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123 recruiting in TX
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Physiological and Psychological Effects of Music Therapy in the Pregnant Woman and Fetus

Music Therapy · Preterm Premature Rupture of Membrane (PPROM)

To evaluate the effects of music therapy in the care of antepartum mothers admitted for long-term hospitalization due to the high-risk status of their pregnancy. The investigators speculate that mothers who receive music therapy will be more successful in forming positive coping habits, bonding with their infant, and increasing the length of incubation during their pregnancy. Furthermore, there is no research that correlates music therapy applied to stress reduction, increased coping, and increased caregiver-infant bonding prior to birth within one protocol. However, there is a significant amount of research supporting music therapy efficacy with neonatal intensive care unit infants and caregiver bonding post-partum as well as improved physiological signs of stress in infants in the post-partum period.

Houston, TX18–64 yrsWomen
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A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

Bipolar Disorder · Bipolar Depression · Bipolar I Disorder

X-CEED is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of azetukalner in adult participants diagnosed with bipolar I or II disorder who are currently in a depressive episode (bipolar depression).

Atascocita, Wichita Falls, TX18–74 yrsAll genders
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A Computerized Depression Intervention in Veterans

Depression

Depressive symptoms are common among Veterans and associated with significant impairment. Timely intervention has the potential to improve mental health outcomes and restore functioning. Interventions delivered through the internet can be completed remotely at any time, and thus minimize burden on Veterans, however the research examining their utility in Veterans is limited. This proposed project will examine Deprexis, a self-guided internet-delivered intervention, which targets depressive symptoms and associated functional impairments. Interviews will be conducted to gain insight into Veterans' perceptions, needs, and preferences vis-a-vis Deprexis, with results informing a randomized controlled trial. Here an 8-week course of Deprexis will be compared to a treatment-as-usual (TAU) control condition to establish if Deprexis is acceptable and effective for Veterans with mild to moderate depressive symptoms. Veterans engaged in Deprexis are hypothesized to show improvements on measures of functioning and decreases in depressive symptoms compared to the TAU control group. The proposed work has great clinical utility, as it could provide a readily accessible, high-quality intervention for the many Veterans suffering from depressive symptoms, with the potential to improve functioning and long-term outcomes.

Waco, TX18+ yrsAll genders
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Mitigating PTSD-CUD After Sexual Assault

Posttraumatic Stress Disorder · Cannabis Use Disorder

683,000 women are sexually assaulted annually in the United States, half of whom develop chronic posttraumatic stress disorder (PTSD) and thus have markedly increased risk for cannabis use disorder (CUD). The current proposal will test the acceptability, initial efficacy, and mechanisms underlying a novel digital therapeutic targeting risk for PTSD-CUD, which could address the critical need for PTSD-CUD prevention for the 100,000 women who annually present for emergency care after sexual assault. In this research context, the applicant will receive key training in multisite, emergency-care based randomized clinical trials (RCTs), advanced statistical analyses for RCTs and ecological momentary assessment data, biobehavioral mechanisms underlying PTSD-CUD prevention, and professional development, launching her independent research career focused on reducing the public health burden of PTSD-CUD among sexual assault survivors by leveraging digital therapeutics.

Austin, TX18+ yrsWomen
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Teen Recovery Through Inspiration, Support, and Empowerment

Suicidal Ideation · Suicide Attempt · Anxiety

The goal of this pilot study is to test the effectiveness of a novel intervention for teenagers (ages 15-18) with mental health conditions who have been released from an acute care psychiatric facility. The intervention aims to reduce suicidality, depression, anxiety, re-hospitalization, and to improve mental health recovery by using an online recovery education and support program. The current standard of care (SOC) for these patients at discharge includes a discharge plan with a list of their medication(s), anticipated outpatient appointment(s), and corresponding information on when and where to find community resources. The intervention being tested involves the implementation of an online recovery education and support (RES) program, involving one-on-one and small group meetings led by trained teen peers (TPs) and peer support specialists (PSS). Participants will be assigned to either Cohort A or B for 8 weeks. Cohort A will be the intervention group with online access to an RES, TP, and PSS. * Week 1-4: One-on-one meetings with PSS and TP for education and support. Assessments will be completed at week 2 and 4. * Week 5 and 7: one-one meetings with PSS and TP for education and support. * Week 6 and 8: small group meetings with PSS, TP, and other participants. Assessments will be completed during Weeks 6 and 8. Cohort B will be the SOC group with no PSS, TP, or RES. * Weeks 1-4: Weekly check in phone calls with a member of the research team. Assessments will be completed at Weeks 2 and 4. * Weeks 5-8: Check in phone calls with a member of the research team every other week. Assessments will be completed at weeks 6 and8. Data collected from participant assessments, adherence to medication, and re-admittance to a psychiatric facility will be used to compare the intervention to the SOC.

Dallas, TX15–18 yrsAll genders
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Integrated Tele-Behavioral Activation and Fall Prevention for Low-income Homebound Seniors With Depression

Depression, Unipolar · Fall

This study will test clinical and cost effectiveness of an integrated tele- and bachelor's-level counselor/coach delivered behavioral activation (BA) and fall prevention (FP) for low-income homebound older adults. The long-term objective of the proposed study is to improve access to depression treatment and fall prevention for growing numbers of low-income homebound seniors. We plan to recruit 320 low-income, racially diverse homebound seniors who are served by a home-delivered meal (HDM) program and other aging-service agencies in Central Texas. In a 4-arm, pragmatic clinical trial with randomization prior to consent, the participants in the integrated Tele-BA and FP (TBF hereafter) arm will receive 5 Tele-BA sessions and 4 in-home FP sessions. Those in the Tele-BA or FP alone arms will receive the respective intervention and 4 bimonthly telephone check-in (booster) calls, and those in the Attention Control (AC) arm will receive 5 weekly telephone check-in calls followed by 4 bimonthly follow-up calls. Follow-up assessments will be at 12, 24, and 36 weeks after baseline.

Austin, TX50–100 yrsAll genders
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The OBSERVE Protocol

Major Depression Disorder

This observational protocol is intended to provide long-term follow-up data on patients initiating or continuing treatment with either Spravato® or IV ketamine. This can provide us information on the patient acceptability and satisfaction, patterns of use, long-term effectiveness, and safety of the two approaches. This 5-year, 6-site study will enroll 450 total patients. The sites will comprise 3 academic medical centers and 3 community psychiatric practices.

Bellaire, TXAll agesAll genders
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Comparative Effectiveness of Internet-based Versus Parent-Coached Cognitive-Behavioral Therapy For Children and Adolescents With Anxiety and OCD

Obsessive Compulsive Disorder (OCD) · Anxiety Disorder of Childhood or Adolescence · Social Anxiety Disorder of Childhood

Anxiety disorders in children and adolescents are common and confer significant disability. Cognitive behavioral therapy (CBT) is the recommended treatment for youth with anxiety, yet many families cannot access CBT due to cost, practicalities of attending in-person treatment sessions, and a shortage of trained providers, especially in rural areas. To combat these barriers, other treatment methods have been developed. Previous research has shown that family-based, internet-delivered CBT (iCBT) for anxiety and OCD in youth has shown a significant reduction in anxiety symptoms. Parent-coached exposure therapy (PCET) focuses entirely on teaching parents and youth together how to address anxiety through the completion of in-session parent-coached exposures and assigning parent-coached exposure as homework in between sessions. Although both iCBT and PCET show positive results in treating pediatric anxiety in comparison to standard-care CBT, little is known about the comparative efficacy of iCBT and PCET. This research is being done to understand the comparative effectiveness of two different types of cognitive-behavioral therapy (CBT) for treating anxiety or OCD in youth.

Houston, TX7–17 yrsAll genders
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Recruiting

A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression

Treatment Resistant Depression

Objectives of this study are to determine whether active VNS Therapy treatment is superior to a no stimulation control in producing a reduction in baseline depressive symptom severity, based on multiple depression scale assessment tools at 12 months from randomization.

Austin, Dallas +more, TX18+ yrsAll genders
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Recruiting

Recovery Through Inspiration, Support, and Empowerment

Suicidal Ideation · Suicide Attempt · Anxiety

The goal of this pilot study is to test the effectiveness of a novel intervention for young adults (ages 18-27) with mental health conditions who have been released from an acute care psychiatric facility. The intervention aims to reduce suicidality, depression, anxiety, re-hospitalization, and improve mental health recovery by using outpatient services. The current standard of care (SOC) for these patients at discharge includes a discharge plan with a list of their medications, anticipated outpatient appointments, and information on when and where to find community resources. The intervention being tested involves the implementation of a mental health recovery education and support program, involving one-on-one and small group meetings led by Peer Support Specialists (PSS) and Recovery Community Organizations (RCO). Participants will be assigned to either Cohort A or B for 8 weeks. Cohort A will be the intervention group with PSS and RCOs. * Weeks 1-4: One-on-one meetings with PSS for education and support. Assessments will be completed at weeks 2 and 4. * Weeks 5 and 7: One-on-one meetings with PSS for education and support. * Week 6 and 8: Group meetings with PSS and other participants from RCOs. Assessments will be completed during these weeks. Cohort B will be the SOC group with no PSS or RCOs. * Weeks 1-4: Weekly check in phone calls with a member of the research team. Assessments will be completed at weeks 2 and 4. * Weeks 5-8: Check in phone calls with a member of the research team every other week. Assessments will be completed at weeks 6 and 8. Data collected from participant assessments, adherence to medication, and re-admittance to a psychiatric facility will be used to compare the intervention to the SOC.

Dallas, TX18–27 yrsAll genders
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Recruiting

Improving Behavioral Health for Caregivers and Children After Pediatric Injury

Quality of Life · PTSD · Depression Not Otherwise Specified

Pediatric traumatic injury (PTI) is a public health priority, with more than 125,000 children experiencing injuries that require hospitalization each year. These children, and their caregivers, are affected in many ways that may affect quality of life, emotional and behavioral health, physical recovery, family roles and routines, and academic functioning; yet US trauma centers do not adequately address these outcomes and a scalable national model of care for these families is needed. This proposal builds on prior research from the investigative team to test a technology-assisted, stepped care behavioral health intervention for children (\<12 years) and their caregivers after PTI, CAARE (Caregivers' Aid to Accelerate Recovery after pediatric Emergencies), via a hybrid type I effectiveness-implementation trial with 348 families randomly assigned to CAARE (n=174) vs. guideline-adherent enhanced usual care (EUC) (n=174).

Houston, TX18+ yrsAll genders
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Deep Brain Stimulation of Treatment-Resistant Bipolar Depression

Bipolar Depression

This study is only enrolling at Baylor College of Medicine. The other research locations listed serve to support data analysis only. This research study is to investigate the use of technology called Deep Brain Stimulation (DBS) to potentially improve Treatment-Resistant Bipolar Depression (TRBD) symptoms in patients with severe cases. DBS involves the surgical implantation of leads and electrodes into specific areas of the brain, which are thought to influence the disease. A pack implanted in the chest, called the neurotransmitter, keeps the electrical current coursing to the brain through a wire that connects the neurotransmitter and electrodes. It is believed DBS may restore balance to dysfunctional brain circuitry implicated in TRBD. The goal of this study is to enhance current approaches to DBS targeting in the brain and to use a novel approach to find a better and more reliable system for TRBD treatment. Its important for participants to understand that this is an investigational study where there could be a lack of effectiveness in improving TRBD symptoms. There may be no directly benefit from taking part in this study. This study is expected to last 20 months and involves 3 main steps. 1. Medical, psychiatric, and cognitive evaluations. 2. Implantation of a brain stimulation system. 3. Follow up after implantation of device, including programming, recording, and psychiatric testing. There are risks and benefits to this study which need to be considered when deciding to participate or not. Some of the risks are from surgery, the DBS device and programming, the tests involved, and potential loss of confidentiality, as well as other unknown risks. Some of the more serious risks involved in this study and the percentage that they occur: 1. Bleeding inside the Brain (1 to 2 percent). 2. Infection from the procedures (3 percent) 3. Seizure caused from the procedures (1.2 percent) However, the benefit of this study is that it may help relieve or decrease TRBD symptoms. This form of treatment has shown to reduce symptom severity in other cases. This could potentially improve quality of life and activities in daily routines. There is also a potential benefit to society in that the data the investigators will obtain from this study may help increase the understanding of the mechanisms underlying TRBD symptoms, as well as enhanced Deep Brain Stimulation techniques. Study participation is expected to last 20 months from the time the DBS device is activated and should include approximately 23 visits. These visits also include 8 separate, 24 hour stays at the Menninger NeuroBehvaioral Monitoring Unit (NBU). These 24-hour sessions will occur at multiple points throughout the study (1 week prior to surgery, the week preceding device activation, the week following activation, then after 2 weeks, 4 weeks, 6 months, 9 months, and 12 months). Participants will need to stay locally for the week of the NBU stay (typically Monday through Friday). Study visits will include clinician administered assessments and questionnaires, subject reported assessments, neuropsychological testing, and mobile behavioral assessments which will occur around 23 visits over the course of 20 months.

Houston, TX22–64 yrsAll genders
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