The effectiveness of unguided self-help psychological interventions for obsessive-compulsive disorder: A meta-analysis of randomized controlled trials.

BACKGROUND: Evidence-based psychological interventions exist for individuals with obsessive-compulsive disorder (OCD), but many individuals with OCD are unable to access them because of barriers, such as geographical isolation, treatment cost, and stigma etc. Unguided self-help psychological intervention has emerged as a potential solution to this problem. However, there is limited research on its overall effectiveness. This study aimed to address this gap. METHODS: Comprehensive searches from inception to 1st Jan 2023 were conducted in both international (PubMed, Embase, PsycINFO, International clinical trials registry platform of WHO) and Chinese (China National Knowledge Infrastructure, WeiPu, WanFang, Chinese Clinical Trial Registry) databases. The registered protocol is accessible at https://doi.org/10.17605/OSF.IO/FKB5W. We included randomized controlled trials (RCTs) comparing unguided self-help psychological interventions to control groups for individuals with OCD. The primary outcome was OCD symptom severity, with Hedges' g calculated post-intervention. Heterogeneity was deemed to be low, moderate, and high if the I2 value was quantified 25%, 50%, and 75% respectively. Relative Risks (RRs) was calculated for dropout rates post-intervention. Random-effects models were used for all analyses. RESULTS: 12 RCTs comparing unguided self-help psychological interventions to control groups were identified, with a total of 20 comparisons and 769 OCD patients. Overall, unguided self-help psychological interventions demonstrated a significant moderate effect on reducing OCD symptom severity (g = -0.42; 95% CI [-0.69; -0.14]) compared to control groups, with a moderate heterogeneity (I2 = 59%; 95% CI [22.73; 78.38]). This finding remained significant in sensitivity analyses for the self-rated Yale-Brown Obsessive-Compulsive Scale (Y-BOCS; k = 7, g = -0.46; 95% CI [-0.71; -0.2]) and after removing an outlier (g = -0.37; 95% CI [-0.55; -0.19]), but not for the clinician-rated Y-BOCS (k = 4, g = -0.78; 95% CI [-2.75; 1.19]) and Obsessive Compulsive Inventory-Revised (k = 6, g = -0.26; 95% CI [-0.53; 0]). Subgroup analyses revealed a significant difference in effect size between studies conducting intention-to-treat and completers-only analyses (p = .01). The completers-only analyses demonstrated a moderate significant effect (g = -0.65; 95% CI [-1.08; -0.21]), whereas the effect of the intention-to-treat analyses was not significant (g = -0.18; 95% CI [-0.36; 0]). Participants in the unguided self-help groups exhibited a significantly higher dropout rate (RR = 2.08; 95% CI [1.53; 2.81]) compared to control groups. Furthermore, participants recruited from the community had a higher likelihood of dropping out compared to those recruited from clinical settings (p < .001). Additionally, participants who received cognitive-behavioural therapy intervention were more likely to drop out than those who received other types of intervention (p < .001). Most trials (92%) were rated at a high risk of bias. CONCLUSION: Unguided self-help psychological interventions demonstrate potential effectiveness in alleviating OCD symptom severity post-intervention. However, caution should be exercised when interpreting the results due to high risk of bias across trials and the relatively small sample size. And the considerable dropout rate might hinder treatment effects. Future studies with strict methodology should investigate the long-term effectiveness of unguided self-help psychological interventions for OCD, explore the reasons for high dropout rates, and improve intervention adherence.

INTERNET-DELIVERED LOW-INTENSITY CBT FOR PEOPLE WITH SOCIAL ANXIETY DISORDER IN A PERIOD OF COVID-19: RESULTS OF PILOT RESEARCH.

OBJECTIVE: The aim: The study aims to provide evidence of the effectiveness of online low-intensity CBT-based psychological interventions on the psychological well-being of people with social anxiety disorders and related impairments in the COVID-19 pandemic. PATIENTS AND METHODS: Materials and methods: 222 volunteers aged 18-35 years included in study: low-intensity CBT group (n=106) and control group (n=116). To assess the mental health prob¬lems were used International Neuropsychiatric Interview (MINI) and a set of IAPT scales. Analyses considered levels of pre-post intervention effect sizes and clinically significant improvement of symptoms of social anxiety disorder, generalized anxiety disorder, depression, and distress in maintaining general and work activity scores. RESULTS: Results: Comparisons between the low-intensity interventions group and control (self-help guide psychological care as usual) indicated more reduction in the severity of symp¬toms of social anxiety disorder and comorbid impairments associated with depression or generalized anxiety disorder. Changes for social phobia and other outcomes indicate that the odds of relapse or exacerbation of symptoms in the control group are more significant than those after a CBT-based low-intensity psychosocial care program. Analysis showed a significant interaction between outcomes scores and the number of sessions: more than five online sessions and homework with a self-help guide improved outcome. CONCLUSION: Conclusions: This pilot trial provides initial evidence that low-intensity online interventions based on CBT result in reductions in psychological problems for persons with a social anxiety disorder during the COVID-19 pandemic.

Testing a stepped care model for binge-eating disorder: a two-step randomized controlled trial.

BACKGROUND: A stepped care approach involves patients first receiving low-intensity treatment followed by higher intensity treatment. This two-step randomized controlled trial investigated the efficacy of a sequential stepped care approach for the psychological treatment of binge-eating disorder (BED). METHODS: In the first step, all participants with BED (n = 135) received unguided self-help (USH) based on a cognitive-behavioral therapy model. In the second step, participants who remained in the trial were randomized either to 16 weeks of group psychodynamic-interpersonal psychotherapy (GPIP) (n = 39) or to a no-treatment control condition (n = 46). Outcomes were assessed for USH in step 1, and then for step 2 up to 6-months post-treatment using multilevel regression slope discontinuity models. RESULTS: In the first step, USH resulted in large and statistically significant reductions in the frequency of binge eating. Statistically significant moderate to large reductions in eating disorder cognitions were also noted. In the second step, there was no difference in change in frequency of binge eating between GPIP and the control condition. Compared with controls, GPIP resulted in significant and large improvement in attachment avoidance and interpersonal problems. CONCLUSIONS: The findings indicated that a second step of a stepped care approach did not significantly reduce binge-eating symptoms beyond the effects of USH alone. The study provided some evidence for the second step potentially to reduce factors known to maintain binge eating in the long run, such as attachment avoidance and interpersonal problems.

Efficacy and cost-effectiveness of an unguided, internet-based self-help intervention for social anxiety disorder in university students: protocol of a randomized controlled trial.

BACKGROUND: Social anxiety disorder (SAD) is highly prevalent among university students, but the majority of affected students remain untreated. Internet- and mobile-based self-help interventions (IMIs) may be a promising strategy to address this unmet need. This study aims to investigate the efficacy and cost-effectiveness of an unguided internet-based treatment for SAD among university students. The intervention is optimized for the treatment of university students and includes one module targeting fear of positive evaluations that is a neglected aspect of SAD treatment. METHODS: The study is a two arm randomized controlled trial in which 200 university students with a primary diagnosis of SAD will be assigned randomly to either a wait-list control group (WLC) or the intervention group (IG). The intervention consists of 9 sessions of an internet-based cognitive-behavioral treatment, which also includes a module on fear of positive evaluation (FPE). Guidance is delivered only on the basis of standardized automatic messages, consisting of positive reinforcements for session completion, reminders, and motivational messages in response to non-adherence. All participants will additionally have full access to treatment as usual. Diagnostic status will be assessed through Structured Clinical Interviews for DSM Disorders (SCID). Assessments will be completed at baseline, 10 weeks and 6-month follow-up. The primary outcome will be SAD symptoms at post-treatment, assessed via the Social Phobia Scale (SPS) and the Social Interaction Anxiety Scale (SIAS). Secondary outcomes will include diagnostic status, depression, quality of life and fear of positive evaluation. Cost-effectiveness and cost-utility analyses will be evaluated from a societal and health provider perspective. DISCUSSION: Results of this study will contribute to growing evidence for the efficacy and cost-effectiveness of unguided IMIs for the treatment of SAD in university students. Consequently, this trial may provide valuable information for policy makers and clinicians regarding the allocation of limited treatment resources to such interventions. TRIAL REGISTRATION: DRKS00011424 (German Clinical Trials Register (DRKS)) Registered 14/12/2016.

Distal suprascapular nerve block-do it yourself: cadaveric feasibility study.

BACKGROUND: A bone landmark-based approach (LBA) to the distal suprascapular nerve (dSSN) block is an attractive "low-tech" method available to physicians with no advanced training in regional anesthesia or ultrasound guidance. The primary aim of this study was to validate the feasibility of an LBA to blockade of the dSSN by orthopedic surgeons using anatomic analysis. The secondary aim was to describe the anatomic features of the sensory branches of the dSSN. MATERIALS AND METHODS: An LBA was performed in 15 cadaver shoulders by an orthopedic resident. Then, 10 mL of methylene blue-infused 0.75% ropivacaine was injected around the dSSN; 2.5mL of red latex solution was also injected to identify the position of the needle tip. The division and distribution of the sensory branches that originate from the suprascapular nerve were described. RESULTS: The median distance between the dSSN and the site of injection was 1.5 cm (0-4.5 cm). The most common injection site was at the proximal third of the scapular neck (n = 8). Fifteen dSSNs were stained proximal to the origin of the most proximal sensory branch. All 15 dSSNs gave off 3 sensory branches that innervated the posterior glenohumeral capsule, the subacromial bursa, and the coracoclavicular and acromioclavicular ligaments. CONCLUSIONS: An LBA for anesthetic blockade of the dSSN by an orthopedic surgeon is a simple, reliable, and accurate method. Injection close to the suprascapular notch is recommended to involve the dSSN proximally and its 3 sensory branches.

A randomized controlled trial of unguided internet cognitive-behavioral treatment for perfectionism in individuals who engage in regular exercise.

OBJECTIVE: Clinical perfectionism has been found to be a risk and maintaining factor in eating disorders (EDs), compulsive exercise, and athlete burnout. This study investigated whether an unguided internet cognitive-behavioral treatment (ICBT) for perfectionism would reduce ED pathology, compulsive exercise, and burnout in individuals who engage in regular exercise. METHOD: Participants were randomly allocated to intervention (n = 38) or waitlist control (n =29). A generalized linear mixed model (GLMM) analysis was conducted pre and post treatment. A follow-up analysis was conducted with the intervention group at 3 and 6 months. RESULTS: The intervention group experienced a significant reduction in perfectionism (FMPS-CM: F[1,117] = 17.53, p = < .001, Cohen's d = .82), ED symptomology (EDE-Q: F[1,55] = 7.27, p = .009,Cohen's d = .53) and compulsive exercise (CET: F[1,116] = 10.33, p < .001,Cohen's d = .63). The changes attained post-treatment were maintained within the intervention group at 3-month (FMPS-CM (t[1,100] = 3.67, p < . 001, Cohen's d = .85) (EDE-Q (t[1,50] = 2.20, p = .03, Cohen's d = 1.26) and 6-month follow-up (FMPS (t[1,100] = 2.74, p = 007, Cohen's d = .70) (EDE-Q (t[1,50] = 2.18, p = .03, Cohen's d = 1.26). DISCUSSION: The results indicate unguided ICBT for perfectionism can have a significant impact on perfectionism, compulsive exercise, and ED symptomatology.

Sky island diversification meets the multispecies coalescent - divergence in the spruce-fir moss spider (Microhexura montivaga, Araneae, Mygalomorphae) on the highest peaks of southern Appalachia.

Microhexura montivaga is a miniature tarantula-like spider endemic to the highest peaks of the southern Appalachian mountains and is known only from six allopatric, highly disjunct montane populations. Because of severe declines in spruce-fir forest in the late 20th century, M. montivaga was formally listed as a US federally endangered species in 1995. Using DNA sequence data from one mitochondrial and seven nuclear genes, patterns of multigenic genetic divergence were assessed for six montane populations. Independent mitochondrial and nuclear discovery analyses reveal obvious genetic fragmentation both within and among montane populations, with five to seven primary genetic lineages recovered. Multispecies coalescent validation analyses [guide tree and unguided Bayesian Phylogenetics and Phylogeography (BPP), Bayes factor delimitation (BFD)] using nuclear-only data congruently recover six or seven distinct lineages; BFD analyses using combined nuclear plus mitochondrial data favour seven or eight lineages. In stark contrast to this clear genetic fragmentation, a survey of secondary sexual features for available males indicates morphological conservatism across montane populations. While it is certainly possible that morphologically cryptic speciation has occurred in this taxon, this system may alternatively represent a case where extreme population genetic structuring (but not speciation) leads to an oversplitting of lineage diversity by multispecies coalescent methods. Our results have clear conservation implications for this federally endangered taxon and illustrate a methodological issue expected to become more common as genomic-scale data sets are gathered for taxa found in naturally fragmented habitats.

Engagement With a Relaxation and Mindfulness Mobile App Among People With Cancer: Exploratory Analysis of Use Data and Self-Reports From a Randomized Controlled Trial.

BACKGROUND: Mobile health (mHealth) apps offer unique opportunities to support self-care and behavior change, but poor user engagement limits their effectiveness. This is particularly true for fully automated mHealth apps without any human support. Human support in mHealth apps is associated with better engagement but at the cost of reduced scalability. OBJECTIVE: This work aimed to (1) describe the theory-informed development of a fully automated relaxation and mindfulness app to reduce distress in people with cancer (CanRelax app 2.0), (2) describe engagement with the app on multiple levels within a fully automated randomized controlled trial over 10 weeks, and (3) examine whether engagement was related to user characteristics. METHODS: The CanRelax app 2.0 was developed in iterative processes involving input from people with cancer and relevant experts. The app includes evidence-based relaxation exercises, personalized weekly coaching sessions with a rule-based conversational agent, 39 self-enactable behavior change techniques, a self-monitoring dashboard with gamification elements, highly tailored reminder notifications, an educational video clip, and personalized in-app letters. For the larger study, German-speaking adults diagnosed with cancer within the last 5 years were recruited via the web in Switzerland, Austria, and Germany. Engagement was analyzed in a sample of 100 study participants with multiple measures on a micro level (completed coaching sessions, relaxation exercises practiced with the app, and feedback on the app) and a macro level (relaxation exercises practiced without the app and self-efficacy toward self-set weekly relaxation goals). RESULTS: In week 10, a total of 62% (62/100) of the participants were actively using the CanRelax app 2.0. No associations were identified between engagement and level of distress at baseline, sex assigned at birth, educational attainment, or age. At the micro level, 71.88% (3520/4897) of all relaxation exercises and 714 coaching sessions were completed in the app, and all participants who provided feedback (52/100, 52%) expressed positive app experiences. At the macro level, 28.12% (1377/4897) of relaxation exercises were completed without the app, and participants' self-efficacy remained stable at a high level. At the same time, participants raised their weekly relaxation goals, which indicates a potential relative increase in self-efficacy. CONCLUSIONS: The CanRelax app 2.0 achieved promising engagement even though it provided no human support. Fully automated social components might have compensated for the lack of human involvement and should be investigated further. More than one-quarter (1377/4897, 28.12%) of all relaxation exercises were practiced without the app, highlighting the importance of assessing engagement on multiple levels.

Group, Blended and Individual, Unguided Online Delivery of Mindfulness-Based Cognitive Therapy for People With Cancer: Feasibility Uncontrolled Trial.

BACKGROUND: Online mindfulness based cognitive therapy (eMBCT) has been shown to reduce psychological distress in people with cancer. However, this population has reported lack of support and asynchronous communication as barriers to eMBCT, resulting in higher nonadherence rates than with face-to-face MBCT. Using a co-creation process, we developed 2 formats of eMBCT: group, blended (combination of therapist-guided group and individual online sessions) and individual, unguided (individual, unguided online sessions only). Group, blended eMBCT offers peer support and guidance, whereas individual, unguided eMBCT offers flexibility and the possibility of large-scale implementation. OBJECTIVE: The objective of this nonrandomized feasibility study was to assess aspects of feasibility of the group, blended and individual, unguided eMBCT interventions. METHODS: Participants were people with cancer who chose between group, blended and individual, unguided eMBCT. Both intervention conditions followed the same 8-week eMBCT program, including an introductory session and a silent day (10 sessions total). All sessions for individual, unguided eMBCT occurred via the platform Minddistrict, whereas group, blended eMBCT consisted of 3 online videoconference sessions guided by a mindfulness teacher and 5 sessions via Minddistrict. We assessed the feasibility of the intervention quantitatively and qualitatively by evaluating its acceptability among participants. Additionally, we assessed limited efficacy by looking at the number of questionnaires participants completed pre- and postintervention. RESULTS: We included 12 participants for each eMBCT condition. Participants in group, blended eMBCT completed, on average, 9.7 of 10 sessions, compared with an average 8.3 sessions for individual, unguided eMBCT (excluding dropouts). Of the 24 participants, 13 (54%) agreed to be interviewed (5 unguided and 8 blended). Participants in both conditions reported positive experiences, including the convenience of not having to travel and the flexibility to choose when and where to participate. However, among the barriers for participation, participants in the group, blended condition reported a preference for more group sessions, and participants in the individual, unguided condition reported a lack of guidance. Additionally, for the group, blended condition, the effect sizes were small for all outcome measures (Hedges g range=0.01-0.36), except for fatigue, which had a moderate effect size (Hedges g=0.57). For the individual, unguided condition, the effect sizes were small for all outcome measures (Hedges g range=0.24-0.46), except for mindfulness skills (Hedges g=0.52) and engagement with the intervention (Hedges g=1.53). CONCLUSIONS: Participants in this study had a positive experience with group, blended and individual, unguided eMBCT. Based on the results from this study, we will adjust the intervention prior to conducting a full-scale randomized controlled trial to evaluate effectiveness; we will add 1 group session to the group, blended eMBCT using Zoom as the platform for the group sessions; and we will send reminders to participants to complete questionnaires. TRIAL REGISTRATION: ClinicalTrials.gov NCT05336916; https://clinicaltrials.gov/ct2/show/NCT05336916.

The impact of therapeutic persuasiveness on engagement and outcomes in unguided interventions: A randomized pilot trial of a digital parent training program for child behavior problems.

Understanding how to design engaging unguided digital health interventions is key in our ability to utilize digital tools to improve access to care. Therapeutic persuasiveness (TP) is a design concept that relates to how the digital intervention features as a whole should be designed to encourage users to make positive changes in their lives, while reducing the experienced effort required from them to engage in these activities. In our previous work, we examined the user traffic of publicly available programs, finding programs' TP quality to be a reliable, robust, and stable predictor of real-world usage; however, these findings have not been subject to experimental manipulation in a controlled trial. The current study examined the impact of TP quality in digital parent training programs (DPTs) aimed at treating child's behavior problems. We conducted a pilot randomized controlled trial comparing two interventions that utilize the same evidence-based content of established DPTs, but that differ in terms of the quality of TP (standard: DPT-STD; enhanced: DPT-TP). Altogether, parents from 88 families who have a child with behavior problems were enrolled in the study. Compared to DPT-STD (n = 43), participants allocated to DPT-TP (n = 45) used the program significantly more (ps < 0.001; Cohen's ds = 0.91-2.22). In terms of program completion, 68.9 % of DPT-TP participants completed it compared to 27.9 % of DPT-STD participants. Significant differences between the interventions were also found in reported improvements in child behavior problems favoring DPT-TP (ps < 0.05; Cohen's ds = 0.43-0.54). The results point to the importance of adequate product design and the utilization of conceptual frameworks in order to improve user engagement challenges.

Improving Mild to Moderate Depression With an App-Based Self-Guided Intervention: Protocol for a Randomized Controlled Trial.

BACKGROUND: Depression is one of the most prevalent mental disorders and frequently co-occurs with other mental disorders. Despite the high direct and indirect costs to both individuals and society, more than 80% of those diagnosed with depression remain with their primary care physician and do not receive specialized treatment. Self-guided digital interventions have been shown to improve depression and, due to their scalability, have a large potential public health impact. Current digital interventions often focus on specific disorders, while recent research suggests that transdiagnostic approaches are more suitable. OBJECTIVE: This paper presents the protocol for a study that aims to assess the efficacy of a self-guided transdiagnostic app-based self-management intervention in patients with mild or moderate depression with and without comorbid mental disorders. Specifically, we are investigating the impact of the intervention on symptoms of depression, quality of life, anxiety symptoms, and mental health-related patient empowerment and self-management skills. METHODS: The intervention under investigation, MindDoc with Prescription, is a self-guided digital intervention aimed at supporting individuals with mild to moderate mental disorders from the internalizing spectrum, including depression. The app can be used as a low-threshold psychosocial intervention. Up to 570 adult patients will be randomized to either receive the intervention in addition to care as usual or only care as usual. We are including adults with a permanent residency in Germany and mild or moderate depression according to International Classification of Diseases, 10th Revision, criteria (F32.0, F32.1, F33.0, and F33.1). Clinical interviews will be conducted to confirm the diagnosis. Data will be collected at baseline as well as 8 weeks and 6 months after randomization. The primary outcome will be depression symptom severity after 8 weeks. Secondary outcomes will be quality of life, anxiety symptom severity, and patient empowerment and self-management behaviors. Data will be analyzed using multiple imputations, using the intention-to-treat principle, while sensitivity analyses will be based on additional imputation strategies and a per-protocol analysis. RESULTS: Recruitment for the trial started on February 7, 2023, and the first participant was randomized on February 14, 2023. As of September 5, 2023, 275 participants have been included in the trial and 176 have provided the primary outcome. The rate of missing values in the primary outcome is approximately 20%. CONCLUSIONS: Data from this efficacy trial will be used to establish whether access to the intervention is associated with an improvement in depression symptoms in individuals diagnosed with mild or moderate depression. The study will contribute to expanding the evidence base on transdiagnostic digital interventions. TRIAL REGISTRATION: German Registry of Clinical Trials DRKS00030852; https://drks.de/search/de/trial/DRKS00030852. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/46651.

Effect of blended and unguided online delivery of mindfulness-based cognitive therapy versus care as usual on distress among cancer patients and survivors: protocol for the three-arm parallel randomized controlled buddy trial.

BACKGROUND: One third of cancer patients and survivors experience psychological distress. Previous studies have shown that online mindfulness-based cognitive therapy (eMBCT) supports cancer patients and survivors in managing distress. Lack of peer support and asynchronicity during online interventions have been reported as barriers for treatment adherence and can result in higher drop-out rates. Considering this, two new formats of eMBCT were created. The primary objective of the Buddy trial is to evaluate the (cost) effectiveness of blended and unguided eMBCT versus care as usual (CAU) on psychological distress among cancer patients and survivors. Secondary objectives include evaluating effects on other psychological outcomes and investigating working mechanisms and treatment effect moderators. METHODS: The Buddy trial is a parallel three-armed randomized controlled trial. Participants will be randomly assigned to blended therapist-assisted eMBCT, unguided individual eMBCT or CAU. Eligible participants will be Dutch-speaking adult cancer patients or survivors with access to internet. The primary outcome will be psychological distress scores as assessed by the Hospital Anxiety and Depression scale immediately post-treatment. Secondary outcome measures include fear of cancer recurrence (FCRI), fatigue (CIS-F), rumination (RRQ), mindfulness skills (FFMQ), decentering (EQ), self-compassion (SCS-SF), positive mental health (MHCSF), health related quality of life (EQ-5D), and costs associated with psychiatric illness (TiC-P). Outcome measures will be evaluated at baseline, mid-treatment, immediately post-treatment, and three-, six-, and nine-months follow-up. Possible mediators, such as engagement with interventions (TWEETS), and moderators will be also analyzed. DISCUSSION: There is room to improve eMBCT for cancer patients prior to implementation to ensure adherence and scalability. Blended and unguided eMBCT may reduce psychological distress and improve quality of life and be easily accessible to cancer patients and survivors. Trial registration clinicaltrials.gov, NCT05336916, registered on April 20th, 2022. https://clinicaltrials.gov/ct2/show/NCT05336916 .

Effects of a Self-Guided Transdiagnostic Smartphone App on Patient Empowerment and Mental Health: Randomized Controlled Trial.

BACKGROUND: Mental disorders impact both individuals and health systems. Symptoms and syndromes often remain undetected and untreated, resulting in chronification. Besides limited health care resources, within-person barriers such as the lack of trust in professionals, the fear of stigmatization, or the desire to cope with problems without professional help contribute to the treatment gap. Self-guided mental health apps may support treatment seeking by reducing within-person barriers and facilitating mental health literacy. Digital mental health interventions may also improve mental health related self-management skills and contribute to symptom reduction and the improvement of quality of life. OBJECTIVE: This study aims to investigate the effects of a self-guided transdiagnostic app for mental health on help seeking, reduced stigma, mental health literacy, self-management skills, mental health symptoms, and quality of life using a randomized controlled design. METHODS: Overall, 1045 participants (recruited via open, blinded, and web-based recruitment) with mild to moderate depression or anxiety-, sleep-, eating-, or somatization-related psychopathology were randomized to receive either access to a self-guided transdiagnostic mental health app (MindDoc) in addition to care as usual or care as usual only. The core features of the app were regular self-monitoring, automated feedback, and psychological courses and exercises. The coprimary outcomes were mental health literacy, mental health-related patient empowerment and self-management skills (MHPSS), attitudes toward help seeking, and actual mental health service use. The secondary outcomes were psychopathological symptom burden and quality of life. Data were collected at baseline and 8 weeks and 6 months after randomization. Treatment effects were investigated using analyses of covariance, including baseline variables as predictors and applying multiple imputation. RESULTS: We found small but robust between-group effects for MHPSS (Cohen d=0.29), symptoms burden (Cohen d=0.28), and quality of life (Cohen d=0.19) 8 weeks after randomization. The effects on MHPSS were maintained at follow-up. Follow-up assessments also showed robust effects on mental health literacy and preliminary evidence for the improvement of help seeking. Predictors of attrition were lower age and higher personality dysfunction. Among the non-attritors, predictors for deterioration were less outpatient treatment and higher initial symptom severity. CONCLUSIONS: A self-guided transdiagnostic mental health app can contribute to lasting improvements in patient empowerment. Symptoms of common mental disorders and quality of life improved faster in the intervention group than in the control group. Therefore, such interventions may support individuals with symptoms of 1 or more internalizing disorders, develop health-centered coping skills, prevent chronification, and accelerate symptom improvement. Although the effects for individual users are small and predictors of attrition and deterioration need to be investigated further, the potential public health impact of a self-guided intervention can be large, given its high scalability. TRIAL REGISTRATION: German Clinical Trials Register DRKS00022531; https://drks.de/search/de/trial/DRKS00022531.

Real-World User Demographics of Three Web-Based Digital Mental Health Interventions Provided by the US Department of Veterans Affairs: Observational Study Using Web Analytics Data.

BACKGROUND: Unguided digital mental health interventions (UDMHIs) have the potential to provide low-cost and effective mental health care at scale. Controlled trials have demonstrated the efficacy of UDMHIs to address mental health symptoms and conditions. However, few previous publications have described the demographics of real-world users of UDMHIs that are freely available to the public. The US Department of Veterans Affairs has created and hosts several UDMHIs on its Veteran Training Portal website. These web-based, free-to-use, and publicly available UDMHIs include Path to Better Sleep, Anger and Irritability Management Skills, and Moving Forward, which focus on insomnia, problematic anger, and depression symptoms, respectively. OBJECTIVE: This study aimed to examine the user demographics of these 3 UDMHIs in the year 2021. In addition, it aimed to compare the age and gender distribution of the users of those 3 UDMHIs with one another and with the age and gender distribution of the total US veteran population. METHODS: Google Analytics was used to collect user data for each of the 3 UDMHIs. The age and gender distribution of the users of each UDMHI was compared with that of the other UDMHIs as well as with that of the overall US veteran population using chi-square tests. Information on the total number of users, the country they were in, and the devices they used to access the UDMHIs was also collected and reported. RESULTS: In 2021, the 3 UDMHIs together recorded 29,306 unique users. The estimated age range and gender were available for 24.12% (7068/29,306) of those users. Each UDMHI's age and gender distribution significantly differed from that of the other UDMHIs and from that of the overall US veteran population (P<.001 on all chi-square tests). Women and younger age groups were overrepresented among UDMHI users compared with the overall US veteran population. The majority of devices used to access the UDMHIs were desktop or laptop devices, although a substantial proportion of devices used were mobile devices (10,199/29,752, 34.28%). Most users (27,789/29,748, 93.41%) were located in the United States, with users from Canada, the United Kingdom, and Australia accounting for another 2.61% (775/29,748) of total users. CONCLUSIONS: Our use of Google Analytics data provided useful information about the users of 3 free and publicly available UDMHIs provided by the US Department of Veterans Affairs. Although our findings should be considered in light of the limitations of autonomously collected web analytics data, they still offer useful information for health care policy makers, administrators, and UDMHI developers.

Abrupt Withdrawal From Chronic High-Dose Zolpidem Use: A Case Report of Resulting Delirium.

We report the case of a male in his twenties who was prescribed 10 mg of zolpidem daily for sleep disturbances. Within one month, he self-augmented the dose to 30 mg daily. Unable to secure an authorized refill, he sought unauthorized suppliers and increased his daily intake to 70 mg over eight months. One day after his medication supply was depleted, he presented to the emergency department with symptoms indicative of acute delirium. Delirium was successfully alleviated within six hours using lorazepam. This was followed by a five-day lorazepam tapering regimen during the patient's hospital stay and then a subsequent four-day taper in an outpatient setting. This case highlights the dangers associated with zolpidem misuse, the swift onset of withdrawal symptoms following abrupt discontinuation, and the crucial importance of rigorous prescription monitoring and patient education regarding the risks of unguided dosage modifications and the sudden cessation of zolpidem.

Designing and Developing an eHealth Program for Patients With Persistent Physical Symptoms: Usability Study.

BACKGROUND: Patients with persistent physical symptoms presenting in primary care are often affected by multiple symptoms and reduced functioning. The medical and societal costs of these patients are high, and there is a need for new interventions tailored to both the patients and health care system. OBJECTIVE: This study aimed to examine the usability of an unguided, self-help treatment program, "My Symptoms," developed to assist patients and general practitioners in symptom management. METHODS: In all, 11 users (4 patients with persistent physical symptoms and 7 laypeople) participated in web-based thinking-aloud interviews involving the performance of predefined tasks in the program. Thematic analysis was used to categorize the severity of usability issues. General usability heuristics were cross-referenced with the usability issues. RESULTS: The analysis identified important usability issues related to functionality, navigation, and content. The study shows how therapeutic knowledge in some cases was lost in the translation of face-to-face therapy to a digital format. The user testing helped uncover how the functionality of the digital elements and general navigation of the program played a huge part in locating and accessing the needed treatment. Examples of redesign to mediate the therapeutic value in the digital format involving health care professionals, web developers, and users are provided. The study also highlights the differences of involving patients and laypeople in the interviews. CONCLUSIONS: Taking the experience of common symptoms as a point of departure, patients and laypeople contributed to finding usability issues on program functionality, navigation, and content to improve the program and make the treatment more accessible to users.

Effects of self-guided stress management interventions in college students: A systematic review and meta-analysis.

BACKGROUND: College students face several sources of stress. Self-guided stress management interventions offer an excellent opportunity for scaling up evidence-based interventions for self-management of these stresses. However, little is known about the overall effects of these interventions. Increasing this understanding is essential because self-guided stress management interventions might be a cost-effective and acceptable way of providing help to this important segment of the population during a critical life course stage. METHODS: We carried out a systematic literature search of bibliographical databases (PubMed, PsycINFO, Embase, and Cochrane Library) for randomized controlled trials (RCTs) of self-guided stress management interventions published up through April 2020. We conducted two separate meta-analyses for perceived stress, depression, and anxiety. The first included interventions for general college student samples. The second included studies for students with high levels of perceived stress. RESULTS: The first meta-analysis included 26 studies with 29 intervention-control comparisons based on a total of 4468 students. The pooled effect size was small but statistically significant (g = 0.19; 95% CI [0.10, 0.29]; p < 0.001). Results showed moderate heterogeneity across studies [I 2 = 48%; 95% CI (19, 66%)]. The second meta-analysis, included four studies based on a total of 491 students with high levels of stress. The pooled effect size was small but statistically significant (g = 0.34; 95% CI [0.16, 0.52]; p < 0.001). Results showed no heterogeneity across studies (I 2 = 0%; 95% CI [0, 79%]), but risk of bias was substantial. DISCUSSION: Our results suggest that self-guided stress management programs may be effective when compared to control conditions, but with small average effects. These programs might be a useful element of a multi-component intervention system. Given the psychological barriers to treatment that exist among many college students, self-help interventions might be a good first step in facilitating subsequent help-seeking among students reluctant to engage in other types of treatment. More studies should be conducted to investigate these interventions, sample specifications, mediating effects, and individual-level heterogeneity of effects.

Satisfaction and Acceptability Ratings of a Web-Based Self-help Intervention for Depression: Retrospective Cross-sectional Study From a Resource-Limited Country.

BACKGROUND: Web-based interventions are at an early stage in non-English-speaking low- and middle-income countries, where they remain scarce. Help for Depression (HDep) is one of the few unguided web-based interventions available in Latin America. The results of a use/usability analysis of the original version served as the basis for generating a more user-friendly second version. OBJECTIVE: The aim of this study is to explore participants' satisfaction and acceptability for the second version of HDep. METHODS: A retrospective cross-sectional design was used. An email invitation to complete a web-based survey was sent to all people who accessed HDep in 2018. The questionnaire included satisfaction and acceptability scales and open-ended questions. Complete questionnaires were retrieved from 191 participants: 35.1% (67/191) from those who visited only the home page (home page users [HPUs]) and 6.47% (124/1916) from those who registered to use the program (program users [PUs]). RESULTS: In all groups, users experienced high levels of depressive symptoms (189/191, 98.9%; Center for Epidemiological Studies Scale-Depression >16). Moderate levels of satisfaction (HPUs: mean 21.9, SD 6.7; PUs: mean 21.1, SD 5.8; range: 8-32) and acceptability (HPUs: mean 13.8, SD 3.9; PUs: mean 13.9, SD 3.2; range: 5-20) were found in both groups. Logistic regression analyses showed that among HPUs, women were more satisfied with HDep (odds ratio [OR] 3.4, 95% CI 1.1-10.0), whereas among PUs, older respondents (OR 1.04, 95% CI 1.01-1.08), those with paid work (OR 3.1, 95% CI 2.4-7.6), those who had not been in therapy (OR 2.42, 95% CI 1.09-5.98), and those who had not attempted suicide (OR 3.4, 95% CI 1.1-11.1) showed higher satisfaction. None of the sociodemographic/mental health variables distinguished the acceptability ratings among HPUs. Among PUs, those with paid work (OR 2.5, 95% CI 1.1-5.5), those who had not been in therapy (OR 3.1, 95% CI 1.3-7.3), those without disability (OR 2.9, 95% CI 1.3-6.6), and those who had not attempted suicide (OR 2.6, 95% CI 1.0-6.6) showed higher acceptability. CONCLUSIONS: HDep has good levels of satisfaction and acceptability for approximately half of its users, and the information provided by respondents suggested feasible ways to remedy some of the deficiencies. This qualitative-quantitative study from a low- to middle-income, non-English-speaking country adds to existing knowledge regarding acceptance and satisfaction with web-based interventions for depression in resource-limited countries. This information is important for the creation and adaptation of web-based interventions in low- and middle-income countries, where access to treatment is a major concern, and web-based prevention and treatment programs can help deliver evidence-based alternatives. It is necessary to document the pitfalls, strengths, and challenges of such interventions in this context. Understanding how users perceive an intervention might suggest modifications to increase adherence.

Support for a non-therapist assisted, Internet-based cognitive-behavioral therapy (iCBT) intervention for mental health in rheumatoid arthritis patients.

BACKGROUND: Anxiety is common in patients with rheumatoid arthritis (RA) and associated with worse RA outcomes. This study assessed the feasibility and preliminary health impacts (mental and physical) of a non-therapist assisted, online mental health intervention targeting anxiety in this population. METHODS: Participants with confirmed RA and elevated anxiety symptoms were enrolled into the Worry and Sadness program, an Internet-based cognitive-behavioral therapy (iCBT) intervention for anxiety and depression shown to be effective in the general population. Validated self-report measures of anxiety, depression, pain interference, fatigue, physical health-related quality of life, functional status, and patient-reported disease severity were collected at baseline, post-intervention, and at three-month follow-up. Emotional distress scores were tracked between lessons. Participants provided qualitative feedback in writing post-intervention. RESULTS: We analyzed the responses of 34 participants; the majority was female (86%) and the mean age was 57 (SD = 13). Of these, 80% (n = 28) completed the study in its entirety. Among these completers, 94.1% described the program as worthwhile. We found statistically significant improvements in anxiety, depression and fatigue from baseline to three-month follow-up, with small to large effect sizes (d = 0.39-0.81). Post-hoc analyses revealed that statistically significant change occurred between baseline and post-intervention for anxiety and depression and was maintained at three-month follow-up, whereas statistically significant change occurred between baseline and three-month follow-up for fatigue. Statistically significant reductions in emotional distress occurred across the program, with a large effect size (d = 1.16) between the first and last lesson. CONCLUSION: The Worry and Sadness program shows promise as a feasible resource for improving mental health in RA.

Effectiveness of an Internet-Based Machine-Guided Stress Management Program Based on Cognitive Behavioral Therapy for Improving Depression Among Workers: Protocol for a Randomized Controlled Trial.

BACKGROUND: The effect of an unguided internet-based cognitive behavioral therapy (iCBT) stress management program on depression may be enhanced by applying artificial intelligence (AI) technologies to guide participants adopting the program. OBJECTIVE: The aim of this study is to describe a research protocol to investigate the effect of a newly developed iCBT stress management program adopting AI technologies on improving depression among healthy workers during the COVID-19 pandemic. METHODS: This study is a two-arm, parallel, randomized controlled trial. Participants (N=1400) will be recruited, and those who meet the inclusion criteria will be randomly allocated to the intervention or control (treatment as usual) group. A 6-week, six-module, internet-based stress management program, SMART-CBT, has been developed that includes machine-guided exercises to help participants acquire CBT skills, and it applies machine learning and deep learning technologies. The intervention group will participate in the program for 10 weeks. The primary outcome, depression, will be measured using the Beck Depression Inventory II at baseline and 3- and 6-month follow-ups. A mixed model repeated measures analysis will be used to test the intervention effect (group × time interactions) in the total sample (universal prevention) on an intention-to-treat basis. RESULTS: The study was at the stage of recruitment of participants at the time of submission. The data analysis related to the primary outcome will start in January 2022, and the results might be published in 2022 or 2023. CONCLUSIONS: This is the first study to investigate the effectiveness of a fully automated machine-guided iCBT program for improving subthreshold depression among workers using a randomized controlled trial design. The study will explore the potential of a machine-guided stress management program that can be disseminated online to a large number of workers with minimal cost in the post-COVID-19 era. TRIAL REGISTRATION: UMIN Clinical Trials Registry（UMIN-CTR) UMIN000043897; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050125. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/30305.