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Improving adherence to an online intervention for low mood with a virtual coach: study protocol of a pilot randomized controlled trial.

ABSTRACT: BACKGROUND:Internet-based cognitive-behavioral therapy (iCBT) is more effective when it is guided by human support than when it is unguided. This may be attributable to higher adherence rates that result from a positive effect of the accompanying support on motivation and on engagement with the intervention. This protocol presents the design of a pilot randomized controlled trial that aims to start bridging the gap between guided and unguided interventions. It will test an intervention that includes automated support delivered by an embodied conversational agent (ECA) in the form of a virtual coach. METHODS/DESIGN:The study will employ a pilot two-armed randomized controlled trial design. The primary outcomes of the trial will be (1) the effectiveness of iCBT, as supported by a virtual coach, in terms of improved intervention adherence in comparison with unguided iCBT, and (2) the feasibility of a future, larger-scale trial in terms of recruitment, acceptability, and sample size calculation. Secondary aims will be to assess the virtual coach's effect on motivation, users' perceptions of the virtual coach, and general feasibility of the intervention as supported by a virtual coach. We will recruit N?=?70 participants from the general population who wish to learn how they can improve their mood by using Moodbuster Lite, a 4-week cognitive-behavioral therapy course. Candidates with symptoms of moderate to severe depression will be excluded from study participation. Included participants will be randomized in a 1:1 ratio to either (1) Moodbuster Lite with automated support delivered by a virtual coach or (2) Moodbuster Lite without automated support. Assessments will be taken at baseline and post-study 4 weeks later. DISCUSSION:The study will assess the preliminary effectiveness of a virtual coach in improving adherence and will determine the feasibility of a larger-scale RCT. It could represent a significant step in bridging the gap between guided and unguided iCBT interventions. TRIAL REGISTRATION:Netherlands Trial Register (NTR) NL8110 . Registered on 23 October 2019.

SUBMITTER: Provoost S

PROVIDER: S-EPMC7565359 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Improving adherence to an online intervention for low mood with a virtual coach: study protocol of a pilot randomized controlled trial.

Provoost Simon S Kleiboer Annet A Ornelas José J Bosse Tibor T Ruwaard Jeroen J Rocha Artur A Cuijpers Pim P Riper Heleen H

Trials 20201016 1

<h4>Background</h4>Internet-based cognitive-behavioral therapy (iCBT) is more effective when it is guided by human support than when it is unguided. This may be attributable to higher adherence rates that result from a positive effect of the accompanying support on motivation and on engagement with the intervention. This protocol presents the design of a pilot randomized controlled trial that aims to start bridging the gap between guided and unguided interventions. It will test an intervention t ...[more]

PMID: 33066805

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Project description:Feasibility studyObjectives:Refine a bespoke enhanced support intervention (ESI) (including self-help materials, intervention manual and training) for implementation by community pharmacy (CP) staff to people with sub-threshold depression and long-term conditions (LTCs) based upon evidence-supported interventions in primary careDevelop and refine study procedures (recruitment strategies and set up, screening, participant recruitment, assessment, suitability of outcome measures and data collection procedures) for testing in the pilot study phaseDesign: A case series/qualitative studySetting: UK community pharmacyPopulation: Adults with long-term health conditions who screen-positive for depression but who do not reach the threshold for DSM IV Moderate Depressive disorderIntervention: Enhanced support intervention (ESI) delivered by an appropriately trained community pharmacy team member involving four to six sessions over four months. ESI is a modified form of an intervention within the collaborative care framework for sub-threshold depression validated in previous studies in UK primary care which appears suitable for implementation in community settings.Sample size: 20-30 participantsOutcomes: Study implementation (recruitment and attrition rates), quality of data collection at baseline and 4 months and ESI adherence (number of contacts, DNA and drop out) as per objectives 1a/bQualitative evaluation: Semi-structured interviews with up to 10 participants and ESI facilitators and focus group(s) (range of pharmacy staff n =?8-10) will be conducted to explore the acceptability of the intervention and feasibility of the study, training and study procedures.External pilot studyObjectives:Quantify the flow of participants (eligibility, recruitment and follow-up rate)Evaluate proposed recruitment, assessment and outcome measure collection methodsExamine the delivery of the enhanced support intervention in a community pharmacy setting (intervention uptake, retention and dose) to inform process evaluationProcess evaluation, using semi-structured interviews with participants across a range of socio-economic settings, and pharmacy staff to explore the acceptability of the ESI within community pharmacy, elements of the intervention that were considered useful (or not) and appropriateness of study proceduresDesign: Pilot randomised controlled trial, including a prospective economic and qualitative evaluationSetting: As abovePopulation: As aboveIntervention: As above with adaptations post feasibility studyComparator: Usual careSample size: 100 participantsOutcomes: Data will be used to estimate recruitment, intervention delivery and study completion rates as per objectives 2a-d. Definitive estimates of the effectiveness of ESI will not be made.Primary outcome: Depression severity (Patient Health Questionnaire 9) at four months.Secondary outcomes: Patient acceptance, uptake and attrition. ICD10 depression status, anxiety (GAD 7), health-related quality of life (SF-12v2) and health-state utility (EQ5D 3L) will be measured at four months.Economic evaluation: The incremental cost per QALY will be calculated from both the NHS and societal perspective.Process evaluation: Using mixed methods, potential mediators/moderators of the intervention, the acceptability (to participants and pharmacy staff), barriers and facilitators to the use of ESI in community pharmacy, and impact on usual practice will be examined. Semi-structured interviews with approximately 30 study participants, 20 pharmacy staff and eight GPs near participating pharmacies will be conducted.Trial registrationISRCTN: ISRCTN11290592Protocol version number: Version 4.1 (dated 16th January 2018)Study Sponsor Tees Esk and Wear Valleys NHS Foundation Trust.

Project description:BackgroundCardiovascular disease (CVD) is the most common cause of death among people with rheumatoid arthritis (RA), with an estimated increased risk of 50-60% compared to the general population. Lipid-lowering strategies have been shown to lower CVD risk significantly in people with RA and hyperlipidemia. Thus, CVD risk assessment has an important role to play in reducing CVD among people with RA. Yet currently only 37 to 45% of this population are receiving primary lipids screening. This paper describes the CArdiovascular Risk assEssment for RA (CARE RA) intervention, which is designed to address this issue. CARE RA is a peer coach intervention, that is, an intervention in which a person with RA coaches another person with RA, which is designed to educate people with RA about the relation between RA and CVD risk and to help them obtain evidence-based CVD risk assessment and treatment.MethodsThis is an open-label pilot study that will test if the participants assigned to complete the CARE RA curriculum with a peer coach will receive a cardiovascular risk assessment more frequently compared to those that complete the CARE RA curriculum by themselves. The CARE RA intervention is guided by Social Cognitive Theory. Participants in the peer coach intervention arm will receive the assistance of a peer coach who will call the participants once a week for 5 weeks to go over the CARE RA curriculum and train them on how to obtain CVD risk assessment. The control arm will complete the CARE RA curriculum without any assistance. Participants will be randomized 1:1 either to the control arm or to the peer coach intervention arm. The primary outcome is a participant's having a CVD risk assessment or initiating a statin, if indicated. Secondary outcomes include patient activation and RA medication adherence. The RE-AIM implementation framework guides the implementation and evaluation of the intervention.DiscussionThis pilot study will test the feasibility of the peer coach intervention in anticipation of a larger trial. CARE RA pioneers the use of peer coaches to facilitate the implementation of evidence-based treatment guidelines among people with RA.Trial registrationClinicalTrials.gov NCT04488497 . Registered on July 28, 2020.

Project description:BACKGROUND:Excessive gestational weight gain (GWG) is associated with adverse health outcomes in both the mother and child. Many previous lifestyle interventions in women with excess weight during pregnancy encouraging appropriate GWG have been unsuccessful, and there remains no consensus about the content, format, or theoretical framework of GWG interventions. We assessed the feasibility and acceptability of a remote health coach intervention to promote healthful lifestyle behaviors and appropriate GWG among overweight pregnant women. METHODS:At one northeastern US clinic, we enrolled 30 overweight (pre-pregnancy BMI ? 25 kg/m2) pregnant women at a median gestation of 12.5 weeks (IQR: 11-15) into a one-arm trial. We connected participants with a health coach to provide behavioral support to help participants adopt healthful lifestyles during pregnancy. Health coaches contacted participants by phone every 2-3 weeks to monitor goals, and sent emails and text messages between calls. Participants completed baseline (N?=?30) and follow-up (N?=?26) surveys at the end of the intervention (36 weeks gestation), as well as follow-up phone interviews (N?=?18). RESULTS:Among 30 participants, median age was 32 years (IQR: 28-33), median self-reported pre-pregnancy BMI was 27.3 kg/m2 (IQR: 25.7-31.1), and 17/30 were white, 9/30 African-American, and 3/30 Asian. Three-quarters (22/29) of participants completed at least a college degree. Although 25/30 participants reported in baseline surveys that they worried about being able to lose the weight postpartum that they expected to gain during pregnancy, just 12/26 participants reported the same at follow-up (P?<?0.001). In follow-up surveys, 21/26 participants reported that health coaches were helpful in keeping them motivated, and 22/26 thought the phone conversations helped them face problems and find solutions. Based on qualitative assessment, several themes emerged in follow-up interviews about the quality of the intervention including accountability and support from health coaches. Participants also expressed desire for more visual resources and integration with standard clinical care to improve the intervention. CONCLUSIONS:We demonstrated feasibility and high participant satisfaction with our remote health coach intervention during pregnancy. We identified areas in which we could refine the intervention for inclusion in a full-scale RCT, such as integration with clinical care and additional visual resources. TRIAL REGISTRATION:Retrospectively registered at ClinicalTrials.gov ( NCT03080064 , 3/14/2017).

Project description:OBJECTIVES:Opioid-related deaths continue to increase in North America, an epidemic that was initiated by high rates of opioid prescribing. We designed a multifaceted, theory-informed Opioid Self-Assessment (OSA) package, to increase adherence to the Canadian Opioid Guideline among family physicians. This study aimed to assess changes in Canadian family physicians' knowledge and practices after completing the OSA package. DESIGN:We conducted a mixed-method evaluation using a pre-test and post-test design that involved the collection of both qualitative and quantitative data. SETTING:This research was conducted in the primary care setting in Ontario, Canada. PARTICIPANTS:We recruited a purposive sample of nine family physicians in Ontario who use long-term opioid therapy to treat patients with chronic pain. INTERVENTIONS:The OSA package included four components: an online knowledge test, an online learning programme, a safe medication practice self-assessment questionnaire and chart audit with feedback. OUTCOME MEASURES:Our measures included changes in knowledge, opioid safety practices and physicians' perspectives on the OSA package. RESULTS:We found statistically significant improvements between pre-test and post-test knowledge scores at both baseline and 6-month follow-up. Physicians' scores improved significantly on five of the seven core characteristics of the practice self-assessment questionnaire. On the chart audits, we observed an improvement in patient education between baseline and 6?months. Qualitative interviews showed that participants appreciated embedded resources in the OSA package. The completion of the package stimulated identification of gaps or deficits in practice and served as a useful reminder to discuss risk and safety with patients. Participants described the chart review as helpful in prompting discussions with their patients, identifying deficits and strengths and a 'primary motivator' for project participation. CONCLUSIONS:The OSA package has the potential to improve medication safety practices in primary care related to opioid monitoring and adherence to current opioid guidelines.

Project description:Addressing the obesity epidemic requires the development of effective, scalable interventions. Pedometers and Web-based programs are beneficial in increasing activity levels but might be enhanced by the addition of nonhuman coaching.We hypothesized that a virtual coach would increase activity levels, via step count, in overweight or obese individuals beyond the effect observed using a pedometer and website alone.We recruited 70 participants with a body mass index (BMI) between 25 and 35 kg/m(2) from the Boston metropolitan area. Participants were assigned to one of two study arms and asked to wear a pedometer and access a website to view step counts. Intervention participants also met with a virtual coach, an automated, animated computer agent that ran on their home computers, set goals, and provided personalized feedback. Data were collected and analyzed in 2008. The primary outcome measure was change in activity level (percentage change in step count) over the 12-week study, split into four 3-week time periods. Major secondary outcomes were change in BMI and participants' satisfaction.The mean age of participants was 42 years; the majority of participants were female (59/70, 84%), white (53/70, 76%), and college educated (68/70, 97%). Of the initial 70 participants, 62 completed the study. Step counts were maintained in intervention participants but declined in controls. The percentage change in step count between those in the intervention and control arms, from the start to the end, did not reach the threshold for significance (2.9% vs -12.8% respectively, P = .07). However, repeated measures analysis showed a significant difference when comparing percentage changes in step counts between control and intervention participants over all time points (analysis of variance, P = .02). There were no significant changes in secondary outcome measures.The virtual coach was beneficial in maintaining activity level. The long-term benefits and additional applications of this technology warrant further study.ClinicalTrials.gov NCT00792207; http://clinicaltrials.gov/ct2/show/NCT00792207 (Archived by WebCite at http://www.webcitation.org/63sm9mXUD).

Project description:ObjectiveScalable, efficiently delivered treatments are needed to address the needs of women Veterans with PTSD. This randomized clinical trial compared an online, coach-assisted cognitive behavioral intervention tailored for women Veterans with PTSD to phone monitoring only.MethodWomen Veterans who met diagnostic criteria for PTSD were randomized to an 8-week web-based intervention, called DElivery of Self TRaining and Education for Stressful Situations (DESTRESS)-Women Veterans version (WV), or to phone monitoring only (N = 102). DESTRESS-WV consisted of online sessions and 15-min weekly phone calls from a study coach. Phone monitoring included 15-min weekly phone calls from a study coach to offer general support. PTSD symptom severity (PTSD Symptom-Checklist-Version 5 [PCL-5]) was evaluated pre and posttreatment, and at 3 and 6 months posttreatment.ResultsMore participants completed phone monitoring than DESTRESS-WV (96% vs. 76%, p = 0.01), although treatment satisfaction was significantly greater in the DESTRESS-WV condition. We failed to confirm the superiority of DESTRESS-WV in intent-to-treat slope changes in PTSD symptom severity. Both treatments were associated with significant reductions in PTSD symptom severity over time. However, post hoc analyses of treatment completers and of those with baseline PCL ≥ 33 revealed that the DESTRESS-WV group had greater improvement in PTSD symptom severity relative to phone monitoring with significant differences at the 3-month follow-up assessment.ConclusionsBoth DESTRESS-WV and phone monitoring resulted in significant improvements in women Veterans' PTSD symptoms. DESTRESS-WV may be an appropriate care model for women Veterans who can engage in the demands of the treatment and have higher baseline symptoms. Future research should explore characteristics of and the methods of reliably identifying women Veterans who are most likely to benefit. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

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Improving adherence to an online intervention for low mood with a virtual coach: study protocol of a pilot randomized controlled trial.

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Improving adherence to an online intervention for low mood with a virtual coach: study protocol of a pilot randomized controlled trial.

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