Dataset Information

Conducting a fully mobile and randomised clinical trial for depression: access, engagement and expense.

ABSTRACT:

Importance

Advances in mobile technology have resulted in federal and industry-level initiatives to facilitate large-scale clinical research using smart devices. Although the benefits of technology to expand data collection are obvious, assumptions about the reach of mobile research methods (access), participant willingness to engage in mobile research protocols (engagement), and the cost of this research (cost) remain untested.

Objective

To assess the feasibility of a fully mobile randomised controlled trial using assessments and treatments delivered entirely through mobile devices to depressed individuals.

Design

Using a web-based research portal, adult participants with depression who also owned a smart device were screened, consented and randomised to 1 of 3 mental health apps for treatment. Assessments of self-reported mood and cognitive function were conducted at baseline, 4, 8 and 12?weeks. Physical and social activity was monitored daily using passively collected phone use data. All treatment and assessment tools were housed on each participant's smart phone or tablet.

Interventions

A cognitive training application, an application based on problem-solving therapy, and a mobile-sensing application promoting daily activities.

Results

Access: We screened 2923 people and enrolled 1098 participants in 5?months. The sample characteristics were comparable to the 2013 US census data. Recruitment via Craigslist.org yielded the largest sample. Engagement: Study engagement was high during the first 2?weeks of treatment, falling to 44% adherence by the 4th week. Cost: The total amount spent on for this project, including staff costs and ? testing, was $314?264 over 2?years.

Conclusions and relevance

These findings suggest that mobile randomised control trials can recruit large numbers of participants in a short period of time and with minimal cost, but study engagement remains challenging.

Trial registration number

NCT00540865.

SUBMITTER: Anguera JA

PROVIDER: S-EPMC4789688 | biostudies-literature | 2016 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Conducting a fully mobile and randomised clinical trial for depression: access, engagement and expense.

Anguera Joaquin A JA Jordan Joshua T JT Castaneda Diego D Gazzaley Adam A Areán Patricia A PA

BMJ innovations 20160101 1

<h4>Importance</h4>Advances in mobile technology have resulted in federal and industry-level initiatives to facilitate large-scale clinical research using smart devices. Although the benefits of technology to expand data collection are obvious, assumptions about the reach of mobile research methods (<i>access</i>), participant willingness to engage in mobile research protocols (<i>engagement</i>), and the cost of this research (<i>cost</i>) remain untested.<h4>Objective</h4>To assess the feasibi ...[more]

PMID: 27019745

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Project description:BackgroundMobile apps for mental health have the potential to overcome access barriers to mental health care, but there is little information on whether patients use the interventions as intended and the impact they have on mental health outcomes.ObjectiveThe objective of our study was to document and compare use patterns and clinical outcomes across the United States between 3 different self-guided mobile apps for depression.MethodsParticipants were recruited through Web-based advertisements and social media and were randomly assigned to 1 of 3 mood apps. Treatment and assessment were conducted remotely on each participant's smartphone or tablet with minimal contact with study staff. We enrolled 626 English-speaking adults (≥18 years old) with mild to moderate depression as determined by a 9-item Patient Health Questionnaire (PHQ-9) score ≥5, or if their score on item 10 was ≥2. The apps were (1) Project: EVO, a cognitive training app theorized to mitigate depressive symptoms by improving cognitive control, (2) iPST, an app based on an evidence-based psychotherapy for depression, and (3) Health Tips, a treatment control. Outcomes were scores on the PHQ-9 and the Sheehan Disability Scale. Adherence to treatment was measured as number of times participants opened and used the apps as instructed.ResultsWe randomly assigned 211 participants to iPST, 209 to Project: EVO, and 206 to Health Tips. Among the participants, 77.0% (482/626) had a PHQ-9 score >10 (moderately depressed). Among the participants using the 2 active apps, 57.9% (243/420) did not download their assigned intervention app but did not differ demographically from those who did. Differential treatment effects were present in participants with baseline PHQ-9 score >10, with the cognitive training and problem-solving apps resulting in greater effects on mood than the information control app (χ22=6.46, P=.04).ConclusionsMobile apps for depression appear to have their greatest impact on people with more moderate levels of depression. In particular, an app that is designed to engage cognitive correlates of depression had the strongest effect on depressed mood in this sample. This study suggests that mobile apps reach many people and are useful for more moderate levels of depression.ClinicaltrialClinicaltrials.gov NCT00540865; https://www.clinicaltrials.gov/ct2/show/NCT00540865 (Archived by WebCite at http://www.webcitation.org/6mj8IPqQr).

Project description:BackgroundMost people with mental health disorders fail to receive timely access to adequate care. US Hispanic/Latino individuals are particularly underrepresented in mental health care and are historically a very difficult population to recruit into clinical trials; however, they have increasing access to mobile technology, with over 75% owning a smartphone. This technology has the potential to overcome known barriers to accessing and utilizing traditional assessment and treatment approaches.ObjectiveThis study aimed to compare recruitment and engagement in a fully remote trial of individuals with depression who either self-identify as Hispanic/Latino or not. A secondary aim was to assess treatment outcomes in these individuals using three different self-guided mobile apps: iPST (based on evidence-based therapeutic principles from problem-solving therapy, PST), Project Evolution (EVO; a cognitive training app based on cognitive neuroscience principles), and health tips (a health information app that served as an information control).MethodsWe recruited Spanish and English speaking participants through social media platforms, internet-based advertisements, and traditional fliers in select locations in each state across the United States. Assessment and self-guided treatment was conducted on each participant's smartphone or tablet. We enrolled 389 Hispanic/Latino and 637 non-Hispanic/Latino adults with mild to moderate depression as determined by Patient Health Questionnaire-9 (PHQ-9) score≥5 or related functional impairment. Participants were first asked about their preferences among the three apps and then randomized to their top two choices. Outcomes were depressive symptom severity (measured using PHQ-9) and functional impairment (assessed with Sheehan Disability Scale), collected over 3 months. Engagement in the study was assessed based on the number of times participants completed active surveys.ResultsWe screened 4502 participants and enrolled 1040 participants from throughout the United States over 6 months, yielding a sample of 348 active users. Long-term engagement surfaced as a key issue among Hispanic/Latino participants, who dropped from the study 2 weeks earlier than their non-Hispanic/Latino counterparts (P<.02). No significant differences were observed for treatment outcomes between those identifying as Hispanic/Latino or not. Although depressive symptoms improved (beta=-2.66, P=.006) over the treatment course, outcomes did not vary by treatment app.ConclusionsFully remote mobile-based studies can attract a diverse participant pool including people from traditionally underserved communities in mental health care and research (here, Hispanic/Latino individuals). However, keeping participants engaged in this type of "low-touch" research study remains challenging. Hispanic/Latino populations may be less willing to use mobile apps for assessing and managing depression. Future research endeavors should use a user-centered design to determine the role of mobile apps in the assessment and treatment of depression for this population, app features they would be interested in using, and strategies for long-term engagement.Trial registrationClinicaltrials.gov NCT01808976; https://clinicaltrials.gov/ct2/show/NCT01808976 (Archived by WebCite at http://www.webcitation.org/70xI3ILkz).

Project description:To address uncertainties prior to conducting a fully powered randomised controlled trial of Morita Therapy plus treatment as usual (TAU) versus TAU alone, or to determine that such a trial is not appropriate and/or feasible.Pilot parallel group randomised controlled feasibility trial.Participants aged ?18 years with Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV major depressive disorder, with or without DSM-IV anxiety disorder(s), recruited from general practice record searches in Devon, UK.We randomised participants on a 1:1 basis stratified by symptom severity, concealing allocation using a secure independent web-based system, to receive TAU (control) or 8-12 sessions of Morita Therapy, a Japanese psychological therapy, plus TAU (intervention).Rates of recruitment, retention and treatment adherence; variance and estimated between-group differences in follow-up scores (on the Patient Health Questionnaire 9 (PHQ-9) (depressive symptoms); Generalised Anxiety Disorder Questionnaire 7 (anxiety symptoms); Short Form 36 Health Survey Questionnaire/Work and Social Adjustment Scale (quality of life); Morita Attitudinal Scale for Arugamama (attitudes)) and their correlation with baseline scores.We recruited 68 participants, 5.1% (95% CI 3.4% to 6.6%) of those invited (34 control; 34 intervention); 64/68 (94%; 95% CI 88.3% to 99.7%) provided 4-month follow-up data. Participants had a mean age of 49 years and mean PHQ-9 score of 16.8; 61% were female. Twenty-four of 34 (70.6%) adhered to the minimum treatment dose. The follow-up PHQ-9 (future primary outcome measure) pooled SD was 6.4 (95% CI 5.5 to 7.8); the magnitude of correlation between baseline and follow-up PHQ-9 scores was 0.42 (95% CI 0.19 to 0.61). Of the participants, 66.7% and 30.0% recovered in the intervention and control groups, respectively; 66.7% and 13.3% responded to treatment in the intervention and control groups, respectively.A large-scale trial of Morita Therapy would require 133 participants per group and is feasible with minor modifications to the pilot trial protocol. Morita Therapy shows promise in treating depression and may provide patients with a distinct alternative to current treatments.ISRCTN17544090; Pre-results.

Project description:BackgroundBonafide psychotherapy is an effective treatment for generalised anxiety disorder compared to no-treatment. Rather than creating increasing numbers of new overall treatment-packets within a medical meta-model, an additional approach to investigating clinical research designs may be to increase the understanding of already effective psychotherapies. Treatment manuals and protocols allow a relatively high degree of freedom for the way therapists implement the overall treatment manuals. There is a systematic lack of knowledge on how therapists should customise these overall protocols. The present study experimentally examines three ways of conducting a bonafide psychotherapy based on a 15 session time-limited cognitive-behavioural therapy (CBT) protocol and their relation to the therapists' protocol adherence and treatment efficacy.Methods/designThis trial will investigate three different methods of customising a bonafide CBT-protocol using dyadic peer-tutoring methodology (primings). The individuals with GAD will be randomly assigned to one of three priming conditions (resource priming, supportive resource priming, or adherence priming). The participant treatment allocation will be performed randomly. Therapists will be assigned to a peer-tutoring partner and priming condition based on a mutual agreement. Treatment outcomes will be assessed at the following times: observer based in-session outcomes, session-by-session post-session outcomes, treatment outcome at post assessment and treatment outcome at 6-month follow-up.DiscussionThe proposed trial addresses the clinically relevant question of how to customise a bonafide psychotherapy protocol using tandem peer-tutoring methodology (three priming conditions). Through the development and testing of the proposed priming procedures, this study describes levels of adherence and how to conduct an overall treatment protocol in a more systematised way.Trial registrationFrom ClinicalTrials.gov Identifier: NCT02039193.

Project description:BackgroundSchool-based programmes, including hearing screening, provide essential preventive services for rural children. However, minimal evidence on screening methodologies, loss to follow-up, and scarcity of specialists for subsequent care compound rural health disparities. We hypothesised telemedicine specialty referral would improve time to follow-up for school hearing screening compared with standard primary care referral.MethodsIn this cluster-randomised controlled trial conducted in 15 rural Alaskan communities, USA, we randomised communities to telemedicine specialty referral (intervention) or standard primary care referral (control) for school hearing screening. All children (K-12; aged 4-21 years) enrolled in Bering Straight School District were eligible. Community randomisation occurred within four strata using location and school size. Participants were masked to group allocation until screening day, and assessors were masked throughout data collection. Screening occurred annually, and children who screened positive for possible hearing loss or ear disease were monitored for 9 months from the screening date for follow-up. Primary outcome was the time to follow-up after a positive hearing screen; analysis was by intention to treat. The trial was registered with ClinicalTrials.gov, NCT03309553.FindingsWe recruited participants between Oct 10, 2017, and March 28, 2019. 15 communities were randomised: eight (750 children) to telemedicine referral and seven (731 children) to primary care referral. 790 (53·3%) of 1481 children screened positive in at least one study year: 391 (52∤1%) in the telemedicine referral communities and 399 (50∤4%) in the primary care referral communities. Of children referred, 268 (68·5%) in the telemedicine referral communities and 128 (32·1%) in primary care referral communities received follow-up within 9 months. Among children who received follow-up, mean time to follow-up was 41·5 days (SD 55·7) in the telemedicine referral communities and 92·0 days (75·8) in the primary care referral communities (adjusted event-time ratio 17·6 [95% CI 6·8-45·3] for all referred children). There were no adverse events.InterpretationTelemedicine specialty referral significantly improved the time to follow-up after hearing screening in Alaska. Telemedicine might apply to other preventive school-based services to improve access to specialty care for rural children.FundingPatient-Centered Outcomes Research Institute.

Dataset Information

Conducting a fully mobile and randomised clinical trial for depression: access, engagement and expense.

Importance

Objective

Design

Interventions

Results

Conclusions and relevance

Trial registration number

Publications

Conducting a fully mobile and randomised clinical trial for depression: access, engagement and expense.

Similar Datasets

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