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About This Study

This study aims to evaluate the effectiveness of an artificial intelligence (AI)-guided cognitive behavioral therapy (CBT) program for the treatment of mild depression and anxiety disorders in adults. Depression and anxiety disorders are among the most common mental health conditions worldwide and are associated with significant individual and societal burden. Despite the availability of effective treatments, access to psychotherapy remains limited due to insufficient resources and long waiting times. Digital mental health interventions, particularly those supported by artificial intelligence, have the potential to increase accessibility and scalability of evidence-based treatments. In this controlled clinical trial, participants diagnosed with mild depressive disorder and/or anxiety disorders will be assigned to either an experimental group receiving AI-guided CBT or a control group receiving standard psychiatric care. The intervention will be delivered through a digital platform and will consist of structured weekly sessions over a 10-week period. The primary objective of the study is to assess changes in symptoms of depression and anxiety. Secondary outcomes include perceived stress, social support, digital therapeutic alliance, and overall clinical improvement. The findings of this study are expected to contribute to the understanding of the role of AI in psychotherapy and its potential to improve access to mental health care.

Design

Interventions / Regimen

• Behavioral: AI-Guided Cognitive Behavioral Therapy — AI-guided cognitive behavioral therapy delivered through a digital platform, consisting of structured weekly sessions over 10 weeks.
• Behavioral: Cognitive Behavioral Therapy (CBT) — Cognitive behavioral therapy delivered by a trained therapist in a standard clinical format, consisting of structured weekly sessions over a 10-week period.

Primary Outcomes

• Change in depressive symptom severity (Baseline, week 5, and week 10)
• Change in anxiety symptom severity (Baseline, week 5, and week 10)

About This Study

Aim: The purpose of the study is to establish the non-inferiority of right-sided inhibitory 1 Hz stimulation compared to left-sided intermittent theta burst stimulation (iTBS) in unipolar and bipolar depression. Design: A national, non-inferiority, register-based, randomized trial, unmasked, with two treatment arms. Primary objective: The primary objective is to determine if right-sided inhibitory 1-Hz stimulation to dorsolateral prefrontal cortex (DLPFC) is non inferior to iTBS in treating unipolar and bipolar depression by measuring reduction in Montgomery-Åsberg Depression Rating Scale, self-assessed version (MADRS-S) from baseline to end of treatment. Secondary objectives: Include testing for differences in: * Observer rated response according to Clinical Global Impression Scale-Improvement (≥2 point reduction CGI). * Response to treatment (a decrease of 50% on MADRS-S) * Self-rated global health measured with the EuroQual-group 5 Dimensions Scale Visual Analogue Scale (EQ-5D-VAS). * Drop-out from treatment. * Stimulation site pain measured with the Numerical Rating Scales (NRS). * Adverse events. * Admission and suicides within 6 months. * New treatment course of rTMS or ECT within 6 months * Remission (score \< 11 on the MADRS-S) * Memory impairment measured with the Comprehensive Psychopathological Rating Scale (CPRS). Study population: Patients with unipolar or bipolar depression. Sample size: 350 patients. Inclusion criteria: * At least 18 years of age at the time of inclusion. * A clinical diagnosis of unipolar or bipolar depression according to ICD-10. * Acceptance of rTMS. * A Swedish personal identity number. * Capable of giving informed consent. Exclusion criteria: • If the investigator judges one of the two treatment protocols inappropriate for the patient. Inclusion time: 2025-07-01 to 2029-01-01

Design

Interventions / Regimen

• Device: repetitive transcranial magnetic stimulation — Repetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive brain stimulation technique that uses pulsed magnetic fields to activate or suppress specific brain regions. It is used to treat various conditions, including major depressive disorder, by inducing small electrical currents that stimulate nerve cells.
• Device: intermittent theta burst stimulation — Intermittent theta-burst stimulation (iTBS) is a form of transcranial magnetic stimulation (TMS) used to modulate brain activity. It involves delivering brief bursts of magnetic pulses to specific brain regions, typically the left dorsolateral prefrontal cortex (DLPFC)

Primary Outcomes

• reduction in the MADRS-S score (6 weeks)

About This Study

Lack of perceived control, particularly during stress, has been critically implicated in major depressive disorder (MDD) and anhedonic symptoms, especially among female adolescents; yet the neural underpinnings of perceived control disruptions in MDD remain poorly understood. Using functional magnetic resonance imaging with a novel "value of control task" in conjunction with a prospective design, this study will provide a comprehensive understanding of stress and perceived control related mechanisms in female adolescents with MDD and will examine stress-induced disruptions in perceived control as a predictor of "real world" expressions of maladaptive coping and anhedonia.

Design

Interventions / Regimen

• Behavioral: Computer Task Manipulation — Participants will complete computer tasks.

Primary Outcomes

• Blood-Oxygen-Level-Dependent Imaging (BOLD) activation of the ventral striatum and ventral medial prefrontal cortex (1.5 hour long scan during session 2)

About This Study

This is a randomized, parallel-group, double-blind, placebo-controlled, monotherapy study to evaluate the efficacy, safety, and tolerability of SPT-300 (GlyphAllo) in adults with major depressive disorder (MDD), with or without anxious distress.

Design

Interventions / Regimen

• Drug: SPT-300 — A prodrug of allopregnanolone, a small molecule drug
• Drug: Placebo — Placebo for SPT-300

Primary Outcomes

• Change From Baseline to Day 42 in Hamilton Depression Rating Scale-17 (HAM-D-17) Total Score (Baseline (Day 0) to Day 42)

About This Study

An 8-week, two-armed, randomized-controlled trial that examines the antidepressant effect of treatment with transcranial pulsed electromagnetic fields (T-PEMF) in patients diagnosed with moderate to severe depression using using a new device, the MoodHeadBand (MHB). The participants will use an active or placebo MHB for 30 minutes daily for 8 weeks. Additionally, the following research questions will be answered: 1\. If there is a positive effect on the patients' emotional and non-emotional cognition after 8 weeks of active treatment compared to the sham group and if possible early changes in the emotional cognition can predict the treatment response after 8 weeks of treatment. 1\. If the T-PEMF treatment provides improvement in restorative sleep after 8 weeks of treatment

Design

Interventions / Regimen

• Device: Treatment with MoodHeadBand (T-PEMF treatment) — The patients will receive treatment with T-PEMF using a headband containing 20 coils placed symmetrically around the head of the patient. The device delivers 55 Hz magnetic field. Duration of treatment is 30 minutes once a day for 8 weeks.
• Device: Inactive treatment with MoodHeadBand (Placebo) — Patients will use an identical device, which does not deliver T-PEMF treatment. The patients will use the headband as the active group for 30 minutes, once a day, for 8 weeks.

Primary Outcomes

• Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) (8 weeks)

About This Study

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can lead to major post-acute sequelae. It is estimated that over 60 million people worldwide are affected by this multisystemic condition, here referred to as post-COVID. Affective symptoms such as fatigue and depressed mood are particularly prevalent in patients with post-COVID and pose significant individual and socioeconomic burdens. This stands in stark contrast to the currently limited number of available therapeutic options. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation modality that has been demonstrated to be both safe and effective in treating various neuropsychiatric disorders, including depression. However, whether rTMS also has an effect on post-COVID associated affective symptoms remains to be elucidated. The overall objective of this randomized, double-blinded study is twofold: First, the investigators will examine the effect of rTMS on post-COVID associated affective symptoms. 52 individuals with post-COVID will be randomized to either receive 20 sessions of rTMS or sham treatment. A detailed psychopathological assessment of the study participants will be performed before and after the completion of rTMS/sham treatment. Secondly, the investigators will perform detailed characterization of the immune system before and after rTMS/sham treatment. The individual burden and socioeconomic costs of post-COVID-associated neuropsychiatric symptoms are enormous, however, treatment options are limited. The investigators believe that the current proposal will address this key gap in the literature by testing whether rTMS, which constitutes a novel treatment with little side effects, could alleviate these debilitating symptoms. If proven effective, this study could pave the way for a completely new way in which post-COVID conditions are treated.

Design

Interventions / Regimen

• Device: repeated transcranial magnetic stimulation — 20 sessions of repeated transcranial magnetic stimulation
• Device: sham treatment — 20 sessions of sham treatment

Primary Outcomes

• Depression severity (overall up to 13 weeks depending on the amount of rTMS/sham sessions per week (including a 4 week follow up))

About This Study

Children with "bothersome" tinnitus and misophonia have elevated anxiety and depression symptoms. The mainstay therapy for adults and children with these disorders is cognitive behavioral therapy (CBT). CBT resources are expensive and scarce for the pediatric population. Immersive virtual reality (IVR) has been shown in the adult population to be a proxy for CBT for several mental health disorders. There is sufficient published evidence that IVR is useful in treating adults with anxiety and depression disorders. However, the evidence in children in treating either anxiety and depression symptoms or disorder is scant. Our group views IVR application as a promising medical device to decrease anxiety and depression scores in children with tinnitus and misophonia disorders. This is a randomized placebo control (single-blinded to the study subjects) study in which there will be a 2:1 ratio between the experimental and placebo subjects, receiving either active IVR or placebo exposure. A total of 30 subjects with 20 experimental (10 tinnitus, 10 misophonia subjects) and 10 placebo (5 tinnitus and 5 misophonia subjects) will enroll in this randomized clinical trial. Assessment of change of quality of life, anxiety and depression symptoms will be based on 5 validated instruments. The 5 validated instruments are: Tinnitus Functional Index (TFI), Amsterdam Misophonia Scale (A-MIS-S), Pediatric Quality of Life PEDQL), Screen for Child Anxiety Related Emotional Disorders (SCARED) and Short Mood and Feelings Questionnaire (SMFQ).

Design

Interventions / Regimen

• Other: Aurora Mindfulness app versus sham — It would either immersive virtual reality exposure for the experimental group or non-immersive virtual reality exposure for the placebo group.

Primary Outcomes

• Tinnitus Functional Index (TFI) (2 weeks)
• Amsterdam Misophonia Scale (A-MIS-S) (2 weeks)
• Pediatric Quality of Life PedQL) (2 weeks)
• Screen for Child Anxiety Related Emotional Disorders (SCARED) (2 weeks)
• Short Mood and Feelings Questionnaire (SMFQ) (2 weeks)
• Tinnitus Functional Index (TFI) (4 weeka)
• Amsterdam Misophonia Scale (A-MIS-S) (4 weeks)
• Pediatric Quality of Life PedQL) (4 weeks)

About This Study

The goal of this randomised clinical trial is to evaluate the effects of transcranial magnetic stimulation (TMS) on major depressive disorder (MDD) and on the levels of 5-hydroxyindoleacetic acid (5-HIAA) and brain-derived neurotrophic factor (BDNF). TMS works to treat MDD by using low-intensity magnetic fields to modulate certain areas of the brain, activating them which can help improve the mood of those suffering from the disorder. Final metabolites of serotonin such as 5-HIAA and growth factors such as BDNF will also be studied before starting the intervention and at the end to check if there is a significant change in their concentration. Likewise, its safety will be evaluated by monitoring the symptoms that they present at the end of the intervention and one month later. The main questions that are intended to be answered are: * Does low-intensity TMS reduce depressive symptoms in patients with MDD? * Does low-intensity TMS significantly change the initial and final concentrations of 5-HIAA and BDNF? * What adverse effects might patients who are exposed to low-intensity TMS experience? The researchers will compare low-intensity and accelerated TMS with sham TMS to see if low-intensity TMS works to treat MDD. Participants: * Will undergo an initial clinical assessment to confirm the disorder, comorbidities, and general health status. * A 5 mL blood sample will be taken before starting the intervention. * Low-intensity TMS will be applied for 4 days, 5 daily sessions of 200 s with 10-minute intersession intervals at a field intensity of 2-4 milliTesla (mT) and frequency of 50 Hz in theta bursts. Symptoms will be monitored daily. * A 5 mL blood sample will be taken at the end of the intervention and general health status clinimetrics will be reapplied.

Design

Interventions / Regimen

• Device: Low-intensity TMS — Low-intensity TMS will be applied for 4 days, 5 daily sessions of 200 s with 10-minute intersession intervals at a field intensity of 2-4 mT and frequency of 50 Hz in theta bursts.
• Device: Transcranial Magnetic Stimulation Sham — The control group will receive the simulation of low-intensity TMS without magnetic field induction.

Primary Outcomes

• Improvement in symptoms of depression (From admission until the end of the 4 days of intervention and one month after the end of the intervention)

About This Study

The main objective of this retrospective and prospective observational register is to identify anthropometric, clinical, laboratory and/or instrumental markers of disease severity and activity in patients suffering from diabetes, endocrine-metabolic disorders, rare diseases in order to improve their diagnosis, monitoring and treatment processes. The Registry is monocentric, observational prospective and retrospective. No additional procedures to those of normal clinical practice are planned, and neither diagnostic approaches nor experimental drugs/prescriptions will be applied. The data under study (demographic, anthropometric, clinical and care characteristics) will be collected as part of outpatient visits of the Diabetes Outpatient Clinic or admission to Diabetes Day Hospital. In case of outpatients, the observation will start at the diagnosis or during the first outpatient visit and will end with the last outpatient visit performed within the total time foreseen for the duration of the study. The study will start once the regulatory authorizations are completed, and is expected to last at least 10 years with the possibility of extension

Design

Primary Outcomes

• GLUCOSE (baseline)
• HBA1C (baseline)
• Insulin (baseline)
• UACR (baseline)
• Anthropometric parameters (baseline)
• c-pep (baseline)

About This Study

Food insecurity affects 20% of the 116 million people in the US with hypertension and is associated with poor adherence to evidence-based treatments and disparities in hypertension outcomes. Interventions are being used to address food insecurity in clinical care settings, but people differ in the support they need to reduce food insecurity and little is known about which food insecurity interventions work best, or for whom. The goal of this study is to develop and test an adaptive food insecurity intervention using a Sequential Multiple Assignment Randomized Trial to determine which initial food insecurity intervention is more effective in improving adherence and blood pressure in patients with hypertension and for those who do not respond to the initial intervention, evaluate how to best provide additional support.

Design

Interventions / Regimen

• Behavioral: Resource information — Participants randomized to this arm will receive a tailored list of information about community resources.
• Behavioral: Community Health Worker (CHW) assistance — The CHW will meet with the participant at the baseline visit and will follow up with participants at least every other week. The CHW will also work directly with the patient's care team.
• Behavioral: Medically-tailored Meals (MTM) — MTM will consist of weekly home meal delivery. During the 3 months, participants will receive 10 medically tailored refrigerated or frozen meals (5 lunches and 5 dinners) delivered to their home weekly.

Primary Outcomes

• Systolic blood pressure value (Month 9)
• Diastolic blood pressure value (Month 9)
• Dietary Approaches to Stop Hypertension (DASH) diet adherence Score (Month 9)
• Medication adherence Score (Month 9)
• Food Security Score (Month 9)

About This Study

The goal of this clinical trial is to evaluate the feasibility of using virtual reality based visual field testing to monitor glaucoma in a clinical setting. This will be done through comparison of a virtual reality (VR) based device to the current gold standard Ziess Humphrey Field Analyzer (HFA). The main questions the study aims to answer are: * Can both devices produce similar results in terms of detecting visual field defects and progression? * Does the stage (early, moderate, advanced) of glaucoma impact results between the two devices? Participants will perform both a standard and a VR based visual field test at each visit, for a total of 5 visits.

Design

Interventions / Regimen

• Device: Virtual Reality Visual Field (VR-VF) — Both devices administer a standard visual field test. The Humphrey is the gold standard desk top model and the VR-VF is a virtual reality headset designed to deliver visual field testing

Primary Outcomes

• Visual field point-wise threshold values (Measured during each visual field test on visits 1 through 5 (throughout study completion, average 2 months))
• Global indices of visual field loss (Measured during each visual field test on visits 1 through 5 (throughout study completion, average 2 months))
• Reliability Indices (Measured during each visual field test on visits 1 through 5 (throughout study completion, average 2 months))

About This Study

The purpose of this study in patients undergoing routine care epidural spinal cord stimulation (SCS) is to determine 1) whether SCS reduces arterial blood pressure (BP) in patients which chronic low back pain and hypertension, 2) whether higher baseline BP (i.e., hypertension) predicts reductions in pain following SCS, and finally 3) whether different SCS waveforms elicits stimulus-evoked compound action potentials (ECAPs) in spinal cord and at the cortex (electroencephalography, and magnetoenchphalography).

Design

Interventions / Regimen

• Device: Permanent Epidural Spinal Cord Stimulation — Permanent Spinal Cord Stimulation implanted in participants undergoing routine care for management of chronic neuropathic pain.

Primary Outcomes

• Arterial Blood Pressure Change (Baseline (1 week pre-op))
• Arterial Blood Pressure Change (Visit 2 (4-6 weeks post-op))