Clinical Research Directory

Transcranial Direct Current Stimulation for Chemotherapy-Related Chronic Pain in Cancer Survivors

The goal of this clinical trial is to learn if transcranial direct current stimulation (tDCS) combined with a working-memory task can treat chronic pain and related emotional and cognitive problems after chemotherapy in adult cancer survivors. tDCS is a non-invasive and painless technique that uses a very weak electrical current, applied through two small electrodes on the head, to modulate the activity of certain brain areas. The main questions it aims to answer are: * Does tDCS reduce chronic pain intensity after chemotherapy in cancer survivors? * Does tDCS also reduce anxiety, depression, and cognitive problems, and improve the regulation of cortisol, a stress-related hormone? * Are the effects on pain, anxiety, depression, cognitive problems, and cortisol sustained when treatment continues with a maintenance phase of up to 2 months? Researchers will compare real tDCS to sham (placebo) tDCS, a look-alike procedure that does not deliver effective stimulation, to see if real tDCS works to reduce pain and improve these symptoms. Participants will: * Receive real or sham tDCS (assigned by chance) in 5 daily sessions over 1 week. Each session lasts 20 minutes: 10 minutes at rest and 10 minutes while doing a working-memory task * If they did not respond to sham tDCS, be offered 5 additional daily sessions of real tDCS * If they respond to treatment, continue with real tDCS twice a week for up to 2 months * Complete assessments of pain, mood, memory, attention, and quality of life before treatment, after each phase, and during and at the end of the maintenance phase * Collect saliva samples to measure cortisol

Aromatherapy in Total Knee Replacement

The purpose of this pilot randomized controlled trial is to investigate the effects of aromatherapy on postoperative anxiety and pain in total knee replacement patients. The primary research questions are: Does Lavender-Peppermint Aromatherapy reduce post operative anxiety in patients after primary total knee replacement when compared to placebo? Does Lavender-Peppermint Aromatherapy reduce post operative pain in patient after primary total knee replacement when compared to placebo? Participants will be assigned to one of the following groups at random: * Intervention: Aromatherapy with the lavender-peppermint scent * Control: Aromatherapy with the almond oil scent Participants will also be asked to complete pre- and post-operative questionnaires. Researchers will compare both groups (intervention vs control) to see if aromatherapy reduces post-operative anxiety and/or pain.

AYA-PeerConnect: A Communication Coaching Intervention for Adolescent/Young Adult Cancer Survivors (AYACS)

This research is being done to test a communication coaching intervention pilot designed to improve communication quality between adolescent/young adult cancer survivors (AYACS) and their friends/peers. The results of the study will help to understand how to best support adolescent/young adult cancer survivors, and may inform the development or future implementation of similar programs for cancer survivor populations.

Internet-Delivered Cognitive Behaviour Therapy for Depression and Anxiety in Perinatal Parents

This study evaluates the effectiveness of the Wellbeing Course for New and Expecting Parents (WCNEP), an internet-delivered cognitive behavioral therapy (ICBT) intervention, in reducing symptoms of anxiety and depression in perinatal parents, within a routine care online therapy clinic (the Online Therapy Unit). The study aims to assess treatment uptake, perceptions, feasibility, and effectiveness of the WCNEP in routine care among birthing and non-birthing parents. Over the duration of 8 weeks, participants will review course materials online and respond to questionnaires aimed at assessing changes in various outcomes over time.

Virtual Reality-Based Hypnotherapy for Pain, Sleep, and Mood in Spinal Cord Injury

The goal of this clinical trial is to learn whether virtual reality (VR)-based hypnotherapy, added to conventional physiotherapy, improves pain, sleep, mood, and quality of life in adults with chronic spinal cord injury. The main questions it aims to answer are: * Does VR-based hypnotherapy added to physiotherapy reduce pain intensity more than physiotherapy alone? * Does it improve neuropathic pain, sleep quality, anxiety and depression, spasticity, and quality of life? Researchers will compare participants who receive VR-based hypnotherapy in addition to physiotherapy with participants who receive physiotherapy alone. Participants will: * Receive a standard physiotherapy and rehabilitation program 5 days a week for 2 weeks (10 sessions). * If assigned to the VR group, also receive an approximately 20-minute VR-based hypnotherapy session after each physiotherapy session, using a VR headset and headphones. * Complete assessments at the start of the study, at the end of the 2-week treatment period, and 2 weeks after treatment ends.

Feasibility and Acceptability of an E-learning Dialectical Behavior Therapy Skills Course

Dialectical behavior therapy (DBT) is a comprehensive, third-wave psychological intervention designed for patients with complex and severe behavioral, emotional, and interpersonal dysfunction. DBT has since been adapted to shorter, briefer, "skills training" formats, which have been effective for a number of mild-to-moderate mental health conditions, including depression and anxiety. Moreover, internet-delivered formats of DBT (iDBT) have similarly started to build support for their effectiveness, although there are fewer studies on digital formats. One study found that over 12 weeks, iDBT was deemed acceptable (e.g., 50% of participants were still active after 4 weeks) and there were improvements in multiple symptom domains, such as depression, anxiety, suicidality, functional disability, as well as alcohol and substance dependence. In the current study, the investigators will examine the feasibility, acceptability, and potential efficacy of a new iDBT intervention, packaged as an online e-learning skills course, with adult participants. The study is a pilot trial as iDBT has never been tested in this format through formal research. Thus, this pilot study aims to examine whether this course is usable, practical, and potentially useful to others in the future. The investigators will recruit up to 40 individuals with mild-to-moderate depression and anxiety for an 8-week study. Following a phone screen to determine eligibility, participants will complete a baseline session where they will provide consent, complete a brief interview and questionnaires, and register for the e-learning skills course. Over the course of 8 weeks, participants will be exposed to material adapted from a DBT manual in a self-guided manner. Participants will complete follow-up assessments at 4 and 8 weeks.

Dyadic Interactions in Depressed and Non-Depressed Mothers and Their Infants

This study will examine 1) differences among mothers behaviors and how these behaviors influence their infants reactions, and 2) how mother-child interactions relate to children s temperament, and cognitive (thought processing) abilities, and other areas of development. Depressed and non-depressed English-speaking mothers between 20 and 45 years of age, with an infant 4 months or younger, may be eligible for this study. Candidates will be screened with a mailed survey regarding their moods and feelings. Participants will undergo the following procedures: * Psychiatric Interview: Subjects will participate in a 30-90 minute interview consisting of a series of standardized questions about the their behaviors and feelings. Participants whose interviews suggest a condition that may impact their mental health will be referred to the study clinician for follow-up to confirm or clarify the preliminary findings. Continued participation in the study will be determined following this. * Home Visit: A study investigator will visit the home for 1 hour to film the mother and baby during the mother s typical daily activities. This visit will take place when the baby is about 5 months old. At the end of the visit, the mother will be given a variety of surveys to fill out at home and return at the next visit (see Lab Visit below). The survey questions deal with the mother s relationship with her partner, support from people in her life, typical behaviors of her infant, and how often she feels certain emotions. A packet of surveys will also be left for the participant s partner to complete and mail back to the investigator. The partner may or may not be the child s biological father and may or may not choose to participate in the study. * Lab Visit: Within 1 week of the home visit, the mother and child will come to the NICHD clinic for about 2 hours. During this time, the mother will return the previous surveys and fill out another one regarding her current mood. She will then interact with her child, who will be seated in front of her. The 20-minute session will be videotaped. (There will be breaks during the session.) The mother will be instructed about how she should act (happy or sad). She and her baby will then participate in a variety of filmed situations that will induce certain emotions in the baby, such as happiness, fear, activity, frustration, and interest, in order to learn how different children react to different situations. Participants will be contacted to continue the study when their babies are 12 months old and again when the children are 24 months old. The above procedures will be repeated and some new measures will be added for toddlers that involve activities investigating aspects of early language and social reasoning.. ...

TRIPS - Treatment to Improve Depression and/or Anxiety Using Psilocybin-assisted Psychotherapy in Cancer Survivors

This clinical research study is to learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy for cancer survivors with depression and/or anxiety.

Effects of Qigong Exercise on Anxiety and Depression in Patients Receiving Inpatient Treatment for Substance Use Disorder

Patients receiving inpatient treatment for substance use disorder may experience anxiety and depressive symptoms. Qigong is a mind-body exercise that combines gentle movements, breathing techniques, and relaxation. This study aimed to evaluate the effects of Qigong exercises on anxiety and depression levels. The study was conducted as a single-blind, randomized controlled trial. Patients meeting the predefined eligibility criteria were randomly assigned to either the intervention group or the control group. The intervention group participated in Shibashi Qigong exercises four times a week for three weeks (12 sessions in total), while the control group did not receive Qigong exercises. Both groups continued their usual treatments. Anxiety and depression levels were assessed using the State-Trait Anxiety Inventory (STAI) and the Beck Depression Inventory (BDI) at three time points: before the intervention, immediately after the three-week exercise program, and one week after its completion.

Early Life Stress and Depression: Molecular and Functional Imaging

Severe childhood adversity accounts for a large portion of psychiatric illness, and an increased risk for major depressive disorder (MDD). For some individuals, childhood adversity has negative psychological and medical consequences; others preserve mental and physical health despite such experiences (they are resilient). In spite of this, little is known about the neurobiological mechanisms related to childhood adversity, especially oxidative stress abnormalities in the brain. To fill this gap, this study combines functional, structural, and molecular imaging approaches to examine the role of oxidative stress abnormalities related to childhood adversity.

Psychological and Physiological Effects of Three-Minute Breathing Space Meditation in UPM Postgraduate Students

Postgraduate students often experience psychological distress linked to academic demands, deadlines, research uncertainty, and financial or social pressures, and international students may face additional adjustment challenges. This study tests whether a brief, low-burden mindfulness practice - a three-minute Breathing Space Meditation (BSM) session, done four days a week for 8 weeks - can reduce stress, anxiety, and depression in postgraduate students at Universiti Putra Malaysia, compared with an active control activity that is matched in format and contact time but does not involve mindfulness training. Participants are randomly assigned to one of the two groups and are grouped by whether they are local or international students. The study also looks at whether the intervention affects stress hormone (cortisol) levels, a marker of inflammation (C-reactive protein), and a brain-wave measure linked to mood, and it collects brief daily check-ins on mood, stress, sleep, and academic pressures over the 8 weeks.

Metacognitive Bibliotherapy for Anxiety, Depression, and Metacognitions in University Students

This study tests whether reading a structured self-help book (bibliotherapy) can reduce anxiety, depression and stress and change unhelpful thinking patterns in medical and health-sciences students. Students in health programs face heavy academic and clinical demands and are at increased risk of emotional distress. A thinking style called the Cognitive Attentional Syndrome (worry, rumination, threat monitoring and unhelpful coping) is thought to link stress to anxiety and depression. Metacognitive therapy targets this thinking style, and low-intensity self-help books may make these principles accessible to students. A total of 165 students at İstanbul Nişantaşı University will be randomly assigned to one of three groups: two groups each receive a different self-help book and read it at their own pace over 8 weeks, and the third group (waitlist) receives the books after the study ends. All participants complete short online questionnaires (DASS-21, CAS-1, MCQ-30) at the start, at week 4 and at week 8, and receive brief telephone calls at weeks 2, 4 and 6 to confirm participation.

Psilocybin FCR Early-Stage Breast Cancer

This trial is designed to evaluate efficacy and psychological mechanisms of single-dose psilocybin-assisted psychotherapy (PAP) to treat fear of cancer recurrence (FCR), psychiatric (anxiety, depression) distress and quality-of-life (QOL), in 100 outpatients with early-stage breast cancer. The study will assess the strength and durability of therapeutic effects in a double-blind, parallel-design, placebo-controlled, two-center randomized controlled trial (RCT) comparing a single 25mg oral 'high' dose of psilocybin to a single 5mg oral 'low dose psilocybin (active placebo), both delivered in conjunction with a psychotherapy platform.

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD. For more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation, please visit the study website: https://embrace-mdd-trial.com/

Perinatal Research on Improving Sleep and Mental Health

The goal of this clinical trial is to compare two sleep programs in pregnant people with insomnia. The main questions it aims to answer are: 1. What is the efficacy of digital cognitive behavioral therapy for insomnia (CBT-I) versus digital sleep hygiene education (SHE) for preventing perinatal depression? 2. Is the effect of digital CBT-I on perinatal depression mediated through prenatal insomnia symptom improvement? 3. Is the effect of digital CBT-I on perinatal depression moderated by baseline depressive symptom severity? Participants will receive one of two sleep programs - SHE or CBT-I. Both involve six weekly online sessions. Participants will complete surveys and interviews until 1 year postpartum.

A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)

The goal of this clinical trial is to learn if a drug called TNX-102 SL works to treat moderate to severe major depressive disorder in adults. It will also learn about the safety of TNX-102 SL. The main questions it aims to answer are: Does TNX-102 SL improve depression symptoms according to a depression symptom rating scale? What medical problems do participants have when taking TNX-102 SL? Researchers will compare TNX-102 SL to a placebo (a look-alike substance that contains no drug) to see if TNX-102 SL works to treat major depressive disorder. Participants will: Take TNX-102 SL or a placebo every night at bedtime for 6 weeks Visit the clinic once every 2 weeks for checkups and tests

The Mindful Smartphone Use Study

The goal of this clinical trial is to understand the feasibility and acceptability on a mindfulness-based intervention to address co-existing smartphone addiction and psychological distress among adolescents ages 13-19 self-reporting elevated levels of depression and/or anxiety symptoms and problematic digital phone use. The main questions it aims to answer are: (1) is Mindwire, a mindfulness-based intervention, feasible and acceptable in addressing co-existing smartphone addiction and psychological distress among adolescents; and (b) what are the mechanistic pathways, particularly the role of circadian rhythm, sleep quality, and emotion regulation, in phone use and psychological distress. Participants will be in this research study for 3 months. After screening and onboarding, they will be asked to: * participate in 18 days of the Mindwire program * answer a 45-60 minute online survey immediately before, immediately after, and approximately six weeks after the Mindwire program * participate in a 60-90 minute interview asking about their experience going through the program

Mechanism of Action Underlying Ketamine's Antidepressant Effects: The AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression

Background: Most drugs that treat mood disorders take a long time to work. Ketamine works within hours. A dose can last for a week or more. Certain receptors in the brain might help ketamine work. A drug that blocks these receptors might affect how it works. Objective: To see if the antidepressant response of ketamine is linked to AMPA receptors. Eligibility: Adults ages 18-70 with major depression disorder without psychotic features Design: Participants will be screened under protocol 01-M-0254. They will have blood tests and a physical exam. Participants will stay at the NIH Clinical Center for 5 weeks. Phase 1 lasts 4 weeks. For 2 weeks, participants will taper off their psychiatric medicine. Then they will have the following tests: * Blood draws * Psychological tests * MRI: Participants will lie in a machine that takes pictures of their brain. * MEG: Participants will lie down and do tasks. A cone lowered on their head will record brain activity. * Optional sleep tests: Electrodes on the scalp and body and belts around the body will monitor participants while they sleep. * Optional TMS: Participants will do tasks while a wire coil is held on their scalp. An electrical current will pass through the coil that affects brain activity. For phase 2, on day 0 participants will take the study drug or a placebo orally. While having a MEG, they will get ketamine infused into a vein in one arm while blood is drawn from a vein in the other arm. On day 1, participants will again take the study drug or a placebo orally. On days 3-7, they will repeat many of the phase 1 tests. Days 8 and 9 are optional and include an open label ketamine treatment and many of the phase 1 tests.

To Improve Depressive Symptoms Using a Web-App

This study is being done to answer a question on whether a Web App-based Lifestyle Physical Activity Promotion Program is effective in improving depressive symptom experience of midlife Korean American women (WPAPP-K).

Mandala Coloring in Late Pregnancy

Anxiety, depression and poor sleep are common in the last months of pregnancy and often occur together. Medication options during pregnancy are limited, so simple, safe non-drug methods are needed. Mandala coloring is an art therapy technique in which a person colors circular patterns; it helps focus attention on the present moment and may have a calming effect. This randomized controlled trial will examine whether mandala coloring during the third trimester reduces depression, anxiety and stress, improves sleep, and reduces fear of childbirth. It will also look at birth outcomes and the childbirth experience. Pregnant women at 28 weeks of gestation who attend the obstetrics outpatient clinics of Malatya Training and Research Hospital will be randomly assigned to a mandala coloring group or a control group. Women in the mandala group will color two mandalas a week at home for 8 weeks (16 mandalas in total, about 20-30 minutes per session). Women in the control group will receive routine antenatal care only and will be offered the mandala materials after the study ends.

Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum

Background: Making decisions during daily life is a complicated behavior. Even simple choices can be affected by a range of emotions, stresses, and moods. Mental health issues such as depression and anxiety can lead people to make decisions that have negative effects on their lives. Learning how changes in feeling affect a person's decisions may help researchers find ways to help them make more positive choices. Objective: To learn how changes in a person's feelings and emotions affect their decisions. Eligibility: People aged 18 to 55 years who are healthy or who have some level of depressive, anxiety, substance-related, or addictive disorders. Design: All study activities can be done remotely; participants may use a smartphone app, a website, or telehealth. Participants will have a baseline visit. They will complete tasks that require decisions; these tasks are like games they play on their phone. They will also answer questions about their habits, how they feel, their sleep quality, and any problem behaviors. They may wear a smartwatch during the study; it will record data such as their movements and heart rate. For 12 weeks, a study app will prompt participants to respond. They will be asked to answer questions about how they are feeling, any problematic behaviors, or big life events; they will be asked to complete tasks that require making decisions. They may record a video or audio clip describing their day and how they feel. For 3 of the 12 weeks, participants will get prompts up to 6 times per day. For 9 weeks, they will get up to 3 prompts per day. They will have an end-of-study visit to discuss their experiences.

Digital Intervention for Depression and Anxiety in Adolescents

The goal of this clinical trial is to evaluate the effectiveness of digital interventions in treating depression and anxiety in adolescents. The main question it aims to answer is: Can digital interventions effectively alleviate symptoms of depression and anxiety in adolescents? The trial will include a comparison group where researchers will compare the effects of the digital intervention to traditional health education methods to assess their relative efficacy. Participants will be asked to engage with the digital intervention platform for a period of two months.

Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder

Background: Most medications that treat depression take weeks or months to work. Researchers want to develop fast-acting treatments. One dose of ketamine has a rapid antidepressant effect. For most people, this lasts a week or less. Repeated doses of ketamine may help maintain this effect. Objective: Main Study: To study the effects of ketamine in treating depression. Ketamine Metabolites Substudy: To study how ketamine effects brain chemistry. To study how ketamine effects the brain. This is done by looking at metabolites, which are created when a drug is broken down. Eligibility: Main Study: People ages 18-65 with major depressive disorder and healthy volunteers Ketamine Metabolites Substudy: Healthy volunteers ages 18-65 Design: Main Study: Participants will be screened in another study, with: * Medical and psychiatric history * Psychiatric and physical exam * Blood, urine, and heart tests Participants will be inpatients at NIH for 4 phases totaling 14-20 weeks. Phase I (2-7 weeks): * Gradually stop current medications * MRI: Participants lie and perform tasks in a machine that takes pictures of the body. * Mood and thinking tests * Blood and urine tests * Sleep test: Monitors on the skin record brain waves, breathing, heart rate, and movement during sleep. * Transcranial magnetic stimulation: A coil on the scalp gives an electrical current that affects brain activity. * Stress tests: Electrodes on the skin measure reactions to loud noises or electric shocks. Phase I tests are repeated in Phases II and III and in the final visit. Phase II (4-5 weeks): * 4 weekly IV infusions of ketamine or a placebo during an MRI or MEG. For the MEG, a cone over the head records brain activity. Phase III (optional): * 8 infusions of ketamine over 4 weeks Phase IV (optional): * Symptoms monitoring for 4 weeks * Participants will have a final visit. They will be offered standard treatment at NIH for up to 2 months. Ketamine Metabolites Substudy: Participants will be screened in another study, with: * Medical and psychiatric history * Psychiatric and physical exam * Blood, urine, and heart tests Participants will be inpatients at NIH for 4 days. Study Procedures: Mood and thinking tests Blood and urine tests 1 infusion of ketamine Spinal tap and spinal catheter: Used to get samples of cerebrospinal fluid (CSF). This is a fluid that moves around and within the brain and spinal cord. Studying CSF will help us learn how ketamine effects brain chemistry ...

Efficacy of Repetitive Transcranial Magnetic Stimulation for Improving Depressive Symptoms in Patients With Parkinson's Disease

The purpose of this study is to evaluate the efficacy of repetitive transcranial magnetic stimulation (rTMS) in improving depressive symptoms in patients with Parkinson's Disease(PD). Participants will be randomly assigned to either an active rTMS group or a sham-control group. The study aims to evaluate the efficacy and feasibility of a neuronavigation-guided bilateral M1 rTMS protocol.