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About This Study

This study addresses a critical unmet need in the treatment of bipolar disorder by investigating whether Subcallosal Cingulate (SCC) Deep Brain Stimulation (DBS) can safely and effectively treat treatment-resistant bipolar depression without inducing manic switches. The researchers propose to accomplish this by incorporating monitoring of the SCC local field potentials (LFP) for depression tracking and amygdala LFP monitoring for mania prediction while treating Bipolar I patients with SCC DBS Stimulation. This approach could establish a new paradigm for personalized neuromodulation therapy that uses real-time neural monitoring to optimize outcomes while minimizing risks. By incorporating bilateral, dual-site LFP monitoring from both the SCC and amygdala, this research will allow the researchers to assess the therapeutic efficacy of continuous SCC-DBS and develop novel safety biomarkers that could transform the clinical management of DBS therapy in psychiatry. The findings will have immediate implications for clinical practice and will advance the study team's fundamental understanding of the neural circuits underlying mood regulation and dysregulation in bipolar disorder.

Design

Interventions / Regimen

• Device: Medtronic Percept PC DBS system — Open label active Deep Brain Stimulation (DBS) with continuous monitoring of local field potentials (LFP) from the SCC and amygdala.

Primary Outcomes

• Hamilton Depression Rating Scale (HDRS) (Baseline and weekly up to 1 year)

About This Study

New challenges, stressors, and a loss of support often accompany the transition from adolescence to adulthood. Not surprisingly, transitional-aged youth (TAY) between the ages of 18-25 experience some of the highest rates of mental distress. However, access to mental health services diminish for TAY due to gaps in care when transitioning from pediatric to adult services. These challenges are exacerbated in rural communities, such as in Northwestern Ontario, where youth already access mental health services less frequently and face longer wait times than those in more urban areas. Limited access and extended waits can exacerbate symptoms, prolong distress, and increase the risk for adverse outcomes. Novel, innovative approaches are urgently needed to support TAY in Northwestern Ontario. In partnership with St. Joseph Care Group and Thunder Bay Counselling Centre, the investigators are evaluating the impact of a mental health app (JoyPop) as a tool for TAY waiting for mental health services. The JoyPop app was developed to support improved emotion regulation - a fundamental difficulty for youth presenting with mental health challenges. A two-arm randomized controlled trial (RCT) will be used to evaluate the effectiveness of the app compared to usual practice while TAY are waiting for mental health services.

Design

Interventions / Regimen

• Behavioral: Usual Practice + JoyPop — Participants will be asked to use the app at least twice daily but will otherwise not be provided with requirements related to feature or total usage.

Primary Outcomes

• Change in emotion regulation (overall) (Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post))
• Change in emotion regulation (strategies) (Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post))
• Change in emotion regulation (non-acceptance) (Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post))
• Change in emotion regulation (impulse) (Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post))
• Change in emotion regulation (goals) (Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post))
• Change in emotion regulation (awareness) (Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post))
• Change in emotion regulation (clarity) (Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post))

About This Study

The goal of this clinical trial is to evaluate the efficacy and safety of sertraline combined with Lactobacillus crispatus in adolescents aged 12-18 years with major depressive disorder. The main question it aims to answer is: Whether sertraline combined with Lactobacillus crispatus is superior to sertraline combined with placebo in reducing depressive symptoms and improving emotional symptoms in adolescents with depression. If there is a comparison group: Researchers will compare sertraline combined with Lactobacillus crispatus with sertraline combined with placebo ( look-alike substance that contains no probiotics) to determine whether the addition of Lactobacillus crispatus provides greater therapeutic benefit in adolescents with depression. Participants will: 1. Receive sertraline combined with Lactobacillus crispatus or sertraline combined with placebo for 8 weeks; 2. Attend clinic visits every 4 weeks for clinical assessments and safety monitoring

Design

Interventions / Regimen

• Combination Product: Sertraline combined with Lactobacillus crispatus — Phase 1 (Weeks 1-4): Sertraline will be initiated at 25 mg/day and titrated according to clinical judgment, with a permissible dose range of 25-150 mg/day. By Week 4, the sertraline dose will reach a minimum of 150 mg/day. Concomitantly, Lactobacillus crispatus powder will be administered at 1 sachet/day (1×10⁹ CFU/sachet). Phase 2 (Weeks 5-8): Sertraline will be maintained at 150-200 mg/day, with dose adjustments guided by the psychiatrist's clinical judgment. Lactobacillus crispatus powder will remain at 1 sachet/day (1×10⁹ CFU/sachet).
• Combination Product: Sertraline combined with placebo — Phase 1 (Weeks 1-4): Sertraline will be initiated at 25 mg/day based on the psychiatrist's clinical assessment, with a permissible dose range of 25-150 mg/day. By Week 4, the sertraline dose will attain at least 150 mg/day, with concomitant placebo powder at 1 sachet/day. Phase 2 (Weeks 5-8): Sertraline will be maintained at 150-200 mg/day, with dose adjustments guided by the psychiatrist's clinical assessment. Placebo powder will be maintained at 1 sachet/day.

Primary Outcomes

• Change in Children's Depression Rating Scale - Revised (CDRS-R) scores (Assessments will be performed at baseline, week 4, and week 8)

About This Study

The goal of this clinical trial is to learn if DT-101 can treat depression in adults. The effect of DT-101 will be compared to placebo. Subjects will attend the clinic every couple of weeks complete general health checks and complete questionnaires.

Design

Interventions / Regimen

• Drug: DT-101 — DT-101 A
• Drug: DT-101 — DT-101 B
• Drug: Placebo — Placebo

Primary Outcomes

• Change from baseline in total Montgomery Åsberg depression rating scale (MADRS) score, at Day 42 (from enrollment to day 42)

About This Study

This study will aim to test whether specific neural circuitry changes, proposed on the basis of a neurocognitive model of anxiety, are a mechanism of action for Cognitive Behavioural Therapy (CBT) interventions. This study aims to provide a theoretical model of the neurobiological mechanisms of CBT's therapeutic effect, where there currently is none, and potentially allow for more targeted/specific approaches to anxiety disorders following the identification of key CBT mechanisms. The ultimate aim is to improve the efficacy of CBT, and more generally, psychological interventions for anxiety disorders.

Design

Interventions / Regimen

• Behavioral: Cognitive Behavioural Therapy — In the Cognitive Behavioural Therapy group (N=87), patients will undergo CBT as part of their routine care in Step 3 of the IAPT programme. This will be administered by suitably trained clinicians. The specification of CBT is as recommended by the National Institute for Health and Care Excellence (NICE) guidelines (CG113 - Generalised anxiety disorder and panic disorder in adults: management). In these guidelines, patients are offered on average, 12-15 hourly, weekly sessions of CBT with a trained and competent practitioners. Therapy sessions involve discussions that identify patterns in thinking or behaviours which may be problematic, and therapists and patients work to set goals to reduce these using cognitive techniques. The principle is to teach the patient how to use CBT techniques in their day-to-day life to promote a lasting effect on mental health. We will test patients before (T1) and after (T2) a course of treatment.
• Other: Waiting List — In the control group (N=87), we will test patients who are currently seeking (but not undergoing) treatment before (T1) and after a wait (T2) of equivalent time (i.e. waiting list controls)

Primary Outcomes

• 'Aversive amplification circuit' connectivity (Day 0, up to 12 weeks (post-CBT or matched time on waiting list))

About This Study

"Patients were divided into two groups: the experimental group (E group) and the control group (C group). The E group received standard care, walking exercise, and elastic band exercise, and wore a smart bracelet to record walking steps and sleep for three months. During the first month, participants performed walking exercise for 100 minutes per week and used a red elastic band for resistance training. In the second month, walking exercise increased to 150 minutes per week with a green elastic band. In the third month, walking exercise increased to 150-300 minutes per week with a blue elastic band. The C group wore the smart bracelet to record walking steps and sleep for three months. Each group included 34 participants. The study was conducted from September 9, 2021, to December 31, 2025. Exclusion criteria included panic disorder, cognitive impairment, current cancer treatment, angina pectoris or myocardial infarction within the past 3 months, participation in high-intensity rehabilitation exercise, and walking dysfunction. Participants were required to follow the study protocol. * Assessments\*\*: * Anxiety and Depression\*\*:Measured using the Chinese version of the Hospital Anxiety and Depression Scale (HADS). * Dyspnea\*\*:Measured using the Modified Medical Research Council (mMRC) scale. * Life and Sleep quality\*\*:Measured using the COPD Assessment Test (CAT) and Chinese Version of the Pittsburgh Sleep Quality Index (CPSQI).

Design

Interventions / Regimen

• Device: Elastic band — Thera-Band® elastic band exercise protocol: First stage (weeks 1-4): Participants performed leg resistance stretching exercises with a red elastic band. In weeks 1-2, exercises were performed 3 times per week, with 2 sets per session; in weeks 3-4, 3 times per week, with 3 sets per session. Second stage (weeks 5-8): Participants performed leg resistance stretching exercises with a green elastic band. In weeks 5-6, exercises were performed 3 times per week, with 2 sets per session; in weeks 7-8, 3 times per week, with 3 sets per session. Third stage (weeks 9-12): Participants performed leg resistance stretching exercises with a blue elastic band. In weeks 9-10, exercises were performed 3 times per week, with 2 sets per session; in weeks 11-12, 3 times per week, with 3 sets per session.
• Device: Xiaomi Mi Band 4 wearable device — The Xiaomi Mi Band 4 wearable device has been certified by the National Communications Commission (Certification No. CCAG19LP0080T6). From weeks 1 to 12, participants' daily walking steps were monitored using the Xiaomi Mi Band 4 wearable device.
• Behavioral: Walking — Walking exercise plan

Primary Outcomes

• Hospital Anxiety and Depression Scale (HADS) (Patients were assessed before discharge as the baseline, and reassessed at 4, 8, and 12 weeks post-discharge.)
• modified Medical Research Council (mMRC) (Patients were assessed before discharge as the baseline, and reassessed at 4, 8, and 12 weeks post-discharge.)
• COPD Assessment Test (CAT) (Patients were assessed before discharge as the baseline, and reassessed at 4, 8, and 12 weeks post-discharge.)
• Chinese Version of the Pittsburgh Sleep Quality Index (CPSQI) (Patients were assessed before discharge as the baseline, and reassessed at 4, 8, and 12 weeks post-discharge.)
• Six-Minute Walk Test ( 6MWT ) (Patients were assessed before discharge as the baseline, and reassessed at 4, 8, and 12 weeks post-discharge.)

About This Study

Low self-efficacy is a transdiagnostic risk factor for several mental disorders. Self-efficacy refers to one's belief that one is capable of performing a behavior necessary to successfully complete a task or achieve a goal. Consistent with theoretical models and empirical findings, individuals with low self-efficacy are more likely to perceive challenges as uncontrollable and threatening and thus are at increased risk for developing mental disorders during sensitive periods such as young adulthood. Self-efficacy interventions have been shown to be effective in promoting health behavior change, quality of life, and treatment adherence in patients with serious illnesses, as well as motivation and performance in students and employees. However, whether targeted self-efficacy training can prospectively prevent the onset of full-threshold anxiety, affective, and substance use disorders in young adults at increased risk for psychopathology remains an open question. The aim of this randomized controlled trial is to test whether a brief cognitive-behavioral intervention in young adults with low self-efficacy can increase general self-efficacy (primary outcome of intervention effectiveness) and thus prevent the onset of DSM-5 mental disorders in the subsequent year (primary outcome of prevention effectiveness). In addition, we examine whether improvements in domain-specific self-efficacy lead to subsequent improvements in general self-efficacy and thus to lower psychopathological symptoms (spillover effects). Young adults (18-30 years) with low self-efficacy but no mental disorder will be included (N=378). The study will include screening, entry, baseline, post, and 12-month follow-up assessments plus additional course assessments in both groups. After the baseline assessment, participants will be randomized to an intervention or control group. The intervention group will receive group-based self-efficacy training (6 sessions of 75-90 minutes each). The control group will also meet in groups (6 sessions) but will only talk about psychological research findings unrelated to self-efficacy or cognitive-behavioral interventions without receiving any training. DSM-5 mental disorders will be assessed at study entry and follow-up with a structured diagnostic interview. Other outcomes will be assessed with established scales and ecological momentary assessments (EMA) at baseline, post and follow-up. Clinical outcomes include psychopathological symptoms (dimensional scores for anxiety, depression, anger, and somatic symptoms, as well as sleep disturbance) and mental disorders (DSM-5 categorical diagnoses of anxiety, affective, and substance use disorders). Intervention effectiveness will be tested using logistic/linear regression and multilevel analyses. Spillover effects between improvements in domain-specific/general self-efficacy and psychopathological symptoms over the course of the study will be examined using cross-lagged panel models.

Design

Interventions / Regimen

• Behavioral: Cognitive-Behavioral Intervention to increase Self Efficacy — Participants in the intervention group will receive a brief (6 sessions of 75-90 min each) cognitive-behavioral intervention. The intervention will be delivered in an online group format (subgroups of 8-12 participants). The courses will be structured according to well-established self-efficacy interventions with proven effectiveness (Bresó et al., 2011; Cieslak et al., 2016; Luszczynska et al., 2007), targeting Bandura's four key sources of self-efficacy (i.e., mastery experience, vicarious experience, verbal persuasion, and physiological/emotional arousal). Each session will consist of a theoretical and a practical part and be structured as follows: opening, discussion of homework (with special emphasis on participants' progress and sharing of experiences), introduction to the topic, practice, answering open questions, closing. The course sessions are accompanied by weekly homework assignments to be completed at home.
• Behavioral: Placebo: Weekly Recap and Group Discussion on Psychological Experiments — Participants in the control group will meet in small groups (8-12 participants per group; 6 sessions, similar to the intervention group). They will receive a brief introduction to well-known psychological experiments and findings (e.g., the Asch experiment, selective attention) and discuss their perspectives on these topics, including personal implications of the experiments. Content related to self-efficacy or cognitive-behavioral interventions will be explicitly avoided. To prevent expectancy effects and other biases, participants will not be informed that they are part of the control group. If suspicions arise, participants will be told that group leaders are not allowed to disclose this. Group sessions will be led by a psychologist. The course materials (workbook, slides, and course instructions) will be shared on OSF.

Primary Outcomes

• Change in general self-efficacy measured by the German version of the General Self-Efficacy Scale (GSE) (From baseline to post (approximately 8-10 weeks).)
• Rates of incident DSM-5 mental disorders assessed by the SCID-CV. (From baseline to follow-up (approximately 14 months).)

About This Study

This research study is studying how thoughts, feelings, surroundings, and individual biology may contribute to why and how people experience anxiety or depression. We are trying to find out the wide variety of reasons that people may experience anxiety or depression, and why different people are helped by different forms of treatment. We are trying to determine why people stay in treatment, and what factors contribute to a positive or negative response to treatment. These reasons may be due to thoughts, feelings, beliefs, personality, biology, social support network, life events, and barriers to treatment. A wide range of information about factors that impact anxiety and depression will be included. These include, among others, measures of inflammation, hormone levels, behavior, spoken language, personality, medical history, social determinants of health, and attitudes toward mental health and its treatment. The study involves psychological and psychiatric treatments in the form of psychotherapy and medication management. The participant will be asked to set specific goals for study treatment, and to provide videos between sessions about relevant medication, emotional, and sleep factors in their life. In summary, this study will collect biological, psychological, and social factors that may play a role in anxiety and depression. This will inform both individual's diagnosis and treatment and will be used in a later set of analyses that can inform diagnosis and treatment for other individuals who share similar characteristics.

Design

Primary Outcomes

• Treatment Engagement and Adherence (Through Phase 1 completion, an average of 2-4 weeks)
• Treatment Response (Through Phase II, an average of 3-6 months)
• Illness Remission & Treatment Maintenance (Participants are to be followed by a clinician throughout their care over a period of weeks to months for the potential full course of treatment that is defined by specific clinical milestones.)

About This Study

This study aims to evaluate the effectiveness of a music-based intervention, guided by the ISO principle, in reducing stress, anxiety and depression induced by work, family or others among adults. The ISO principle suggests that emotional regulation can be supported by gradually modifying the emotional characteristics of music to help individuals transition to a desired emotional state. Participants in this study will be randomly assigned to either a music intervention group or a control group. The intervention group will receive personalized music playlists designed to help reduce stress, anxiety and depression. The control group will not receive any music intervention during the same period. Outcomes will be measured using self-report questionnaires assessing stress, emotional state, and well-being. The study is designed to contribute to the development of accessible, non-invasive stress management tools using music as a behavioral intervention.

Design

Interventions / Regimen

• Behavioral: ISO Principle Music Intervention — Participants will receive music playlists designed according to the ISO principle, which involves matching the participant's current emotional state and gradually transitioning to music reflecting a desired mood. The intervention aims to reduce stress and support emotional regulation by guiding affective resonance through music progression.
• Behavioral: DUL Principle Music Intervention — Participants will receive music playlists based on the compensation principle, where the music contrasts the participant's current emotional state by directly presenting tracks aligned with the desired emotional outcome (e.g., calm music for stressed mood). This approach seeks to counteract stress and shift affective states through musical contrast.
• Behavioral: ISO Principle Music Intervention with Waiting-list — Participants will receive music playlists designed according to the IS0 principle, which involves matching the participant's current emotional state and gradually transitioning to music reflecting a desired mood. The intervention aims to reduce stress and support emotional regulation by guiding affective resonance through music progression. The intervention will be delivered to participants after 5 day's waiting.
• Behavioral: DUL Principle Music Intervention with Waiting-list — Participants will receive music playlists based on the compensation principle, where the music contrasts the participant's current emotional state by directly presenting tracks aligned with the desired emotional outcome (e.g., calm music for stressed mood). This approach seeks to counteract stress and shift affective states through musical contrast. The intervention will be delivered to participants after 5 days' waiting.

Primary Outcomes

• Occupational Stress (Baseline, pre-intervention, Day1; Post-intervention, Day 7; 1 week post-intervention, Day 13; 1 month post-intervention, Day 37.)
• Anxiety (Baseline, pre-intervention, Day1; Post-intervention, Day 7; 1 week post-intervention, Day 13; 1 month post-intervention, Day 37.)
• Depression (Baseline, pre-intervention, Day1; Post-intervention, Day 7; 1 week post-intervention, Day 13; 1 month post-intervention, Day 37.)

About This Study

The purpose of this project is to determine the feasibility and preliminary efficacy of a mental health skill-building and empowerment program (MH-POWER) for college students on the autism spectrum facing stress, anxiety, and depression. The program, grounded in cognitive behavioral therapy (CBT), acceptance and commitment therapy (ACT), and habit formation, will be implemented through weekly sessions and daily practice over 8 weeks. To evaluate the program's preliminary efficacy, we will measure mental health symptoms at baseline, mid-point, post-intervention, and one-month follow-up. Positive outcomes could lead to scalable interventions.

Design

Interventions / Regimen

• Behavioral: The MH-POWER program — The MH-POWER program is an 8-week, structured, and manualized program to improve mental health skills. The program design consists of weekly 60-minute group sessions (8-12 in each group) and daily structured practice activities to reinforce the skills learned in each session. Based on the Self-Regulation Framework, the MH-POWER program systematically integrates (a) CBT with a specific focus on cognitive restructuring and behavioral activation; (b) ACT with mindfulness, acceptance strategies, and values clarification; and (c) the science of habit formation, which includes action planning, goal setting, prompts, and self-monitoring. The program focuses on developing greater relationships between thoughts, emotions, and behaviors, as well as the ability to cope effectively. The focus areas of development include learning how thoughts create emotions and influence actions, developing a positive mindset, enhancing stress management and coping skills, employing structured problem

Primary Outcomes

• Perceived Stress Scale (PSS) (It will be administered at baseline (Week 0), mid-intervention (Week 4), post-intervention (Week 8), and follow-up (Week 12))
• State-Trait Anxiety Inventory (STAI) (It will be administered at baseline (Week 0), mid-intervention (Week 4), post-intervention (Week 8), and follow-up (Week 12))
• Beck Depression Inventory-II (BDI-II) (It will be administered at baseline (Week 0), mid-intervention (Week 4), post-intervention (Week 8), and follow-up (Week 12))

About This Study

The purpose of this study is to investigate the feasibility of early access to mental healthcare during sarcoma treatment as well as to assess the association between early access to psychiatric care and depression, anxiety, postoperative outcomes, and patient satisfaction in patients undergoing surgery for musculoskeletal sarcoma.

Design

Interventions / Regimen

• Other: referral to the Memorial Sloan-Kettering Cancer Center (MSK) Department of Psychiatry and Behavioral Sciences. — The primary intervention in this study is referral to the Memorial Sloan-Kettering Cancer Center (MSK) Department of Psychiatry and Behavioral Sciences. This study will not dictate specific psychiatry interventions beyond providing the referral.

Primary Outcomes

• The number of participants who complete scheduled study visits (2 years)

About This Study

Depression and migraine are among the most prevalent conditions in the general population, and many research shows they are closely related. Migraine is one of the most common debilitating diseases, affecting over one billion people worldwide. Migraine is frequently comorbid with psychiatric conditions such as anxiety disorders and major depression, with a negative impact on quality of life (QoL) and disability. The knowledge of the pathophysiology of migraine involves changes in physiological processes, functional connectivity, and structural changes of the central nervous system (CNS) in patients with underlying genetic susceptibility. Upregulation of vasoactive and pro-inflammatory mediators such as calcitonin gene-related peptide (CGRP) and cytokines have been found in the trigeminal ganglia and the plasma, cerebrospinal fluid, saliva, and tears of these patients. Various classes of antidepressants - like Selective Serotonin Reuptake Inhibitors (SSRI), Selective Serotonin and Norepinephrine Inhibitors (SNRI), and Tricyclic Antidepressants (TCAs) - were investigated but in a low number of studies and with inconsistent results. Vortioxetine (VO) is a novel multimodal serotonergic antidepressant, approved in the last decade for the treatment of major depression. VO inhibits 5-HT transporter (SERT), like commonly used antidepressants, but different from them, it directly modulates the activity of 5-HT receptors. Vortioxetine also modifies the release of glutamate and gamma amino butyric acid (GABA), implicated in migraine pathogenesis. Recent experimental and clinical studies have shown that VO exerts antidepressant and pro-cognitive activities and is also effective in modulating pain hypersensitivity and could be effective in treating chronic pain syndromes.

Design

Primary Outcomes

• Response to Vortioxetine (6 months)