A self-guided Internet-delivered intervention for adults with ADHD: a protocol for a randomized controlled trial.
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ABSTRACT: Background
Attention-deficit/hyperactivity disorder (ADHD) in adulthood, with an estimated prevalence of 2-3%, is associated with several challenges in daily life functioning. The availability of evidence-based psychological interventions for adults with ADHD is still poor. Interventions delivered over the Internet on smartphones or personal computers may help to increase the availability of effective psychological interventions. The primary aim of this randomized controlled trial is to examine the efficacy of a self-guided Internet-delivered intervention on severity levels of ADHD symptomatology and quality of life.Methods
We aim to include 118 participants with a self-reported ADHD diagnosis in a randomized controlled trial with two arms: 1) self-guided Internet-delivered intervention for coping with ADHD (N = 59); 2) self-guided online psychoeducation (control group, N = 59). After 3 months, the control group will be given access to the intervention. The primary clinical outcomes are inattention and quality of life. Secondary clinical outcomes are hyperactivity, stress and depression. Measures will be obtained at three time points: before (baseline), immediately after (8 weeks) and 3 months after the intervention. Uptake, usage, adherence and satisfaction will be explored.Discussion
This RCT will provide valuable information on the clinical effectiveness of an Internet-delivered intervention for adults with ADHD. This study is, to our knowledge, one of the first randomized control trials that investigates the effects of a self-guided Internet-delivered psychological intervention in a fairly large group of adults with ADHD.Trial registration
ClinicalTrials.gov, Identifier NCT04726813, January 27, 2021.
SUBMITTER: Kenter RMF
PROVIDER: S-EPMC8632851 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundSelf-guided Internet-delivered interventions may serve as an accessible and flexible non-pharmacological treatment supplement for adults with ADHD. However, these interventions are challenged by low adherence.ObjectiveTo examine whether weekly SMS reminders improve adherence to a self-guided Internet-delivered intervention for adults with ADHD.MethodThe study used a multiple randomized trial design where the participants who had not completed their weekly module within 2 days were randomized to either receive or not receive an SMS reminder. The primary outcome was adherence, defined as module completion, logins, time spent on intervention, and self-reported practice of coping strategies.ResultsA total of 109 adults with a self-reported ADHD diagnosis were included in the study. The results showed that SMS reminders were associated with an increased likelihood of login within 48 h during the second module of the intervention, but not for the remaining modules. Moreover, receiving an SMS reminder was associated spending more time on the modules and faster login time in module three and five, specifically. However, the overall results did not show an effect of SMS reminders on module completion, number of logins or practice of coping strategies.ConclusionThe results showed that SMS reminders do not improve number of logins, module completion rates or practice of coping strategies, but they may lead to faster login time and more time spent on the modules. To utilize the potential of self-guided Internet-delivered intervention in making non-pharmacological accessible for adults with ADHD, new methods to facilitate meaningful engagement should be developed and tested.Trial registrationClinicalTrials.gov NCT04511169.
| S-EPMC9149073 | biostudies-literature
Project description:BackgroundAlthough effective pharmacological treatment exists, many adults with attention-deficit/hyperactivity disorder (ADHD) prefer a nonpharmacological option for managing their symptoms. Internet-delivered self-help interventions have the potential to address this unmet supportive care need reported by adults with ADHD, at relatively low costs. However, if the intervention does not offer optimal functions, content, and layout, it could decrease adherence and engagement and potentially compromise the effectiveness of such interventions. Thus, there is a need for examining the usability and factors that enhance and impair the usability of internet-delivered self-help interventions.ObjectiveThis study evaluates the usability of an internet-delivered self-help intervention for adults with ADHD (MyADHD). The main goals were to (1) collect qualitative and quantitative data on usability and (2) identify usability problems.MethodsIndividual think-aloud interviews and staged usability testing (N=5) were conducted to evaluate the usability of the MyADHD intervention in terms of function, content, and design. MyADHD end users provided iterative feedback to maximize engagement and usability. They performed tasks involved in operating the intervention and provided "think-aloud" commentary and postsession usability ratings. The interviews were recorded, transcribed verbatim, and analyzed.ResultsParticipants were satisfied with the overall usability of the program. The average perceived usability score out of 100 was 70 for the first round of testing and improved to 77.5 after applying modifications, with a mean score of 75.5 (SD 5.9) for all rounds of usability testing. The analysis of the interviews revealed 3 central themes: functionality, content, and layout.ConclusionsOptimizing the usability of internet-delivered self-guided interventions is a critical step in the design and development process. The usability testing in this study provided valuable information from users' perspectives on the content and platform of the intervention. Analysis revealed the need for intervention enhancement with regard to design, functionality, and content from the perspective of potential end users. Overall, participants saw value in the MyADHD intervention and were confident that they could use it for the self-management of symptoms and expressed the desire to use the entire intervention when it becomes available. Through this development process, we produced an intervention that is likely to be used successfully and is ready for deployment in a randomized controlled trial.Trial registrationClinicalTrials.gov NCT04511169; https://clinicaltrials.gov/ct2/show/NCT04511169.
| S-EPMC9636529 | biostudies-literature
Project description:BackgroundOnly a small fraction of individuals with pathological or problematic gambling seek professional help despite available evidence-based treatments such as cognitive behavioral therapy (CBT). Anonymous Internet-based interventions may help to overcome treatment barriers. Results of a pilot study using an Internet-based intervention for depression in a sample of individuals with problematic or pathological gambling behavior show that both depressive and gambling-related symptomatology can be reduced with a generic depression program compared with a wait-list control group. Based on encouraging results of the pilot study, we developed a low-threshold, anonymous and cost-free online self-help program ("Restart") to test whether a program tailored to the needs of gamblers yields better results compared to the effects of the intervention evaluated in the pilot study. The online self-help program is based on CBT, targeting emotional problems and gambling-related symptoms and is accompanied by a smartphone application to sustain treatment benefits.MethodA randomized controlled trial with two conditions (intervention group and wait-list control group), two assessment times (reassessment after 8 weeks) and a total of 136 participants is planned. The primary outcome will be change in pathological gambling measured with the Pathological Gambling Adaptation of Yale-Brown Obsessive-Compulsive Scale from pre to post intervention. The change in depressive symptoms (assessed with the Patient Health Questionnaire - 9 depression module) and gambling-related dysfunctional thoughts (assessed with the Gambling Attitudes and Beliefs Survey) will represent secondary outcomes. The intervention includes modules on debt management, impulse control, gambling-specific cognitive biases, self-esteem, social competence, sleep hygiene, mindfulness and positive activities.DiscussionThis study is one of the first investigations of Internet-based self-help programs in a sample of problematic gamblers. Self-guided Internet-based interventions represent a promising possibility to narrow the existing treatment gap while saving expensive and scarce resources (e.g., psychotherapists). The expected findings will add substantial knowledge in the development of effective Internet-based treatments for individuals with gambling problems. The empirical and clinical implications (e.g., broader use and promotion of such interventions in the future) and the limitations of the study will be discussed.Trial registrationClinicalTrials.gov, NCT03372226 . Registered on 13 December 2017.
| S-EPMC6343284 | biostudies-literature
Project description:Major depression will become the second most important cause of disability in 2020. Computerized cognitive-behaviour therapy could be an efficacious and cost-effective option for its treatment. No studies on cost-effectiveness of low intensity vs self-guided psychotherapy has been carried out. The aim of this study is to assess the efficacy of low intensity vs self-guided psychotherapy for major depression in the Spanish health system.The study is made up of 3 phases: 1.- Development of a computerized cognitive-behaviour therapy for depression tailored to Spanish health system. 2.- Multicenter controlled, randomized study: A sample (N=450 patients) with mild/moderate depression recruited in primary care. They should have internet availability at home, not receive any previous psychological treatment, and not suffer from any other severe somatic or psychological disorder. They will be allocated to one of 3 treatments: a) Low intensity Internet-delivered psychotherapy + improved treatment as usual (ITAU) by GP, b) Self-guided Internet-delivered psychotherapy + ITAU or c) ITAU. Patients will be diagnosed with MINI psychiatric interview. Main outcome variable will be Beck Depression Inventory. It will be also administered EuroQol 5D (quality of life) and Client Service Receipt Inventory (consume of health and social services). Patients will be assessed at baseline, 3 and 12 months. An intention to treat and a per protocol analysis will be performed.The comparisons between low intensity and self-guided are infrequent, and also a comparative economic evaluation between them and compared with usual treatment in primary. The strength of the study is that it is a multicenter, randomized, controlled trial of low intensity and self-guided Internet-delivered psychotherapy for depression in primary care, being the treatment completely integrated in primary care setting.Clinical Trials NCT01611818.
| S-EPMC3626601 | biostudies-literature
Project description:BACKGROUND:Perfectionism is elevated across, and increases risk for, a range of psychological disorders as well as having a direct negative effect on day-to-day function. A growing body of evidence shows that cognitive behavioral therapy (CBT) reduces perfectionism and psychological disorders, with medium to large effect sizes. Given the increased desire for Web-based interventions to facilitate access to evidence-based therapy, Internet-based CBT self-help interventions for perfectionism have been designed. Existing Web-based interventions have not included personalized guidance which has been shown to improve outcome rates. OBJECTIVE:To assess the efficacy of an Internet-based guided self-help CBT intervention for perfectionism at reducing symptoms of perfectionism and psychological disorders posttreatment and at 6-month follow-up. METHODS:A randomized controlled trial method is employed, comparing the treatment arm (Internet-based guided self-help CBT) with a waiting list control group. Outcomes are examined at 3 time points, T1 (baseline), T2 (postintervention at 12 weeks), T3 (follow-up at 24 weeks). Participants will be recruited through universities, online platforms, and social media and if eligible will be randomized using an automatic randomizer. RESULTS:Data will be analyzed to estimate the between group (intervention, control) effect on perfectionism, depression, and anxiety. Completer and intent-to-treat analyses will be conducted. Additional analysis will be conducted to investigate whether the number of modules completed is associated with change. Data collection should be finalized by December 2016, with submission of results for publication expected in mid-year 2017. Results will be reported in line with recommendations in the Consolidated Standards of Reporting Trials Statement for Randomized Controlled Trials of Electronic and Mobile Health Applications and Online TeleHealth (CONSORT-EHEALTH). CONCLUSIONS:Findings will contribute to the literature on treatment of perfectionism, the effect of treating perfectionism on depression and anxiety, and the efficacy of Internet-based guided self-help interventions. CLINICALTRIAL:ClinicalTrials.gov NCT02756871; https://clinicaltrials.gov/ct2/show/NCT02756871 (Archived by WebCite at http://www.webcitation.org/6lmIlSRAa).
| S-EPMC5124110 | biostudies-literature
Project description:The majority of individuals with problematic and pathological gambling remain untreated, and treatment barriers are high. Internet-based interventions can help to address existing barriers, and first studies suggest their potential for this target group. Within a randomized controlled trial (N = 150) with two assessment times (baseline and post-intervention), we aimed to investigate the feasibility, acceptance, and effectiveness of a self-guided Internet-based intervention targeted at gambling problems. We expected a significant reduction in gambling symptoms (primary outcome) and depressive symptoms as well gambling-specific dysfunctional thoughts (secondary outcomes) in the intervention group (IG) compared to a wait-list control group with access to treatment-as-usual (control group, CG) after the intervention period of 8 weeks. Results of the complete cases, per protocol, intention-to-treat (ITT), and frequent user analyses showed significant improvements in both groups for primary and secondary outcomes but no significant between-group differences (ITT primary outcome, F(1,147) = .11, p = .739, ηp2 < .001). Moderation analyses indicated that individuals in the IG with higher gambling and depressive symptoms, older age, and comorbid anxiety symptoms showed significant improvement relative to the CG. The intervention was positively evaluated (e.g., 96.5% rated the program as useful). Possible reasons for the nonsignificant between-group differences are discussed. Future studies should include follow-up assessments and larger samples to address limitations of the present study. Trial Registration ClinicalTrials.gov (NCT03372226), http://clinicaltrials.gov/ct2/show/NCT03372226 , date of registration (13/12/2017).
| S-EPMC8219798 | biostudies-literature
Project description:BackgroundDepression is most common among the elderly and is associated with major impairment. With limited accessible treatments available, remotely provided interventions are needed. Internet-based interventions have been proven effective for a number of mental and somatic health problems. However, the elderly population has received relatively limited attention in previous studies. This study aims to address this gap by investigating the effectiveness of a tailored Internet-delivered modular intervention based on cognitive behavioral therapy (CBT).MethodsA minimum of 60 participants will be recruited and randomly assigned to groups in a two-armed parallel controlled trial with a waiting list. The intervention group will have access to an 8-week therapist-supported modular intervention. The waiting list group will be instructed to wait for 8 weeks and then granted access to the intervention for 8 weeks. Pre, post, and 3-, 12-, and 24-month follow-up assessments are planned for measuring changes in depression symptoms, anxiety symptoms, and psychological well-being using PHQ-9, GDS, GAD-7, and WHO-5. Primary outcomes of all the participants will be analyzed using the intention-to-treat principle, and within- and between-group effect sizes will be calculated.DiscussionInternet-based interventions could help address the existing treatment gap for depressed older adults. However, to date, the effectiveness of Internet-based CBT (ICBT) for depressed older adults has only been tested in a few studies. This trial will demonstrate if Internet-based CBT is effective for this population when compared to a waiting list control. Further analysis of secondary outcomes and participant behavior in the intervention will potentially reveal effectiveness moderating factors.Trial registrationClinicalTrials.gov NCT04728204. Registered on 15 January 2021. https://www.clinicaltrials.gov/ct2/show/NCT04728204?term=NCT04728204&draw=2&rank=1.
| S-EPMC8674830 | biostudies-literature
Project description:BackgroundEmotional and stress-related disorders show high incidence, prevalence, morbidity, and comorbidity rates in Mexico. In recent decades, research findings indicate that cognitive behavioral interventions, from a disorder-specific perspective, are the effective front-line treatment for anxiety and depression care. However, these treatments are not often used. Reasons include limited access and low availability to effective interventions and comorbidity between mental disorders. Emotional deregulation of negative affectivity has been found to be a mediating factor in addressing emotional disorders from a transdiagnostic perspective, aimed at two or more specific disorders. In addition, technological advancement has created alternatives for psychological assistance, highlighting the possibilities offered by technologies since Internet-supported intervention programs have been empirically tested for effectiveness, efficiency and efficacy and can be key to ensuring access to those who are inaccessible. The aim of the study is to evaluate the efficacy, moderators of clinical change and acceptability of a transdiagnostic guided Internet-delivered intervention versus a transdiagnostic self-guided Internet-delivered intervention for emotional, trauma and stress-related disorders, and waiting list in community sample.MethodsA three-armed, parallel group, superiority randomized controlled clinical trial with repeated measurements at four times: pretest, posttest, follow-up at 3, 6 and 12 months. Outcomes assessor, participant, care provider and investigator will be blinded. Participants aged 18 to 70 years will be randomly allocated 1:1:1 to one of three study arms: a) Transdiagnostic guided internet-delivered intervention with synchronous assistance, b) Transdiagnostic self-guided internet-delivered intervention, c) Waiting list group. Based on sample size estimation, a minimum of 207 participants (69 in each intervention group) will be included.DiscussionThe study could contribute to improving the efficacy of transdiagnostic internet-delivered interventions to promote the dissemination of evidence-based treatments and eventually, to decrease the high prevalence of emotional and trauma-related disorders in the Mexican population.Trial registrationClinicalTrial.gov: NCT05225701 . Registered February 4, 2022.
| S-EPMC9360670 | biostudies-literature
Project description:BackgroundPreventing recurrence of depression forms an important challenge for current treatments. Cognitive control impairments often remain present during remission of depression, putting remitted depressed patients at heightened risk for new depressive episodes by disrupting emotion regulation processes. Importantly, research indicates that cognitive control training targeting working memory functioning shows potential in reducing maladaptive emotion regulation and depressive symptomatology in clinically depressed patients and at-risk student samples. The current study aims to test the effectiveness of cognitive control training as a preventive intervention in a remitted depressed sample, exploring effects of cognitive control training on rumination and depressive symptomatology, along with indicators of adaptive emotion regulation and functioning.Methods/designWe present a double blind randomized controlled design. Remitted depressed adults will complete 10 online sessions of a cognitive control training targeting working memory functioning or a low cognitive load training (active control condition) over a period of 14 days. Effects of training on primary outcome measures of rumination and depressive symptomatology will be assessed pre-post training and at three months follow-up, along with secondary outcome measure adaptive emotion regulation. Long-term effects of cognitive control training on broader indicators of functioning will be assessed at three months follow-up (secondary outcome measures).DiscussionThis study will provide information about the effectiveness of cognitive control training for remitted depressed adults in reducing vulnerability for depression. Furthermore, this study will address key questions concerning the mechanisms underlying the effects of cognitive control training, will take into account the subjective experience of the patients (including a self-report measure for cognitive functioning), and explore whether these effects extend to broad measures of functioning such as Quality of Life and disability.Trial registrationThis study is registered with ClinicalTrials.Gov, number NCT02407652 .
| S-EPMC4459439 | biostudies-literature
Project description:BackgroundThe financial costs associated with asthma care continue to increase while care remains suboptimal. Promoting optimal self-management, including the use of asthma action plans, along with regular health professional review has been shown to be an effective strategy and is recommended in asthma guidelines internationally. Despite evidence of benefit, guided self-management remains underused, however the potential for online resources to promote self-management behaviors is gaining increasing recognition. The aim of this paper is to describe the protocol for a pilot evaluation of a website 'Living well with asthma' which has been developed with the aim of promoting self-management behaviors shown to improve outcomes.Methods/designThe study is a parallel randomized controlled trial, where adults with asthma are randomly assigned to either access to the website for 12 weeks, or usual asthma care for 12 weeks (followed by access to the website if desired). Individuals are included if they are over 16-years-old, have a diagnosis of asthma with an Asthma Control Questionnaire (ACQ) score of greater than, or equal to 1, and have access to the internet. Primary outcomes for this evaluation include recruitment and retention rates, changes at 12 weeks from baseline for both ACQ and Asthma Quality of Life Questionnaire (AQLQ) scores, and quantitative data describing website usage (number of times logged on, length of time logged on, number of times individual pages looked at, and for how long). Secondary outcomes include clinical outcomes (medication use, health services use, lung function) and patient reported outcomes (including adherence, patient activation measures, and health status).DiscussionPiloting of complex interventions is considered best practice and will maximise the potential of any future large-scale randomized controlled trial to successfully recruit and be able to report on necessary outcomes. Here we will provide results across a range of outcomes which will provide estimates of efficacy to inform the design of a future full-scale randomized controlled trial of the 'Living well with asthma' website.Trial registrationThis trial is registered with Current Controlled Trials ISRCTN78556552 on 18/06/13.
| S-EPMC4055289 | biostudies-literature