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Contemporary Clinical Trials

ISSN 1559-2030, 1551-7144

39 papers in the library · 96 citations · publishing 2011-2026

Papers

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Randomized controlled trial of acute ketamine versus midazolam for recurrence of suicidality in adolescents (TASK): Rationale, design, and baseline characteristics.

Contemporary Clinical Trials October 8, 2026 Madhukar H. Trivedi, Cherise R Chin Fatt, Emine Rabia Ayvaci et al.

Suicide is one of the leading causes of death among adolescents in the United States. The 'Acute Course of Ketamine Versus Midazolam for Recurrence of Suicidality in Adolescents' (TASK), a double-blind, randomized, controlled trial, was designed to examine the signal for efficacy of ketamine, compared to midazolam (active control), in reducing 1) repeat suicidal events, 2) implicit cognition,...

DOI: 10.1016/j.cct.2026.108498 (opens in new tab) Full text (opens in new tab) Adolescents Intravenous ketamine Randomized controlled trial Suicidality +1

Primary care brief mindfulness training for veterans with psychological distress: Protocol for a hybrid type I effectiveness-implementation randomized controlled trial.

Contemporary Clinical Trials August 1, 2026 Dessa Bergen-Cico, A. Ramon, Benjamin I. Felleman et al.

Psychological distress, encompassing PTSD, depression, and anxiety-is highly prevalent among Veterans receiving care in Veterans Health Administration (VHA) primary care settings, yet it frequently goes untreated or undertreated. Traditional psychotherapies and psychiatric medications are often misaligned with Veterans' preferences for self-reliance, low-stigma formats, and skill-based...

A randomized controlled trial comparing a mindfulness-based program with standard therapeutic follow-up during pregnancy: Effects on maternal mental health, infant outcomes, and mother-infant attachment.

Contemporary Clinical Trials July 8, 2026 Clara Beauvois, Andrea Soubelet

Pregnancy and childbirth represent a major transition into motherhood, marked by psychosocial changes that may increase women's vulnerability to mental health difficulties such as prenatal depression, anxiety, or PTSD, in addition to physical pain. These difficulties can negatively impact maternal well-being, the mother-infant relationship, and child development. Prenatal mindfulness-based...

Non-inferiority, comparative effectiveness study of intravenous ketamine v. intranasal esketamine for treatment-resistant depression: The EQUIVALENCE trial protocol.

Contemporary Clinical Trials March 2, 2026 Samuel T. Wilkinson, Sandhya Prashad, Rachel Dalthorp et al. 1 citation

Ketamine is a powerful and rapid-acting antidepressant but has no regulatory authorization for any psychiatric illness. The S-enantiomer of ketamine, esketamine, was approved by the FDA in 2019 as adjunctive therapy for treatment-resistant depression. Substantial controversy exists as to whether there is a significant clinical difference between intravenous (IV) ketamine racemate and intranasal...

DOI: 10.1016/j.cct.2026.108273 (opens in new tab) Ketamine Humans Antidepressive agents Administration, intranasal +6

Remote delivery of a mindfulness-based intervention for adults with tics: Protocol of a randomized controlled trial.

Contemporary Clinical Trials January 13, 2026 Hannah E. Reese, W Alan Brown, Yaerin H Wallenberger et al.

Tourette Syndrome and persistent tic disorders (collectively, TS) are characterized by involuntary motor and/or vocal tics that onset in childhood. Existing evidence-based treatments-including behavior therapy and pharmacotherapy-are often only partially effective, associated with burdensome side effects, and/or inaccessible. The current paper describes a randomized controlled trial designed to...

Randomized trial of delta-9-tetrahydrocannabinol (THC) versus placebo to augment the effects of prolonged exposure therapy on fear extinction learning in post-traumatic stress disorder: Study rationale and protocol.

Contemporary Clinical Trials 2026 Christine A Rabinak, Paul E Kilgore, Mark A. Lumley et al.

Prolonged exposure (PE) therapy is effective for PTSD, yet dropout and partial response remain concerning. Preclinical and human studies suggest Δ9-tetrahydrocannabinol (THC) enhances fear extinction and recall through brain cannabinoid receptor activation in fear processing. Examine whether synthetic THC (dronabinol) augments PE effectiveness. Double-blind, placebo-controlled, trial with...

DOI: 10.1016/j.cct.2025.108148 (opens in new tab) Full text (opens in new tab) Delta9-Tetrahydrocannabinol THC Exposure therapy Extinction Memory +1

Protocol for a hybrid type 1 effectiveness-implementation study of mindfulness-based therapy for insomnia in Black women.

Contemporary Clinical Trials November 25, 2025 Soohyun Nam, Guangyu Tong, Joanne Iennaco et al.

Black women in the U.S. disproportionately suffer from insomnia and related cardiometabolic health burdens. However, there is a lack of sleep intervention and implementation research specifically targeting Black women. The aim of this study is to co-design and evaluate equity-focused, community-engaged implementation strategies for an online, group-based mindfulness-based therapy for insomnia...

Addressing chronic pain and suicide risk using Mindfulness-Based Cognitive Therapy: Rationale, design and baseline characteristics.

Contemporary Clinical Trials November 1, 2025 Lisham Ashrafioun, Anna Stephens, Hugh F Crean et al.

Suicide risk and chronic pain are significant public health problems affecting veterans at a disproportionally high rate. There is a dearth of interventions directly targeting both chronic pain and suicide risk. Mindfulness-Based Cognitive Therapy for Pain and Suicide (MBCT-P/S) integrates components from MBCT-Pain and MBCT-Suicide, both of which demonstrate promising effects on their...

DOI: 10.1016/j.cct.2025.108105 (opens in new tab) Full text (opens in new tab) Chronic pain Mindfulness-based cognitive therapy Suicide Veterans

Food-Body-Mind study protocol: A mindfulness-based lifestyle intervention to promote whole child health among preschoolers from economically marginalized families

Contemporary Clinical Trials November 1, 2025 Jiying Ling, T. Kao, Lorraine B. Robbins et al.

Socioeconomic, racial/ethnic, and urban/rural disparities in mental, emotional, behavioral, and physical health are evident among U.S. preschoolers. To reduce these disparities, we plan to test our Food-Body-Mind intervention with preschoolers from racially/ethnically diverse, low-income, urban, and rural areas. The aims of the study are to determine the effects of the intervention on improving...

Peer-supported mindfulness-based intervention for managing depressive symptoms in community-dwelling older adults: Protocol for a randomized controlled trial.

Contemporary Clinical Trials June 20, 2025 Yun-Lin Wang, Yun-Han Wang, Dara Kiu Yi Leung et al. 1 citation

Depression in old age is a public health concern contributing to individual and societal burdens. Mindfulness-based stress reduction (MBSR) and mindfulness-based cognitive therapy (MBCT) have shown promise in reducing depressive symptoms. However, time commitments associated with these interventions could pose challenges to older adults. To address this, we propose a briefer mindfulness-based...

DOI: 10.1016/j.cct.2025.107991 (opens in new tab) Full text (opens in new tab) Depressive symptoms Older adults Peer support Social worker +1

Effects of virtual reality mindfulness on cognition and well-being in ALS: A randomized trial protocol.

Contemporary Clinical Trials May 1, 2025 Juliette Faure-De Baets, Jeremy Besnard, Frédéric Banville et al. 3 citations

Amyotrophic Lateral Sclerosis (ALS) is a neurodegenerative disease primarily affecting motor neurons but also leading to significant non-motor symptoms, including cognitive impairments, anxiety, depression, and behavioral changes, which severely impact quality of life. While mindfulness-based interventions (MBIs) have shown promise in alleviating psychological distress, their accessibility is...

DOI: 10.1016/j.cct.2025.107876 (opens in new tab) Full text (opens in new tab) Cognitive impairment Mindfulness-based interventions mbi Psychological care Quality of life +1

Ketamine treatment in youth for fast reduction of suicidality and engagement in psychotherapy: A randomized placebo-controlled trial protocol.

Contemporary Clinical Trials February 1, 2025 Noreen A Reilly-Harrington, Tatiana Falcone, David A Jobes et al.

Suicide is a leading cause of death in young persons. While ketamine has demonstrated rapid anti-suicidal effects, its safety and efficacy in youth has not been fully investigated. The Collaborative Assessment and Management of Suicidality (CAMS), a suicide-focused treatment shown to decrease suicidal ideation and symptom distress, has never been studied in combination with ketamine. This study...

eMPower: An online Mind-body wellness Program for adults living with chronic health conditions: A three-armed randomized controlled trial protocol.

Contemporary Clinical Trials October 1, 2024 Emily K. Johnson, Kathleen Ismond, Ashley Hyde et al. 3 citations

Symptoms of depression and anxiety are prevalent among adults with chronic health conditions, contributing to reduced quality of life, morbidity, and mortality. Mind-body wellness interventions (i.e. psychology programming, mindful movement, breathwork, meditation) may impact mental health symptoms, with online delivery offering access and scalability. Whether online mind-body wellness...

Ketamine-enhanced prolonged exposure therapy in veterans with PTSD: A randomized controlled trial protocol.

Contemporary Clinical Trials August 1, 2024 Paulo R Shiroma, Paul Thuras, Melissa A Polusny et al. 7 citations

The 2023 VA/DoD Clinical Practice Guideline for the Management of PTSD recommends individual, manualized trauma-focused such as Prolonged Exposure (PE) over pharmacologic interventions for the primary treatment of PTSD. Unfortunately, clinical trials of trauma-based therapies in the military and veteran population showed that 30% to 50% of patients did not demonstrate clinically meaningful...

DOI: 10.1016/j.cct.2024.107569 (opens in new tab) Full text (opens in new tab) Prolonged exposure PTSD-Treatment Veterans-mental-health Ketamine-therapy +2

Mindfulness-based intervention for depression and insulin resistance in adolescents: Protocol for BREATHE, a multisite, pilot and feasibility randomized controlled trial.

Contemporary Clinical Trials June 1, 2024 Natalia Sanchez, Michele Chen, Sally Ho et al. 3 citations

Elevated depression symptoms have been associated with higher insulin resistance in adolescents, and consequently, greater risk for type 2 diabetes (T2D). Mindfulness-based intervention (MBI) may be suited for adolescents at risk for T2D given its potential to decrease depression and improve stress-related behavior/physiology underpinning insulin resistance. To prepare for a future multisite...

Development of a mobile mindfulness smartphone app for post-traumatic stress disorder and alcohol use problems for veterans: Beta test results and study protocol for a pilot randomized controlled trial.

Contemporary Clinical Trials April 12, 2023 Jordan P Davis, Eric R Pedersen, Brian Borsari et al.

Background: Post-traumatic stress disorder (PTSD) and alcohol use disorder (AUD) are highly prevalent, and co-occurring among post-9/11 veterans. Mobile health (mHealth) applications, specifically those focused on mindfulness-based techniques, may be an effective avenue to intervene with veterans who cannot or will not seek care at traditional in-person settings. Thus, to address areas of...

Mindfulness-based stress reduction for men on active surveillance for prostate cancer and their spouses: Design and methodology of a randomized controlled trial.

Contemporary Clinical Trials February 2023 David Victorson, Todd Morgan, Alexander Kutikov et al.

Although active surveillance (AS) is an increasingly adopted treatment paradigm for management of very low risk prostate cancer, many men and their partners face a variety of AS-related psychosocial stressors. Stressors may include anxiety and fear of progression, which may negatively affect short- and long-term psychosocial adjustment and influence early withdrawal from AS in order to seek...

Psilocybin for alcohol use disorder: Rationale and design considerations for a randomized controlled trial.

Contemporary Clinical Trials December 1, 2022 Kelley C O'Donnell, Sarah E. Mennenga, Lindsey T. Owens et al. 24 citations

Several lines of evidence suggest that classic psychedelics (5-HT2A receptor agonists or partial agonists) such as psilocybin might facilitate behavior change in individuals with substance use disorders. We conducted a multi-site, double-blind, randomized controlled trial (RCT) to assess the effects of psilocybin-assisted psychotherapy in alcohol-dependent volunteers. In addition to a...

Acceptance and commitment therapy for episodic migraine: Rationale and design of a pilot randomized controlled trial.

Contemporary Clinical Trials October 2022 Carolyn Ann Bernstein, Julie P Connor, Eric S Vilsmark et al.

Migraine is a debilitating disorder with limited pharmacological options. Many migraine medications can have intolerable side effects leading patients to seek complementary and integrative health (CIM) approaches for treatment. One option that is growing in popularity and evidence is Acceptance and Commitment Therapy (ACT), a mindfulness-based therapy. The purpose of this paper is to describe...

DOI: 10.1016/j.cct.2022.106907 (opens in new tab) Full text (opens in new tab) Chronic pain management Migraine Mindfulness-based cognitive therapy Randomized controlled trial

Test of daily app-based mindfulness meditation preceding a planned smoking quit attempt date on abstinence: Protocol for a randomized controlled trial recruiting across the 58 counties of California.

Contemporary Clinical Trials September 2022 David S Black, Matthew G. Kirkpatrick

A majority of the 34 million people who currently smoke cigarettes report wanting to quit smoking yet most attempts to quit end in relapse. A mindfulness based intervention (MBI) is an intervention package used to reinforce an individual's practice of mindfulness meditation in daily life. MBIs delivered by phone app offer daily prompts to guide bouts of mindfulness meditation, that is,...

An integrated mindfulness meditation and acceptance and commitment therapy intervention for chronic pain: Rationale, design, and methodology of a pilot randomized controlled trial of Acting with Mindfulness for Pain (AMP).

Contemporary Clinical Trials August 1, 2022 Matthew S Herbert, Mara Tynan, Ariel J Lang et al.

Acceptance and commitment therapy (ACT) is an evidence-based psychosocial intervention for chronic pain; however, in its present form ACT produces modest improvements in function and is no more effective than cognitive behavioral therapy (CBT), the current gold standard. This protocol paper describes the Acting with Mindfulness for Pain (AMP) protocol, which emphasizes and integrates formal...

Mentalizing imagery therapy to augment skills training for dementia caregivers: protocol for a randomized, controlled trial of a mobile application and digital phenotyping

Contemporary Clinical Trials March 1, 2022 Felipe A Jain, O. Okereke, Laura N. Gitlin et al.

More than 50 million people worldwide live with a dementia, and most are cared for by family members. Family caregivers often experience chronic stress and insomnia, resulting in decreased mental and physical health. Accessibility of in-person stress reduction therapy is limited due to caregiver time constraints and distance from therapy sites. Mentalizing imagery therapy (MIT) provides...

The design and methods of the OPTIMUM study: A multisite pragmatic randomized clinical trial of a telehealth group mindfulness program for persons with chronic low back pain.

Contemporary Clinical Trials October 2021 Carol M. Greco, Susan A Gaylord, Kim Faurot et al.

Mindfulness-based stress reduction (MBSR) is an evidence-based non-pharmacological approach for chronic low back pain (cLBP), yet it is not readily available or reimbursable within primary care clinics. Primary care providers (PCPs) who wish to avoid prescribing opioids and other medications typically have few options for their cLBP patients. We present the protocol of a pragmatic clinical...

DOI: 10.1016/j.cct.2021.106545 (opens in new tab) Full text (opens in new tab) Medical group visits Mindfulness meditation Online intervention Quadruple aim

Development of a mindfulness-based treatment for smoking cessation and the modification of alcohol use: A protocol for a randomized controlled trial and pilot study findings.

Contemporary Clinical Trials November 14, 2020 Mikaela Hemenway, Katie Witkiewitz, Marina Unrod et al.

The combined use of cigarettes and alcohol is associated with an increased risk of morbidity and mortality. Yet, efficacious interventions that address both behaviors concurrently are lacking. Smoking cessation and alcohol modification not only garner health benefits, but there is also value in addressing alcohol use in the context of smoking cessation to reduce the risk for smoking relapse. In...

Treatment for anxiety: Mindfulness meditation versus escitalopram (TAME): Design of a randomized, controlled non-inferiority trial.

Contemporary Clinical Trials February 19, 2020 Elizabeth A Hoge, Eric Bui, Mihriye Mete et al.

Anxiety disorders (generalized anxiety disorder, social anxiety disorder, panic disorder, and agoraphobia) are common, distressing, and impairing. While pharmacotherapy and psychotherapy are first-line treatment strategies for anxiety disorders, many patients are reluctant to take psychiatric medication, and many prefer to avoid any kind of mental health treatment due to stigma or distrust of...