Using early phase studies to advance intervention research: The science of behavior change.

Davidson, Karina W.; Mogavero, Jazmin N.; Rothman, Alexander J.

doi:10.1037/hea0000897

Cited by 9 publications

(7 citation statements)

References 20 publications

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“…The successful completion of this early stage study will provide data regarding the feasibility and acceptability to conduct a future RCT testing the efficacy and mechanisms of this breathing self-management practice for adults with cLBP [ 131 , 163 ]. The study is designed to be consistent with recommendations for conducting pilot RCTs [ 100 , 117 , 164 , 165 ] and for intervention development [ 61 , 166 , 167 ]. Specifically, this pilot feasibility study is considered a smaller-scale version of an anticipated RCT where the target population is recruited and participants are randomly assigned to the active intervention or sham control intervention and complete all questionnaires, behavioral assessments, and procedures as planned in a future efficacy trial.…”

Section: Discussionmentioning

confidence: 99%

Conscious connected breathing with breath retention intervention in adults with chronic low back pain: protocol for a randomized controlled pilot study

Pratscher

Sibille

Fillingim

2023

Pilot Feasibility Stud

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Background Chronic pain is a major source of human suffering, and chronic low back pain (cLBP) is among the most prevalent, costly, and disabling of pain conditions. Due to the significant personal and societal burden and the complex and recurring nature of cLBP, self-management approaches that can be practiced at home are highly relevant to develop and test. The respiratory system is one of the most integrated systems of the body, and breathing is bidirectionally related with stress, emotion, and pain. Thus, the widespread physiological and psychological impact of breathing practices and breathwork interventions hold substantial promise as possible self-management strategies for chronic pain. The primary aim of the current randomized pilot study is to test the feasibility and acceptability of a conscious connected breathing with breath retention intervention compared to a sham control condition. Methods The rationale and procedures for testing a 5-day conscious connected breathing with breath retention intervention, compared to a deep breathing sham control intervention, in 24 adults (18–65 years) with cLBP is described. Both interventions will be delivered using standardized audio recordings and practiced over 5 days (two times in-person and three times at-home), and both are described as Breathing and Attention Training to reduce possible expectancy and placebo effects common in pain research. The primary outcomes for this study are feasibility and acceptability. Feasibility will be evaluated by determining rates of participant recruitment, adherence, retention, and study assessment completion, and acceptability will be evaluated by assessing participants’ satisfaction and helpfulness of the intervention. We will also measure other clinical pain, psychological, behavioral, and physiological variables that are planned to be included in a follow-up randomized controlled trial. Discussion This will be the first study to examine the effects of a conscious connected breathing with breath retention intervention for individuals with chronic pain. The successful completion of this smaller-scale pilot study will provide data regarding the feasibility and acceptability to conduct a subsequent trial testing the efficacy of this breathing self-management practice for adults with cLBP. Trial registration Clinicaltrials.gov, identifier NCT04740710. Registered on 5 February 2021.

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Section: Discussionmentioning

confidence: 99%

Conscious connected breathing with breath retention intervention in adults with chronic low back pain: protocol for a randomized controlled pilot study

Pratscher

Sibille

Fillingim

2023

Pilot Feasibility Stud

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“…In terms of the experimental medicine approach, the findings reflect a "full test" of both mechanistic pathways (Sheeran et al, 2017;p. 591) rather than tests focused solely on one pathway (e.g., studies testing the intervention-tomechanism effect; see Davidson et al, 2020).…”

Section: Discussionmentioning

confidence: 99%

“…These data expand understanding of the main trial findings for the self-persuasion app (Tiro et al, under review), and represent the first time that memory and autonomous motivation have been investigated as mechanisms of adolescent HPV vaccination. In terms of the experimental medicine approach, the findings reflect a “full test” of both mechanistic pathways (Sheeran et al, 2017; p. 591) rather than tests focused solely on one pathway (e.g., studies testing the intervention-to-mechanism effect; see Davidson et al, 2020).…”

Section: Discussionmentioning

confidence: 99%

Mechanisms of self-persuasion intervention for HPV vaccination: Testing memory and autonomous motivation.

Baldwin¹,

Zhu²,

Rochefort³

et al. 2021

Health Psychology

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Objective: Optimizing a self-persuasion intervention app for adolescent HPV vaccination requires investigating its hypothesized mechanisms. Guided by the experimental medicine approach, we tested whether (a) self-persuasion intervention components (verbalize vaccination reasons, choose HPV topics) changed putative mechanisms (memory, autonomous motivation) and (b) measures of the putative mechanisms were associated with HPV vaccination. Method: These are secondary analyses from a randomized 2 (cognitive processing: verbalize reasons vs. listen) 3 2 (choice: choose HPV topics vs. assigned) factorial trial (Tiro et al., 2016). Undecided parents (N = 161) with an unvaccinated child (11-17 years old) used the self-persuasion app, recalled reasons for vaccination (memory measure), and completed an autonomous motivation measure. Adolescent vaccination status was extracted from electronic medical records 12 months postintervention. Results: The verbalize component resulted in greater recall accuracy of vaccination reasons (p , .001); however, the choose topics component did not increase autonomous motivation scores (p = .74). For associations with HPV vaccination, recall accuracy was not associated (ps . .51), but autonomous motivation scores significantly predicted vaccination (ps , .03), except when controlling for baseline motivation (p = .22). Conclusion: The intervention app engages parents in reasons for vaccination; however, memory may not be a viable mechanism of vaccination. Although the intervention did not affect autonomous motivation, associations with vaccination status suggest it is a viable intervention target for HPV vaccination but alternative strategies to change it are needed. Future testing of a refined app should examine implementation strategies to optimize delivery in clinical or community settings.

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“…The limited impact of behavioral prevention research has led to recent and urgent calls for early-stage intervention development studies to elucidate previously overlooked mechanisms (i.e., mediators) of health behavior change. Later-stage intervention studies focusing only on efficacy leave many unknowns about the basic mechanisms of behavior change components, limiting generalizability and contributing to the replication crisis (35). A crucial step is understanding how and why intervention components may lead to changes in the outcome.…”

Section: Introductionmentioning

confidence: 99%

“…, mediators) of health behavior change. Later-stage intervention studies focusing only on efficacy leave many unknowns about the basic mechanisms of behavior change components, limiting generalizability and contributing to the replication crisis (35). A crucial step is understanding how and why intervention components may lead to changes in the outcome.…”

Section: Introductionmentioning

confidence: 99%

Affective Response During Real-World Physical Activity as an Intervention Mediator

Dunton

Crosley-Lyons

Rhodes

2023

Exercise and Sport Sciences Reviews

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Some people experience pleasure during physical activity, whereas it can be unpleasant for others. Modifying affective responses during physical activity in real-world situations may be an intervention strategy for increasing physical activity. This article follows an experimental medicine framework to summarize evidence identifying, assessing, and influencing affective response during real-world physical activity to inform interventions targeting this mediating mechanism.

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Using early phase studies to advance intervention research: The science of behavior change.

Cited by 9 publications

References 20 publications

Conscious connected breathing with breath retention intervention in adults with chronic low back pain: protocol for a randomized controlled pilot study

Conscious connected breathing with breath retention intervention in adults with chronic low back pain: protocol for a randomized controlled pilot study

Mechanisms of self-persuasion intervention for HPV vaccination: Testing memory and autonomous motivation.

Affective Response During Real-World Physical Activity as an Intervention Mediator

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