Placebo, usual care and wait-list interventions for all mental health disorders

Faltinsen, Erlend; Todorovac, Adnan; Hróbjartsson, Asbjørn; Gluud, Christian; Kongerslev, Mickey; Simonsen, Erik; Storebø, Ole Jakob

doi:10.1002/14651858.mr000050

Cited by 8 publications

(5 citation statements)

References 105 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Accordingly, the effect sizes for studies with wait-list control designs may have been artificially inflated. A better understanding of the influence of control conditions on treatment effects should be a focus of future research to develop empirical guidelines that aim to optimize the design of future RCTs …”

Section: Discussionmentioning

confidence: 99%

Behavioral Intervention for Social Challenges in Children and Adolescents

et al. 2021

View full text Add to dashboard Cite

IMPORTANCE Social deficits are a common and disabling feature of many pediatric disorders; however, whether behavioral interventions are associated with benefits for children and adolescents with social deficits is poorly understood. OBJECTIVE To assess whether behavioral interventions in children and adolescents with neurodevelopmental or mental health disorders are associated with improvements in social function and social cognition, and whether patient, intervention, and methodological characteristics moderate the association.DATA SOURCES For this systematic review and meta-analysis, the PsycINFO, MEDLINE, and PubMed electronic databases were searched in December 2020 for randomized clinical trials published from database inception to December 1, 2020, including terms related to neurodevelopmental or mental health disorders, social behavior, randomized clinical trials, and children and adolescents. Data were analyzed in January 2021.STUDY SELECTION Randomized clinical trials that enrolled participants aged 4 to 17 years with social deficits and examined the efficacy of a clinician-administered behavioral intervention targeting social functioning or social cognition were included. A total of 9314 records were identified, 78 full texts were assessed for eligibility, and 33 articles were included in the study; 31 of these reported social function outcomes and 12 reported social cognition outcomes.DATA EXTRACTION AND SYNTHESIS Articles were reviewed using the Cochrane Risk of Bias Assessment for randomized clinical trials. Data were independently extracted and pooled using a weighted random-effects model. MAIN OUTCOMES AND MEASURESThe main outcome was the association of behavioral intervention with social function and social cognition. Hedges g was used to measure the standardized mean difference between intervention and control groups. Standardized effect sizes were calculated for the intervention group vs the comparison group for each trial.RESULTS A total of 31 trials including 2131 participants (1711 [80%] male; 420 [20%] female; mean [SD] age, 10.8 [2.2] years) with neurodevelopmental or mental health disorders (autism spectrum disorder [ASD] [n = 23], attention-deficit/hyperactivity disorder [n = 4], other conditions associated with social deficits [n = 4]) were analyzed to examine differences in social function between the intervention and control groups. Significantly greater gains in social function were found among participants who received an intervention than among the control groups (Hedges g, 0.61; 95% CI, 0.40-0.83; P < .001). The type of control condition (wait list vs active control vs treatment as usual) was a significant moderator of effect size (Q 2 , 7.11; P = .03). Twelve studies including 487 individuals with ASD (48 [10%] female; 439 [90%] male; mean [SD] age, 10.4 [1.7] years) were analyzed to examine differences in social cognition between intervention and control groups. The overall mean weighted effect was significant (Hedges g, 0.67; 95% CI, 0.39-0.96; P < .001), indicating the treatme...

show abstract

Section: Discussionmentioning

confidence: 99%

Behavioral Intervention for Social Challenges in Children and Adolescents

et al. 2021

View full text Add to dashboard Cite

show abstract

“…Despite promising early evidence, only 20% of randomized controlled trials (RCT) studies on selective preventions include some active control condition (ACC) [ 11 ]. The use of waitlist control conditions (WLCs) in RCTs may also overestimate treatment effects and thus artificially inflate the effect sizes of prevention programs [ 1 , 26 , 31 , 36 , 74 ]. Further, it is suggested that the positive effects diminish over time [ 17 ].…”

Section: Introductionmentioning

confidence: 99%

Randomized controlled trial for selective preventive transdiagnostic intervention for adolescents at risk for emotional disorders

Vivas-Fernandez

García-López

Piqueras

et al. 2023

Child Adolesc Psychiatry Ment Health

View full text Add to dashboard Cite

Significant evidence does exist on the effectiveness of transdiagnostic interventions to improve emotional problems in clinical populations, and their application as universal and indicated prevention programs. However, no randomized controlled trials (RCT) studying selective transdiagnostic prevention intervention have been published. This is the first known RCT to evaluate the efficacy/effectiveness of an evidence-based selective prevention transdiagnostic program for emotional problems in adolescents. The impact of three different interventions was evaluated: (1) PROCARE (Preventive transdiagnostic intervention for Adolescents at Risk for Emotional disorders), which is a group-based, abbreviated version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A), along with adding a booster session to reduce risk of onset of anxiety and depression, (2) PROCARE + , which includes the PROCARE protocol along with personalized add-on modules tailored to match adolescents’ risk factors, and (3) an active control condition (ACC) based on emotional psychoeducation. In total, 208 adolescents (48.5% girls) evidencing high risk and low protective factors were randomized and allocated to PROCARE, PROCARE + or ACC. Data from 153 adolescents who completed all assessments in the different phases of the study were analyzed. Self- and parent-reported measures were taken at baseline, as well as after the intervention, a 6 month follow-up was carried out, together with a 1 month follow-up after the booster session. Differences between conditions were significant on most of the outcome measures, with superior effect sizes for PROCARE + in the short and long term. Interventions were acceptable in terms of acceptability, with good satisfaction rates. Tailored targeted selective transdiagnostic interventions focused on mitigating risk factors and promoting protective factors in vulnerable adolescents are promising.

show abstract

“…• Studies using as a control condition one of the following: treatment / care as usual, wait-list, active control, and placebo. In keeping with standard definitions used by the Cochrane database (Faltinsen et al, 2019), usual care was defined as an intervention that reflects locally accepted treatment practices for individuals with bipolar disorder. Wait list was defined as receiving the experimental intervention after the trial ended.…”

Section: Eligibility Criteriamentioning

confidence: 99%