Cognitive Behavioral Therapy clinical trials at University of California Health

Taking prescription opioids for pain together with benzodiazepines for the treatment of anxiety disorders is not recommended by the U.S. Food and Drug Administration (FDA) because of the elevated risk of serious complications, including fatal overdose. However, this concurrent prescription use continues to be prevalent, likely due to the high comorbidity between pain and anxiety disorders. Efforts are urgently needed to reduce benzodiazepine use among patients taking opioids. Cognitive behavioral therapy (CBT) is a first-line treatment for anxiety disorders, and represents a safer and more effective treatment for anxiety disorders compared to benzodiazepines. The proposed study aims to make minor adaptations to a CBT protocol to facilitate benzodiazepine tapering and to then conduct a 2-arm randomized clinical trial with primary care patients who receive benzodiazepine and opioid prescriptions. Participants will be randomized to receive a telehealth-delivered intervention consisting of a gentle, 12-week benzodiazepine taper (BZT) with either CBT or a health education control (HE). Participants will be assessed at baseline, several points throughout treatment, at post-treatment, and at a 2-month follow-up assessment on benzodiazepine use, opioid use, and anxiety symptoms. Should CBT + BZT outperform HE + BZT, this intervention could make a significant impact by reducing major consequences of concurrent use of opioids and benzodiazepines, including mortality.

The primary objectives of this clinical investigation are to (1) determine the feasibility of joining psilocybin treatment with CBT (cognitive-behavioral therapy) for patients with depression, (2) optimize CBT to most effectively integrate the psilocybin experience with psychotherapy and (3) determine the initial efficacy of psilocybin as an adjunct to cognitive-behavioral therapy (CBT) for major depressive disorder. Psilocybin will be administered orally in two doses during the course of 12 sessions of CBT to eligible study participants - a 10mg dose following the third session and a 25mg dose following the sixth session. Participants will be in active treatment for the first 4 months (psilocybin + CBT) of the study and then followed for an additional 3-months following the termination of CBT.

Cognitive Behavioral Therapy (CBT) is the most well researched and most effective treatment for IBS targeting the brain-gut-microbiome (BGM) axis, and preliminary data show that this therapeutic effect is associated with a reduction of brainstem connectivity with other brain networks. The increased prevalence of IBS in women, the higher rate of comorbid non-GI pain conditions, as well as the higher prevalence in female IBS of increased sensitivity to a variety of internal and external stimuli (multisensory sensitivity) suggest the presence of important sex differences in some of these BGM mechanisms. Research performed by UCLA SCOR during previous funding has established an increased responsiveness of the CRF-Locus Coeruleus (LCC) system in female IBS subjects, suggesting that this central noradrenergic brainstem system plays an important role in IBS pathophysiology. In addition, the study team's earlier research has begun to identify clinical, functional and structural brain mechanisms that may underlie these sex effects. Based on the preliminary data, the overall goal of this project is to use CBT as a probe to study the relationship between specific disease-related alterations of the brain, the gut microbiome, and symptomatic outcome, and identify the role of sex differences in these relationships. Investigators will study male and female IBS patients before and after CBT using the advanced neuroimaging and microbiome technologies of the overall SCOR.