Depression

Baltimore, MD

86 Depression Trials near Baltimore, MD

Power is an online platform that helps thousands of Depression patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.

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No Placebo
Highly Paid
Stay on Current Meds
Pivotal Trials (Near Approval)
Breakthrough Medication

Wellness Program for Trauma

Baltimore, Maryland
This trial involves women in emergency shelters attending group sessions to practice mindfulness and learn about health. The goal is to reduce their stress and help them manage long-term health issues.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Sex:Female

40 Participants Needed

THC-Based Medication for Agitation in Alzheimer's

Baltimore, Maryland
This trial tests a natural THC-based medicine called IGC-AD1, given in small doses regularly. It targets people aged 60 and above with Alzheimer's-related dementia who have been experiencing agitation. The THC in the medicine helps reduce agitation by interacting with brain signals. The most recent trial reported significant improvement in agitation using nabilone.

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2
Age:60+

164 Participants Needed

Zelquistinel for Depression

Towson, Maryland
The goal of this clinical trial is to learn if GATE-251 works to treat depression in adults. It will also learn about the safety of GATE-251. The main questions it aims to answer are: Does GATE-251 reduce depression scores in participants compared to participants who take a placebo (a look-alike tablet that contains no GATE-251)? What medical problems are observed in participants who take GATE-251? Participants will take one tablet of GATE-251 or placebo every week for 6 weeks. Participants will visit the clinic every week of the 6 week period to have the severity of their depression evaluated.

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:18 - 64

164 Participants Needed

ALTO-203 for Depression

Pikesville, Maryland
The goal of this clinical trial is to determine the pharmacodynamic effects of ALTO-203 in patients with MDD in a randomized, placebo-controlled, single-dose crossover treatment period. Additionally, safety, tolerability, and PK will be assessed in a subsequent randomized placebo-controlled multi-dose parallel-group treatment period of 28 days. Participants will complete subjective response questionnaires and perform cognitive tasks during the single-dose period, in which participants will receive ALTO-203 25 μg and 75 μg, as well as placebo. During the multiple-dose period, participants will receive either ALTO-203 25 μg, 75 μg , or placebo. Safety will be assessed over the single dose and 28-day multiple dose periods.

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2
Age:25 - 64

60 Participants Needed

Probiotics for Bipolar Disorder

Towson, Maryland
The purpose of this study is to determine if taking a probiotic supplement versus a placebo will reduce relapse and improve the clinical course among participants who have been hospitalized for bipolar depression.

Trial Details

Trial Status:Enrolling By Invitation
Age:18 - 65

80 Participants Needed

VNS for Bipolar Depression

Baltimore, Maryland
This trial is testing whether VNS Therapy, which sends electrical impulses to the vagus nerve, can reduce depression symptoms in patients who haven't responded to other treatments. The study will observe the effects of VNS therapy over a year. Vagus nerve stimulation (VNS) is a recognized treatment for severe treatment-resistant depression and has shown promising results.

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

6800 Participants Needed

Aticaprant + Antidepressant for Depression

Towson, Maryland
The purpose of this study is to assess how well aticaprant works compared to placebo when given in addition to antidepressant therapy (selective serotonin reuptake inhibitor \[SSRI\] or serotonin-norepinephrine reuptake inhibitor \[SNRI\]) in preventing return of depression symptoms in participants with major depressive disorder who experience a loss of interest and pleasure and who achieve a stable response after treatment with adjunctive aticaprant.
Stay on current meds
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:18 - 64

660 Participants Needed

Psilocybin for Depression

Baltimore, Maryland
This trial explores the safety of a single 25mg dose of psilocybin given to adults with depression that hasn't improved with other treatments and who have ongoing suicidal thoughts. Psilocybin works by changing brain cell communication to improve mood and reduce negative thoughts. Psilocybin has shown promise in treating depression, anxiety, and other mental health conditions in recent studies.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18 - 65

20 Participants Needed

Psilocybin for Treatment-Resistant Depression

Pikesville, Maryland
This trial is testing a new medication called COMP360 to help people with severe depression that hasn't improved with other treatments. The study involves adults aged 18 and older. Researchers want to see if a single dose of COMP360 can reduce depression symptoms when given with psychological support.
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 3

255 Participants Needed

Centanafadine for Depression

Laurel, Maryland
This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-arm trial to assess the efficacy, safety, and tolerability of centanafadine once-daily (QD) extended-release (XR) capsules for the treatment of adult subjects diagnosed with Major Depressive Disorder (MDD). The trial will evaluate the efficacy and safety of centanafadine QD XR capsules as monotherapy or as adjunct to the selective serotonin reuptake inhibitor (SSRI), escitalopram.

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 65

336 Participants Needed

Digital Therapeutic for Depression After Traumatic Brain Injury

Bethesda, Maryland
This trial tests a mobile app designed to help military service members and veterans with mild traumatic brain injury reduce their depression. The app helps users change negative thoughts and behaviors to improve their mood. This type of therapy has been shown to be effective for various mental health issues, including depression, and can be delivered through different methods such as mobile apps.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Age:18 - 65

113 Participants Needed

Rosie Chatbot Assistance for Pregnancy and Infant Care

College Park, Maryland
Rosie the Chatbot is an educational chatbot that moms can have on their computers or cellphones and will work by moms typing in their questions about pregnancy, health, infant milestones, and other variety of health related topics and receiving back a response immediately. Rosie only provides information from verified sources such as children's hospitals, health organizations and government agencies. Rosie does not ask moms to provide any personal information on her or her child, her chat is completely confidential, it works in English and Spanish and will be free.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:14 - 99
Sex:Female

400 Participants Needed

SuperSite

SEP-363856 for Major Depressive Disorder

Gaithersburg, Maryland
A Phase 2/3 Trial is designed to evaluate SEP-363856 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:18 - 65

900 Participants Needed

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Osavampator as an Adjunctive Treatment for Depression

Gaithersburg, Maryland
This trial evaluates whether adding the investigational drug Osavampator (also known as NBI-1065845) to existing oral antidepressant therapy can improve depressive symptoms in patients with depression who aren’t adequately responding to their current antidepressant medication(s).
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3

200 Participants Needed

Active on Power

Psilocybin Analog for Depression

Rockville, Maryland
The purpose of this study is to examine the efficacy, safety, and tolerability of CYB003 compared to matching placebo as adjunctive treatment in participants with MDD.
Stay on current meds
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3

220 Participants Needed

Active on Power

Psychedelic-Assisted Therapy for Treatment Resistant Depression

Rockville, Maryland
This study is testing VLS-01, a treatment containing DMT that is placed in the mouth and dissolved, to see if it can quickly help people with depression who haven’t improved with other treatments. Participants will receive either 1 or 3 doses of VLS-01, with support throughout the study, to evaluate its safety and effectiveness.

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 65

142 Participants Needed

CYB003 for Depression

Rockville, Maryland
This is a long- term extension of the double-blind trials APPROACH (CYB003-002) and EMBRACE (CYB003-003). Its aim is to examine the safety and long-term efficacy of CYB003 in participants with MDD.
No Placebo Group
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3

468 Participants Needed

Brain Imaging + Ketamine for Suicide Risk

Bethesda, Maryland
Background: There are no good treatments for people considering suicide. Researchers want to study suicide with questions, blood tests, brain imaging, and sleep studies. They hope to better understand suicide, so they can help suicidal people. Objective: To understand what happens in the brain when someone has thought about or attempted suicide. Eligibility: Group 1: Adults ages 18 70 who have thought about or attempted suicide recently Group 2: Adults ages 18 70 who have thought about or attempted suicide in the past Group 3: Adults ages 18 70 who have depression or anxiety, but have never thought about suicide Group 4: Healthy volunteers the same ages. Design: Participants will be screened in another protocol. Adults who have recently thought about or attempted suicide must be referred by a doctor. They may do up to 3 phases of this study. Groups 2, 3 and 4 will do only Phase 1 and will not get ketamine. Phase 1: 1 week in hospital. Participants will have: Physical exam. Questions about thoughts and feelings. Thinking and memory tests and simple tasks. Blood and urine tests. Two MRI scans. Participants will lie on a table that slides into a metal cylinder that takes pictures. They will have a coil over their head and earplugs and do a computer task. Sleep test. Disks and bands will be placed on the body to monitor it during sleep. Magnetic detectors on their head while they perform tasks. A wrist monitor for activity and sleep. Lumbar puncture (optional). A needle will collect fluid from the back. Shock experiments (optional). Participants will observe pictures and sounds and feel a small shock on the hand. Phase 2: 4 days in hospital. A thin plastic tube will be placed in each arm, one for blood draws, the other to get the drug ketamine once. Participants will repeat most of the Phase 1 tests. Phase 3: up to 4 more ketamine doses over 2 weeks. Participants will have follow-up calls or visits at 6 months and then maybe yearly for 5 years. ...
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2

325 Participants Needed

Psilocybin for Depression in Adults with Cancer

Rockville, Maryland
This is a Phase 2, single-center study to explore the efficacy, safety, and tolerability of up to two 25-mg doses of psilocybin administered at an interval of 9 to 10 weeks in patients with MDD and cancer. This two-part study will administer a fixed dose (25 mg) of psilocybin in a double-blind, randomized, placebo-controlled portion (Dosing Session 1) and subsequently allow rollover into an open-label portion (Dosing Session 2; fixed dose of psilocybin, 25 mg) for patients who do not achieve remission of MDD symptoms after the first dose. In Dosing Session 1, groups of two to four patients will be randomized, as a cohort, to receive either psilocybin 25 mg or niacin 100 mg (active placebo) in a group session, with each patient supported by their dedicated study therapist and monitored by a second therapist via video feed. In Dosing Session 2, all eligible participants (i.e., patients who have not achieved remission defined as MADRS \< 10 at V7) will receive psilocybin 25 mg in an open-label fashion using the group session model. The study population will include adult men and women who are 18 years of age or older and have diagnoses of both MDD and a malignant neoplasm. MDD is defined as the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) diagnostic criteria for a single or recurrent episode of MDD without psychotic features. A diagnosis of a malignant neoplasm is defined as having a diagnostic code from C00 to C97 according to the International Classification of Diseases, 10th edition (ICD-10). Participants will be recruited through referrals from specialized psychiatric and oncology services as well as through patient self-referrals. The majority of participants will have no prior exposure to psilocybin or so-called "magic mushrooms"; however, participants with prior recreational experience with psilocybin or "magic mushrooms" are eligible.

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2

56 Participants Needed

Psilocybin for Depression

Rockville, Maryland
Safety, Tolerability, pharmacokinetics and efficacy of a single administration of COMP360 in participants with recurrent Major Depressive Disorder.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 2

102 Participants Needed

Why Other Patients Applied

"I've been struggling with alcoholism and depression on-and-off for about 12 years. I have heard of people have good outcomes for various mental health issues after using psilocybin but would not be willing to try it without a doctor's care. So I'm applying to a trial. "

QJ
Depression PatientAge: 60

"I'm taking a medication for anxiety and it's not helping/working. I want to try and find something that would help with my anxiety. My research brought me to clinical trials."

ZD
Social Anxiety PatientAge: 36

"I was first diagnosed with major depressive disorder and anxiety over twenty years ago. I have tried different medications. Had to come off medications due to pregnancies, and have worked through different side effects like weight gain, nausea, sleepiness, and the more severe where i have tried to claw my way out of my skin it itched so bad. I dont want other people to have to go through this and I wish I could be off of my medication for good but it just hasnt happened. IF something is out there to improve the life of an anxious and/or depressed person I'd like to be able to say I helped find it."

HD
Depression PatientAge: 46

"I've been through a substance abuse program three times. Clearly, it's not working. I need to try something totally different and new to deal with my depression (plus alcohol usage) once and for all. I did some research on psilocybin and want to try."

QP
Depression PatientAge: 55

"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."

ZS
Depression PatientAge: 51

NBI-1070770 for Depression

Gaithersburg, Maryland
To evaluate the efficacy, safety, and tolerability of NBI-1070770 compared to placebo on improving symptoms of depression in participants with major depressive disorder (MDD).

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18 - 65

73 Participants Needed

Ketamine for Depression

Bethesda, Maryland
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.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 1

70 Participants Needed

[18F]PF-06445974 PET Imaging for Depression

Bethesda, Maryland
Background: Major depressive disorder (MDD) is a psychiatric condition. People with MDD have occasional bouts of depressive symptoms; these bouts are called major depressive episodes (MDEs). Researchers want to know if people having MDEs have lower levels of an enzyme called PDE4B in their brains. Primary Objective: To determine whether PDE4B is reduced in the brains of individuals with MDD experiencing a major depressive episode (MDE). Secondary Objectives: To determine the optimal length of scanning and the retest variability and reliability of \[18F\]PF-06445974, and whether PDE4B binding correlates with clinical rating scales. To measure if PDE4B radioligand binding can be blocked by taking apremilast. Eligibility: People aged 18-70 years with MDD. Healthy volunteers are also needed. Design: Participants will have up to 5 clinic visits. Participants will be screened. They will have a physical exam with blood tests. They will have a test of their heart function. Some participants may have a psychiatric assessment; they will answer questions about their state of mind and related topics. Participants will have magnetic resonance imaging (MRI) of the brain. They will lie on a table that slides into a metal cylinder. Participants will have a positron emission tomography (PET) scan. A needle will be used to guide a thin plastic tube (catheter) into a vein in one arm. An experimental substance called a radioactive tracer (\[18F\]PF-06445974) will be injected through the catheter. Participants will lie on a table that slides into a doughnut-shaped machine. The scan will last up to 4 hours with a 15-minute break. Participants blood pressure, heart rate, and breathing will be monitored before, during, and after the PET scan. A second catheter will be inserted in the artery of the wrist so blood can be drawn during the scan. Some participants may return for a second PET scan; have a lung scan or receive apremilast. https://nimhcontent.nimh.nih.gov/start/surveys/?s=KE88DXXPLDFHHTF8
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 1

108 Participants Needed

PET Imaging for Depression

Bethesda, Maryland
Background: Researchers developed \[11C\]MC1, a radioligand for cyclooxygenase-2 (COX-2). COX-2 is an enzyme induced in the brain during inflammation. Researchers want to see the levels of COX-1 (measured as distribution volume VT) are elevated in the brain of two groups of mood disorders patients undergoing MDE relative to the control group. Objective: To determine whether COX-1 and COX-2 are detectable in the brains of individuals with MDD experiencing a major depressive episode (MDE). Eligibility: People aged 18-70 years with MDD and Healthy Volunteers aged 18 70 years. Design: Group A: MDD participants will be studied with the same dose of \[11C\]MC1 before and after administration of 600 mg celecoxib; the study is neither randomized nor placebo-controlled. Group B: MDD participants, both medicated and unmedicated, will be studied with \[11C\]PS13 and compared to healthy volunteers.. https://nimhcontent.nimh.nih.gov/start/surveys/?s=TJW4RA4WN3LDD988
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 1

64 Participants Needed

Ketamine for Major Depressive Disorder

Bethesda, Maryland
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 ...

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 65

150 Participants Needed

Interpersonal Psychotherapy for Depression

Washington D.C., District of Columbia
The goal of this clinical trial is to test the effectiveness and implementation of delivering Enhanced Brief Interpersonal Psychotherapy (IPT-B), an evidence-based maternal depression treatment, to mothers of children aged 4-11 years in an urban pediatric asthma clinic. Researchers will compare Enhanced IPT-B and supplemented usual care (brief care coordination). The main questions the trial aims to answer are: 1. Does Enhanced IPT-B decrease maternal depressive symptoms? 2. Does Enhanced IPT-B improve child asthma management and health outcomes (exacerbations, symptoms, control)? 3. What are the preliminary implementation outcomes of delivering Enhanced IPT-B in an urban pediatric asthma clinic?
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:4+

60 Participants Needed

Trauma Resilience and Recovery Program for PTSD

Washington, Virginia
The purpose of this study to learn about patients' experience with the Trauma Resilience and Recovery program (TRRP) and/or the enhanced care group.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:16+

350 Participants Needed

rTMS for TBI-related Depression

Bethesda, Maryland
The purpose of this study is to investigate the efficacy, safety, and tolerability of two dorsolateral prefrontal cortex (DLPFC) repetitive transcranial magnetic stimulation (rTMS) protocols to alleviate symptoms of depression in United States (U.S.) military service members and veterans with a history of concussion/mild traumatic brain injury (TBI).

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 55

198 Participants Needed

rTMS + Cognitive Therapy for Depression

Bethesda, Maryland
Background: Repetitive transcranial magnetic stimulation (rTMS) is a treatment for depression. It stimulates the brain. Researchers want to see if using magnetic resonance imaging (MRI) scans helps locate the best area for rTMS in each person. They also want to find other ways to make it more effective. Objective: To study the effects of combining MRI- guided transcranial magnetic stimulation (TMS) and talk therapy on the brain in people with depression. Eligibility: Adults ages 18-75 with a major depressive disorder and current depression. If taking an antidepressant, should have been doing so for at least 4 weeks. Design: Participants will be screened with medical and psychiatric history, psychiatric evaluation, physical exam, and blood and urine tests. Phase 1 is 1-4 visits in 1 week. Participants will have: * Brain MRI. Participants will lie on a table in a scanner. * Questions about their medical history and psychology symptoms * Tests of mood and thinking * Tests of brain activity. Participants may do tasks during these tests: * A cone with magnetic detectors is put on the head. * A cap with electrodes is put on the scalp. * TMS. A brief electrical current passes through a wire coil on the scalp. * A metal disk will be placed on the arm. A nerve will be stimulated with a small electrical shock. Phase 2 is about 6 to 7 weeks. * There will be 30 daily sessions of combined therapy and repetitive TMS (rTMS) for 6 weeks. * Participants will receive rTMS and another therapy by computer. * For rTMS, repeated pulses will pass through the coil. * This is followed by up to 3 additional visits, when: * Participants will repeat Phase 1 tests * Participants will rate their depression symptoms. Phase 3 is 3 visits over 3 months. Participants will rate their depression symptoms and repeat some of the previous questionnaires and tests of mood and thinking.

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased

32 Participants Needed

CBT-I vs. MBTI for TBI-Related Insomnia

Bethesda, Maryland
This study is a prospective two-arm, single blind randomized controlled trial design to compare the clinical effectiveness of telemedicine-delivered, 6-session, standardized cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI) in treating insomnia symptoms and ameliorating depressive symptoms in persons with mild to moderate TBI and comorbid Post-Traumatic Stress Symptoms (PTSS) and insomnia symptoms in a 360 patients. Participants will undergo assessment (psychosocial questionnaires, neurocognitive testing, sleep monitoring) at baseline, at the end of treatment, and at 2-, 6- and 12-weeks post-treatment. The primary outcome is sleep as measured by the Insomnia Severity Index (ISI).
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

360 Participants Needed

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