Web-Based Single Session Intervention for Perceived Control Over Anxiety During COVID-19: Randomized Controlled Trial

Abstract

Background Anxiety is rising across the United States during the COVID-19 pandemic, and social distancing mandates preclude in-person mental health care. Greater perceived control over anxiety has predicted decreased anxiety pathology, including adaptive responses to uncontrollable stressors. Evidence suggests that no-therapist, single-session interventions can strengthen perceived control over emotions like anxiety; similar programs, if designed for the COVID-19 context, could hold substantial public health value. Objective Our registered report evaluated a no-therapist, single-session, online intervention targeting perceived control over anxiety in the COVID-19 context against a placebo intervention encouraging handwashing. We tested whether the intervention could (1) decrease generalized anxiety and increase perceived control over anxiety and (2) achieve this without decreasing social-distancing intentions. Methods We tested these questions using a between-subjects design in a weighted-probability sample of US adults recruited via a closed online platform (ie, Prolific). All outcomes were indexed via online self-report questionnaires. Results Of 522 randomized individuals, 500 (95.8%) completed the baseline survey and intervention. Intent-to-treat analyses using all randomized participants (N=522) found no support for therapeutic or iatrogenic effects; effects on generalized anxiety were d=–0.06 (95% CI –0.27 to 0.15; P=.48), effects on perceived control were d=0.04 (95% CI –0.08 to 0.16; P=.48), and effects on social-distancing intentions were d=–0.02 (95% CI –0.23 to 0.19; P=.83). Conclusions Strengths of this study included a large, nationally representative sample and adherence to open science practices. Implications for scalable interventions, including the challenge of targeting perceived control over anxiety, are discussed. Trial Registration ClinicalTrials.gov NCT04459455; https://clinicaltrials.gov/show/NCT04459455

A Digital Single-Session Intervention Platform for Youth Mental Health: Cultural Adaptation, Evaluation, and Dissemination

“…The Program Feedback Scale (PFS) is commonly used to evaluate the acceptability and user perceptions of SSIs [ 16 , 20 , 46 , 47 ]. It asks participants to rate their level of agreement with 7 statements that indicate the perceived acceptability and feasibility of the SSI they chose (eg, “I enjoyed the program”) on a 5-point Likert scale (1=“really disagree,” 2=“disagree,” 3=“neutral,” 4=“agree,” and 5=“totally agree”).…”

Improving transportability of randomized controlled trial inference using robust prediction methods

“…Most RCTs use more "pragmatic designs" that attempt to recruit from routine clinical practices or other relevant convenience sample settings; indeed, a search of the ClinicalTrials.gov database at the (US) National Library of Medicine (https://clinicaltrials.gov/) using the key words "representative sample" and "probability sample" finds only 8 registered clinical trials out of over 450,000 that could be confirmed to have recruited subjects in something reasonably approximating a probability sample from a well defined population, of which 7 have reported results. [11][12][13][14][15][16][17] As noted by Olson, 18 bias in the estimation of population causal effects from RCT arises from heterogeneity in treatment effects and systematic selection bias in the RCT with respect to the effect modifiers. Hence the basic approach revolves around accounting for differences between RCT and population effect modifiers.…”

“…For ΔWE (12) we will consider a version in which we treat 𝜋 R i as fixed at the posterior mean of a BART model fit to covariates (Δ WE1 ) (7) and a version where variances are estimated using independent posterior draws of 𝜋 R i (Δ WE2 ) (8). Finally we will consider an estimator that relies only on RCT data given by 15 for a total of five estimators.…”

“…Most RCTs use more “pragmatic designs” that attempt to recruit from routine clinical practices or other relevant convenience sample settings; indeed, a search of the ClinicalTrials.gov database at the (US) National Library of Medicine (https://clinicaltrials.gov/) using the key words “representative sample” and “probability sample” finds only 8 registered clinical trials out of over 450,000 that could be confirmed to have recruited subjects in something reasonably approximating a probability sample from a well defined population, of which 7 have reported results. 11–17…”

Efficacy of an Unguided, Digital Single-Session Intervention for Internalizing Symptoms in Web-Based Workers: Randomized Controlled Trial

“…However, in a meta-analysis by Schleider and Weisz [ 17 ], the effect sizes were very small for depression as a treatment target or secondary outcomes. Mullarkey et al [ 20 ] found no support for the efficacy of an unguided SSI focused on perceived control over anxiety versus a placebo control in a nationally representative sample of 500 adults. Thus, the efficacy of unguided digital SSIs for adult internalizing symptoms is still a matter to be established.…”