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Changes in anxiety, quality of life, and functioning following psilocybin-assisted therapy in veterans with treatment-resistant depression.

Carlton M Kelly, Mathieu Fradet, Catherine Bostian, Anna Donnelly, Sara Ellis, Michael Ostacher, Scott T Aaronson, Trisha Suppes

Journal of Affective Disorders June 4, 2026 DOI: 10.1016/j.jad.2026.122063 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Open-label trial Longitudinal Peer reviewed
Sample size 15
Population Veterans with treatment-resistant depression
Intervention Psilocybin
Dose 25 mg
Duration Single dose, 3-week primary endpoint, follow-up to 12 months
Topics Anxiety Depression Psilocybin
Keywords Posttraumatic stress disorder Veteran
Registration NCT04433858
Key findings Psilocybin with psychological support was associated with improvements in anxiety, quality of life, functioning, and PTSD symptoms that largely correlated with concurrent improvements in depressive symptoms.

Abstract

Psilocybin has demonstrated promise for improving depressive symptoms in treatment-resistant depression, but its effects on anxiety, quality of life, functioning, and posttraumatic stress symptoms are less well studied. This study reports exploratory findings from an open-label trial in Veterans with TRD. Participants received a single 25-mg dose of psilocybin administered with psychological support. The primary endpoint was assessed 3 weeks post-dose, with follow-up extending to 12 months. Outcomes included anxiety severity (GAD-7), quality of life (Q-LES-Q-SF), functional impairment (WSAS), and posttraumatic stress disorder symptoms (PCL-5). Experiential outcomes were measured with the Mystical Experience Questionnaire (MEQ), Challenging Experiences Questionnaire (CEQ-30), and Emotional Breakthrough Inventory (EBI). Mixed-effects models were used to evaluate longitudinal changes, and correlation analyses examined associations between measures and changes in depressive symptoms on the Montgomery-Åsberg Depression Rating Scale. Fifteen participants were included, with ten completing long-term follow-up. GAD-7 scores demonstrated sustained improvements through 12 months, with a 59% reduction from baseline at Week 3. Q-LES-Q-SF gains were significant through Week 12, with a 24% increase at Week 3, and WSAS improvements persisted through Month 6 before declining, with a 46% reduction at Week 3. These effects were no longer statistically significant after accounting for improvements in depression. Unadjusted PCL-5 reductions were observed at all timepoints. Exploratory analyses of acute subjective experiences did not correlate to treatment response. This study is limited by its small sample size and open-label design. Psilocybin with psychological support was associated with improvements in anxiety, quality of life, functioning, and PTSD symptoms which largely correlated to concurrent improvements in depressive symptoms. NCT04433858.

In the evidence

This study is part of the evidence base for a synthesis in the library. Here is how each one recorded it.

  • A single 25 mg dose of psilocybin with psychological support was associated with sustained improvements in anxiety (59% reduction at Week 3) through 12 months, though effects were no longer significant after accounting for depressive symptom improvement.

    Synthesized

Comparable studies

Other non-randomized and open-label trials on psilocybin for anxiety, most cited first.

Study Year Design Participants
Quality of Acute Psychedelic Experience Predicts Therapeutic Efficacy of Psilocybin for Treatment-Resistant Depression Patients with treatment-resistant depression 2018 Clinical trial n = 20
Safety, Tolerability, and Efficacy of Psilocybin in 9 Patients With Obsessive-Compulsive Disorder Subjects with obsessive-compulsive disorder (OCD) 2006 Controlled clinical trial
Emotions and brain function are altered up to one month after a single high dose of psilocybin. Healthy volunteers (7 female, 5 male) 2020 Open-label pilot study n = 12
Psilocybin-assisted group therapy for demoralized older long-term AIDS survivor men: An open-label safety and feasibility pilot study Older long-term AIDS survivor (OLTAS) self-identified gay men with moderate-to-severe... 2020 Open-label study
Psilocybin-Assisted Group Therapy and Attachment: Observed Reduction in Attachment Anxiety and Influences of Attachment Insecurity on the Psilocybin Experience Male long-term AIDS survivors with moderate-severe demoralization 2020 Open-label trial n = 18

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