Conceptualizing Acceptance and Knowledge as Process Variables in Internet-Delivered and Therapist-Supported Cognitive Behavioral Therapy and Acceptance and Commitment Therapy in Primary Care for Insomnia: Pilot Feasibility and Process-Oriented Randomized Controlled Trial

Background: Internet-based interventions for insomnia show promise, but understanding the process variables, such as knowledge acquisition and psychological acceptance, is crucial for enhancing digital adherence and clinical effectiveness. Objective: This study aimed to evaluate the feasibility, adherence, and preliminary clinical signals of 2 therapist-assisted interventions—internet-delivered cognitive behavioral therapy (iCBT) and internet-delivered acceptance and commitment therapy (iACT)—for insomnia in a primary care setting. Methods: This was a pilot randomized controlled trial. Adults seeking help for insomnia (n=18) were recruited via primary care and randomized to either a 5-module iCBT or iACT program delivered via a secure digital platform with weekly therapist feedback. Blinding of participants and therapists was not possible due to the nature of the interventions. Primary outcomes included the Insomnia Severity Index; secondary outcomes included the 9-item Patient Health Questionnaire, 7-item Generalized Anxiety Disorder, and WHO Disability Assessment Schedule. A novel sleep knowledge test was used as a process variable. The data were analyzed using split-plot analyses of variance (intention-to-treat or last observation carried forward and complete case analysis) and nonparametric Friedman and Kruskal-Wallis tests. Results: A total of 18 participants were randomized (iCBT: n=9; iACT: n=9). High attrition was observed, with only 33.3% (n=3) of iCBT and 55.6% (n=5) of iACT participants completing all modules. The iACT group demonstrated a significant within-group reduction in insomnia severity (=.01, Friedman test), whereas iCBT results were nonsignificant (=.10, Friedman test). No significant between-group differences were found for any clinical or process variables. Participants rated both treatments as credible (Credibility/Expectancy Questionnaire scores remained stable), though qualitative feedback indicated a need for more flexible, less burdensome content. Conclusions: This pilot study demonstrates that while internet-delivered insomnia treatments are feasible and credible in primary care, high attrition remains a significant barrier. Preliminary signals suggest that iACT may be a viable alternative to iCBT, potentially offering better adherence. Larger, fully powered pilot randomized controlled trials (estimated N=404) with refined recruitment and automated retention strategies are required to determine definitive comparative efficacy and the mediating role of sleep knowledge and acceptance. Trial Registration: Research and Development in the Västra Götaland Region (FoU i VGR) 272866;
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Melatonin for Kids: Is It Safe?

If you’ve spent any time talking to other parents about sleep, you’ve probably heard about melatonin. One person swears by it. Someone else warns against it. And if your child is struggling to fall asleep, it can be hard to know what to believe.

Melatonin is widely available, often marketed as a “natural” sleep aid, and increasingly used to help kids of all ages. But it may not be the right solution. The key is knowing when it makes sense, when it doesn’t, and how to make it work best as part of a bigger sleep plan.

What is melatonin?

Melatonin is a hormone the body produces naturally to regulate sleep. As it gets dark, the brain releases melatonin to signal that it’s time to wind down. Light exposure at night — especially blue light from screens — can disrupt the body’s natural rhythm so you don’t feel sleepy even when it’s bedtime.

“Melatonin supplements can help facilitate that circadian rhythm, that 24-hour sleep cycle,” says Rohn Nahmias, DO, a child and adolescent psychiatrist at the Child Mind Institute. Because it’s sold over the counter, melatonin seems to be harmless. In practice, clinicians are much more cautious. While they tend to consider it relatively low risk, with few side effects, they still don’t view it as something to take casually or indefinitely.

That’s because there are real gaps in what we know about melatonin — especially when kids take it regularly over long periods. “The longest study was about four years, and they did not find any issues,” says Judith Owens, MD, MPH, a pediatric sleep expert and professor of neurology at Harvard Medical School. “But the data are very limited in subject numbers and long-term follow-up.”

So, the question parents often ask — is melatonin safe for kids? — doesn’t have a simple yes or no answer. The more useful question may be whether melatonin is right for your kid and what guidelines should you follow if you’re going to give it to them.  

That’s why it’s especially important to consult your child’s pediatrician or tell them if you’ve already started your child on melatonin. “Because melatonin is over the counter, families often forget to mention it,” says Dr. Nahmias. But doctors need to know about supplements, especially if a child is on other medications or has additional health concerns.

Melatonin can be helpful in the right situations, but using it without looking deeper can be “kind of slapping a Band-Aid onto a problem,” Dr. Nahmias says. In his practice, he always wants to rule out anxiety, mood concerns, or a medical issue that may be impacting sleep (such as snoring, breathing problems, or pain) before introducing something new like melatonin.

When melatonin can help

Melatonin is most useful when the issue is falling asleep, not staying asleep. For example, if your child has persistent trouble falling asleep — not just occasional bedtime resistance — and you have already tried using behavioral strategies.

The immediate-release melatonin sold in the United States is primarily helpful for sleep onset. (A prolonged-release form approved in the UK and EU may help with staying asleep, but it’s not available here.) Melatonin can also help with circadian rhythm issues like delayed sleep-wake phase disorder, when a child or teen’s natural sleep and wake times are much later than their schedule allows. “That is the other real indication for melatonin,” Dr. Owens says.

How to use melatonin thoughtfully

If melatonin does make sense for your child, experts agree: Start low and go slow. Dr. Nahmias recommends beginning with 1 to 2 milligrams for kids four and up and increasing the dose only if needed — up to 3 milligrams for kids ages 6–10. Many children respond well to low amounts. More than 5 milligrams, he says, isn’t much more effective and is more likely to cause side effects like grogginess or irritability. Dr. Owens emphasizes a similarly cautious approach: Use the lowest effective dose, monitor whether it’s actually helping, and reassess regularly rather than letting it quietly become an open-ended routine.

Dr. Nahmias recommends using melatonin in “clusters” — short, purposeful stretches of nightly use to help realign the circadian rhythm — and then pulling back to use as needed. A cluster might make sense for a few weeks after travel, during a tough transition, or while the family works on behavioral changes.

If a child needs melatonin every night for months, that’s a signal to dig deeper. “That tells me that there’s something likely going on underneath that’s not being addressed,” Dr. Nahmias says.

Side effects and safety

Melatonin is generally well tolerated, but knowing the possible side effects can help you catch problems early. The most common is grogginess the next morning. Others include irritability, headaches, dizziness, stomach upset, and — in toddlers and younger children — increased bedwetting. Some children may also experience vivid dreams or nightmares, though these tend to be mild.

Check in with your child’s pediatrician if side effects appear, your child needs melatonin frequently or for more than a short period, the dose keeps creeping up, sleep problems get worse, or if you notice signs of anxiety, depression, or ADHD that might be driving their sleep struggles.

One important safety note: melatonin gummies look like candy, and Dr. Owens describes an “astronomical increase” in calls to poison control centers and emergency room visits related to melatonin in children, largely due to accidental ingestion. Store melatonin — especially gummies — like any other medication: out of reach, ideally in a locked cabinet. Never present them to children as a treat.

A bigger concern: what’s actually in the bottle

Melatonin isn’t tightly regulated in the United States, which means the dose on the label may not match what’s actually in the product. Studies have found that 22 out of 25 over-the-counter melatonin gummies were labeled inaccurately, with some containing far more melatonin than advertised.

Dr. Owens describes the variability as “huge” and says she was genuinely shocked by the findings. When shopping, look for products with a USP Verified mark. USP (United States Pharmacopeia) is an independent nonprofit that tests supplements to confirm the product contains what the label says, in the correct amount, and without harmful contaminants.

Melatonin for kids with ADHD or autism

There’s solid evidence that melatonin can benefit children with neurodevelopmental conditions, particularly autism and ADHD, who are more likely to have disrupted sleep-wake cycles. “There is a pretty robust literature supporting efficacy, without a lot of side effects,” Dr. Owens says about children on the autism spectrum.

But Dr. Nahmias encourages parents of kids with autism or ADHD to take a closer look at bedtime routines before turning to melatonin. “Both of those populations of kids do best when there is structure put into their day,” he says. He recommends having a posted list of the sleep routine that a child needs to accomplish as a helpful visual reminder that will start to become second nature as it is built into their evening.

If getting to sleep is still an issue, trying melatonin makes sense. But for kids with autism and ADHD, it may take more time to see an effect. “It can be helpful to give it a bit longer to re-right the sleep cycle,” Dr. Nahmias says. “Trying it for two to three months may be more beneficial than just a few weeks.”

 Many neurodivergent kids may also need to stay on melatonin longer than neurotypical children. “This makes it absolutely imperative that administration of melatonin for these children is under the supervision of a health professional who can monitor efficacy and side effects, and recommend periodic ‘off-drug holidays,’” Dr. Owens says. The goal is to get sleep back on track and consistent for some time. Once that goal is achieved, Dr. Nahmias adds, “it is important that there be attempts to take breaks from the medication or try lower doses.”

When melatonin is not likely to help

Melatonin is often used in situations where it’s unlikely to make much difference. That’s not a criticism of parents — sleep deprivation is exhausting, and it’s natural to reach for something that seems gentle and accessible. But if the real issue is an inconsistent routine, untreated anxiety, or an unidentified medical problem, melatonin may only be a temporary solution. The real problem will persist and need diagnosis and treatment.

For younger children — kids under five, especially — sleep problems are almost always better addressed with changes in habits and routines rather than supplements. For kids under two, “there’s no reason to use melatonin… and really, honestly, under five, for the most part,” Dr. Owens says. At those ages, behavioral approaches almost always work better.

What to try before using melatonin

Small, consistent changes in sleep habits can make a real difference — and unlike a supplement, these strategies can help children build skills that support sleep for years to come. Dr. Nahmias focuses on what’s often called sleep hygiene: a consistent bedtime and wake time, a predictable wind-down routine, and a sleep environment that actually supports rest, like keeping the bedroom dark, cool, and quiet. “The bed is meant for one thing and one thing only, and that is for sleep,” he says, emphasizing no TV or cellphones before bed. Even small amounts of light can interfere with the body’s natural melatonin production.

He also suggests addressing anxiety, rumination, or bedtime fears directly. “Behavioral interventions, time and time again, have really been shown to be very effective,” Dr. Owens says. For younger children, that might mean learning to fall asleep without a parent in the room. For older kids and teens, it often means setting limits around devices and making sure the schedule they’re keeping is actually realistic.

Making a melatonin plan

Melatonin is a tool that works best with a plan behind it. Before starting, write down what problem you’re actually trying to solve. Is your child unable to fall asleep before 11pm? Waking during the night? Scared to sleep alone? Anxious about school?

A simple sleep log can make your conversation with your child’s doctor much more useful. For a week or two, track bedtime, approximate time asleep, any night wakings, morning wake time, screen use, and whether melatonin was used and, if so, at what dose. Dr. Owens calls sleep diaries “invaluable” because they reveal patterns that are nearly impossible to see when everyone’s tired and running on memory. That information helps you and your child’s doctor decide whether melatonin is worth trying, whether it’s working, and when it might be time to stop — keeping the focus not just on getting through tonight, but on helping your child build the sleep habits they’ll carry with them for years.

Frequently Asked Questions

Is melatonin safe for kids?

Melatonin is generally considered low risk and can be helpful for some children who have trouble falling asleep, especially when used short term and under a doctor’s guidance. But experts caution that there are still gaps in research about long-term use in kids, so it shouldn’t be treated as harmless or used casually without looking at underlying issues.

Can you OD on melatonin?

Accidental overuse can happen, especially because melatonin gummies may look like candy to young children. In recent years, there has been a major increase in poison control and ER visits related to accidental ingestion, so melatonin should always be stored like any medication — out of reach and ideally locked away.

Is melatonin bad for kids?

Melatonin is not inherently “bad” for kids, but it’s not the right solution for every sleep problem. If poor sleep is caused by anxiety, inconsistent routines, or a medical issue, melatonin may only mask the problem.

How much melatonin is safe for kids?

Experts recommend starting with the lowest effective dose. Some clinicians suggest starting with 1–2 milligrams for children ages four and up, and generally not exceeding 3 milligrams for kids ages 6–10 unless advised by a doctor.

The post Melatonin for Kids: Is It Safe? appeared first on Child Mind Institute.

<![CDATA[Unpack gaming, gambling, social media, and exercise addiction, spotlighting comorbid anxiety, withdrawal signs, and harm-reduction treatment.]]>

Lifestyle, psychological and demographic predictors of anxiety: insights from a large-scale survey and machine learning analysis

ObjectiveAnxiety is influenced by a combination of lifestyle, psychological, and demographic factors. This study aimed to evaluate these associations and explore the potential of machine learning in predicting anxiety severity.MethodsAnxiety levels were evaluated using a large survey-based dataset of 11, 000 adults alongside demographic, physiological, and psychological measures. Descriptive statistics and inferential analyses were conducted in IBM SPSS to identify associations between key variables. Several machine learning regression algorithms, including linear, regularized, and ensemble models, were implemented in Python to predict anxiety levels. Model performance was evaluated using standard error metrics.ResultsOur findings revealed significant associations of anxiety with stress and sleep duration, while demographic attributes such as family history of anxiety and occupation also influenced outcomes. Ensemble machine learning algorithms achieved superior performance compared to single and linear-model approaches. Feature importance analysis identified stress, sleep, and caffeine intake as top predictors of anxiety.ConclusionsThe integration of statistical approaches with machine learning applications highlights the multifactorial nature of anxiety and demonstrates the potential of predictive modeling in mental health care. Future research should emphasize longitudinal designs and the incorporation of biological and digital markers to enhance clinical applicability and prediction.

Aspects of Quality of Life in Interstitial Lung Disease: Pilot Observational Cross-Sectional Study in a Single Center

Background: Quality of life (QOL) is an important aspect of every chronic disease, including interstitial lung disease (ILD). QOL is perceived as a significant patient-centered outcome. Objective: This study aims to identify factors correlating with different aspects of QOL in patients with various ILDs. Methods: We recruited 57 participants hospitalized in a tertiary care clinical center to this pilot observational cross-sectional study. These included 22 patients with idiopathic interstitial pneumonia (IIP), 19 patients with connective tissue disease–associated ILD (CTD-ILD), and 16 patients with interstitial pneumonia with autoimmune features (IPAF). The Saint George’s Respiratory Questionnaire (SGRQ) and World Health Organization Quality of Life Questionnaire (WHOQOL-BREF) were used to assess QOL, and the Hospital Anxiety and Depression Scale – Modified Version (HADS-M) and Patient Health Questionnaire – 9 (PHQ-9) were used to evaluate depression severity. Functional parameters including forced vital capacity (FVC), forced expiratory volume in 1 second (FEV), transfer lung capacity for carbon monoxide (TLCO), and 6-minute walk distance (6MWD) were assessed. Assessment of QOL was a secondary outcome measure in a multicenter prospective study aimed at determining the characteristics of Polish patients with interstitial pneumonia with autoimmune features. Results: In each study group, positive correlations existed between the WHOQOL-BREF physical domain score and FEV % predicted value (=.001) and TLCO % predicted value (=.03). Regardless of diagnosis, higher depression, anxiety, and aggression scores (ie, worse mental health) correlated negatively with multiple domains of QOL measured using the WHOQOL-BREF. Predictors of QOL aspects varied in each study group. In the IPAF group, the TLCO % predicted value was a predictor of QOL expressed as the SGRQ total score (=.005). In the CTD-ILD group, short 6MWD (<.001) and high HADS-M aggression score (=.01) correlated with low QOL (expressed as a high SGRQ total score). In the IIP group, 6MWD (=.002) and PHQ-9 scores (<.001) were predictors for SGRQ symptoms score. Gender-based differences were revealed: In all study groups, men had higher scores in the psychological, social, and environmental domains of the WHOQOL-BREF, indicating better QOL, without a statistically significant difference in the physical domain scores between genders. Diagnosis-based differences in the psychological aspects of QOL were also revealed: The QOL psychological domain scores were significantly lower in the CTD-ILD and IPAF groups than in the IIP group, indicating worse QOL (=.01). Conclusions: QOL is a multifaceted issue with various factors impacting its assessment. 6MWD, TLCO predicted value, and worse functional ability might specifically impact QoL in ILD. Mental health is an important aspect of QOL in the ILD population, as patients with a chronic, potentially life-limiting disease may be more prone to developing depression or anxiety. Assessment of QOL should be taken into account in clinical decision-making and research on chronic diseases, as this patient-related outcome may impact therapeutic decisions and patient compliance. Trial Registration: ClinicalTrials.gov NCT03870828; https://clinicaltrials.gov/study/NCT03870828

Feasibility of Videoconference-Based Cognitive Behavioral Therapy for Somatic Symptom Disorder: Single-Arm Pilot Trial

Background: Somatic symptom disorder (SSD) is a mental disorder marked by persistent somatic symptoms and maladaptive health-related thoughts, feelings, or behaviors. Cognitive behavioral therapy has been shown to be effective in treating SSD, reducing patients’ somatic symptoms, depressive symptoms, and anxiety symptoms. However, challenges remain—including limited access to treatment. Videoconference-based cognitive behavioral therapy (vCBT) has emerged as a promising approach, offering flexible and tailored treatment while addressing the shortage of medical resources and potentially reducing patient dropout. Objective: This study examined the feasibility of vCBT for patients with SSD and explored secondary outcomes related to the physical component of health-related quality of life (HRQOL) as assessed using the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) physical component summary (PCS) score and other exploratory clinical outcomes. Methods: This single-arm pilot trial evaluated feasibility as the primary outcome assessed via recruitment rate, retention rate, session completion rate, and safety. Ten participants with SSD were enrolled, and all received 6 weekly 50-minute vCBT sessions. Secondary outcomes included physical HRQOL (SF-36 PCS) as the key secondary outcome, as well as mental HRQOL, depressive symptoms, somatic symptom severity, anxiety symptoms, health anxiety, pain, insomnia, and generic HRQOL. These outcomes were measured at the preintervention (week 0) and postintervention (week 6) time points and 1-month follow-up (week 10) and were analyzed using 2-sided paired tests. Results: All feasibility criteria were met, with a recruitment rate of 83.3% (10/12), a retention rate of 100% (10/10), a session completion rate of 100% (10/10), and no adverse events reported. The SF-36 PCS score improved by 4.99 points at the postintervention time point, representing a large within-group effect (Cohen =0.99, 95% CI 0.21‐1.74). Medium to large improvements were also observed in mental HRQOL, depressive symptoms, anxiety symptoms, health anxiety, pain, insomnia, and generic HRQOL, and most of these improvements were observed at the 1-month follow-up. Conclusions: Our findings indicate that vCBT is a feasible and safe approach for SSD, with findings suggesting acceptability and preliminary evidence of effectiveness. Trial Registration: University Hospital Medical Information Network Clinical Trials Registry UMIN000046138; https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000052664
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Impact of Restriction-Resumption Protocols on Mood and Anxiety in Healthy Adults: Randomized Controlled Trial

<strong>Background:</strong> Simple behavioral and cognitive actions can reduce symptoms of anxiety and depression. However, there is limited research investigating whether restricting those same actions increases symptoms and whether resuming those actions reduces symptoms. <strong>Objective:</strong> The primary aim was to examine the impact of restricting, then resuming (the “restriction-resumption protocol”), 5 groups of actions called the Things You Do (TYD), on symptoms of depression and anxiety. Participant satisfaction with life and perceptions of changes in behavior and mental health were also evaluated. <strong>Methods:</strong> In total, 70 adults were randomly allocated to an intervention group (IG) or a control group (CG). IG participants completed a 3-phase protocol over 8 weeks: a 2-week baseline period (phase A), 2 weeks of restricted TYD actions (phase B), and a 4-week resumption phase (phase C). CG participants were instructed to maintain their usual activities and routines. Primary outcomes included symptoms of depression (Patient Health Questionnaire–9), anxiety (Generalized Anxiety Disorder–7), and frequency of TYD actions. Secondary outcomes included satisfaction with life and perceived changes in mental well-being. Outcomes were measured weekly throughout the 8-week trial and again after the trial at week 9. <strong>Results:</strong> Scores on outcome measures did not differ between groups during phase A and after the trial. However, by the end of phase B, IG participants showed significantly increased symptoms of depression and anxiety compared to CG participants (<i>P</i>s&lt;.001). Large within-group effect sizes were observed on the Patient Health Questionnaire–9 and Generalized Anxiety Disorder–7 from baseline to the end of phase B (Cohen <i>d</i>&gt;1.8) and from phase B to after the trial (Cohen <i>d</i>&gt;1.9). Changes in satisfaction with life and evaluations of mental health corresponded with symptom changes. <strong>Conclusions:</strong> These findings demonstrate a relationship between the frequency of performing specific actions and symptoms of depression and anxiety. The restriction-resumption protocol has the potential to increase our understanding of causal mechanisms underlying common mental disorders and may lead to the development of new models of prevention and treatment. <strong>Trial Registration:</strong> Australian and New Zealand Clinical Trials Registry ACTRN12624001491550; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=388828&amp;isReview=true

Anti-Inflammatory Drug Could Help Some People with Depression

Research led by the University of Bristol suggests treatment with an anti-inflammatory drug, already approved to treat arthritis, could help some people with depression.

The study, published in JAMA Psychiatry,  was small but showed gradual improvement in the severity of depression and physical symptoms like fatigue, as well as a lowering of anxiety in those treated with tocilizumab versus placebo.

“Low-grade systemic inflammation is a putative causal factor in depression, present in approximately 30% of patients,” write co-lead author Golam Khandakar, MD, PhD, a professor and researcher at the University of Bristol, and colleagues.

“Individuals with difficult-to-treat depression have higher cytokine, e.g., interleukin 6 (IL-6) and C-reactive protein (CRP) levels, than treatment-responsive patients and controls.”

Tocilizumab is a humanized monoclonal antibody that blocks the IL‑6 receptor and is used as an immunosuppressive drug in several inflammatory and cytokine‑driven conditions. For example, it is approved by the FDA to treat rheumatoid arthritis and cytokine release syndrome in patients with severe COVID-19.

To test whether IL-6 inhibition could help people with depression, the authors carried out a small randomized controlled trial as a proof-of-concept study. Overall, 14 participants were given a tocilizumab infusion, and 16 participants were randomly assigned to receive a saline placebo infusion.

Adults were eligible to be in the study if they had moderate‑to‑severe, difficult‑to‑treat depression despite antidepressants, showed persistent low‑grade inflammation on repeat CRP tests, and had prominent physical depressive symptoms like fatigue.

After receiving a single infusion, the participants were followed up for four weeks with evaluations at one week, two weeks and four weeks. All were taking anti-depressants when enrolled and continued them during the trial.

The trial was not large enough or long enough to show a statistically significant improvement, but it did show a consistent pattern of greater, clinically sized improvement with tocilizumab by the end of the follow-up period, especially in patients with higher baseline CRP.

No real differences were seen at one or two weeks, but at four weeks people given tocilizumab showed bigger improvements in overall depression scores, fatigue, energy levels, anxiety and quality of life than those in the placebo group. Around 54% of participants in the tocilizumab went into remission at four weeks versus 31% of the placebo group.

“This work represents an important milestone in the development of new treatments for depression especially difficult-to-treat depression, which affects millions of people in the U.K. alone,” said Khandakar in a press statement.

“This is one of the first randomized controlled trials to test immunotherapy for depression, the first to test the IL-6 receptor as the treatment target, and the first to use a targeted approach to select patients most likely to benefit, and to show that it works.”

The researchers now want to carry out a larger randomized trial to assess if the effects they saw are significant in a bigger treatment population.

The post Anti-Inflammatory Drug Could Help Some People with Depression appeared first on Inside Precision Medicine.

<![CDATA[Synendos launches a phase 2 trial of SYT-510, a first-in-class endocannabinoid modulator, aiming to ease generalized anxiety symptoms with improved safety and adherence.]]>