UNASSIGNED: Despite the existence of effective treatments, many individuals with bulimia nervosa (BN) do not receive evidence-based therapies. Integrating digital interventions into routine care might reach more patients and reduce the clinical burden of BN.
UNASSIGNED: To evaluate the effectiveness of a web-based cognitive behavioral self-help intervention for individuals with BN.
UNASSIGNED: A 2-group randomized clinical trial without follow-up was conducted between February 2, 2021, and July 9, 2022, in Germany. Participants aged between 18 and 65 years who met the diagnostic criteria for BN were enrolled online via self-referral. Data analyses were conducted from October 24, 2022, to December 23, 2023.
UNASSIGNED: A web-based cognitive behavioral self-help intervention including 12 weekly modules was compared with a waiting-list control group only having access to routine care.
UNASSIGNED: The primary outcome was the change in the number of bulimic episodes between baseline and posttreatment. Secondary outcomes included changes in global eating disorder symptoms, clinical impairment, well-being, work capacity, comorbid symptoms, self-esteem, and emotion regulation complemented by weekly measures and ecological momentary assessment. Intention-to-treat analyses were performed.
UNASSIGNED: Participants (N = 154; mean [SD] age, 29.6 [8.6] years; 149 [96.8%] female) receiving the web-based intervention demonstrated a significantly greater decrease in bulimic episodes compared with the control group (Cohen d = -0.48; 95% CI, -0.75 to -0.20; P < .001), representing a significant change in binge-eating episodes (Cohen d = -0.61; 95% CI, -0.89 to -0.33; P < .001), but not in compensatory behaviors (Cohen d = -0.25; 95% CI, -0.51 to 0.02; P = .21). The intervention was superior in improving global eating disorder symptoms (Cohen d = -0.61; 95% CI, -0.89 to -0.32; P < .001) and clinical impairment (Cohen d = -0.62; 95% CI, -0.92 to -0.33; P < .001). No significant effects were found for well-being (Cohen d = -0.08; 95% CI, -0.37 to 0.22; P > .99) and work capacity (Cohen d = -0.01; 95% CI, -0.68 to 0.66; P = .99). Exploratory analyses indicated significant changes in self-esteem and emotion regulation difficulties, but not in comorbid symptoms.
UNASSIGNED: In this randomized clinical trial, a web-based cognitive behavioral self-help intervention effectively decreased eating disorder symptoms and illness-related burden in individuals with BN, underlining the potential of digital interventions to complement established treatments.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT04876196.

Background: Many youth with posttraumatic stress symptoms (PTSS) do not receive evidence-based care. Internet- and Mobile-Based Interventions (IMIs) comprising evidence-based trauma-focused components can address this gap, but research is scarce. Thus, we investigated the feasibility of a trauma-focused IMI for youth with PTSS.Methods: In a one-arm non-randomized prospective proof-of-concept study, 32 youths aged 15-21 years with clinically relevant PTSS (CATS ≥ 21) received access to a trauma-focused IMI with therapist guidance, comprising nine sessions on an eHealth platform accessible via web-browser. We used a feasibility framework assessing recruitment capability, sample characteristics, data collection, satisfaction, acceptability, study management abilities, safety aspects, and efficacy of the IMI in PTSS severity and related outcomes. Self-rated assessments took place pre-, mid-, post-intervention and at 3-month follow-up and clinician-rated assessments at baseline and post-intervention.Results: The sample mainly consisted of young adult females with interpersonal trauma and high PTSS levels (CATS, M = 31.63, SD = 7.64). The IMI sessions were found useful and comprehensible, whereas feasibility of trauma processing was perceived as difficult. Around one-third of participants (31%) completed the IMI\'s eight core sessions. The study completer analysis showed a significant reduction with large effects in self-rated PTSS at post-treatment [t(21) = 4.27; p < .001; d = 0.88] and follow-up [t(18) = 3.83; p = .001; d = 0.84], and clinician-rated PTSD severity at post-treatment [t(21) = 4.52; p < .001; d = 0.93]. The intention-to-treat analysis indicated significant reductions for PTSS at post-treatment and follow-up with large effect sizes (d = -0.97- -1.02). All participants experienced at least one negative effect, with the most common being the resurfacing of unpleasant memories (n = 17/22, 77%).Conclusion: The study reached highly burdened young adults. The IMI was accepted in terms of usefulness and comprehensibility but many youths did not complete all sessions. Exploration of strategies to improve adherence in trauma-focused IMIs for youth is warranted, alongside the evaluation of the IMI\'s efficacy in a subsequent randomized controlled trial.
Youth often lack access to evidence-based care after trauma. This study assessed the feasibility of a trauma-focused internet- and mobile-based intervention with therapist guidance.The intervention was accepted by youths, and the preliminary evaluation of participant responses suggests its efficacy.Future studies should examine strategies to improve adherence and the IMI’s efficacy in a RCT.

暂无摘要。

This study explored clinical and sociodemographic moderators of treatment response to \"Be a Mom\", an internet-based cognitive behavioral therapy (iCBT) intervention, from baseline to postintervention, in women at high risk for postpartum depression (PPD). The study also assessed the stability of women\'s treatment gains from baseline to 4-months postintervention (follow-up). This open-label randomized controlled trial (RCT) involved a sample of 1,053 postpartum Portuguese women identified as being at high risk for PPD (i.e., having a score of 5.5 or higher on the Postpartum Depression Predictors Inventory-Revised); participants were allocated to \"Be a Mom\" intervention group or a waiting-list control group, and completed self-report measures at baseline, postintervention, and a 4-month follow-up (554 women completed follow-up assessments). Depressive and anxiety symptoms were measured using the Edinburgh Postnatal Depression Scale and the anxiety subscale of the Hospital Anxiety and Depression Scale, and flourishing/positive mental health was assessed with the Mental Health Continuum. Regression models and linear mixed models were used to examine moderators of treatment and the mid-term efficacy of the \"Be a Mom\" intervention, respectively. The results revealed that treatment completion, higher depression scores at baseline, and higher income levels were linked to greater symptom reduction and positive mental health enhancement. Moreover, the efficacy of the \"Be a Mom\" intervention was supported at the 4-month follow-up. The \"Be a Mom\" intervention appears to be an effective iCBT tool for reducing psychological distress and enhancing positive mental health in women at risk for PPD, with therapeutic improvements maintained over a 4-month period.

BACKGROUND: Cancer has emerged as a considerable global health concern, contributing substantially to both morbidity and mortality. Recognizing the urgent need to enhance the overall well-being and quality of life (QOL) of cancer patients, a growing number of researchers have started using online mindfulness-based interventions (MBIs) in oncology. However, the effectiveness and optimal implementation methods of these interventions remain unknown.
OBJECTIVE: This study evaluates the effectiveness of online MBIs, encompassing both app- and website-based MBIs, for patients with cancer and provides insights into the potential implementation and sustainability of these interventions in real-world settings.
METHODS: Searches were conducted across 8 electronic databases, including the Cochrane Library, Web of Science, PubMed, Embase, SinoMed, CINAHL Complete, Scopus, and PsycINFO, until December 30, 2022. Randomized controlled trials involving cancer patients aged ≥18 years and using app- and website-based MBIs compared to standard care were included. Nonrandomized studies, interventions targeting health professionals or caregivers, and studies lacking sufficient data were excluded. Two independent authors screened articles, extracted data using standardized forms, and assessed the risk of bias in the studies using the Cochrane Bias Risk Assessment Tool. Meta-analyses were performed using Review Manager (version 5.4; The Cochrane Collaboration) and the meta package in R (R Foundation for Statistical Computing). Standardized mean differences (SMDs) were used to determine the effects of interventions. The Reach, Effectiveness, Adoption, Implementation, and Maintenance framework was used to assess the potential implementation and sustainability of these interventions in real-world settings.
RESULTS: Among 4349 articles screened, 15 (0.34%) were included. The total population comprised 1613 participants, of which 870 (53.9%) were in the experimental conditions and 743 (46.1%) were in the control conditions. The results of the meta-analysis showed that compared with the control group, the QOL (SMD 0.37, 95% CI 0.18-0.57; P<.001), sleep (SMD -0.36, 95% CI -0.71 to -0.01; P=.04), anxiety (SMD -0.48, 95% CI -0.75 to -0.20; P<.001), depression (SMD -0.36, 95% CI -0.61 to -0.11; P=.005), distress (SMD -0.50, 95% CI -0.75 to -0.26; P<.001), and perceived stress (SMD -0.89, 95% CI -1.33 to -0.45; P=.003) of the app- and website-based MBIs group in patients with cancer was significantly alleviated after the intervention. However, no significant differences were found in the fear of cancer recurrence (SMD -0.30, 95% CI -1.04 to 0.44; P=.39) and posttraumatic growth (SMD 0.08, 95% CI -0.26 to 0.42; P=.66). Most interventions were multicomponent, website-based health self-management programs, widely used by international and multilingual patients with cancer.
CONCLUSIONS: App- and website-based MBIs show promise for improving mental health and QOL outcomes in patients with cancer, and further research is needed to optimize and customize these interventions for individual physical and mental symptoms.
BACKGROUND: PROSPERO CRD42022382219; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=382219.

OBJECTIVE: This study aimed to explore the acceptability, feasibility, usability, and preliminary effect of an electronic patient-reported outcome (ePRO) intervention for patients with breast cancer in Mexico.
METHODS: We conducted a multimethod non-randomised pilot study. We used a pre-test/post-test design for quantitative assessment of the intervention\'s effect on patients\' supportive care needs and quality of life. We conducted in-depth interviews (IDIs) with participants and healthcare workers to explore the intervention\'s benefits and barriers and understand its feasibility.
METHODS: 50 women aged 20-75 diagnosed with stage I-III breast cancer were enrolled within 2 weeks of starting neoadjuvant or adjuvant treatment with chemotherapy or radiotherapy. We excluded illiterate women and those with visual impairment, cognitive disability or severe depression. IDIs were conducted with 18 participants and 10 healthcare providers.
METHODS: Oncology services in three public hospitals of the Mexican Social Security Institute.
METHODS: The ePRO intervention consisted of a responsive web application for weekly symptom reporting combined with proactive follow-up by nurses guided by predefined clinical algorithms for 6 weeks.
RESULTS: 50 women were enrolled out of 66 eligible patients approached (75.8%). All 50 completed the 4-week follow-up assessment (100% retention). Completion of the symptom registry declined from 100% in week 1 to 66% in week 6. Participants experienced decreases in supportive care needs and increased quality of life. The ePRO application was rated highly usable. Participants and health professionals both perceived intervention benefits. Drawbacks included poor fit for women receiving radiotherapy and challenges using the application for women with low digital literacy or experiencing severe symptoms.
CONCLUSIONS: This pilot study provided evidence of the high usability and potential efficacy of a web-based ePRO intervention. We revised recruitment during the pilot to include multiple facilities, and we will further revise for the randomised trial to address barriers to successful ePRO implementation.
BACKGROUND: ClinicalTrials.gov ID: NCT05925257.

UNASSIGNED: Most individuals with problem gambling or gambling disorder remain untreated due to barriers to treatment. Limited research exists on alternative treatments.
UNASSIGNED: To investigate the efficacy of a self-guided internet-based intervention for individuals with gambling problems and to identify potential outcome moderators.
UNASSIGNED: This single-center randomized clinical trial was conducted from July 13, 2021, to December 31, 2022, at the University Medical Center Hamburg-Eppendorf. Participants were recruited across Germany for 2 assessments (before intervention [t0] and 6 weeks after intervention [t1]). Eligible participants were individuals aged 18 to 75 years with gambling problems, internet access, German proficiency, and willingness to participate in 2 online assessments.
UNASSIGNED: The self-guided internet-based intervention was based on cognitive behavioral therapy, metacognitive training, acceptance and commitment therapy, and motivational interviewing.
UNASSIGNED: The primary outcome was change in gambling-related thoughts and behavior as measured with the pathological gambling adaption of the Yale-Brown Obsessive-Compulsive Scale. Secondary outcomes were change in depressive symptoms, gambling severity, gambling-specific dysfunctional thoughts, attitudes toward online interventions, treatment expectations, and patient satisfaction.
UNASSIGNED: A total of 243 participants (154 [63.4%] male; mean [SD] age, 34.73 [10.33] years) were randomized to an intervention group (n = 119) that gained access to a self-guided internet-based intervention during 6 weeks or a wait-listed control group (n = 124). Completion at t1 was high (191 [78.6%]). Results showed a significantly greater reduction in gambling-related thoughts and behavior (mean difference, -3.35; 95% CI, -4.79 to -1.91; P < .001; Cohen d = 0.59), depressive symptoms (mean difference, -1.05; 95% CI, -1.87 to -0.22; P = .01; Cohen d = 0.33), and gambling severity (mean difference, -1.46; 95% CI, -2.37 to -0.54; P = .002; Cohen d = 0.40) but not in gambling-specific dysfunctional thoughts (mean difference, -1.62; 95% CI, -3.40 to 0.15; P = .07; Cohen d = 0.23) favoring the intervention group. Individuals in the intervention group who had a positive treatment expectation and more severe gambling-specific dysfunctional thoughts and gambling symptoms benefited more on the primary outcome relative to the control group.
UNASSIGNED: In this randomized clinical trial, the effectiveness of a self-guided internet-based intervention for individuals with self-reported problematic gambling behavior was demonstrated when measured 6 weeks after start of the intervention. The study\'s findings are particularly relevant given the increasing need for accessible and scalable solutions to address problematic gambling.
UNASSIGNED: bfarm.de Identifier: DRKS00024840.

BACKGROUND: Internet-based cognitive behavioral interventions (iCBTs) are efficacious treatments for depression and anxiety. However, it is unknown whether adding human guidance is feasible and beneficial within a large educational setting.
OBJECTIVE: This study aims to potentially demonstrate the superiority of 2 variants of a transdiagnostic iCBT program (human-guided and computer-guided iCBT) over care as usual (CAU) in a large sample of university students and the superiority of human-guided iCBT over computer-guided iCBT.
METHODS: A total of 801 students with elevated levels of anxiety, depression, or both from a large university in the Netherlands were recruited as participants and randomized to 1 of 3 conditions: human-guided iCBT, computer-guided iCBT, and CAU. The primary outcome measures were depression (Patient Health Questionnaire) and anxiety (Generalized Anxiety Disorder scale). Secondary outcomes included substance use-related problems (Alcohol Use Disorder Identification Test and Drug Abuse Screening Test-10 items). Linear mixed models were used to estimate the effects of time, treatment group, and their interactions (slopes). The primary research question was whether the 3 conditions differed in improvement over 3 time points (baseline, midtreatment, and after treatment) in terms of depression and anxiety symptoms. Results were analyzed according to the intention-to-treat principle using multiple imputation. Patients were followed exploratively from baseline to 6 and 12 months.
RESULTS: In both short-term and long-term analyses, the slopes for the 3 conditions did not differ significantly in terms of depression and anxiety, although both web-based interventions were marginally more efficacious than CAU over 6 months (P values between .02 and .03). All groups showed significant improvement over time (P<.001). For the secondary outcomes, only significant improvements over time (across and not between groups) were found for drug use (P<.001). Significant differences were found in terms of adherence, indicating that participants in the human-guided condition did more sessions than those in the computer-guided condition (P=.002).
CONCLUSIONS: The transdiagnostic iCBT program offers a practical, feasible, and efficacious alternative to usual care to tackle mental health problems in a large university setting. There is no indication that human guidance should be preferred over technological guidance. The potential preference of human support also depends on the scale of implementation and cost-effectiveness, which need to be addressed in future trials.
BACKGROUND: International Clinical Trials Registry Platform NL7328/NTR7544; https://trialsearch.who.int/Trial2.aspx?TrialID=NL-OMON26795.

BACKGROUND: Hematopoietic cell transplantation (HCT) is a highly invasive and life-threatening treatment for hematological neoplasms and some types of cancer that can challenge the patient\'s meaning structures. Restoring meaning (i.e., building more flexible and significant explanations of the disease and treatment burden) can be aided by strengthening psychological flexibility by means of an Acceptance and Commitment Therapy (ACT) intervention. Thus, this trial aims to examine the effect of the ACT intervention on the meaning-making process and the underlying mechanisms of change in patients following HCT compared to a minimally enhanced usual care (mEUC) control group. The trial will be enhanced with a single-case experimental design (SCED), where ACT interventions will be compared between individuals with various pre-intervention intervals.
METHODS: In total, 192 patients who qualify for the first autologous or allogeneic HCT will be recruited for a two-armed parallel randomized controlled trial comparing an online self-help 14-day ACT training to education sessions (recommendations following HCT). In both conditions, participants will receive once a day a short survey and intervention proposal (about 5-10 min a day) in the outpatient period. Double-blinded assessment will be conducted at baseline, during the intervention, immediately, 1 month, and 3 months after the intervention. In addition, 6-9 participants will be invited to SCED and randomly assigned to pre-intervention measurement length (1-3 weeks) before completing ACT intervention, followed by 7-day observations at the 2nd and 3rd post-intervention measure. The primary outcome is meaning-related distress. Secondary outcomes include psychological flexibility, meaning-making coping, meanings made, and well-being as well as global and situational meaning.
CONCLUSIONS: This trial represents the first study that integrates the ACT and meaning-making frameworks to reduce meaning-related distress, stimulate the meaning-making process, and enhance the well-being of HCT recipients. Testing of an intervention to address existential concerns unique to patients undergoing HCT will be reinforced by a statistically rigorous idiographic approach to see what works for whom and when. Since access to interventions in the HCT population is limited, the web-based ACT self-help program could potentially fill this gap.
BACKGROUND: ClinicalTrials.gov ID: NCT06266182. Registered on February 20, 2024.

BACKGROUND: Depression poses a major threat to public health with an increasing prevalence in the United States. Mindfulness-based interventions, such as mindfulness-based cognitive therapy (MBCT), are effective methods for managing depression symptoms and may help fortify existing efforts to address the current disease burden. The in-person group format of MBCT, however, incurs barriers to care such as expenses, childcare needs, and transportation issues. Alternate delivery modalities such as MBCT delivered via the web can be investigated for their capacity to overcome these barriers and still reduce symptoms of depression with adequate feasibility and efficacy.
OBJECTIVE: This study protocol aims to examine the feasibility and efficacy of MBCT delivered via the web for the treatment of depression.
METHODS: To attain study aims, 2 phases will be implemented using a waitlist control design. A total of 128 eligible participants will be randomized into either an 8-week MBCT intervention group plus treatment as usual (MBCT + TAU; group 1) or an 8-week waitlist control group (group 2). In phase I (8 weeks), group 1 will complete the intervention and group 2 will proceed with TAU. In phase II (8 weeks), group 2 will complete the intervention and group 1 will continue with TAU until reaching an 8-week follow-up. TAU may consist of receiving psychotherapy, pharmacotherapy, or combined treatment. Data collection will be completed at baseline, 8 weeks (postintervention for group 1 and preintervention for group 2), and 16 weeks (follow-up for group 1, postintervention for group 2). The primary outcomes will include (1) current, residual, or chronic depression symptoms and (2) psychiatric distress. Secondary outcomes will include perceived stress and facets of mindfulness. The feasibility will be measured by assessing protocol adherence, retention, attendance, and engagement. Finally, the extent of mindfulness self-practice and executive functioning skills will be assessed as mediators of intervention outcomes.
RESULTS: This study began screening and recruitment in December 2022. Data collection from the first cohort occurred in January 2023. By November 2023, a total of 30 participants were enrolled out of 224 who received screening. Data analysis began in February 2024, with an approximate publication of results by August 2024. Institutional review board approval took place on September 11, 2019.
CONCLUSIONS: This trial will contribute to examining mindfulness-based interventions, delivered via the web, for improving current, residual, or chronic depression symptoms. It will (1) address the feasibility of MBCT delivered via the web; (2) contribute evidence regarding MBCT\'s efficacy in reducing depression symptoms and psychiatric distress; and (3) assess the impact of MBCT on several important secondary outcomes. Findings from this study will develop the understanding of the causal pathways between MBCT delivered via the web and depression symptoms further, elucidating the potential for future larger-scale designs.
BACKGROUND: ClinicalTrials.gov NCT05347719; https://www.clinicaltrials.gov/ct2/show/NCT05347719.
UNASSIGNED: DERR1-10.2196/53966.