Clin Sleep Med. 2021;17(9):1841-1852.

“Song of Life”: Results of a multicenter randomized trial on the effects of biographical music therapy in palliative care

Background: Awareness for the importance of psychological and spiritual needs in patients with terminal diseases has increased in recent years, but randomized trials on the effects of psychosocial interventions are still rare. Aim: To investigate the efficacy of the “Song of Life” music therapy intervention regarding the emotional and psycho-spiritual dimensions of quality of life. Design: Patients were randomly assigned to either “Song of Life” or a relaxation intervention. “Song of Life” is a novel three-session music therapy intervention working with a biographically meaningful song. Primary outcome was the improvement in psychological quality of life. Secondary outcomes included spiritual well-being, ego-integrity, momentary distress, and global quality of life and the explorative assessment of treatment satisfaction (patient and family member version). Intention-to-treat analysis was conducted including adjustment for multiple testing in secondary outcomes. Setting/participants: Between December 2018 and August 2020, 104 patients receiving specialized palliative care were recruited from two palliative care wards. Results: No significant differences were found regarding psychological and global quality of life, but “Song of Life” participants reported significantly higher spiritual well-being (p = 0.04) and ego-integrity (p < 0.01), as well as lower distress (p = 0.05) than patients in the control group. Both patients’ and family members’ treatment satisfaction was higher after “Song of Life” with large between-group effect sizes on items asking for meaningfulness (d = 0.96) and importance (d = 1.00). Conclusions: Our findings provide evidence that “Song of Life” is an effective and meaningful biographical music therapy intervention to facilitate psycho-spiritual integration in terminally ill patients. Trial Registration: German Clinical Trials Register (DRKS)—DRKS00015308 (date of registration: September 7th 2018).

Internet-Based Cognitive Behavioral Therapy for Informal Caregivers: Randomized Controlled Pilot Trial.

BackgroundCaregiving for a family member can result in reduced well-being for the caregiver. Internet-delivered cognitive behavioral therapy (ICBT) may be one way to support this population. This is especially the case for caregivers in countries with limited resources, but high demand for psychological services.ObjectiveIn this study we evaluated the effects of a therapist-guided 8-week-long ICBT intervention for informal caregivers.MethodsIn total, 63 participants were recruited online and randomized either to the intervention or to the wait-list control group. The main study outcome was the Caregiver Burden Inventory (CBI). Secondary outcomes included measures of caregiver depression, anxiety, stress, and quality of life.ResultsModerate between-group effect sizes were observed for the CBI measure, in favor of the intervention group, with a Cohen d=–0.70 for the intention-to-treat analysis. Analyses of the subscales of the CBI showed significant reductions on the subscales of Development and Physical Health. Moderate reductions were found for depression and anxiety scores as indicated by the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) scores. Large between-group effects were observed for reduction in stress and increase in quality of life as indicated by the Perceived Stress Scale-14 (PSS-14), The Brunnsviken Brief Quality of Life Scale (BBQ), and The World Health Organization-Five Well-Being Index (WHO-5). In addition, participants experienced little to no difficulty in using the program and were mostly satisfied with the intervention’s platform and the choice of content.ConclusionsThis is the first internet intervention study for informal caregivers in Lithuania. The results suggest that therapist-guided ICBT can be effective in reducing caregiver burden, anxiety, depression, stress, and improving quality of life.Trial RegistrationClinicalTrials.gov NCT04052724; https://clinicaltrials.gov/ct2/show/NCT04052724

Effectiveness of stress control large group psychoeducation for anxiety and depression: Systematic review and meta-analysis.

This review sought to evaluate the effectiveness of the 'Stress Control' (SC) large psychoeducational 6-session group programme developed to increase access to treatment for patients with anxiety and depression. Systematic review and meta-analysis (Prospero registration: CRD42020173676). Pre-post and post-treatment follow-up effect sizes were extracted and synthesized in a random effects meta-analysis, and variations in effect sizes were investigated via moderator analyses. Secondary analyses synthesized between-group effect sizes from controlled studies containing comparator treatments and calculated the average dropout rate. The quality of the meta-analysis was assessed using the GRADE approach. Nineteen studies with pre-post treatment outcomes were included. The average group size was N=39, and the average dropout rate was 34%. Pooled effect sizes indicated moderate pre-post treatment reductions in anxiety (ES=0.58; CI 0.41 to 0.75; N=5597; Z=7.13; p<.001), moderate reductions in depression (ES=0.62; CI 0.44 to 0.80; N=5538, Z=7.30; p<.001), and large reductions in global distress (ES=0.86; CI 0.61 to 1.11; N=591; Z=7.41; p<.001). At follow-up, improvements in anxiety, depression, and global distress were maintained. When SC was compared to active and passive controls, outcomes were equivalent for anxiety (ES=0.12, 95% CI -0.25 to 0.49, Z=-0.70; p=.482) and depression (ES=0.15, 95% CI -0.24 to 0.54, Z=0.84; p=.401). SC appears to be a clinically effective and durable low-intensity group intervention that facilitates access to treatment for large patient numbers. However, conclusions are limited by the low methodological quality of the evidence. The stress control version of large group psychoeducation is appropriate and effective for mild-to-moderate anxiety and depression The evidence base for stress control is predominantly made up of practice-based studies Stress control needs to form one component of the overall offer made to patients presenting with mild-to-moderate anxiety and depression The competencies required to deliver such groups need better specification.

Proof of Concept for the Autobiographical Memory Flexibility (MemFlex) Intervention for Posttraumatic Stress Disorder.

Autobiographical memory distortions are a key feature of posttraumatic stress disorder (PTSD). In this proof-of-concept randomized controlled trial (N = 43), we evaluated an autobiographical memory flexibility intervention, MemFlex. We aimed to determine whether the mechanism-focused intervention, which aims to improve autobiographical memory processes, may also affect other cognitive predictors of PTSD and potentially reduce PTSD symptoms in Iranian trauma survivors diagnosed with PTSD. Results indicated significant, moderate to large between-groups effect sizes in favor of MemFlex, relative to wait-list control, for the targeted cognitive mechanism of autobiographical memory flexibility and PTSD symptoms. A large, significant effect was also observed on maladaptive posttraumatic cognitions—a strong predictor of PTSD prognosis, which is a key target of high-intensity cognitive therapies for PTSD. Findings support future completion of a scaled-up trial to evaluate treatment efficacy of MemFlex for PTSD to determine whether MemFlex may offer a culturally adaptive, low-cost, low-intensity intervention able to improve cognitive mechanisms of PTSD.

Behavioral Therapy Teams for Obsessive-Compulsive Disorder: Lessons Learned From a Pilot Randomized Trial in a Community Mental Health Center

Community mental health centers (CMHCs) provide the majority of mental health services for low-income individuals in the United States. Exposure and response prevention (ERP), the psychotherapy of choice for obsessive-compulsive disorder (OCD), is rarely delivered in CMHCs. This study aimed to establish the acceptability and feasibility of testing a behavioral therapy team (BTT) intervention to deliver ERP in CMHCs. BTT consisted of individual information-gathering sessions followed by 12 weeks of group ERP and concurrent home-based coaching sessions. The sample consisted of 47 low-income individuals with OCD who were randomized to receive BTT or treatment as usual (TAU). Symptom severity and quality-of-life measures were assessed at pretreatment, posttreatment, and 3- and 6-month posttreatment. Feasibility of training CMHC staff was partially successful. CMHC therapists successfully completed rigorous training and delivered ERP with high fidelity. However, training paraprofessionals as ERP coaches was more challenging. ERP was feasible and acceptable to patients. BTT participants were more likely than TAU participants to attend their first therapy session and attended significantly more treatment sessions. A large between-group effect size was observed for reduction in OCD symptoms at posttreatment but differences were not maintained across 3- and 6-month follow-ups. For BTT participants, within-group effect sizes reflecting change from baseline to posttreatment were large. For TAU participants, depression scores did not change during the active treatment phase but gradually improved during follow-up. Results support feasibility and acceptability of ERP for this patient population. Findings also underscore the importance of implementation frameworks to help understand factors that impact training professionals.