A randomized controlled trial on a self-guided Internet-based intervention for gambling problems.
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ABSTRACT:
SUBMITTER: Bucker L
PROVIDER: S-EPMC8219798 | biostudies-literature |
REPOSITORIES: biostudies-literature
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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:Gambling Disorder is a prevalent non-substance use disorder, which contrasts with the low number of people requesting treatment. Information and Communication Technologies (ICT) could help to enhance the dissemination of evidence-based treatments and considerably reduce the costs. The current study seeks to assess the efficacy of an online psychological intervention for people suffering from gambling problems in Spain. The proposed study will be a two-arm, parallel-group, randomized controlled trial. A total of 134 participants (problem and pathological gamblers) will be randomly allocated to a waiting list control group (N = 67) or an intervention group (N = 67). The intervention program includes 8 modules, and it is based on motivational interviewing, cognitive-behavioral therapy (CBT), and extensions and innovations of CBT. It includes several complementary tools that are present throughout the entire intervention. Therapeutic support will be provided once a week through a phone call with a maximum length of 10 min. The primary outcome measure will be gambling severity and gambling-related cognitions, and secondary outcome measures will be readiness to change, and gambling self-efficacy. Other variables that will be considered are depression and anxiety symptoms, positive and negative affect, difficulties in emotion regulation strategies, impulsivity, and quality of life. Individuals will be assessed at baseline, post-treatment, and 3-, 6-, and 12-month follow-ups. During the treatment, participants will also respond to a daily Ecological Momentary Intervention (EMI) in order to evaluate urges to gamble, self-efficacy to cope with gambling urges, gambling urge frequency, and whether gambling behaviour occurs. The EMI includes immediate automatic feedback depending on the participant's responses. Treatment acceptance and satisfaction will also be assessed. The data will be analysed both per protocol and by Intention-to-treat. As far as we know, this is the first randomized controlled trial of an online psychological intervention for gambling disorder in Spain. It will expand our knowledge about treatments delivered via the Internet and contribute to improving treatment dissemination, reaching people suffering from this problem who otherwise would not receive help.Trial registrationClinicaltrials.gov as NCT04074681. Registered 22 July 2019.
| S-EPMC8501496 | 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:BackgroundAttention-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.MethodsWe 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.DiscussionThis 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 registrationClinicalTrials.gov, Identifier NCT04726813, January 27, 2021.
| S-EPMC8632851 | biostudies-literature
Project description:BackgroundIn spite of the psychosocial burden and medical risks associated with skin picking disorder, the health care system does not provide sufficient treatment for affected individuals to date. Therefore, an internet-based self-help program for skin picking was developed to offer easily accessible support for this population.ObjectiveThis pilot study evaluated the internet-based self-help program SaveMySkin. The 12-week program is based on cognitive-behavioral therapy and contains comprehensive information and exercises, a daily supportive monitoring system, and dermatological and psychological counseling via internet chat. Primary objectives were the investigation of attitudes and expectations toward the program, intervention effects on skin picking severity, user satisfaction, adherence, and willingness to participate. Secondary outcomes included the feasibility of study procedures, adequacy of assessment instruments, effects on skin picking-related impairment, dimensions of skin picking, and general psychological impairment.MethodsA two-arm randomized controlled trial was conducted in a sample of 133 participants (female: 124/133, 93.2%; mean age 26.67 [SD 6.42]) recruited via the internet. Inclusion required a minimum age of 17 years and at least mild skin picking severity. Participants were randomly allocated to the intervention (64/133, 48.1%) or waitlist control group (69/133, 51.9%). All assessments were conducted online and based on self-report.ResultsThe willingness to participate was very high in the study, so the initially planned sample size of 100 was exceeded after only 18 days. Participant expectations indicate that they believed the program to be beneficial for them (131/133, 98.5%) and provide a feeling of support (119/133, 89.5%). Reasons for study participation were insufficient outpatient health care (83/133, 62.4%) and flexibility regarding time (106/133, 79.7%) and location (109/133, 82.0%). The post-assessment was completed by 65.4% (87/133) of the sample. The majority of the intervention group who completed the entire post-assessment were satisfied with SaveMySkin (28/38, 74%) and agreed that the program is an appropriate support service (35/38, 92%). On average, participants viewed 29.31 (SD 42.02) pages in the program, and 47% (30/64) of the intervention group used the monitoring at least once a week. In comparison with the control group, the intervention group displayed substantial improvements in the skin picking severity total score (Cohen d=0.67) and especially on the subscale Symptom Severity (Cohen d=0.79). No effects on secondary outcomes were found.ConclusionsThis study confirms the need for easily accessible interventions for skin picking disorder and the high interest in internet-based self-help within the target population. It provides important insights into the attitudes toward online support and actual user experiences. Participant feedback will be used to further enhance the intervention. Our results point to the preliminary efficacy of SaveMySkin and may lay the foundation for future research into the efficacy and cost-effectiveness of the program in a multicenter clinical trial.Trial registrationGerman Clinical Trial Register DRKS00015236; https://www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00015236.International registered report identifier (irrid)RR2-10.1016/j.conctc.2018.100315.
| S-EPMC6779027 | biostudies-literature
Project description:BackgroundSelf-guided internet-based interventions have several advantages over guided interventions and are generally effective in treating psychiatric symptoms.ObjectiveWe aimed to investigate whether the use of a new self-guided internet-based intervention (MOOD) would lead to a significant reduction in depressive symptoms compared with a care-as-usual (CAU) control group in a sample of individuals with depressive symptoms, most of whom had already used a different self-guided internet-based intervention in a previous trial.MethodsA total of 125 individuals were randomized to the intervention condition (MOOD) and received access to the intervention for a period of six weeks or a CAU group. After six weeks, all participants were invited to take part in the post assessment. The Beck Depression Inventory-II served as the primary outcome.ResultsBoth intention-to-treat as well as per-protocol analyses indicated that the depressive symptomatology decreased in both conditions but showed no advantage for those who had used MOOD. Subsequent moderation analyses suggested that those individuals who had less experience with psychotherapy benefitted to a greater extent compared with those with more experience.ConclusionsSelf-guided internet-based interventions are deemed a suitable first-step approach to the treatment of depression. However, our results indicate that they are more efficacious in those with less psychotherapy experience.Trial registrationClinicalTrials.gov NCT03795480; http://clinicaltrials.gov/ct2/show/NCT03795480.
| S-EPMC6777284 | biostudies-literature
Project description:There is little evidence relating to the effects of adding guidance to internet-based gambling interventions. The primary aim was to compare the effectiveness of an online self-directed cognitive-behavioural gambling program (GamblingLess) with and without therapist-delivered guidance. It was hypothesised that, compared to the unguided intervention, the guided intervention would result in superior improvements in gambling symptom severity, urges, frequency, expenditure, psychological distress, quality of life and help-seeking. A two-arm, parallel-group, randomised trial with pragmatic features and three post-baseline evaluations (8 weeks, 12 weeks, 24 months) was conducted with 206 gamblers (106 unguided; 101 guided). Participants in both conditions reported significant improvements in gambling symptom severity, urges, frequency, expenditure, and psychological distress across the evaluation period, even after using intention-to-treat analyses and controlling for other low- and high-intensity help-seeking, as well as clinically significant changes in gambling symptom severity (69% recovered/improved). The guided intervention resulted in additional improvements to urges and frequency, within-group change in quality of life, and somewhat higher rates of clinically significant change (77% cf. 61%). These findings, which support the delivery of this intervention, suggest that guidance may offer some advantages but further research is required to establish when and for whom human support adds value.
| S-EPMC8196610 | biostudies-literature
Project description:ObjectiveMigration is a profound life transition that may threaten migrants' well-being and mental health. Results of several studies suggest that social self-efficacy beliefs may be beneficial for the psychological adjustment of migrants, buffering the effect of specific stressors related to migration, helping them reduce anxiety levels, and providing support in forming of new social bonds and better integration with a new community or culture. The primary purpose of this randomized controlled trial was to examine the effectiveness of the New in Town internet-based self-efficacy intervention for internal migrants in Poland.MethodsParticipants were 158 internal adult migrants who had changed residence in the last 6 months. They were randomized into two groups: an experimental group (receiving an internet-based self-efficacy intervention), and a waiting list control group. We examined if the intervention was effective in enhancing participants' social self-efficacy (primary outcome), general self-efficacy, social support, satisfaction with life, and reduced reported loneliness (secondary outcomes). Outcome measures were assessed at baseline (Time 1) and 3-weeks later (Time 2). The dropout rate was 50.6%. Initially, we planned to gather follow-up data also 8-weeks after baseline (Time 3). However, due to health and safety reasons related to the COVID-19 pandemic, we decided to stop the trial. Finally, we included in our analysis only data gathered before the COVID-19 pandemic at Time 1 and Time 2.ResultsA total of 159 individuals who met the study's inclusion criteria and completed the baseline assessment were randomly assigned to either the experimental group (n = 80) or the waiting list control group (n = 79). Nevertheless, one participant assigned to the control group was excluded from the analyses because they withdrew their consent to participate after being randomized. The study results suggest that compared to the waitlist control group (n = 78), participants in the experimental group (n = 80) reported a higher level of general self-efficacy beliefs at Time 2 (Cohen's d = 0.47; 95% CI: 0.15-0.79). However, there were no statistically significant effects on social self-efficacy, social support, satisfaction with life, and loneliness.ConclusionThe study offers preliminary support for the effectiveness of an internet-based self-efficacy intervention designed for internal migrants on general self-efficacy beliefs.Trial registrationThe trial was registered with ClinicalTrials.gov (identifier: NCT04088487) on 11th September 2019.
| S-EPMC10919843 | biostudies-literature
Project description:Procrastination is a widespread problem that is highly prevalent among the young adult population and is associated with several negative consequences. However, current evidence on the effectiveness of e-health interventions for procrastination either lack a comparison to an inactive control, do not include a student population or are of poor quality. This protocol describes the design of a trial that will overcome these limitations and examine the effectiveness of a guided internet-based intervention (GetStarted) to reduce problematic procrastinating behaviors in college students compared to a waitlist control. This study will be a two-armed randomized controlled trial with a calculated sample size of N = 176. Participants will be students from seven universities in the Netherlands. The intervention group will receive a four-week e-coach-guided intervention for procrastination. The waitlist control group will get access to treatment four weeks after randomization. Assessments will take place at baseline, post-test (4 weeks post-baseline) and follow-up (6 months post-baseline). Data will be analyzed with an intent-to-treat principle. The primary outcome is change in procrastination behaviors measured on the Irrational Procrastination scale (IPS). Secondary outcomes are depression, anxiety, stress, and quality of life. Additionally, sociodemographic characteristics of the participants, satisfaction with treatment, program usability, satisfaction with e-coach and treatment adherence will be examined as potential moderators. The results from this study can build evidence for the effectiveness of a guided internet-based intervention for treating procrastination in college students. Should it be effective, GetStarted could provide a flexible, low-intense and cost-effective treatment for procrastination and prevent common mental health problems in college students.Trial registrationThis trial is registered at ClinicalTrials.gov Protocol Registration and Results System (Trial number: NCT05478096).
| S-EPMC10009202 | biostudies-literature
Project description:BackgroundLoneliness, or perceived social isolation, is prevalent in both the general population and clinical practice. Although loneliness has repeatedly been associated with mental and physical health, research on interventions that reduce loneliness effectively is still rather scarce.ObjectiveThis study aims to evaluate the efficacy of a guided and an unguided version of the same internet-based cognitive behavioral self-help program for loneliness (SOLUS-D) for adults.MethodsA total of 250 participants will be randomly assigned to 1 of 2 intervention groups (SOLUS-D with guidance or SOLUS-D without guidance) or a wait-list control group (2:2:1 allocation ratio). Adult participants experiencing high levels of loneliness will be recruited from the general population. Individuals currently experiencing at least moderately severe depressive symptoms, an ongoing severe substance use disorder, previous or current bipolar or psychotic disorder, or acute suicidality will be excluded from the trial. Assessments will take place at baseline, 5 weeks (midassessment), and 10 weeks (postassessment). The primary outcome is loneliness assessed using the 9-item University of California, Los Angeles Loneliness Scale at the posttreatment time point. Secondary outcomes include depressive symptoms, symptoms of social anxiety, satisfaction with life, social network size, and variables assessing cognitive bias and social behavior. The maintenance of potentially achieved gains will be assessed and compared at 6 and 12 months after randomization in the 2 active conditions. Potential moderators and mediators will be tested exploratorily. Data will be analyzed on an intention-to-treat basis.ResultsRecruitment and data collection started in May 2021 and are expected to be completed by 2022, with the 12-month follow-up to be completed by 2023. As of the time of submission of the manuscript, 134 participants were randomized.ConclusionsThis 3-arm randomized controlled trial will add to the existing research on the efficacy of loneliness interventions. Furthermore, it will shed light on the role of human guidance in internet-based treatments for individuals with increased levels of loneliness and the possible mechanisms of change. If SOLUS-D proves effective, it could provide a low-threshold, cost-efficient method of helping and supporting individuals with increased levels of loneliness.Trial registrationClinicalTrials.gov NCT04655196; https://clinicaltrials.gov/ct2/show/NCT04655196.International registered report identifier (irrid)DERR1-10.2196/36358.
| S-EPMC9356337 | biostudies-literature