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4. Psychedelic-assisted psychotherapy: where is the psychotherapy research?

Author

Aday, Jacob S., Horton, David, Fernandes-Osterhold, Gisele, O'Donovan, Aoife, Bradley, Ellen R., Rosen, Raymond C., and Woolley, Joshua D.

Subjects
PSYCHOTHERAPY, MENTAL health services
Abstract

Rationale: Psychedelic-assisted psychotherapy (PAP) has emerged as a potential treatment for a variety of mental health conditions, including substance use disorders and depression. Current models of PAP emphasize the importance of psychotherapeutic support before, during, and after ingestion of a psychedelic to maximize safety and clinical benefit. Despite this ubiquitous assumption, there has been surprisingly little empirical investigation of the "psychotherapy" in PAP, leaving critical questions about the necessary and sufficient components of PAP unanswered. Objectives: As clinical trials for psychedelic compounds continue the transition from safety- and feasibility-testing to evaluating efficacy, the role of the accompanying psychotherapy must be better understood to enhance scientific understanding of the mechanisms underlying therapeutic change, optimize clinical outcomes, and inform cost-effectiveness. Results: The present paper first reviews the current status of psychotherapy in the PAP literature, starting with recent debates regarding "psychotherapy" versus "psychological support" and then overviewing published clinical trial psychotherapy models and putative models informed by theory. We then delineate lessons that PAP researchers can leverage from traditional psychotherapy research regarding standardizing treatments (e.g., publish treatment manuals, establish eligibility criteria for providers), identifying mechanisms of change (e.g., measure established mechanisms in psychotherapy), and optimizing clinical trial designs (e.g., consider dismantling studies, comparative efficacy trials, and cross-lagged panel designs). Throughout this review, the need for increased research into the psychotherapeutic components of treatment in PAP is underscored. Conclusions: PAP is a distinct, integrative, and transdisciplinary intervention. Future research designs should consider transdisciplinary research methodologies to identify best practices and inform federal guidelines for PAP administration. [ABSTRACT FROM AUTHOR]

Published
2024
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16. Quality of Life and Sexual Function Benefits of Long-Term Testosterone Treatment: Longitudinal Results From the Registry of Hypogonadism in Men (RHYME)

Author

Maggi, M., Behre, H.M., Meuleman, E., Dohle, G., Arver, S., Wu, F., Porst, H., Jones, T.H., Quinton, R., Lenzi, A., Bouloux, P.-M., Morales, A.M., Hackett, G., Stroberg, P., Maggio, M., Cruz, N., Balercia, G., Yassin, A., Reisman, C., Bassas, L., Pescatori, E., Salamanca, J.I. Martinez, Otero, J. Romero, Jockenhoevel, F., Debruyne, F., Rosen, Raymond C., Wu, Frederick, Behre, Hermann M., Porst, Hartmut, Meuleman, Eric J.H., Maggi, Mario, Romero-Otero, Javier, Martinez-Salamanca, Juan I., Jones, Thomas Hugh, Debruyne, Frans M.J., Kurth, Karl-Heinz, Hackett, Geoff I., Quinton, Richard, Stroberg, Peter, Reisman, Yacov, Pescatori, Edoardo S., Morales, Antonio, Bassas, Lluis, Cruz, Natalio, Cunningham, Glenn R., and Wheaton, Olivia A.

Published
2017
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18. The association of tadalafil exposure with lower rates of major adverse cardiovascular events and mortality in a general population of men with erectile dysfunction.

Author

Kloner, Robert A., Stanek, Eric, Desai, Karishma, Crowe, Christopher L., Paige Ball, Kathryn, Haynes, Aaron, and Rosen, Raymond C.

Subjects
MAJOR adverse cardiovascular events, MYOCARDIAL infarction, IMPOTENCE, TADALAFIL, CARDIOVASCULAR diseases risk factors, PHOSPHODIESTERASE-5 inhibitors, ANGINA pectoris
Abstract

Background: Tadalafil is a long‐acting phosphodiesterase‐5 inhibitor (PDE‐5i) indicated for erectile dysfunction (ED). Hypothesis: Our hypothesis was that tadalafil will reduce the risk of major adverse cardiovascular events (MACE: composite of cardiovascular death, myocardial infarction, coronary revascularization, unstable angina, heart failure, stroke) and all‐cause death in men with ED. Methods: A retrospective observational cohort study was conducted in a large US commercial insurance claims database in men with a diagnosis of ED without prior MACE within 1 year. The exposed group (n = 8156) had ≥1 claim for tadalafil; the unexposed group (n = 21 012) had no claims for any PDE‐5i. Results: Primary outcome was MACE; secondary outcome was all‐cause death. Groups were matched for cardiovascular risk factors, including preventive therapy. Over a mean follow‐up of 37 months for the exposed group and 29 months for the unexposed group, adjusted rates of MACE were 19% lower in men exposed to tadalafil versus those unexposed to any PDE‐5i (hazard ratio [HR] = 0.81; 95% confidence intervals [CI] = 0.70−0.94; p =.007). Tadalafil exposure was associated with lower adjusted rates of coronary revascularization (HR = 0.69; 95% CI = 0.52−0.90; p =.006); unstable angina (HR = 0.55; 95% CI = 0.37−0.81; p =.003); and cardiovascular‐related mortality (HR = 0.45; CI = 0.22−0.93; p =.032). Overall mortality rate was 44% lower in men exposed to tadalafil (HR = 0.56; CI = 0.43−0.74; p <.001). Men in the highest quartile of tadalafil exposure had the lowest rates of MACE (HR: 0.40; 95% CI: 0.28−0.58; p <.001) compared to lowest exposure quartile. Conclusion: In men with ED, exposure to tadalafil was associated with significant and clinically meaningful lower rates of MACE and overall mortality. [ABSTRACT FROM AUTHOR]

Published
2024
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33. All Men with Vasculogenic Erectile Dysfunction Require a Cardiovascular Workup

Author

Miner, Martin, Nehra, Ajay, Jackson, Graham, Bhasin, Shalender, Billups, Kevin, Burnett, Arthur L., Buvat, Jacques, Carson, Culley, Cunningham, Glenn, Ganz, Peter, Goldstein, Irwin, Guay, Andre, Hackett, Geoff, Kloner, Robert A., Kostis, John B., LaFlamme, K. Elizabeth, Montorsi, Piero, Ramsey, Melinda, Rosen, Raymond, Sadovsky, Richard, Seftel, Allen, Shabsigh, Ridwan, Vlachopoulos, Charalambos, and Wu, Frederick

Published
2014
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42. Diagnosis and Treatment of Erectile Dysfunction for Reduction of Cardiovascular Risk

Author

Nehra, Ajay, Jackson, Graham, Miner, Martin, Billups, Kevin L., Burnett, Arthur L., Buvat, Jacques, Carson, Culley C., Cunningham, Glenn R., Goldstein, Irwin, Guay, Andre T., Hackett, Geoff, Kloner, Robert A., Kostis, John, Montorsi, Piero, Ramsey, Melinda, Rosen, Raymond C., Sadovsky, Richard, Seftel, Allen D., Vlachopoulos, Charalambos, and Wu, Frederick C.W.

Published
2013
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47. Testosterone treatment is not associated with increased risk of prostate cancer or worsening of lower urinary tract symptoms: prostate health outcomes in the Registry of Hypogonadism in Men

Author

Debruyne, Frans M.J., Behre, Hermann M., Roehrborn, Claus G., Maggi, Mario, Wu, Frederick C.W., Schröder, Fritz H., Jones, Thomas Hugh, Porst, Hartmut, Hackett, Geoffrey, Wheaton, Olivia A., Martin-Morales, Antonio, Meuleman, Eric, Cunningham, Glenn R., Divan, Hozefa A., Rosen, Raymond C., Dohle, G., Arver, S., Lenzi, A., Stroberg, P., Maggio, M., Cruz, N., Balercia, G., Yassin, A., Reisman, C., Bassa, L., Pescatori, E., Salamanca, Martinez J.I., Otero, Romero J., and Jockenhoevel, F.

Published
2017
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