Attention Placebo Control Research Articles

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.

First report of quality of life in adults with neurofibromatosis 2 who are deafened or have significant hearing loss: results of a live-video randomized control trial.

To test the feasibility, acceptability, and preliminary efficacy of a mind-body program for patients with neurofibromatosis 2 (NF2) who are deaf or have significant hearing loss (d3RP-NF2) against an attention placebo control (dHEP-NF2) in a single-blind randomized control trial. Both were delivered using Communication Access Real-Time Translation and live group videoconferencing. Forty-five adults with NF2 were randomized. Co-primary outcomes were physical quality of life (QoL) and psychological QoL and secondary outcomes were social QoL and environmental QoL, all measured with the World Health Organization Quality of Life Abbreviated Instrument (WHOQOL-BREF). Assessments were conducted at baseline, post-treatment, and six-month follow-up. Forty-one participants (91%) completed the intervention, and 29 (64%) completed the six-month follow up. Participants in the d3RP-NF2 showed significantly greater improvements from baseline to post-treatment on physical QoL (14.79, 95% CI 5.41-24.18; p ≤ 0.001), psychological QoL (18.77, 95% CI 7.09-30.44, p ≤ 0.001), and environmental QoL (13.25, 95% CI 1.10-25.39, p = 0.03) compared to the dHEP-NF2. Social QoL also significantly increased in the d3RP-NF2 (16.32, 95% CI 6.66-25.97, p = 0.001), but improvement was not beyond the dHEP-NF2. Gains in QoL were clinically meaningful and maintained at the 6-month follow-up for d3RP-NF2 participants across all QoL domains. There were more treatment responders in the d3RP-NF2 compared to the dHEP-NF2. The d3RP-NF2 was well accepted, highly feasible, and resulted in sustained improvements in QoL in patients with NF2 who are deaf or have significant hearing loss.

Effects of a moderate-intensity aerobic exercise programme on the cognitive function and quality of life of community-dwelling elderly people with mild cognitive impairment: A randomised controlled trial

BackgroundIndividuals with mild cognitive impairment have a heightened risk of developing dementia. Physical exercise, especially moderate-intensity aerobic exercise, is a promising lifestyle intervention to improve the cognitive function of this patient group. However, the mechanisms underlying the exercise–cognition relationship are not fully understood. Whether the cognitive benefits of physical exercise can improve the overall well-being of this group remains unknown. This study aims to address these research gaps in the under-researched Chinese population. ObjectivesThis study aimed to evaluate the effects of a moderate-intensity aerobic exercise programme on the cognitive function and health-related quality of life of Chinese elderly with mild cognitive impairment and to explore the mediating roles of depressive mood and sleep quality in the exercise–cognition relationship. DesignA single-blinded randomised controlled trial. Settings and participantsThis study was conducted in two urban community healthcare centres in Hangzhou City, China. Elderly people aged over 60 years screened with mild cognitive impairment were included. MethodsA total of 120 eligible participants were randomly assigned to receive either the group-based moderate-intensity aerobic exercise programme or the health education programme (as attention–placebo control). Montreal Cognitive Assessment, Quality of Life-Alzheimer’s Disease, Geriatric Depression Scale and Pittsburgh Sleep Quality Index were administered at baseline before randomisation and immediately after the completion of the interventions. Analysis followed the intention-to-treat principle. Generalised estimating equation was used to compare the changes in the cognitive function and health-related quality of life over the pre-test and post-test periods between the groups. The mediating roles of depressive mood and sleep quality in the exercise–cognition relationship were examined with the PROCESS macro. ResultsParticipants in the intervention group had a significantly greater improvement in terms of cognitive function (β = 1.895; 95% confidential interval [CI] = 1.421, 2.368; p < 0.001) and health-related quality of life (β= 0.605; 95% CI= 0.295, 0.914; p < 0.001) compared with the control group over the pre-test and post-test periods. The exercise–cognition relationship was significantly mediated by reduced depressive symptoms (indirect effect: β= −0.705; 95% CI: −1.028, −0.382) and improved sleep quality (indirect effect: β=−0.205; 95% CI: −0.122, 0.831). ConclusionsThis study revealed the benefits and outlined the underlying mediating mechanism of an aerobic exercise programme to the cognitive function and health-related quality of life of Chinese elderly people with mild cognitive impairment. The findings provided insights into the development of public health initiatives to promote brain health amongst the elderly with mild cognitive impairment.

Home practice and quality of life among patients with neurofibromatosis randomized to a mind-body intervention

ObjectivesThe purpose of this study was to summarize home practice in patients with neurofibromatosis (NF) randomized to an 8-week group mind-body intervention, the Relaxation Response Resiliency Program for NF (3RP-NF). We further examined the association between home practice and changes in four domains of quality of life (QoL). MethodsData are derived from a single-blind RCT of the 3RP-NF (N = 31) delivered via videoconferencing versus an attention placebo control. 3RP-NF participants submitted weekly home practice logs to the group leader prior to each weekly session, which included information regarding their engagement of relaxation response (RR)-eliciting skills and appreciation skills. Physical, psychological, social and environmental QoL were measured at baseline, post-intervention and at a 6-months follow up. ResultsParticipants reported engaging in home practice of RR-eliciting skills on average 28.55 days (SD = 10.79) and appreciation skills on average 24.39 days (SD = 13.48) over the 49-day treatment period. Participants reported an average of 383.42 (SD = 274.38) minutes of RR-eliciting skills home practice and an average of 49.13 (SD = 41.90) appreciations skills home practice. A significant association was observed between frequency of RR-eliciting skills home practice and physical QoL at the 6-month follow-up (r = .383, p = .034). ConclusionsParticipants with NF are able and willing to practice RR-eliciting skills and appreciation skills outside of treatment sessions. Frequency of RR-eliciting skills home practice may be associated with improvement in physical QoL. Future research should replicate these efforts with larger samples, and attempt to identify additional factors that predict optimal response to mind-body interventions other than home practice.

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.

Does a Brief Mindfulness Exercise Improve Outcomes in Upper Extremity Patients? A Randomized Controlled Trial.

Mindfulness-based interventions are useful in reducing psychologic distress and pain intensity in patients with chronic pain. However, most mindfulness-based interventions are resource-intensive, lengthy, and not feasible for busy orthopaedic surgical practices. The purpose of this study was to determine if a 60-second personalized mindfulness-based video exercise is (1) associated with improved pain intensity, emotional distress, and state anxiety compared with an attention placebo control (a time-matched educational pamphlet about pain and stress); and (2) feasible and acceptable for patients with upper extremity injury in an orthopaedic practice. This was a single-center, single-blind randomized controlled trial of the mindfulness-based video exercise (60 seconds duration, free online) versus an attention placebo control (an educational pamphlet about pain and stress presented to patients to read over 60 seconds). One hundred forty-nine patients presenting for a new or followup appointment at the office of one of two orthopaedic hand and upper extremity outpatient surgical practices at an urban academic hospital were invited to participate between September 2016 and December 2016. Of 149 patients screened, 125 patients were randomized and completed a demographic questionnaire, the Numeric Rating Scale to assess pain intensity, the State Anxiety subscale of the State Trait Anxiety Inventory to assess state anxiety, and Emotion Thermometers to assess anxiety, anger, and depression before and after the interventions. Postintervention, patients also completed the Client Satisfaction Questionnaire Scale-3 to assess the acceptability. A mean score of 21 or higher is considered acceptable. Feasibility was determined based on number of patients approached who refused participation. The intervention was defined as feasible if refusal rate was lower than 25%. Analysis of covariance was used to test comparative improved pain intensity on the NRS, psychologic distress on the Emotion Thermometers, and state anxiety on the State Anxiety Subscale of the State Trait Anxiety Index after controlling for respective baseline scores. A 1-point minimal clinically important difference (MCID) was used on the NRS for pain intensity. Adjusted for the baseline means, compared with patients who received the attention placebo control, patients who participated in the mindfulness-based video exercise demonstrated improved pain intensity (mindfulness-based video exercise: 3.03 ± 0.12; control: 3.49 ± 0.12; mean difference: 0.46 [0.12-0.80]; p = 0.008); state anxiety (mindfulness-based video exercise: 32.35 ± 0.59; control: 35.29 ± 0.59; mean difference: 2.94 [1.29-4.59]; p = 0.001); anxiety symptoms (mindfulness-based video exercise: 1.49 ± 0.19; control: 2.10 ± 0.19; mean difference: 0.61 [0.08-1.14]; p = 0.024); depression (mindfulness-based video exercise: 1.03 ± 0.10; control: 1.47 ± 0.11; mean difference: 0.44 [0.15-0.73]; p = 0.004); and anger (mindfulness-based video exercise: 0.76 ± 0.12; control: 1.36 ± 0.12; mean difference: 0.60 [0.26-0.94]; p = 0.001). However, the observed differences in pain intensity were below 1 point on the NRS, which is the MCID established in patients with chronic pain. No MCID is available for the other measures. The mindfulness-based video exercise was feasible based on a dropout rate of 0%, and acceptability reached the medium range with similar scores in both groups (mindfulness-based video exercise: 20.70 ± 5.48; control: 20.52 ± 6.42). A 60-second mindfulness-based video exercise is feasible to implement and acceptable to patients in busy orthopaedic practices. This video exercise is also effective in improving momentary pain, anxiety, depression, and anger in this population, but it is unclear whether these improved pain and distress levels are meaningful to patients who present with low levels of pain and psychologic distress. Future studies should seek to discern whether the improved pain and distress levels we observed are clinically important or whether the intervention delivers larger effects in subgroups of patients experiencing greater pain intensity and if the improved pain and distress levels are durable. Such studies might also assess cost-effectiveness, because this mindfulness-based tool takes little time and few resources to use, and the effects and durability of multiple sessions of a mindfulness-based video exercise. Level II, therapeutic study.

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.

The impact of a mind-body program on multiple dimensions of resiliency among geographically diverse patients with neurofibromatosis.

The neurofibromatoses (NF) are incurable genetic disorders that can cause nerve sheath tumors, chronic pain, and disfiguration. Patients with NF report lower quality of life and greater distress, and may benefit from programs that promote resiliency. To test effects of an 8-week mind-body program (Relaxation Response Resiliency Program for NF [3RP-NF]) on resiliency, using data derived from a larger randomized controlled trial of the 3RP-NF versus attention placebo control (Vranceanu et al. in Neurology 87:806-814, 2016). Participants (N = 63; 46 female; 52 White) were randomized to 3RP-NF (n = 32, M age = 42.86) or control (n = 31, M age = 39.90), completed intervention sessions via group videoconferencing, and provided self-report measures of resiliency (i.e., perceived coping abilities, perceived social support, gratitude, optimism, spiritual well-being, mindfulness) at baseline, post-intervention, and 6-month follow-up. All participants attended at least 6/8 sessions and 83% (N = 52) provided 6-month follow-up data. The 3RP-NF (vs. control) produced greater improvements from pre- to post-intervention in perceived coping abilities (M difference = 6.68; p = .008), perceived social support (M difference = 9.16; p = .032), and mindfulness (M difference = 2.23; p = .035), which were maintained at 6-month follow up. We did not observe group differences in spiritual well-being, optimism, or gratitude. The 3RP-NF produced sustained increases in multiple dimensions of resiliency (perceived coping abilities, perceived social support, and mindfulness). Promoting resiliency may be particularly important for a population that is underserved and living with a chronic, incurable illness.

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

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

Effects of Psyching-Up on Sprint Performance

Hammoudi-Nassib, S, Nassib, S, Chtara, M, Briki, W, Chaouachi, A, Tod, D, and Chamari, K. Effects of psyching-up on sprint performance. J Strength Cond Res 31(8): 2066-2074, 2017-The present research aimed at examining whether the psyching up (PU) strategies improve performance in 30-m sprinting. Sixteen male sprinters (age, 20.6 ± 1.3 years; body mass, 77.5 ± 7.1 kg; height, 180.8 ± 5.6 cm) participated in this study. Before each experimental session, the Hooper index was used to monitor the subject's feeling for the quality of sleep of the previous night, perceived quantity of stress, delayed onset muscle soreness, and fatigue. After completing general and specific warm-up, participants had to rate their degree of self-confidence. Then, they were asked to follow 1 of these 4 conditions: Imagery (experimental PU condition), Preparatory arousal (experimental PU condition), Attention placebo (control condition), and Distraction (control condition) during the final 30 seconds of the rest period right before performing a 30-m sprint. Participants separately and randomly performed all conditions. Results showed that although the imagery and preparatory arousal strategies contributed to increase the performance in the short-distance sprints (from 0 to 10 m), the imagery strategy contributed to increase the performance in the 30-m sprints. These findings support the general view that the PU strategies could improve athletic performance.

Preventing intrusive memories after trauma via a brief intervention involving Tetris computer game play in the emergency department: a proof-of-concept randomized controlled trial

After psychological trauma, recurrent intrusive visual memories may be distressing and disruptive. Preventive interventions post trauma are lacking. Here we test a behavioural intervention after real-life trauma derived from cognitive neuroscience. We hypothesized that intrusive memories would be significantly reduced in number by an intervention involving a computer game with high visuospatial demands (Tetris), via disrupting consolidation of sensory elements of trauma memory. The Tetris-based intervention (trauma memory reminder cue plus c. 20 min game play) vs attention-placebo control (written activity log for same duration) were both delivered in an emergency department within 6 h of a motor vehicle accident. The randomized controlled trial compared the impact on the number of intrusive trauma memories in the subsequent week (primary outcome). Results vindicated the efficacy of the Tetris-based intervention compared with the control condition: there were fewer intrusive memories overall, and time-series analyses showed that intrusion incidence declined more quickly. There were convergent findings on a measure of clinical post-trauma intrusion symptoms at 1 week, but not on other symptom clusters or at 1 month. Results of this proof-of-concept study suggest that a larger trial, powered to detect differences at 1 month, is warranted. Participants found the intervention easy, helpful and minimally distressing. By translating emerging neuroscientific insights and experimental research into the real world, we offer a promising new low-intensity psychiatric intervention that could prevent debilitating intrusive memories following trauma.

Examining motor vehicle crash involvement and readiness to change on drinking and driving behaviors among injured emergency department patients

ABSTRACTObjective: To measure the effect of motor vehicle crash (MVC) involvement and readiness to change drinking and driving behaviors on subsequent driving and drinking behaviors among injured emergency department (ED) patients who use alcohol at harmful levels.Methods: This was a secondary analysis of a randomized controlled trial of injured ED patients who screened positive for harmful alcohol use, who at recruitment reported driving in the past 12 months and received at least one of the intended intervention sessions (brief behavioral intervention versus attention placebo control; N = 407). Outcome variables were as follows: (1) change in 6 impaired driving behaviors and (2) report of MVCs and traffic violations in the 12 months following recruitment; predictor variables were as follows: (1) treatment assignment, (2) MVC involvement at recruitment, and (3) baseline readiness to change alcohol use and drinking and driving.Results: Modeling of change in the 6 impaired driving variables indicated that neither the recruitment visits being MVC related nor baseline readiness to change alcohol use and drinking and driving behaviors predicted greater changes in impaired driving over time. Baseline reports of past moving traffic violations and the ED visit being MVC related predicted a greater likelihood of each behavior at 12 months following study recruitment.Conclusions: This study and others have demonstrated that ED patients with harmful alcohol use are willing to engage in behavioral interventions directed at changing risky behaviors. However, this study did not demonstrate that patients considered having the potential to be more engaged with the intervention because their ED visit was MVC related and/or they had expressed intent to change their risky alcohol use and drinking and driving behaviors were more likely to change these risky behaviors.

A meta-analysis of indicated mental health prevention programs for at-risk higher education students.

This meta-analysis found empirical support for the effectiveness of indicated prevention programs for higher education students at risk for subsequent mental health difficulties based on their current subclinical levels of various presenting problems, such as depression, anxiety, or interpersonal difficulties. A systematic literature search identified 79 controlled published and unpublished interventions involving 4,470 college, graduate, or professional students. Programs were effective at post-intervention overall (ES = 0.49, CI [0.43, 0.55]), and for both targeted outcomes (ES = 0.58, CI [0.51, 0.64]) as well as additional nontargeted outcomes assessed in the studies (ES = 0.32, CI [0.25, 0.39]). Interventions compared with a no-intervention or a wait-list control (ES = 0.64, CI [0.57, 0.71], k = 68) demonstrated significantly larger effects overall than did interventions compared with an attention-placebo control (ES = 0.27, CI [0.11, 0.43], k = 11), although both were significant. Among the former group, modality and presenting problem emerged as significant moderators of intervention effectiveness, and among the 43 of these that assessed effectiveness at an average follow-up period of 35 weeks, the positive effects from intervention remained strong (ES = 0.59, CI [0.50, 0.68]). Overall, programs were fairly brief, attracted and retained students, were positively rated by students, and effective when administered by paraprofessionals as well as professionals. Current findings are promising and stimulate recommendations for improving future research, such as expanding the range of outcomes assessed, and clarifying moderators and mediators of intervention impact. (PsycINFO Database Record

A randomized control intervention trial to improve social skills and quality of life in pediatric brain tumor survivors.

To determine if a group social skills intervention program improves social competence and quality of life (QOL) in pediatric brain tumor survivors (PBTS). We conducted a randomized control trial in which PBTS (8-16years old, off therapy for over 3months) were allocated to receive social skills training (eg, cooperation, assertion, using social cognitive problem solving strategies, role playing, games, and arts and crafts) in 8 weekly 2-hour sessions, or an attention placebo control (games and arts and crafts only). Outcomes were self-reported, proxy-reported (caregiver), and teacher-reported using the Social Skills Rating System (SSRS), to measure social competence, and the Pediatric Quality of Life (PedsQL4.0, generic) to measure QOL at baseline, after intervention, and at 6months follow-up. At baseline, SSRS were stratified into low and high scores and included as a covariate in the analysis. Compared to controls (n=48), PBTS in the intervention group (n=43) reported significantly better total and empathy SSRS scores, with improvements persisting at follow-up. The PBTS in the intervention group who had low scores at baseline reported the greatest improvements. Proxy and teacher reports showed no intervention effect. Participating in group social skills intervention can improve self-reported social competence that persisted to follow up. The PBTS should be given the opportunity to participate in social skills groups to improve social competence.

Cognitive behavioural therapy (CBT), third-wave CBT and interpersonal therapy (IPT) based interventions for preventing depression in children and adolescents.

Cognitive behavioural therapy (CBT), third-wave CBT and interpersonal therapy (IPT) based interventions for preventing depression in children and adolescents.

Mind-body therapy via videoconferencing in patients with neurofibromatosis: An RCT.

To test, within a single-blind randomized controlled trial, the feasibility, acceptability, efficacy, and durability of a mind-body program (the Relaxation Response Resiliency Program for neurofibromatosis [3RP-NF]) vs an attention placebo control (Health Enhancement Program for NF [HEP-NF]), both delivered via group videoconferencing. Sixty-three patients completed baseline assessments and were randomized. Primary outcomes were physical health and psychological quality of life (QoL), measured by the WHOQOL-BREF (World Health Organization QoL abbreviated instrument). Secondary outcomes were social relations and environment QoL, depression, anxiety, pain intensity, and pain interference. Sixty-three participants completed the intervention (100%) and 52 the 6-month follow-up (82.5%). Acceptability was 4.1 (5-point scale). Patients in the 3RP-NF showed greater improvement in physical health QoL (7.69; 95% confidence interval [CI]: 0.29-15.10; p = 0.040), psychological QoL (5.57; 95% CI: 0.17-11.34; p = 0.056), social relations QoL (10.95; 95% CI: 1.57-20.31; p = 0.021), environment QoL (8.02; 95% CI: 2.57-13.48; p = 0.005), and anxiety (-2.32; 95% CI: -3.96 to 0.69; p = 0.006) compared to those in HEP-NF, and gains were maintained at follow-up. Patients in the 3RP-NF did not improve more than those in HEP-NF on depression, with both groups showing improvement. Patients in the 3RP-NF with baseline pain ≥5 of 10 showed improvement in pain intensity from baseline to posttest (1.30; 95% CI: -2.26 to -0.34; p = 0.009) with effects maintained at follow-up; this improvement was not greater than that in HEP-NF. There were more treatment responders in the 3RP-NF group (p < 0.05). The 3RP-NF delivered via videoconferencing was highly feasible and accepted by patients, and resulted in sustained improvement in QoL. This study provides Class II evidence that for patients with NF, a mind-body program is superior to an attention placebo control in improving QoL.

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.