The selection of comparators for randomized controlled trials of health-related behavioral interventions: recommendations of an NIH expert panel

Freedland, Kenneth E.; King, Abby C.; Ambrosius, Walter T.; Mayo‐Wilson, Evan; Mohr, David C.; Czajkowski, Susan M.; Thabane, Lehana; Collins, Linda M.; Rebok, George W.; Treweek, Shaun; Cook, Thomas D.; Edinger, Jack D.; Stoney, Catherine M.; Campo, Rebecca; Young-Hyman, Deborah Lee; Riley, William T.

doi:10.1016/j.jclinepi.2019.02.011

Cited by 142 publications

(116 citation statements)

References 54 publications

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“…As outlined in our peer‐reviewed published systematic review protocol, we indicated in our PICO criteria that comparison groups may include attention control groups (ie, participants receive some attention such as education that is different from the intervention being tested). We included a range of comparison groups in our review as it is common in behavioral intervention trials to have some type of active comparison group . Based on our inclusion criteria, we feel it was appropriate to include the RESTORE trial in our systematic review.…”

Section: Summary Of Results From Studies Included In Review (N = 41)mentioning

confidence: 99%

Response to Letter to the Editor

Cuthbert¹

2020

Psycho-Oncology

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We would like to thank you for the opportunity to respond to the comments raised by Dr Clare Foster et al. in their letter to the editor about the publication "A Web-based intervention (RESTORE) to support self-management of cancer-related fatigue following primary cancer treatment: a multi-centre proof of concept randomised controlled trial 1 " and clarify aspects in relation to the methodology and findings of our systematic review entitled "Self-management interventions for cancer survivors: a systematic review and evaluation of intervention content and theories." 2 We would also like to thank Dr Foster and her colleagues for their interest in our paper and for taking the time to express their views. We respectfully disagree on several points. Dr Foster and colleagues' first comment pertains to the inclusion of their study in our review. They contend that their randomized controlled trial included an active control group (educational leaflet) andshould not have been included. As outlined in our peer-reviewed pub-

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Section: Summary Of Results From Studies Included In Review (N = 41)mentioning

confidence: 99%

Response to Letter to the Editor

Cuthbert¹

2020

Psycho-Oncology

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“…First, we wished to better account for contact time and expectancies for improvement across conditions for a future large‐scale trial. We also wanted to find a comparison that matched the mode of treatment delivery of LifeStories, which is video‐based and streamed over the internet, as the public is increasingly turning to the internet for health‐related information (Freedland et al, ). We further wanted to offer a novel intervention option that might be attractive to participants looking for an alternative approach to treating their depression.…”

Section: Methodsmentioning

confidence: 99%

Pilot randomized controlled trial of a video self‐help intervention for depression based on acceptance and commitment therapy: Feasibility and acceptability

Gaudiano

Davis

Miller

et al. 2020

Clin Psychology and Psychoth

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A common setting where depression is identified and treated is in primary care, where there is a need for low-intensity and cost-effective interventions to be used as part of a stepped-care model. The current study involved a pilot, parallel-group, randomized controlled trial of a video self-help intervention for primary care patients based on acceptance and commitment therapy (ACT). The intervention, called LifeStories, consisted of storytelling vignettes of patients describing their use of ACTconsistent coping skills for depression. Primary care patients were recruited to determine feasibility, acceptability, and potential clinical effects of the intervention.Twenty-one participants were assigned to use LifeStories over a period of 4 weeks, and 19 participants were assigned to an attention-matched comparison group. Qualitative feedback indicated that participants using LifeStories found the intervention to be engaging and useful in transmitting key ACT principles. Furthermore, those receiving LifeStories rated their level of "transportation" or immersion in the videos higher than the control group. Both conditions showed large improvements in levels of depression at a 12-week follow-up. There were no significant differences in symptom outcomes between groups; however, because this was a pilot study, it was not powered to detect differences between interventions. Both conditions additionally showed smaller effect size changes in psychological flexibility, a key ACT mechanism.The results suggest LifeStories to be a feasible and acceptable psychological intervention that may improve depression, and further research is warranted to determine its effectiveness as part of a stepped-care approach to treating depression in primary care. K E Y W O R D Sacceptance and commitment therapy, depression, mHealth, primary care, self-help, steppedcare

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“…As such, for pharmaceuticals only, one could think of classic RCTs as mechanistic science in real-world contexts. Within the social and behavioral sciences, the placebo is often not an appropriate control condition [ 136 ]. With new technologies and methods, the social and behavioral science can begin to localize effects in contexts to support both clinical decision-making and mechanistic science (see earlier discussion of HeartSteps microrandomization trial in the methods section, which illustrates this possibility).…”

Section: Opportunities For the Social And Behavioral Sciences Within mentioning

confidence: 99%

Precision Health: The Role of the Social and Behavioral Sciences in Advancing the Vision

Hekler

Tiro

Hunter

et al. 2020

Annals of Behavioral Medicine

110

107

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Background In 2015, Collins and Varmus articulated a vision for precision medicine emphasizing molecular characterization of illness to identify actionable biomarkers to support individualized treatment. Researchers have argued for a broader conceptualization, precision health. Precision health is an ambitious conceptualization of health, which includes dynamic linkages between research and practice as well as medicine, population health, and public health. The goal is a unified approach to match a full range of promotion, prevention, diagnostic, and treatment interventions to fundamental and actionable determinants of health; to not just address symptoms, but to directly target genetic, biological, environmental, and social and behavioral determinants of health. Purpose The purpose of this paper is to elucidate the role of social and behavioral sciences within precision health. Main body Recent technologies, research frameworks, and methods are enabling new approaches to measure, intervene, and conduct social and behavioral science research. These approaches support three opportunities in precision health that the social and behavioral sciences could colead including: (a) developing interventions that continuously “tune” to each person’s evolving needs; (b) enhancing and accelerating links between research and practice; and (c) studying mechanisms of change in real-world contexts. There are three challenges for precision health: (a) methods of knowledge organization and curation; (b) ethical conduct of research; and (c) equitable implementation of precision health. Conclusions Precision health requires active coleadership from social and behavioral scientists. Prior work and evidence firmly demonstrate why the social and behavioral sciences should colead with regard to three opportunity and three challenge areas.

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The selection of comparators for randomized controlled trials of health-related behavioral interventions: recommendations of an NIH expert panel

Cited by 142 publications

References 54 publications

Response to Letter to the Editor

Response to Letter to the Editor

Pilot randomized controlled trial of a video self‐help intervention for depression based on acceptance and commitment therapy: Feasibility and acceptability

Precision Health: The Role of the Social and Behavioral Sciences in Advancing the Vision

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