Contemporary clinical trials
December 1, 2022
Kelley C O'Donnell, Sarah E Mennenga, Lindsey T Owens et al.
24 citations
Classic psychedelics like psilocybin may help people change their behavior in substance use disorders. This paper describes the protocol for a multi-site, double-blind, randomized controlled trial that tested psilocybin-assisted psychotherapy in 96 alcohol-dependent volunteers. Participants received either psilocybin or an active placebo (diphenhydramine) during two dosing sessions, alongside a structured 12-week psychotherapy platform. The primary outcome was the proportion of heavy drinking days over 32 weeks after the first dose. Secondary outcomes included safety, abstinence, craving, and self-efficacy. The primary results are reported elsewhere; this paper focuses on the rationale and design decisions.
Contemporary clinical trials
August 1, 2024
Paulo R Shiroma, Paul Thuras, Melissa A Polusny et al.
7 citations
Trauma-focused therapies like Prolonged Exposure (PE) are recommended over medication for PTSD, but 30% to 50% of military and veteran patients do not show meaningful symptom improvement. Ketamine, an anesthetic that affects glutamate signaling, has shown in preclinical studies to improve extinction learning and reduce fear renewal. A planned randomized controlled trial will compare three ketamine infusions to an active placebo (midazolam) given alongside PE therapy in veterans with PTSD. Infusions occur 24 hours before PE sessions for the first three weeks. Out of 100 veterans, 80 are expected to reach the primary outcome assessment. Secondary outcomes include depression, anxiety, safety, cognition, and dropout rates. Results may clarify which components are essential and which patients benefit most.
Contemporary clinical trials
May 1, 2025
Juliette Faure-De Baets, Jeremy Besnard, Frédéric Banville et al.
3 citations
A randomized controlled trial will test whether virtual-reality-based mindfulness training improves quality of life more than traditional mindfulness for people with amyotrophic lateral sclerosis (ALS). Forty-six participants will be randomly assigned to an eight-week mindfulness program delivered either through VR or in a conventional format. The primary outcome is quality of life, measured by the ALS-Specific Quality of Life Scale; secondary outcomes include cognitive function, anxiety, depression, behavioral changes, and mindfulness propensity, assessed at baseline, after the intervention, and three months later. The study also examines VR usability and accessibility challenges. If effective, VR mindfulness could make psychological support more accessible for patients with severe physical limitations.
Contemporary clinical trials
October 1, 2024
Emily Johnson, Kathleen Ismond, Ashley Hyde et al.
3 citations
Anxiety and depression are common in adults with chronic health conditions, harming quality of life and increasing risks. Online mind-body wellness programs—including psychology, mindful movement, breathwork, and meditation—may help, but their effectiveness across diverse chronic conditions is unclear. This pragmatic randomized controlled trial tests the online eMPower intervention at two support levels against a waitlist control. As of April 2024, 656 participants have enrolled, with 598 completing 12-week follow-up. The primary outcome compares anxiety and depression scores between the group receiving eMPower plus weekly check-ins and controls. Findings aim to clarify how people with chronic conditions engage with and benefit from online mind-body programming.
Contemporary clinical trials
June 1, 2024
Natalia Sanchez, Michele Chen, Sally Ho et al.
3 citations
A protocol for a multisite pilot and feasibility randomized controlled trial compares a six-week mindfulness-based intervention, cognitive-behavioral therapy, and health education groups for 120 adolescents ages 12-17 with elevated depression symptoms, body mass index at or above the 85th percentile, and a family history of diabetes. The trial, conducted across four U.S. sites, aims to assess intervention fidelity, recruitment feasibility, and acceptability. Primary outcomes include at least 80% adherence to intervention protocols and at least 80% enrollment of eligible youth. Findings will guide the design of a future multisite efficacy trial evaluating whether mindfulness can reduce depression and improve insulin resistance in adolescents at risk for type 2 diabetes.
Contemporary clinical trials
June 20, 2025
Yun-Lin Wang, Yun-Han Wang, Dara Kiu Yi Leung et al.
1 citation
Depression in older adulthood is a public health concern. Mindfulness-based stress reduction and cognitive therapy can reduce depressive symptoms but require substantial time commitments. This protocol describes a randomized controlled trial testing a briefer, peer-supported mindfulness intervention. Community-dwelling adults over 60 with mild to moderately severe depressive symptoms will receive either a social worker-led six-session mindfulness intervention or the same intervention with peer supporters. A total of 138 participants will be recruited. Depressive symptoms, measured by the PHQ-9, will be assessed at baseline, post-intervention, and three months later. Data from a prior study will be matched as a comparison group. Results will suggest whether this scalable approach improves accessibility and mental health outcomes.
Contemporary clinical trials
February 1, 2025
Noreen A Reilly-Harrington, Tatiana Falcone, David A Jobes et al.
A randomized controlled trial is testing whether ketamine infusions, compared to placebo, rapidly reduce severe suicidality in youth and young adults (ages 14-30) hospitalized with suicidal ideation or after a suicide attempt. Participants receive up to six treatments of ketamine or placebo while also engaging in Collaborative Assessment and Management of Suicidality (CAMS) sessions, a suicide-focused therapy, starting in the hospital and continuing after discharge. The study enrolls 140 participants and follows them for three months. The hypothesis is that ketamine will produce faster improvement in suicidality, enhance engagement in CAMS, and reduce suicide attempts, emergency visits, and readmissions compared to placebo.