Dataset Information

The PTSD help app in a Danish PTSD population: research protocol of a randomized controlled feasibility trial.

ABSTRACT: Background:Due to an increase in PTSD patients seeking help in the Danish mental health sector and the addition of Complex PTSD to the ICD-11, there is a need to increase efficiency of existing treatments for PTSD. mHealth interventions have been shown to reduce PTSD symptoms. Therefore, the implementation of a mHealth intervention designed for psychiatric PTSD patients as a therapy add-on may improve treatment outcome. No study to date has explored the effects of mHealth interventions for PTSD in the Danish mental health sector, the feasibility and effect of this type of intervention needs testing. Methods:The study is an investigator-initiated randomized controlled feasibility trial investigating the clinical mHealth tool PTSD help combined with care as usual (CAU) compared to CAU for adults with PTSD. Seventy patients will be recruited and receive either the mHealth intervention combined with CAU or CAU alone. The primary feasibility outcome is the proportion of eligible patients that participate in the study until the end assessment. Secondary outcome data consists of the fraction of compliant patients in the experimental group and exploratory data on PTSD help on PTSD symptom severity, level of psychological distress, sleep quality, dissociation symptoms, therapy readiness, quality of life, disability levels, and recovery. Discussion:This study may help increase our knowledge of possible benefits of, as well as potential barriers to, the implementation of mHealth tools in the psychiatric sector. It may also provide a cost-efficient means to increase therapy outcomes and decrease the duration of suffering for PTSD patients in the psychiatric sector. Trial registration:The trial is registered at ClinicalTrials.gov (ID: NCT03862703) https://clinicaltrials.gov/ct2/show/NCT03862703 on the 27 of February 2019 and has been approved by the Danish Data Protection Agency (journal number: VD-2018-200 ISuite number 6443). Referring to the committee law §2, the National Committee on Health Research Ethics (DNVK) [H-18024180] decided that the study could proceed without approval as the use of PTSD help did not constitute a health science intervention according to Danish health science legislation.

SUBMITTER: Scharff FB

PROVIDER: S-EPMC7325563 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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The PTSD help app in a Danish PTSD population: research protocol of a randomized controlled feasibility trial.

Scharff Frederik Bernt FB Lau Marianne Engelbrecht ME Riisager Lisa Helena Grønberg LHG Møller Stine Bjerrum SB Salimi Mehrak Lykkeberg ML Gondan Matthias M Folke Sofie S

Pilot and feasibility studies 20200630

<h4>Background</h4>Due to an increase in PTSD patients seeking help in the Danish mental health sector and the addition of Complex PTSD to the ICD-11, there is a need to increase efficiency of existing treatments for PTSD. mHealth interventions have been shown to reduce PTSD symptoms. Therefore, the implementation of a mHealth intervention designed for psychiatric PTSD patients as a therapy add-on may improve treatment outcome. No study to date has explored the effects of mHealth interventions f ...[more]

PMID: 32617173

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Project description:BackgroundSurgical site infections (SSIs) are the most common nosocomial infection and occur in 16.3% of patients undergoing colorectal surgery at our institution (The Ottawa Hospital), the majority of which are identified after discharge from hospital. Patients who suspect having an SSI generally present to the emergency department or surgery clinic. Both options for in-person interaction are costly to the health care system and patients. A mobile app, how2trak, has proven to be beneficial for patients with complex wounds at our institution by facilitating at-home monitoring and virtual consultations.ObjectiveThis study aims to assess the feasibility of a randomized controlled trial to assess if how2trak can improve patients' experience and increase detection of SSIs after colorectal surgery while reducing patients' risk of COVID-19 exposure.MethodsIn this single-center prospective feasibility trial, eligible patients undergoing colorectal surgery will be randomized to either standard care or how2trak postoperative monitoring of their incision, symptoms, and ostomy function. Patient self-assessments will be monitored by a nurse specialized in wound and ostomy care who will follow-up with patients with a suspected SSI. The primary outcome is feasibility as measured by enrollment, randomization, app usability, data extraction, and resource capacity.ResultsThis study was approved by our institution's ethics board on February 26, 2021, and received support from The Ottawa Hospital Innovation and Care Funding on November 12, 2021. Recruitment started June 3, 2021, and 29 were patients enrolled as of September 2021. We expect to publish results in spring 2022.ConclusionsThis study will determine the feasibility of using a mobile app to monitor patients' wounds and detect SSIs after colorectal surgery. If feasible, we plan to assess if this mobile app facilitates SSI detection, enhances patient experience, and optimizes their care.Trial registrationClinicalTrials.gov NCT04869774; https://clinicaltrials.gov/ct2/show/NCT04869774.International registered report identifier (irrid)DERR1-10.2196/26717.

Project description:BACKGROUND:Shared decision making (SDM) is recognized as a person-centered approach to improving health care quality and outcomes. Few digital interventions to improve SDM have been tested in child and adolescent mental health (CAMH) settings. One such intervention is Power Up, a mobile phone app for young people (YP), which has shown some evidence of promise that YP who received Power Up reported greater levels of SDM. However, even though parents play a critical role in CAMH care and treatment, they often feel excluded from services. OBJECTIVE:This protocol is for a pilot trial to determine the feasibility of a large-scale randomized trial to develop and evaluate a Web app called Power Up for Parents (PUfP) to support parents and promote involvement in CAMH decisions. METHODS:A 2-stage process, consisting of the development stage and pilot-testing stage of the initial PUfP prototype, will be conducted. At the development stage, a qualitative study with parents and clinicians will be conducted. The interviews will aim to capture the experience of making CAMH decisions, preferences for involvement in SDM, and determine situations within which PUfP can be useful. At the pilot-testing stage, up to 90 parents and their clinicians will be invited to participate in the testing of the prototype. Parents will be randomly allocated to receive the intervention or be part of the control group. This study design will allow us to assess the acceptability and usefulness of PUfP in addition to examining the feasibility of a prospective randomized trial. Clinicians' perceptions of the prototype and how it has influenced parents' involvement in SDM will also be examined. RESULTS:Recruitment began in January 2019 and is scheduled to last for 10 months. Interviews and baseline data collection are currently in progress. To date, 11 CAMH sites have been recruited to take part in the study. It is anticipated that data collection will be completed by October 2019. CONCLUSIONS:The lack of parents' involvement in CAMH care and treatment can lead to higher rates of dropout from care and lower adherence to therapeutic interventions. There are significant benefits to be gained globally if digital SDM interventions are adopted by parents and shown to be successful in CAMH settings. TRIAL REGISTRATION:ISRCTN Registry ISRCTN39238984; http://www.isrctn.com/ISRCTN39238984. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/14571.

Project description:BackgroundSyrian refugees residing in Germany often develop posttraumatic stress as a result of the Syrian civil war, their escape, and postmigration stressors. At the same time, there is a lack of adequate treatment options. The smartphone-based app Sanadak was developed to provide cognitive behavioral therapy-based self-help in the Arabic language for Syrian refugees with posttraumatic stress.ObjectiveThe aim of this study was to evaluate the effectiveness and cost-effectiveness of the app.MethodsIn a randomized controlled trial, eligible individuals were randomly allocated to the intervention group (IG; app use) or control group (CG; psychoeducational reading material). Data were collected during structured face-to-face interviews at 3 assessments (preintervention/baseline, postintervention/after 4 weeks, follow-up/after 4 months). Using adjusted mixed-effects linear regression models, changes in posttraumatic stress and secondary outcomes were investigated as intention-to-treat (ITT) and per-protocol (PP) analysis. Cost-effectiveness was evaluated based on adjusted mean total costs, quality-adjusted life years (QALYs), and cost-effectiveness acceptability curves using the net benefit approach.ResultsOf 170 screened individuals (aged 18 to 65 years), 133 were eligible and randomized to the IG (n=65) and CG (n=68). Although there was a pre-post reduction in posttraumatic stress, ITT showed no significant differences between the IG and CG after 4 weeks (Posttraumatic Diagnostic Scale for DSM-5, Diff -0.90, 95% CI -0.24 to 0.47; P=.52) and after 4 months (Diff -0.39, 95% CI -3.24 to 2.46; P=.79). The same was true for PP. Regarding secondary outcomes, ITT indicated a treatment effect for self-stigma: after 4 weeks (Self-Stigma of Mental Illness Scale/SSMIS-stereotype agreement: d=0.86, 95% CI 0.46 to 1.25; stereotype application: d=0.60, 95% CI 0.22 to 0.99) and after 4 months (d=0.52, 95% CI 0.12 to 0.92; d=0.50, 95% CI 0.10 to 0.90), the IG showed significantly lower values in self-stigma than the CG. ITT showed no significant group differences in total costs and QALYs. The probability of cost-effectiveness was 81% for a willingness-to-pay of €0 per additional QALY but decreased with increasing willingness-to-pay.ConclusionsSanadak was not more effective in reducing mild to moderate posttraumatic stress in Syrian refugees than the control condition nor was it likely to be cost-effective. Therefore, Sanadak is not suitable as a standalone treatment. However, as the app usability was very good, no harms detected, and stigma significantly reduced, Sanadak has potential as a bridging aid within a stepped and collaborative care approach.Trial registrationGerman Clinical Trials Register DRKS00013782; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00013782.International registered report identifier (irrid)RR2-10.1186/s12888-019-2110-y.

Project description:Approximately 50% of women gain excessive weight in pregnancy. Optimizing gestational weight gain is important for the short- and long-term health of the childbearing woman and her baby. Despite this, there is no recommendation for routine weighing in pregnancy, and weight is a topic that many maternity care providers avoid. Resource-intensive interventions have mainly targeted overweight and obese women with variable results. Few studies have examined the way that socioeconomic status might influence the effectiveness or acceptability of an intervention to participants. Given the scale of the problem of maternal weight gain, maternity services will be unlikely to sustain resource intensive interventions; therefore, innovative strategies are required to assist women to manage weight gain in pregnancy.The primary aim of the trial was to examine the effectiveness of the Eating4Two smartphone app in assisting women of all body mass index categories to optimize gestational weight gain. Secondary aims include comparing childbirth outcomes and satisfaction with antenatal care and examining the way that relative advantage and disadvantage might influence engagement with and acceptability of the intervention.This randomized controlled trial will randomize 1330 women to control or intervention groups in 3 regions of different socioeconomic status. Women will be recruited from clinical and social media sites. The intervention group will be provided with access to the Eating4Two mobile phone app which provides nutrition and dietary information specifically tailored for pregnancy, advice on food serving sizes, and a graph that illustrates women's weight change in relation to the range recommended by the Institute of Medicine. Women will be encouraged to use the app to prompt conversations with their maternity care providers about weight gain in pregnancy. The control group will receive routine antenatal care.Recruitment has commenced though the recruitment rate is slower than expected. Additional funds are required to employ research assistants and promote the study in an advertising campaign.Feasibility testing highlighted the inadequacy of the original recruitment strategy and the need to provide the app in both major platforms (Android and iOS). Smartphone technologies may offer an effective alternative to resource intensive strategies for assisting women to optimize weight gain in pregnancy.Australian New Zealand Clinical Trials Registry ACTRN12617000169347; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371470 (Archived by WebCite at http://www.webcitation.org /6zDvgw5bo).RR1-10.2196/9920.

Project description:BackgroundThere is a need for more resources to support the cognition and quality of life of people with dementia. The individual cognitive stimulation therapy (iCST) app aims to provide cognitive stimulation and social interaction to people with dementia and carers through interactive touchscreen technology. The iCST app has been developed according to the principles of CST and iCST, which have previously shown to improve the cognition and quality of life of people with dementia and benefit the relationship between the person with dementia and his/her carer. The iCST app has also shown to improve the quality of the carer's life.ObjectiveThe aim of this study is to evaluate the usability of the iCST app intervention and the feasibility of conducting a full-scale randomized controlled trial (RCT) to assess the clinical effectiveness of the iCST app intervention compared to that of treatment-as-usual for people with mild-to-moderate dementia.MethodsWe aim to recruit 60 people with mild-to-moderate dementia and their informal carers as dyads in a multi-center feasibility RCT with a treatment-as-usual control group. Both parties must be able to provide informed consent and participate in the intervention. Dyads will complete a baseline assessment that will include cognition and quality of life measures and they will subsequently be randomized (1:1) to the iCST app intervention in addition to usual care or to usual care only. All participants will be followed up at 5 weeks and at 11 weeks after the baseline assessments. A range of feasibility outcomes will be assessed, including recruitment and retention rates, intervention fidelity and usability, and acceptability of the outcome measures. A sample of the experimental group will be invited to a semistructured posttrial interview to further examine the experience of using the iCST app.ResultsThis study received funding in May 2015 and obtained ethical approval in March 2018. Data collection began in November 2018 and was completed in March 2020 with a total of 61 dyads recruited. Data analyses are in progress and the final results are expected to be available in the spring of 2021.ConclusionsThis study will investigate whether it is feasible to conduct a full-scale RCT to evaluate the clinical effectiveness of the iCST app in comparison to that of usual care alone. In addition, this study will examine the usability of the iCST app. The data will provide information on potential modifications to be made to the intervention, study design, and study process.Trial registrationClinicalTrials.gov NCT03282877; https://clinicaltrials.gov/ct2/show/NCT03282877.International registered report identifier (irrid)DERR1-10.2196/24628.

Project description:ObjectivePosttraumatic stress disorder (PTSD) symptoms (PTSS) are common after minor injuries and can impair recovery. We sought to understand whether an evidence-based mobile phone application with self-help tools (PTSD Coach) could be useful to improve recovery after acute trauma among injured emergency department (ED) patients. This pilot study examined the feasibility, acceptability, and potential benefit of using PTSD Coach among acutely injured motor vehicle crash (MVC) patients.MethodsFrom September 2017 to September 2018, we recruited adult patients within 24 hours post-MVC from the EDs of two Level I trauma centers in the United States. We randomly assigned 64 injured adults to either the PTSD Coach (n = 33) or treatment as usual (TAU; n = 31) condition. We assessed PTSS and associated symptoms at 1 month (83% retained) and 3 months (73% retained) postenrollment.ResultsEnrollment was feasible (74% of eligible subjects participated) but usability and engagement were low (67% used PTSD Coach at least once, primarily in week 1); 76% of those who used it rated the app as moderately to extremely helpful. No differences emerged between groups in PTSS outcomes. Exploratory analyses among black subjects (n = 21) indicated that those in the PTSD Coach condition (vs. TAU) reported marginally lower PTSS (95% CI = -0.30 to 37.77) and higher PTSS coping self-efficacy (95% CI = -58.20 to -3.61) at 3 months.ConclusionsWe demonstrated feasibility to recruit acutely injured ED patients into an app-based intervention study, yet mixed evidence emerged for the usability and benefit of PTSD Coach. Most patients used the app once and rated it favorably in regard to satisfaction with and helpfulness, but longitudinal engagement was low. This latter finding may explain the lack of overall effects on PTSS. Additional research is warranted regarding whether targeting more symptomatic patients and the addition of engagement and support features can improve efficacy.

Project description:BackgroundAlcohol misuse is higher in the UK armed forces (AF) than in the general population. Research demonstrates that alcohol misuse persists after an individual leaves service, and this is notably the case for those who are seeking help for a mental health difficulty. Despite this, there is no work on testing a mobile alcohol reduction intervention that is personalized to support the UK AF.ObjectiveTo address this gap, we investigated the efficacy of a 28-day brief alcohol intervention delivered via a mobile app in reducing weekly self-reported alcohol consumption among UK veterans seeking help for mental health difficulties.MethodsWe performed a 2-arm participant-blinded randomized controlled trial (RCT). We compared a mobile app that included interactive features designed to enhance participants' motivation and personalized messaging (intervention arm) with a version that provided government guidance on alcohol consumption only (control arm). Adults were eligible if they had served in the UK AF, were currently receiving or had received clinical support for mental health symptoms, and consumed 14 units (approximately 112 g of ethanol) or more of alcohol per week. Participants received the intervention or the control mobile app (1:1 ratio). The primary outcome was a change in self-reported weekly alcohol consumption between baseline and day 84 assessed using the validated Timeline Follow Back for Alcohol Consumption (TLFB) (prior 7 days), with a secondary outcome exploring self-reported change in the Alcohol Use Disorder Identification Test (AUDIT) score.ResultsBetween October 2020 and April 2021, 2708 individuals were invited to take part, of which 2531 (93.5%) did not respond, 54 (2%) were ineligible, and 123 (4.5%) responded and were randomly allocated (62, 50.4%, intervention; 61, 49.6%, control). At day 84, 41 (66.1%) participants in the intervention arm and 37 (60.7%) in the control arm completed the primary outcome assessment. Between baseline and day 84, weekly alcohol consumption reduced by -10.5 (95% CI -19.5 to -1.5) units in the control arm and -28.2 (95% CI -36.9 to -19.5) units in the intervention arm (P=.003, Cohen d=0.35). We also found a significant reduction in the AUDIT score of -3.9 (95% CI -6.2 to -1.6) in the intervention arm (Cohen d=0.48). Our primary and secondary effects did not persist over the longer term (day 168). Two adverse events were detected during the trial.ConclusionsThis study examined the efficacy of a fully automated 28-day brief alcohol intervention delivered via a mobile app in a help-seeking sample of UK veterans with hazardous alcohol consumption. We found that participants receiving Drinks:Ration reduced their alcohol consumption more than participants receiving guidance only (at day 84). In the short term, we found Drinks:Ration is efficacious in reducing alcohol consumption in help-seeking veterans.Trial registrationClinicalTrials.gov NCT04494594; https://tinyurl.com/34em6n9f.International registered report identifier (irrid)RR2-10.2196/19720.

Project description:BACKGROUND:Obsessive-compulsive disorder (OCD) is a disabling condition with a wide variety of clinical presentations including contamination fears, fear of harm, and relationship-related obsessions. Cognitive behavioral models of OCD suggest that OC symptoms result from catastrophic misinterpretations of commonly occurring intrusive experiences and associated dysfunctional strategies used to manage them. OCD-related maladaptive beliefs including inflated responsibility, importance and control of thoughts, perfectionism, and intolerance for uncertainty increase the likelihood of such misinterpretations. OBJECTIVE:Considering accumulating evidence suggesting that mobile health (mHealth) apps based on cognitive-behavioral principles may lead to significant reductions in psychopathological symptoms, we assessed the effectiveness of a novel cognitive training app (GGRO) designed to challenge OCD-related beliefs. METHODS:A total of 97 students were randomized to groups undertaking immediate-use (iApp) or delayed use (dApp) of GGRO. All participants were requested to complete Web-based assessments, with questionnaires relating to maladaptive beliefs, mood, and OC symptoms at baseline (T1), 15 days from baseline (T2), and 30 days from baseline (T3). Participants in iApp group started using the app at baseline and continued using the app for 15 consecutive days. They were then requested to stop using the app until T3. Participants in the dApp group were requested to wait for 15 days and only then start using the app (crossover) for 15 consecutive days. RESULTS:All participants used the app for a mean of 14.07 (SD 1.41) days with 2.94 levels per day. Consistent with previous findings, app use was associated with medium-large effect size reductions in both iApp (n=51) and dApp (n=46) groups. In the iApp group, all effects remained significant during the 15 days of follow-up. Analyses focusing on the first two assessment occasions revealed significant treatment × repeated measures interactions on maladaptive beliefs, several OC symptom measures, and self-esteem. CONCLUSIONS:This study provides further evidence for the efficacy of GGRO as a mobile-delivered training exercise that is useful for reducing OCD-related beliefs and symptoms. TRIAL REGISTRATION:ClinicalTrials.gov NCT03571464; https://clinicaltrials.gov/ct2/show/NCT03571464 (Archived by WebCite at http://www.webcitation.org/7675sYPsH).

Dataset Information

The PTSD help app in a Danish PTSD population: research protocol of a randomized controlled feasibility trial.

Publications

The PTSD help app in a Danish PTSD population: research protocol of a randomized controlled feasibility trial.

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