Randomized non-inferiority trial comparing an asynchronous remotely-delivered versus clinic-delivered lifestyle intervention.

OBJECTIVE: Lifestyle interventions are effective, but those delivered via in-person group meetings have poor scalability and reach. Research is needed to establish if remotely delivered lifestyle interventions are non-inferior to in-person delivered lifestyle interventions. METHODS: We conducted a randomized non-inferiority trial (N = 329) to compare a lifestyle intervention delivered remotely and asynchronously via an online social network (Get Social condition) to one delivered via in-person groups (Traditional condition). We hypothesized that the Get Social condition would result in a mean percent weight loss at 12 months that was not inferior to the Traditional condition. Additional outcomes included intervention delivery costs per pound lost and acceptability (e.g., convenience, support, modality preferences). RESULTS: At 12 months, no significant difference in percent weight change was observed between the Get Social and Traditional conditions (2.7% vs. 3.7%, p = 0.17) however, criteria for non-inferiority were not met. The Get Social condition costs $21.45 per pound lost versus $26.24 for the Traditional condition. A greater percentage of Get Social condition participants rated participation as convenient (65% vs 44%; p = 0.001). CONCLUSIONS: Results revealed a remotely-delivered asynchronous lifestyle intervention resulted in slightly less weight loss than an in-person version but may be more economical and convenient. TRIAL REGISTRATION: ClinicalTrials.gov NCT02646618; https://clinicaltrials.gov/ct2/show/NCT02646618 .

Proof-of-Concept Feasibility Trial of a Dissonance-Based Sun Safety Intervention for Young Adult Tanners.

BACKGROUND: Melanoma is the second most common cancer in young adults. Social media may be a means to conduct interventions to increase sun safety in young adults. PURPOSE: We conducted a randomized proof-of-concept pilot trial to evaluate the feasibility and acceptability of a dissonance-based social media intervention designed to promote sun safety in young adult tanners. METHODS: Young adult tanners (N = 66) were randomized into two 4-week interventions in which participants were incentivized to create content for a social media campaign on healthy skin or healthy lifestyle. Feasibility outcomes included retention, participation, acceptability, and contamination. We also examined the impact of participation on motivation to engage in the target health behaviors and outdoor tanning intentions. RESULTS: Retention was 100%. Most Healthy Skin (88%) and Healthy Lifestyle participants (91%) created ≥1 post. Acceptability was high with 94% and 97% of participants in Healthy Skin and Healthy Lifestyle conditions, respectively, agreeing they would recommend the campaign to a friend. At 4 weeks, Healthy Skin participants reported greater declines in motivation to tan indoors (p = .0017) and outdoors (p = .0003), and greater increases in motivation to wear sunscreen (p = .0009) and protective clothing (p = .0342). Healthy Skin participants reported greater declines in intentions to tan outdoors in the next year (p = .0286). CONCLUSIONS: A dissonance-based, social media sun safety intervention was feasible and acceptable. Future research should examine the efficacy and longer-term effects of this intervention in young adults at elevated risk for skin cancer. TRIAL REGISTRATION: Clinicaltrials.gov NCT03834974 https://clinicaltrials.gov/ct2/show/NCT03834974.

Mixed-Handedness in Identical Twins Discordant for Combat Exposure in Vietnam: Relationship to Posttraumatic Stress Disorder.

This study evaluated the degree of mixed-handedness in predominantly right-handed Vietnam combat veteran twins and their identical, combat-unexposed cotwins. The "high-risk" cotwins of combat veterans with combat-related posttraumatic stress disorder (PTSD) had more mixed-handedness (i.e., less right-handedness) than the "low-risk" cotwins of combat veterans without PTSD. Self-reported combat exposure in combat-exposed twins was a mediator of the association between handedness in their unexposed cotwins and PTSD in the twins themselves. We conclude that mixed-handedness is a familial risk factor for combat-related PTSD. This risk may be mediated in part by a proclivity for mixed-handed soldiers and Marines to experience heavier combat.

The Relationship Between How Participants Articulate Their Goals and Accomplishments and Weight Loss Outcomes: Secondary Analysis of a Pilot of a Web-Based Weight Loss Intervention.

BACKGROUND: In behavioral weight loss interventions, participants are asked to set weekly goals to support long-term habits that lead to weight loss. Although participants are asked to set and accomplish weekly goals, we do not know how often they do this and whether doing so is associated with weight loss. Web-based weight loss interventions allow for the analysis of participant engagement data, including how participants articulate their goals and accomplishments. OBJECTIVE: Using engagement data from a web-based weight loss intervention, we examined whether participants articulating their goals and accomplishments in measurable and repeating terms were associated with greater weight loss. METHODS: Adults with overweight or obesity received a 12-week Facebook-delivered weight loss intervention based on the Diabetes Prevention Program Lifestyle Intervention. Participants replied to conversation threads that queried about their goals and accomplishments. Two independent coders classified participants' posts that articulated goals or accomplishments as measurable or repeating. Crude and age-adjusted linear regression models were used to examine the relationship between the frequency of post type and percent weight loss. RESULTS: Participants (N=53; n=48, 91% female; n=48, 91% non-Hispanic White) were on average 46.2 (SD 10.5) years old with a mean BMI of 32.4 (SD 4.8) kg/m2. Over 12 weeks, participants shared a median of 4 (IQR 1-8) posts that reported goals and 10 (IQR 4-24) posts that reported accomplishments. Most participants shared ≥1 post with a goal (n=43, 81%) and ≥1 post with an accomplishment (n=47, 89%). Each post reporting a goal was associated with 0.2% greater weight loss (95% CI -0.3% to 0.0%). Sharing ≥1 post with a repeating goal was associated with an average of 2.2% greater weight loss (95% CI -3.9% to -0.4%). Each post with a repeating goal was associated with an average of 0.5% greater weight loss (95% CI -1.0% to 0.0%). Sharing ≥1 post with measurable and repeating goals was associated with an average of 1.9% greater weight loss (95% CI -3.7% to -0.2%). Sharing each post with an accomplishment was associated with an average of 0.1% greater weight loss (95% CI -0.1% to 0.0%). Every post with an accomplishment that was repeating was associated with an average of 0.2% greater weight loss (95% CI -0.3% to 0.0%). Sharing other types of goals and accomplishments was not associated with weight loss. CONCLUSIONS: In a web-based weight loss intervention, stating goals in repeating or both measurable and repeating terms was associated with greater weight loss, but simply stating them in measurable terms was not. For accomplishments, only those articulated in repeating terms were associated with greater weight loss. Posts about one-time goals and accomplishments represent an opportunity to encourage planning for future behaviors. Future research should examine if stating goals and accomplishments in repeating terms signals habit formation.

A Facebook-Delivered Weight Loss Intervention Using Open Enrollment: Randomized Pilot Feasibility Trial.

BACKGROUND: Behavioral weight loss programs typically enroll 12-40 people into groups that then suffer from declining engagement over time. Web-based patient communities, on the other hand, typically offer no limits on capacity and membership is fluid. This model may be useful for boosting engagement in behavioral weight loss interventions, which could lead to better outcomes. OBJECTIVE: In this study, we aimed to examine the feasibility and acceptability of continuously enrolling participants into a Facebook-delivered weight loss intervention for the first 8 of 16 weeks relative to the same intervention where no new participants were enrolled after randomization. METHODS: We conducted a randomized pilot trial to compare a Facebook weight loss group that used open enrollment with a group that used closed enrollment on feasibility and acceptability in adults with BMI 27-45 kg/m2. The feasibility outcomes included retention, engagement, and diet tracking adherence. We described the percentage loss of ≥5% weight in both groups as an exploratory outcome. We also explored the relationship between total volume of activity in the group and weight loss. The participants provided feedback via web-based surveys and focus groups. RESULTS: Randomized participants (68/80, 85% women) were on average, aged 40.2 (SD 11.2) years with a mean BMI of 34.4 (SD 4.98) kg/m2. We enrolled an additional 54 participants (50/54, 93% female) in the open enrollment condition between weeks 1 and 8, resulting in a total group size of 94. Retention was 88% and 98% under the open and closed conditions, respectively. Randomized participants across conditions did not differ in engagement (P=.72), or diet tracking adherence (P=.42). Participant feedback in both conditions revealed that sense of community was what they liked most about the program and not enough individualized feedback was what they liked the least. Weight loss of ≥5% was achieved by 30% (12/40) of the participants randomized to the open enrollment condition and 18% (7/40) of the participants in the closed enrollment condition. Exploratory analyses revealed that the open condition (median 385, IQR 228-536.5) had a greater volume of engagement than the closed condition (median 215, IQR 145.5-292; P=.007). Furthermore, an increase of 100 in the total volume of engagement in the Facebook group each week was associated with an additional 0.1% weekly weight loss among the randomized participants (P=.02), which was independent of time, individual participant engagement, and sociodemographic characteristics. CONCLUSIONS: Open enrollment was as feasible and acceptable as closed enrollment. A greater volume of engagement in the Facebook group was associated with weight loss, suggesting that larger groups that produce more engagement overall may be beneficial. Future research should examine the efficacy of the open enrollment approach for weight loss in a fully powered randomized trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT02656680; https://clinicaltrials.gov/ct2/show/NCT02656680.

Clinic Versus Online Social Network-Delivered Lifestyle Interventions: Protocol for the Get Social Noninferiority Randomized Controlled Trial.

BACKGROUND: Online social networks may be a promising modality to deliver lifestyle interventions by reducing cost and burden. Although online social networks have been integrated as one component of multimodality lifestyle interventions, no randomized trials to date have compared a lifestyle intervention delivered entirely via online social network with a traditional clinic-delivered intervention. OBJECTIVE: This paper describes the design and methods of a noninferiority randomized controlled trial, testing (1) whether a lifestyle intervention delivered entirely through an online social network would produce weight loss that would not be appreciably worse than that induced by a traditional clinic-based lifestyle intervention among overweight and obese adults and (2) whether the former would do so at a lower cost. METHODS: Adults with body mass index (BMI) between 27 and 45 kg/m2 (N=328) will be recruited from the communities in central Massachusetts. These overweight or obese adults will be randomized to two conditions: a lifestyle intervention delivered entirely via the online social network Twitter (Get Social condition) and an in-person group-based lifestyle intervention (Traditional condition) among overweight and obese adults. Measures will be obtained at baseline, 6 months, and 12 months after randomization. The primary noninferiority outcome is percentage weight loss at 12 months. Secondary noninferiority outcomes include dietary intake and moderate intensity physical activity at 12 months. Our secondary aim is to compare the conditions on cost. Exploratory outcomes include treatment retention, acceptability, and burden. Finally, we will explore predictors of weight loss in the online social network condition. RESULTS: The final wave of data collection is expected to conclude in June 2019. Data analysis will take place in the months following and is expected to be complete in September 2019. CONCLUSIONS: Findings will extend the literature by revealing whether delivering a lifestyle intervention via an online social network is an effective alternative to the traditional modality of clinic visits, given the former might be more scalable and feasible to implement in settings that cannot support clinic-based models. TRIAL REGISTRATION: ClinicalTrials.gov NCT02646618; https://clinicaltrials.gov/ct2/show/NCT02646618 (Archived by WebCite at http://www.webcitation.org/6v20waTFW).

Pharmacological blockade of memory reconsolidation in posttraumatic stress disorder: three negative psychophysiological studies.

Posttraumatic stress disorder (PTSD) may involve over-consolidated emotional memories of the traumatic event. Reactivation (RP) can return a memory to an unstable state, from which it must be restabilized (reconsolidated) if it is to persist. Pharmacological agents administered while the memory is unstable have been shown to impair reconsolidation. The N-methyl-d-aspartate (NMDA) partial agonist d-cycloserine (DCS) may promote memory destabilization. In the three studies reported here, we investigated whether the ß-adrenergic blocker propranolol or the glucocorticoid (GR) antagonist mifepristone, given at the time of traumatic memory reactivation, could reduce PTSD symptoms and physiological responding during subsequent traumatic imagery. Individuals with PTSD were randomized as follows: Study One: propranolol with memory reactivation (n=10) or without reactivation (n=8); Study Two: reactivation mifepristone (n=13), non-reactivation (NRP) mifepristone (n=15), or double placebo (PL) (n=15); Study Three: reactivation mifepristone plus d-cycloserine (n=16), or two placebos (n=15). Subjects underwent memory retrieval by describing their traumatic event. A week later they engaged in script-driven traumatic mental imagery, while heart rate (HR), skin conductance (SC), and facial electromyogram (EMG) responses were measured. There were no significant group differences in physiological responsivity or change in PTSD symptoms in any of the studies. These results do not support successful blockade of reconsolidation of traumatic memories in PTSD.

Effect of acute posttrauma propranolol on PTSD outcome and physiological responses during script-driven imagery.

INTRODUCTION: Animal and human research suggests that the development of posttraumatic stress disorder (PTSD) may involve the overconsolidation of memories of a traumatic experience. Previous studies have attempted to use pharmaceutical agents, especially the ß-adrenergic blocker propranolol, to reduce this overconsolidation. AIMS: In this randomized, placebo-controlled study of the efficacy of propranolol in reducing the development of PTSD, we optimized dosages and conducted both psychophysiological and clinical assessments 1 and 3 months after the traumatic event. Forty-one emergency department patients who had experienced a qualifying acute psychological trauma were randomized to receive up to 240 mg/day of propranolol or placebo for 19 days. At 4 and 12 weeks post-trauma, PTSD symptoms were assessed. One week later, participants engaged in script-driven imagery of their traumatic event while psychophysiological responses were measured. RESULTS: Physiological reactivity during script-driven traumatic imagery, severity of PTSD symptoms, and the rate of the PTSD diagnostic outcome were not significantly different between the two groups. However, post hoc subgroup analyses showed that in participants with high drug adherence, at the 5-week posttrauma assessment, physiological reactivity was significantly lower during script-driven imagery in the propranolol than in the placebo subjects. CONCLUSIONS: The physiological results provide some limited support for a model of PTSD in which a traumatic conditioned response is reduced by posttrauma propranolol. However, the clinical results from this study do not support the preventive use of propranolol in the acute aftermath of a traumatic event.

Is trauma a causal agent of psychopathologic symptoms in posttraumatic stress disorder? Findings from identical twins discordant for combat exposure.

OBJECTIVE: The diagnosis of posttraumatic stress disorder (PTSD) is unique in that its criteria are embedded with a presumed causal agent, viz, a traumatic event. This assumption has come under scrutiny as a number of recent studies have suggested that many symptoms of PTSD may not necessarily be the result of trauma and may merely represent general psychiatric symptoms that would have existed even in the absence of a trauma event but are subsequently misattributed to it. The current study tests this hypothesis. METHOD: A case-control twin study conducted between 1996-2001 examined psychopathologic symptoms in a national convenience sample of 104 identical twin pairs discordant for combat exposure in Vietnam, with (n = 50) or without (n = 54) combat-related PTSD (DSM-IV-diagnosed) in the exposed twin. Psychometric measures used were the Symptom Checklist-90-Revised, the Clinician-Administered PTSD Scale, and the Mississippi Scale for Combat-Related PTSD. If a psychopathologic feature represents a factor that would have existed even without traumatic exposure, then there is a high chance that it would also be found at elevated rates in the non-trauma-exposed, identical cotwins of trauma-exposed twins with PTSD. In contrast, if a psychopathologic feature is acquired as a result of an environmental factor unique to the exposed twin, eg, the traumatic event, their cotwins should not have an increased incidence of the feature. RESULTS: Combat veterans with PTSD demonstrated significantly higher scores (P < .0001) on the Symptom Checklist-90-Revised and other psychometric measures of psychopathology than their own combat-unexposed cotwins (and than combat veterans without PTSD and their cotwins). CONCLUSIONS: These results support the conclusion that the majority of psychiatric symptoms reported by combat veterans with PTSD would not have been present were it not for their exposure to traumatic events.

Resting metabolic activity in the cingulate cortex and vulnerability to posttraumatic stress disorder.

CONTEXT: Recent neuroimaging research has revealed functional abnormalities in the anterior cingulate cortex, amygdala, and hippocampus in individuals with posttraumatic stress disorder (PTSD). OBJECTIVE: To determine whether resting functional abnormalities found in PTSD are acquired characteristics or familial risk factors. DESIGN: Cross-sectional design including identical twins discordant for trauma exposure. SETTING: Academic medical center. PARTICIPANTS: Combat-exposed veterans with PTSD (n = 14) and their identical co-twins not exposed to combat (n = 14) as well as combat-exposed veterans without PTSD (n = 19) and their identical co-twins not exposed to combat (n = 19). MAIN OUTCOME MEASURES: We used positron emission tomography and fluorodeoxyglucose 18 to examine resting regional cerebral metabolic rate for glucose (rCMRglu). RESULTS: Veterans with PTSD and their co-twins had significantly higher resting rCMRglu in the dorsal anterior cingulate cortex/midcingulate cortex (dACC/MCC) compared with veterans without PTSD and their co-twins. Resting rCMRglu in the dACC/MCC in unexposed co-twins was positively correlated with combat exposure severity, PTSD symptom severity, and alcohol use in their exposed twins. CONCLUSIONS: Enhanced resting metabolic activity in the dACC/MCC appears to represent a familial risk factor for developing PTSD after exposure to psychological trauma.