Information-only Control Condition Research Articles

The EMBER trial for weight management engagement: A hybrid type 1 randomized controlled trial protocol

BackgroundAlmost 40% of Veterans Health Administration (VHA) users have obesity. VHA's national weight management program is associated with weight loss and improved health. However, while 94% of eligible VHA users are offered weight management programs, <8% use them. We developed EMBER – a novel, Motivational Interviewing-based, self-help tool – with the goal of Enhancing Motivation for Better Engagement and Reach for weight management. EMBER is not a weight management program; instead it engages people in existing programs by informing and guiding choices about weight management. MethodsThe EMBER Trial is a randomized hybrid type 1 effectiveness implementation trial. Participants are Palo Alto or Houston VA Health Care System users with obesity who have not used a VHA weight management program in the past two years (target N = 470). Participants are randomly assigned to EMBER or an information-only control condition, after which they receive materials on paper or digitally, per their preference. The trial's primary goal is to determine whether participants randomized to EMBER are more likely to have any weight management engagement at two-month follow-up compared to those in the control condition. Secondary outcomes include 6-month retention in weight management, weight management behaviors, weight loss, quality of life, and implementation outcomes (e.g., reach, appropriateness). ConclusionEMBER is the first self-directed, Motivational Interviewing-based intervention designed to increase weight management program engagement. The study takes a low-touch, population health approach that could be modified for other programs if effective. The Hybrid Type 1 design will ensure results can be scaled and sustained.

Effects of Internet-Based Cognitive Behavioral Therapy for Harmful Alcohol Use and Alcohol Dependence as Self-help or With Therapist Guidance: Three-Armed Randomized Trial.

BackgroundAlcohol use is a major contributor to health loss. Many persons with harmful use or alcohol dependence do not obtain treatment because of limited availability or stigma. They may use internet-based interventions as an alternative way of obtaining support. Internet-based interventions have previously been shown to be effective in reducing alcohol consumption in studies that included hazardous use; however, few studies have been conducted with a specific focus on harmful use or alcohol dependence. The importance of therapist guidance in internet-based cognitive behavioral therapy (ICBT) programs is still unclear.ObjectiveThis trial aims to investigate the effects of a web-based alcohol program with or without therapist guidance among anonymous adult help-seekers.MethodsA three-armed randomized controlled trial was conducted to compare therapist-guided ICBT and self-help ICBT with an information-only control condition. Swedish-speaking adult internet users with alcohol dependence (3 or more International Classification of Diseases, Tenth Revision criteria) or harmful alcohol use (alcohol use disorder identification test>15) were included in the study. Participants in the therapist-guided ICBT and self-help ICBT groups had 12-week access to a program consisting of 5 main modules, as well as a drinking calendar with automatic feedback. Guidance was given by experienced therapists trained in motivational interviewing. The primary outcome measure was weekly alcohol consumption in standard drinks (12 g of ethanol). Secondary outcomes were alcohol-related problems measured using the total alcohol use disorder identification test-score, diagnostic criteria for alcohol dependence and alcohol use disorder, depression, anxiety, health, readiness to change, and access to other treatments or support. Follow-up was conducted 3 (posttreatment) and 6 months after recruitment.ResultsDuring the recruitment period, from March 2015 to March 2017, 1169 participants were included. Participants had a mean age of 45 (SD 13) years, and 56.72% (663/1169) were women. At the 3-month follow-up, the therapist-guided ICBT and control groups differed significantly in weekly alcohol consumption (−3.84, 95% Cl −6.53 to −1.16; t417=2.81; P=.005; Cohen d=0.27). No significant differences were found in weekly alcohol consumption between the self-help ICBT group and the therapist-guided ICBT at 3 months, between the self-help ICBT and the control group at 3 months, or between any of the groups at the 6-month follow-up. A limitation of the study was the large number of participants who were completely lost to follow-up (477/1169, 40.8%).ConclusionsIn this study, a therapist-guided ICBT program was not found to be more effective than the same program in a self-help ICBT version for reducing alcohol consumption or other alcohol-related outcomes. In the short run, therapist-guided ICBT was more effective than information. Only some internet help-seekers may need a multisession program and therapist guidance to change their drinking when they use internet-based interventions.Trial RegistrationClinicalTrials.gov NCT02377726; https://clinicaltrials.gov/ct2/show/NCT02377726

Effectiveness of energy conservation management on fatigue and participation in multiple sclerosis: A randomized controlled trial

Background: Fatigue is a frequently reported and disabling symptom in multiple sclerosis (MS). Objective: To investigate the effectiveness of an individual energy conservation management (ECM) intervention on fatigue and participation in persons with primary MS-related fatigue. Methods: A total of 86 severely fatigued and ambulatory adults with a definite diagnosis of MS were randomized in a single-blind, two-parallel-arm randomized clinical trial to the ECM group or the information-only control group in outpatient rehabilitation departments. Blinded assessments were carried out at baseline and at 8, 16, 26 and 52 weeks after randomization. Primary outcomes were fatigue (fatigue subscale of Checklist Individual Strength – CIS20r) and participation (Impact on Participation and Autonomy scale – IPA). Results: Modified intention-to-treat analysis was based on 76 randomized patients (ECM, n = 36; MS nurse, n=40). No significant ECM effects were found for fatigue (overall difference CIS20r between the groups = −0.81; 95% confidence interval (CI), −3.71 to 2.11) or for four out of five IPA domains. An overall unfavourable effect was found in the ECM group for the IPA domain social relations (difference between the groups = 0.19; 95% CI, 0.03 to 0.35). Conclusion: The individual ECM format used in this study did not reduce MS-related fatigue and restrictions in participation more than an information-only control condition.

Decreasing Substance use Risk among African American Youth: Parent-based Mechanisms of Change.

African American couples (N = 139; 67.7% married; with children between the ages of 9 and 14) were randomly assigned to (a) a culturally sensitive, couple- and parenting-focused program designed to prevent stress-spillover (n = 70) or (b) an information-only control condition in which couples received self-help materials (n = 69). Eightmonths after baseline, youth whose parents participated in the program, compared with control youth, reported increased parental monitoring, positive racial socialization, and positive self-concept, as well as decreased conduct problems and self-reported substance use. Changes in youth-reported parenting behavior partially mediated the effect of the intervention on conduct problems and fully mediated its impact on positive self-concept, but did not mediate effects on lifetime substance use initiation. Results suggest the potential for a culturally sensitive family-based intervention targeting adults' couple and parenting processes to enhance multiple parenting behaviors as well as decrease youths' substance use onset and vulnerability.

Reducing Unintended Pregnancies Through Web-Based Reproductive Life Planning and Contraceptive Action Planning among Privately Insured Women: Study Protocol for the MyNewOptions Randomized, Controlled Trial

BackgroundThe Affordable Care Act mandates that most women of reproductive age with private health insurance have full contraceptive coverage with no out-of-pocket costs, creating an actionable time for women to evaluate their contraceptive choices without cost considerations. The MyNewOptions study is a three-arm, randomized, controlled trial testing web-based interventions aimed at assisting privately insured women with making contraceptive choices that are consistent with their reproductive goals. MethodsPrivately insured women between the ages of 18 and 40 not intending pregnancy were randomly assigned to one of three groups: 1) a reproductive life planning (RLP) intervention, 2) a reproductive life planning enriched with contraceptive action planning (RLP+) intervention, or 3) an information only control group. Both the RLP and RLP+ guide women to identify their individualized reproductive goals and contraceptive method requirements. The RLP+ additionally includes a contraceptive action planning component, which uses if–then scenarios that allow the user to problem solve situations that make it difficult to be adherent to their contraceptive method. All three groups have access to a reproductive options library containing information about their contraceptive coverage and the attributes of alternative contraceptive methods. Women completed a baseline survey with follow-up surveys every 6 months for 2 years concurrent with intervention boosters. Study outcomes include contraceptive use and adherence. ClinicalTrials.gov identifier: NCT02100124. DiscussionResults from the MyNewOptions study will demonstrate whether web-based reproductive life planning, with or without contraceptive action planning, helps insured women make patient-centered contraceptive choices compared with an information-only control condition.

Online prevention of postpartum depression for Spanish- and English-speaking pregnant women: A pilot randomized controlled trial

BackgroundPostpartum depression (PPD) is a maternal mental health problem that affects women from all regions of the world. Unfortunately, even in developed countries, half of the cases go undetected and, consequently, untreated. Individuals from low and middle income countries trend toward underutilization of mental health services, partly due to the limited number of available psychological resources. The primary aims of this pilot randomized controlled trial were to adapt to the Internet using the Mothers and Babies Course/Curso Mamás y Bebés, a prevention of PPD intervention, to describe the characteristics of the pregnant women who engaged in the intervention site, and to obtain preliminary data on the efficacy of the Internet intervention to reduce the risk of PPD. MethodsPregnant women, 18years or older who were interested in using the site for themselves were recruited and randomly assigned to a fully-automated self-help Internet intervention or to an information-only control condition. Randomized participants were invited to complete monthly depression assessments up to six months postpartum. To examine the prevention effects of the Internet intervention, pregnant women who did not meet current criteria for a major depressive episode, who engaged with the study website, and who provided depression data during the postpartum follow-up period were included in the study analyses. ResultsParticipants were 111 predominantly Spanish-speaking (82.9%) and Latino/Hispanic (71.3%) pregnant women residing in 23 countries worldwide. The effect of the prevention intervention condition failed to reach significance at the a priori alpha-level. However, the observed coefficient trended in the hypothesized direction (b=−0.514, χ2 (1)=3.43, p=.061; HR=0.598). The benefits of receiving the e-MB Internet intervention were greater for pregnant women reporting high (vs. low) levels of prenatal depression symptoms (b=−0.605, χ2 (1)=5.20, p=.023). ConclusionsThis study provides preliminary evidence that Internet interventions are a promising method toward expanding the reach of psychological resources to perinatal women at-risk for PPD.

Treatment for insomnia in combat-exposed OEF/OIF/OND Military Veterans: Preliminary randomized controlled trial

Chronic insomnia is highly prevalent among military personnel returning from Iraq and Afghanistan. We evaluated the effects of a military version of a brief behavioral treatment of insomnia (BBTI-MV) compared to an information only control (IC) condition in combat-exposed Veterans of Operations Enduring/Iraqi Freedom or Operation New Dawn (OEF/OIF/OND) on insomnia, sleep quality, and daytime symptoms of anxiety and depression. Forty OEF/OIF/OND Veterans (Mean age = 38.4 years old, s.d. = 11.69; 85% men; 77.5% white) were randomized to one of two conditions. BBTI-MV consisted of two in-person sessions and two telephone contacts delivered over four weeks, and included personalized recommendations to reduce insomnia. The IC condition also consisted of 2 in-person sessions two telephone contacts delivered over four weeks, and Veterans were encouraged to read written information about sleep-promoting behaviors. The Insomnia Severity Index, Pittsburgh Sleep Quality Index, PTSD Checklist, and Beck Depression and Anxiety Inventories were completed at baseline, post-treatment, and at the six-month follow-up. Both interventions were associated with clinically significant improvements in insomnia, although the magnitude of improvements in sleep and rates of treatment response and remission were greater for BBTI-MV compared to IC from pre- to post-treatment. Both BBTI-MV and the provision of information were associated with clinically significant improvements in insomnia among Veterans. Despite the preliminary nature of the findings and limitations inherent to small controlled trials, the findings suggest that both approaches may provide viable options in a stepped-care approach to the treatment of insomnia in retuning combat-exposed Veterans. Larger, confirmatory effectiveness trials are required. ClinicalTrials.gov IdentifierNCT00840255.

The effect of communication change on long-term reductions in child exposure to conflict: impact of the promoting strong African American families (ProSAAF) program.

African American couples (n=331) with children, 89% of whom were married, were assigned to either (a) a culturally sensitive couple- and parenting-enhancement program (ProSAAF) or (b) an information-only control condition in which couples received self-help materials. Husbands averaged 41years of age and wives averaged 39years. We found significant effects of program participation in the short term on couple communication, which was targeted by the intervention, as well as over the long term, on self-reported arguing in front of children. Long-term parenting outcomes were fully mediated by changes in communication for wives, but not for husbands. For husbands, positive change depended on amount of wife reported change. We conclude that wives' changes in communication from baseline to posttest may be more pivotal for the couples' long-term experience of decreased arguing in front of children than are husbands' changes, with wives' changes leading to changes in both partners' reports of arguments in front of children.

Multimedia decision support intervention: a promising approach to enhance the intention to complete an advance directive among hospitalized adults.

We examined the acceptability and initial efficacy of a multimedia decision support (MDS) intervention to improve intention to complete an advanced directive (AD) among hospitalized adults following an episode of critical illness. We used comparative quasi-experimental posttest only design. Forty-nine hospitalized adults, recovering from a critical illness, received either MDS or AD educational brochure. Demographic characteristics and self-report measures of AD knowledge were captured at baseline and used as covariates. Helpfulness of the intervention (acceptability) and the outcome variable, intention to complete an AD decision, were assessed after exposure to the MDS intervention or educational brochure (information-only control condition). The MDS was a more acceptable form of education compared to a brochure. After adjusting for covariates, participants exposed to the MDS intervention were 24.7 times more likely to intend to complete an AD compared to those who were assigned to the information-only control condition. This pilot study establishes the acceptability and initial efficacy of the MDS intervention among individuals with critical illness, who are at high risk for hospital readmission life-sustaining treatment. This study illuminates a teachable moment in which patients are more receptive to interventions to complete an AD.

The Efficacy of Minimal Contact Interventions for Acute Tinnitus: A Randomised Controlled Study

Acute tinnitus can lead to substantial distress and eventually result in long-lasting impairment. The aim of this study was to compare the efficacy of a cognitive-behavioural intervention (delivered as Internet self-management, bibliotherapy or group training) to the information-only control condition. Applicants suffered from subjective tinnitus for up to six months, were between 18 and 75 years old and received no other tinnitus-related psychological treatment. A total of 304 participants were randomly assigned to one of the four study arms. Tinnitus distress, depressive symptoms, psychosomatic discomfort and treatment satisfaction were assessed. At the post-assessment tinnitus distress was significantly lower in the Internet and the group training conditions compared to the control condition. Inter-group effect sizes were moderate to large. At follow-up, all active training conditions showed significantly reduced tinnitus distress compared to the control condition (intention-to-treat analysis). An additional completer analysis showed a significant reduction in tinnitus distress only for the group condition. All effect sizes were moderate. There were no differences regarding psychosomatic discomfort, but depressive symptoms were reduced in the group condition at the post-assessment (intention-to-treat analysis). Treatment satisfaction was significantly higher in the training conditions. The dropout rate was 39%. The present study shows that distress can be reduced as early as the acute stadium and that minimal-contact interventions are a promising way to do this. In particular, the Internet and group conditions led to a large, immediate decrease in distress, and the participants were highly satisfied with the training.

Enhancing marital enrichment through spirituality: Efficacy data for prayer focused relationship enhancement.

We examined 393 African American married couples assigned to (a) a culturally sensitive version of a widely disseminated relationship enhancement program (CSPREP); (b) a similar version of the same program that also included a focus on prayer (PFP condition); or (c) an information-only control condition in which couples received a self-help version of the same program. Husbands averaged 40.5 years of age and wives averaged 38.9 years. We found a significant interaction between intervention and time of assessment, reflecting group differences in linear trends for the three conditions, with the two intervention conditions performing better than the control condition, and PFP producing superior outcomes to CS-PREP only for wives at post and marginally better results at 12-month follow-up. Results support continued exploration of the adjunctive use of prayer in the context of relationship enhancement programs where appropriate to make them more culturally sensitive.

Curbing Alcohol Use in Male Adults Through Computer Generated Personalized Advice: Randomized Controlled Trial

Background In recent years, interventions that deliver online personalized feedback on alcohol use have been developed and appear to be a feasible way to curb heavy drinking. Randomized controlled trials (RCTs) among the general adult population, however, are scarce. The present study offers an RCT of Drinktest.nl, an online personalized feedback intervention in the Netherlands.ObjectiveThe aim of this study was to assess the effectiveness of computer-based personalized feedback on heavy alcohol use in male adults.MethodsRandomization stratified by age and educational level was used to assign participants to either the intervention consisting of online personalized feedback or an information-only control condition. Participants were told as a cover story that they would evaluate newly developed health education materials. Participants were males (n = 450), aged 18 to 65 years, presenting with either heavy alcohol use (> 20 units of alcohol weekly) and/or binge drinking (> 5 units of alcohol at a single occasion at least 1 day per week) in the past 6 months. They were selected with a screener from a sampling frame of 25,000 households. The primary outcome measure was the percentage of the participants that had successfully reduced their drinking levels to below the Dutch guideline threshold for at-risk drinking.ResultsIntention-to-treat analysis showed that in the experimental condition, 42% (97/230) of the participants were successful in reducing their drinking levels to below the threshold at the 1-month follow-up as compared with 31% (67/220) in the control group (odds ratio [OR] = 1.7, number needed to treat [NNT] = 8.6), which was statistically significant (χ2 1 = 6.67, P = .01). At the 6-month follow-up, the success rates were 46% (105/230) and 37% (82/220) in the experimental and control conditions, respectively (OR = 1.4, NNT = 11.9), but no longer statistically significant (χ2 1 = 3.25, P = .07).ConclusionsPersonalized online feedback on alcohol consumption appears to be an effective and easy way to change unhealthy drinking patterns in adult men, at least in the short-term.Trial registrationInternational Standard Randomized Controlled Trial Number: NTR836; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=836 (Archived by WebCite at http://www.webcitation.org/5ytnEz2vp)

Modeling missing binary outcome data in a successful web‐based smokeless tobacco cessation program

To examine various methods to impute missing binary outcome from a web-based tobacco cessation intervention. The ChewFree randomized controlled trial used a two-arm design to compare tobacco abstinence at both the 3- and 6-month follow-up for participants randomized to either an enhanced web-based intervention condition or a basic information-only control condition. Internet in the United States and Canada. Secondary analyses focused upon 2523 participants in the ChewFree trial. Point-prevalence tobacco abstinence measured at 3- and 6-month follow-up. The results of this study confirmed the findings for the original ChewFree trial and highlighted the use of different missing-data approaches to achieve intent-to-treat analyses when confronted with substantial attrition. The use of different imputation methods yielded results that differed in both the size of the estimated treatment effect and the standard errors. The choice of imputation model used to analyze missing binary outcome data can affect substantially the size and statistical significance of the treatment effect. Without additional information about the missing cases, they can overestimate the effect of treatment. Multiple imputation methods are recommended, especially those that permit a sensitivity analysis of their impact.

Mediators of a successful web‐based smokeless tobacco cessation program

To examine self-efficacy and program exposure as possible mediators observed treatment effects for a web-based tobacco cessation intervention. The ChewFree trial used a two-arm design to compare tobacco abstinence at both the 3- and 6-month follow-up for participants randomized to either an enhanced intervention condition or a basic information-only control condition. Internet in US and Canada. Our secondary analyses focused upon 402 participants who visited the web-based program at least once, whose baseline self-efficacy rating showed room for improvement, who reported that they were still using tobacco at the 6-week assessment, and for whom both 3- and 6-month follow-up data were available. An enhanced web-based behavioral smokeless tobacco cessation intervention delivered program content using text, interactive activities, testimonial videos and an ask-an-expert forum and a peer forum. The basic control condition delivered tobacco cessation content using static text only. Change in self-efficacy and program exposure from baseline to 6 weeks were tested as simple and multiple mediators on the effect of treatment condition on point-prevalence tobacco abstinence measured at 3- and 6-month follow-up. While both participant self-efficacy and program exposure satisfied the requirements for simple mediation, only self-efficacy emerged as a mediator when we used the more robust test of multiple mediation. Results confirm the importance of self-efficacy change as a probable underlying mechanism in a successful web-based behavioral intervention. While program exposure was found to be a simple mediator of tobacco abstinence, it failed to emerge as a mediator when tested with self-efficacy change in a multiple mediator test suggesting that self-efficacy and program exposure share a complex, possibly reciprocal relationship with the tobacco abstinence outcome. Our results underscore the utility of searching for mediators in research on web-based interventions.

E-Care: A Telecommunications Technology Intervention for Family Caregivers of Dementia Patients

This study evaluated the effectiveness of a technology-based psychoeducational intervention for family caregivers of dementia patients. An additional objective was to determine if the intervention could be implemented by a community-based social service agency. Forty-six caregivers were randomly assigned to either a technology-based intervention or an information-only control condition. Caregivers assigned to the intervention condition reported a significant decrease in burden postintervention and those who evidenced high depression at baseline experienced a significant decline in depression. This study provides evidence that technology offers a cost-effective and practical method for delivering interventions to caregivers.

An information-motivation-behavioral skills (IMB) model-based HIV prevention intervention for truck drivers in India

The incidence of HIV/AIDS in India is increasing drastically, and truck drivers are seen as critical sources of HIV transmission due to their high rates of unprotected sex with multiple partners. An intervention based on the Information-Motivation-Behavioral Skills (IMB) model was compared to an information-only control condition in a randomized trial. IMB constructs were assessed among 250 male truck drivers immediately prior to and following implementation of the intervention, and sexual and condom use behaviors were assessed approximately 10 months later. The intervention consisted of a single-session group workshop with 5 interactive activities designed to address HIV prevention-related IMB constructs and to motivate condom use. Findings showed mixed support for the effectiveness of the intervention. There was an effect of the IMB intervention on attitudes, norms, behavioral skills, and intentions specific to condom use with marital partners, but no effects on constructs related to non-marital partners. There was some evidence of greater condom use with marital and non-marital partners at behavioral follow-up for participants in the IMB condition, and effects on condom use with marital partners were mediated by changes in IMB constructs. These findings provide initial evidence for the effectiveness of theoretically-based approaches to HIV prevention in India.

Internet cognitive behavioural therapy for panic disorder: Does the inclusion of stress management information improve end-state functioning?

Previous research has established Internet-based cognitive behavioural therapy (CBT) for panic disorder (PD) as effective in reducing panic severity and frequency. There is evidence, however, that such programs are less effective at improving overall end-state functioning, defined by a PD clinician severity rating of ⩽2 and panic free. In order to test the effect on end-state functioning of the incorporation of stress management material within a CBT program for PD, 32 people with PD were randomised to either Internet-based CBT (PO1), Internet-based CBT plus stress management (PO2) or an Internet-based information-only control condition (IC). Both CBT treatments were more effective at posttreatment assessment than the control condition in reducing PD severity, panic and agoraphobia-related cognition, negative affect and self-ratings of health. PO2 was more effective than PO1 at posttreatment assessment on PD severity and general anxiety, although at 3-month follow-up these differences were no longer apparent. This study provides further support for the efficacy of Internet-based CBT for PD and suggests that although the incorporation of stress management material confers short-term advantages over a standard program, it is not associated with any longer term improvements on panic severity and related cognitions, negative affect, general wellbeing and end-state functioning.