Attention-placebo Control Group Research Articles

Evaluating the impact of short animated videos on COVID-19 vaccine hesitancy: An online randomized controlled trial

Addressing the global challenge of vaccine hesitancy, amplified during the COVID-19 pandemic due to misinformation propagated via social media, necessitates innovative health communication strategies. This investigation scrutinizes the efficacy of Short, Animated, Story-based (SAS) videos in fostering knowledge, behavioral intent, and engagement around COVID-19 vaccination.We conducted an online three-arm parallel randomized controlled trial (RCT) involving 792 adult participants (≥18 years, English-speaking) from the United States. The intervention group viewed a SAS video on COVID-19 vaccination, the attention placebo control group watched a SAS video on hope, and the control group received no intervention. Our primary objectives were to assess the influence of SAS videos on knowledge, behavioral intent, and engagement regarding COVID-19 vaccination.Participants in the intervention group displayed significantly higher mean knowledge scores (20.6, 95 % CI: 20.3–20.9) compared to both the attention placebo control (18.8, 95 % CI: 18.5–19.1, P < .001) and control groups (18.7, 95 % CI: 18.4–19.0, P < .001). However, SAS videos did not notably affect behavioral intent. Perception of COVID-19 as a significant health threat emerged as a strong predictor for engaging with the post-trial video without further incentives (OR: 0.44; 95 % CI: 0.2–0.96). The 35–44 age group exhibited the highest post-trial engagement (P = .006), whereas right-wing political inclination negatively associated with engagement (OR: 1.98; 95 % CI: 3.9–1.01). Vaccination status correlated significantly with self-efficacy (P < .001), perceived social norms (P < .001), and perceived response efficacy of the COVID-19 vaccine (P < .001), all heightened in the intervention group.These findings suggest that while SAS videos effectively amplify COVID-19 vaccination knowledge, their impact on behavioral intent is not direct. They do, however, affect determinants of vaccination status, thereby indirectly influencing vaccination behavior. The study highlights the appeal of SAS videos among younger audiences, but underscores the need for further examination of factors impeding vaccination engagement. As SAS videos closely mirror conventional social media content, they hold significant potential as a public health communication tool on these platforms.Trial Registration: Trial was registered at drks.de with the identifier DRKS00027938, on 5 January 2022.

Single-session visuospatial task procedure to prevent childbirth-related posttraumatic stress disorder: a multicentre double-blind randomised controlled trial

Preventive evidence-based interventions for childbirth-related posttraumatic stress disorder (CB-PTSD) are lacking. Yet, 18.5% of women develop CB-PTSD symptoms following an unplanned caesarean section (UCS). This two-arm, multicentre, double-blind superiority trial tested the efficacy of an early single-session intervention including a visuospatial task on the prevention of maternal CB-PTSD symptoms. The intervention was delivered by trained maternity clinicians. Shortly after UCS, women were included if they gave birth to a live baby, provided consent, and perceived their childbirth as traumatic. Participants were randomly assigned to the intervention or attention-placebo group (allocation ratio 1:1). Assessments were done at birth, six weeks, and six months postpartum. Group differences in maternal CB-PTSD symptoms at six weeks (primary outcomes) and six months postpartum (secondary outcomes) were assessed with the self-report PTSD Checklist for DSM-5 (PCL-5) and by blinded research assessors with the Clinician-administered PTSD scale for DSM-5 (CAPS-5). Analysis was by intention-to-treat. The trial was prospectively registered (ClinicalTrials.gov, NCT03576586). Of the 2068 women assessed for eligibility, 166 were eligible and 146 were randomly assigned to the intervention (n = 74) or attention-placebo control group (n = 72). For the PCL-5, at six weeks, a marginally significant intervention effect was found on the total PCL-5 PTSD symptom count (β = −0.43, S.E. = 0.23, z = −1.88, p < 0.06), and on the intrusions (β = −0.73, S.E. = 0.38, z = −1.94, p < 0.0525) and arousal (β = −0.55, S.E. = 0.29, z = −1.92, p < 0.0552) clusters. At six months, a significant intervention effect on the total PCL-5 PTSD symptom count (β = −0.65, S.E. = 0.32, z = −2.04, p = 0.041, 95%CI[−1.27, −0.03]), on alterations in cognition and mood (β = −0.85, S.E. = 0.27, z = −3.15, p = 0.0016) and arousal (β = −0.56, S.E. = 0.26, z = −2.19, p < 0.0289, 95%CI[−1.07, −0.06]) clusters appeared. No group differences on the CAPS-5 emerged. Results provide evidence that this brief, single-session intervention carried out by trained clinicians can prevent the development of CB-PTSD symptoms up to six months postpartum.

Correction to Maheu et al. (2023).

Most fear of cancer recurrence (FCR) interventions have small effects, and few target FCR. This randomized controlled trial (RCT) with breast and gynecological cancer survivors evaluated the efficacy of a cognitive-existential fear of recurrence therapy (FORT) compared to an attention placebo control group (living well with cancer [LWWC]) on FCR. One hundred and sixty-four women with clinical levels of FCR and cancer distress were randomly assigned to 6-weekly, 120 min FORT (n = 80) or LWWC (n = 84) group sessions. They completed questionnaires at baseline (T1), posttreatment (T2; primary endpoint), 3 (T3), and 6 months (T4) posttreatment. Generalized linear models were used to compare group differences in the fear of cancer recurrence inventory (FCRI) total score and secondary outcomes. FORT participants experienced greater reductions from T1 to T2 on FCRI total with a between-group difference of -9.48 points (p = .0393), resulting in a medium effect of -0.530, with a maintained effect at T3 (p = .0330) but not at T4. For the secondary outcomes, improvements were in favor of FORT, including FCRI triggers (p = .0208), FCRI coping (p = .0351), cognitive avoidance (p = .0155), need for reassurance from physicians (p = .0117), and quality of life (mental health; p = .0147). This RCT demonstrated that FORT, compared to an attention placebo control group, resulted in a greater reduction in FCR posttreatment and at 3 months posttreatment in women with breast and gynecological cancer, indicating its potential as a new treatment strategy. We recommend a booster session to sustain gains. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Fear of cancer recurrence therapy (FORT): A randomized controlled trial.

Most fear of cancer recurrence (FCR) interventions have small effects, and few target FCR. This randomized controlled trial (RCT) with breast and gynecological cancer survivors evaluated the efficacy of a cognitive-existential fear of recurrence therapy (FORT) compared to an attention placebo control group (living well with cancer [LWWC]) on FCR. One hundred and sixty-four women with clinical levels of FCR and cancer distress were randomly assigned to 6-weekly, 120 min FORT (n = 80) or LWWC (n = 84) group sessions. They completed questionnaires at baseline (T1), posttreatment (T2; primary endpoint), 3 (T3), and 6 months (T4) posttreatment. Generalized linear models were used to compare group differences in the fear of cancer recurrence inventory (FCRI) total score and secondary outcomes. FORT participants experienced greater reductions from T1 to T2 on FCRI total with a between-group difference of -9.48 points (p = .0393), resulting in a medium effect of -0.530, with a maintained effect at T3 (p = .0330) but not at T4. For the secondary outcomes, improvements were in favor of FORT, including FCRI triggers (p = .0208), FCRI coping (p = .0351), cognitive avoidance (p = .0155), need for reassurance from physicians (p = .0117), and quality of life (mental health; p = .0147). This RCT demonstrated that FORT, compared to an attention placebo control group, resulted in a greater reduction in FCR posttreatment and at 3 months posttreatment in women with breast and gynecological cancer, indicating its potential as a new treatment strategy. We recommend a booster session to sustain gains. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Mitigating behavioral assimilation to age stereotypes: A preliminary analogue investigation of a contextual behavioral science approach

Behavioral assimilation to age stereotypes (BAAS) is referred to as the behavioral phenomenon of impaired task performance among older adults that is consistent with negative aging-related stereotypes. This laboratory study evaluated the inoculating effect of a contextual behavioral science (CBS)-informed intervention on a cognitive performance task (i.e., Block Design) among Japanese older adults who were primed with a negative aging-related stereotype. Fifty-nine older adult participants were randomly assigned to either the CBS-informed intervention group (n = 30) or attention-placebo control group (n = 29). The CBS-informed intervention group completed a self-as-observer exercise and rapid word repetition defusion task, whereas the attention-placebo control group received general conversation with the experimenter. The CBS-informed group showed significantly greater scores on the Block Design task than the attention-placebo control group. Fusion with a conceptualized self did not moderate the intervention effect. Limitations and implications of results are discussed.

Improving mental health and physiological stress responses in mothers following traumatic childbirth and in their infants: study protocol for the Swiss TrAumatic biRth Trial (START)

IntroductionEmergency caesarean section (ECS) qualifies as a psychological trauma, which may result in postnatal post-traumatic stress disorder (PTSD). Maternal PTSD may not only have a significant negative impact on mother–infant...

Use of Mindfulness-based Cognitive Therapy to Change Pain-related Cognitive Processing in Patients with Primary Headache: A Randomized Trial with Attention Placebo Control Group.

BackgroundMindfulness-based interventions have shown to be efficient in managing chronic pain. Cognitive factors play a prominent role in chronic pain complications and negative cognitive contents about pain are often the first issues targeted in cognitive-based therapies, which are known as first-line treatment of chronic pain over the past decades. Little, however, is known about the manner of thinking about pain or pain-related cognitive processing.ObjectivesTherefore, the purpose of this study was to investigate the effect of mindfulness-based cognitive therapy (MBCT) on pain-related cognitive processing and control of chronic pain in patients with primary headache.MethodsA clinical trial was conducted in 2017 - 2018 on 85 Persian language patients with one type of primary headache selected through purposive sampling in Emam Hossein Hospital in Tehran province. To measure the variables of the study, we used the Brief Pain Inventory (BPI) and Pain-related Cognitive Processing Questionnaire (PCPQ). All data were analyzed by independent t-test and chi-square and longitudinal data were analyzed using linear mixed model analysis.ResultsStatistically significant time × group interactions were found in pain intensity (P < 0.001), pain interference (P < 0.001), as well as in three cognitive processing subscales including pain focus, pain distancing, and pain openness (P < 0.001). However, the results of pain diversion were not meaningful.ConclusionsMBCT is a potentially efficacious approach for individuals with headache pain. Regulation and correction of cognitive processing are considered as effective cognitive coping strategies in MBCT treatment.

Physical activity, diet and other behavioural interventions for improving cognition and school achievement in children and adolescents with obesity or overweight.

Physical activity, diet and other behavioural interventions for improving cognition and school achievement in children and adolescents with obesity or overweight.

“Susan Moger: She was beloved on earth”—Tudor Rickards, 2017

<i>“Susan Moger: She was beloved on earth”</i>—Tudor Rickards, 2017

Mind and body therapy for fibromyalgia.

Mind and body therapy for fibromyalgia.

Brief Consultation to Families of Treatment Refusers with Symptoms of Obsessive Compulsive Disorder: Does It Impact Family Accommodation and Quality of Life?

Family members are often directly and significantly impacted by the restrictive demands of OCD, a frequently disabling disorder. Family accommodation behaviors (i.e., doing things for or because of the OCD sufferer that a person would not normally do) are associated with dysfunction, including poorer treatment responses in OCD sufferers and greater distress in family members. Although evidence suggests family-based intervention can reduce symptoms in OCD sufferers who participate in treatment, there is a lack of research documenting the impact of interventions designed for the families of OCD treatment refusers (TR). Brief Family Consultation (BFC) was developed by our clinical team to help families refocus their efforts on the things that they can realistically control and change (e.g., participation in compulsions). In this crossover study, twenty families related to an individual who exhibited OCD symptoms but had refused treatment were assigned to five phone sessions of either BFC or a psychoeducation condition. Compared to this credible, attention-placebo control group (Brief Educational Support; BES), BFC (but not BES) resulted in reductions in family accommodation behavior, yet neither BFC nor BES resulted in improved quality of life for family members of treatment refusers. BFC is one of the first interventions to be evaluated for its ability to help families when their loved ones with obsessive compulsive symptoms refuse treatment. This pilot study provides new insights for clinicians and researchers to better address the needs of these neglected families.

Randomized clinical trial of the effects of screening and brief intervention for illicit drug use: the Life Shift/Shift Gears study.

BackgroundAlthough screening, brief intervention, and referral to treatment (SBIRT) has shown promise for alcohol use, relatively little is known about its effectiveness for adult illicit drug use. This randomized controlled trial assessed the effectiveness of the SBIRT approach for outcomes related to drug use among patients visiting trauma and emergency departments (EDs) at two large, urban hospitals.MethodsA total of 700 ED patients who admitted using illegal drugs in the past 30 days were recruited, consented, provided baseline measures of substance use and related problems measured with the Addiction Severity Index-Lite (ASI-Lite), and then randomized to the Life Shift SBIRT intervention or to an attention-placebo control group focusing on driving and traffic safety (Shift Gears). Both groups received a level of motivational intervention matched to their condition and risk level by trained paraprofessional health educators. Separate measurement technicians conducted face-to-face follow-ups at 6 months post-intervention and collected hair samples to confirm reports of abstinence from drug use. The primary outcome measure of the study was past 30-day drug abstinence at 6 months post-intervention, as self-reported on the ASI-Lite.ResultsOf 700 participants, 292 (42%) completed follow-up. There were no significant differences in self-reported abstinence (12.5% vs. 12.0% , p = 0.88) for Life Shift and Shift Gears groups, respectively. When results of hair analyses were applied, the abstinence rate was 7 percent for Life Shift and 2 percent for Shift Gears (p = .074). In an analysis in which results were imputed (n = 694), there was no significant difference in the ASI-Lite drug use composite scores (Life Shift +0.005 vs. Shift Gears +0.017, p = 0.12).ConclusionsIn this randomized controlled trial, there was no evidence of effectiveness of SBIRT on the primary drug use outcome.Trial registrationClinicalTrials.gov NCT01683227.

Randomized controlled trial to evaluate screening and brief intervention for drug-using multiethnic emergency and trauma department patients.

BackgroundScreening and brief intervention (SBI) is a comprehensive, integrated public health approach to identify and deliver a spectrum of early detection and intervention services for substance use in general medical care settings. Although the SBI approach has shown promise for alcohol use, relatively little is known about its effectiveness for illicit drug use. We are evaluating the SBI approach for drug use using a rigorous randomized controlled trial. The purpose of the report is to describe the overall trial and its programmatic and methodological strengths with a focus on health educator (HE) selection and training. In addition, the baseline characteristics of the recently enrolled multiethnic cohort are described.Methods/designA randomized two-group repeated measures design is being used in which drug-related outcomes of an intervention group will be compared with those of an attention-placebo control group. Selection of bicultural paraprofessional HEs—their training in research concepts, comorbid mental health issues, special treatment of marijuana use, and nonscripted enhanced motivational interviewing as well as their ongoing monitoring and evaluation—are among the features described. The HEs enrolled, consented, and conducted an intervention among 700 illicit drug users in two large hospital emergency departments/trauma units. To be eligible, a participant needed to be an adult (age ≥18 years), an English or Spanish speaker, awake and able to give consent, and reachable by telephone to schedule a six-month follow-up interview.DiscussionA comprehensive HE training protocol combined with rigorous, ongoing process measurement resulted in skill mastery in many areas and a successful participant recruitment period. Strengths and limitations of the study protocol are discussed as well as the characteristics of those recruited. This trial will be among the first to provide information about the effectiveness of SBI for illicit drug use. Outcome analysis has not yet been completed, but demonstrated programming and design successes have implications for future research and service delivery.Trial registrationhttp://NCT01683227

Effectiveness of a Comprehensive Lifestyle Modification Program for Asthma Patients: A Randomized Controlled Pilot Trial

Objective. The aim of the study was to investigate the effectiveness and feasibility of conducting a complementary 8-week comprehensive lifestyle modification program (CLMP) compared to standard care in patients with bronchial asthma over a 6-month period. Methods. This was a randomized controlled pilot trial with two groups: intervention (N = 15) group and attention-placebo control (N = 14) group. The intervention group received an 8-week CLMP in addition to standard care. Quality of life, asthma control, lung function, reduction of rescue medication, perceived stress, and psychosocial and spiritual status were measured at the end of the intervention and at the 4-month follow-up. Results. In the intervention group, there was a statistically significant difference in the improvements of quality of life, asthma control, lung function, and the reduction of rescue medication intake at both the end of the intervention and at the 4-month follow-up, with no change being observed in the control group. Significant stress reduction and greater psychosocial and spiritual well-being were observed during the 8-week CLMP in the intervention group. At the end of the intervention, the measures of stress and psychological and spiritual well-being reached statistical significance. Conclusions. Preliminary findings suggest that adding a CLMP to standard care in patients with bronchial asthma offers greater clinical benefit than standard care alone and also suggest that conducting a large randomized clinical trial is feasible.

Evaluation of an ICF‐based patient education programme for stroke patients: A randomized, single‐blinded, controlled, multicentre trial of the effects on self‐efficacy, life satisfaction and functioning

There is a current need for interventions that provide information to stroke survivors in a patient-centred, interactive, personalized and flexible manner. To this purpose, a standardized but content-flexible patient education programme based on the International Classification of Functioning, Disability and Health (ICF) was developed. This study evaluated the effect of this programme on perceived self-efficacy. Single-blind, randomized, multi-centre controlled trial. Stroke patients undergoing neurological rehabilitation were enrolled. Perceived self-efficacy was measured with the Liverpool Self-Efficacy Scale. Secondary outcomes were life satisfaction and self-perception of the impact of the stroke on life, measured with the WHOQOL and the Stroke Impact Scale, respectively. Data obtained at baseline, post-intervention and 6-month follow-up were analysed using multi-level models of change. Two hundred and thirteen patients received either the ICF-based patient education (n = 110) or an attention-placebo (n = 103) control intervention. Over time, patients' self-efficacy (p < .01) and participation (p < .01) improved, while emotional functioning (p < .01) deteriorated, although no significant between-group differences were observed. Explorative analyses showed that gender, loci of control, difficulty in accessing health services after discharge and life satisfaction were significant predictors of self-efficacy. There was no significant benefit of the ICF-based patient education in comparison with an attention-placebo control group. Considering the importance of the programme for the further implementation of the ICF and the need of developing effective health education interventions for stroke, the methodology used was reviewed and an updated version proposed.

Effectiveness of an adventure-based training programme in promoting the psychological well-being of primary schoolchildren

This study tested the effectiveness of an adventure-based training programme in promoting the psychological well-being of primary schoolchildren. A randomised controlled trial was conducted, with 56 primary school pupils randomly assigned to the experimental group participating in the adventure-based training programme and 64 to the attention placebo control group. Children in the experimental group reported significantly fewer depressive symptoms, lower anxiety levels and higher self-esteem than those in the attention placebo control group. This study provides some evidence that the adventure-based training programme is effective in promoting the psychological well-being of Hong Kong Chinese schoolchildren.

Brief Field-Based Intervention to Reduce Alcohol-Related Problems Among Men Who Have Sex With Men

This study evaluated the utility of a brief field-based intervention to reduce alcohol use and alcohol-related problems among men who have sex with men. A randomized control trial was designed to test a brief alcohol intervention against an attention-placebo control intervention. Over a 13-week period in fall 2009, a sample (n = 152) of men who have sex with men was recruited at a local gay bar in San Diego, CA, and were randomized to a brief alcohol intervention or an attention-placebo control group. Sober bar patrons were recruited before bar entrance and asked to undergo a brief survey and give a breath alcohol sample at exit from the bar. Breath alcohol concentrations at exit from the bar were not significantly different between those in the experimental alcohol feedback condition and those in the attention-placebo control condition. However, among participants in the experimental condition, those categorized as high risk for alcohol-related problems at entrance drank significantly less than planned as compared with participants categorized as low risk for alcohol-related problems. Brief, venue-based interventions may be appropriate for men who have sex with men who plan to drink at rates that would put them at higher risk of alcohol-related problems. Additional studies exploring the utility of brief intervention in risk settings are warranted.

Motivation, self-efficacy, physical activity and nutrition in college students: Randomized controlled trial of an internet-based education program

Objective MyStudentBody.com-Nutrition (MSB-N) is an internet-based nutrition and physical activity education program for college students. Method Students from six universities ( N = 476) in the U.S. were randomly assigned in the fall of 2005 to one of three groups: MSB-N (Experimental I), MSB-N plus Booster (Experimental II), or an attention placebo control group. Results Experimental I and II group participants increased their fruit and vegetable intake by .33 and .24 servings, respectively, relative to the control group at post-test. Both experimental groups improved their motivation to change eating behaviors ( p < .05) and were also more likely to increase their social support and self-efficacy for dietary change ( p's < .05). Experimental groups also improved their attitude toward exercise ( p < .05), but no behavioral changes in physical activity were noted. Conclusion MyStudentBody.com-Nutrition is an effective internet-based program that may have wide applicability on college campuses for nutrition education and promoting change in health behaviors.

Treating Delusional Disorder: A Comparison of Cognitive-Behavioural Therapy and Attention Placebo Control

Cognitive-behavioural therapy (CBT) has proved effective in treating delusions, both in schizophrenia and delusional disorder (DD). Clinical trials of DD have mostly compared CBT with either treatment as usual, no treatment, or a wait-list control. This current study aimed to assess patients with DD who received CBT, compared with an attention placebo control (APC) group. Twenty-four individuals with DD were randomly allocated into either CBT or APC groups for a 24-week treatment period. Patients were diagnosed on the basis of structured clinical interviews for mental disorders and the Maudsley Assessment of Delusion Schedule (MADS). Completers in both groups (n = 11 for CBT; n = 6 for APC) showed clinical improvement on the MADS dimensions of Strength of Conviction, Insight, Preoccupation, Systematization, Affect Relating to Belief, Belief Maintenance Factors, and Idiosyncrasy of Belief. When compared with APC, CBT produced more impact on the MADS dimensions for Affect Relating to Belief, Strength of Conviction, and Positive Actions on Beliefs.

Poster 78: The Impact of Personalized Information Provision on Traumatic Brain Injury Rehabilitation Outcomes

Objective: To evaluate providing personalized information to patients with acute traumatic brain injury (TBI). Design: Randomized, blinded, controlled trial. Setting: Single-center, acute TBI rehabilitation unit. Participants: 28 active duty military personnel and veterans who sustained severe TBI. Interventions: The experimental group received 3 one-hour sessions of personalized information about their injuries, cognitive problems, rehabilitation treatment, and clinical progress. The attention-placebo control group watched 3 one-hour videotapes about brain injury and rehabilitation services.