Pilot and feasibility studies
October 5, 2023
Carina Joy Donegan, Dimitri Daldegan-Bueno, Rachael Sumner et al.
23 citations
An estimated 260 million people worldwide have depression, and many self-treat with microdoses of psychedelics like LSD and psilocybin despite limited clinical evidence. A prior phase 1 study in healthy volunteers found LSD microdosing safe, well tolerated, and feasible with good adherence. This open-label pilot trial (LSDDEP1) will test tolerability and feasibility of an 8-week LSD microdosing regimen in 20 patients with major depressive disorder. Participants receive a sublingual LSD formulation (MB-22001) twice weekly at 5–15 µg. Tolerability is measured by withdrawal due to adverse events; feasibility by clinic visit attendance. Antidepressant response will be assessed with MADRS scores over 8 weeks. Results will inform a future randomized controlled trial.
Pilot and feasibility studies
February 12, 2024
Alesha Wells, A P Suresh Muthukumaraswamy, Eva Morunga et al.
10 citations
A proposed trial will test whether adding a low, non-hallucinogenic dose of LSD to meaning-centred psychotherapy (MCP) is feasible for advanced cancer patients with anxiety or depression. Forty participants (20 Māori, 20 non-Māori) will receive seven MCP sessions plus either an LSD microdose (4-20 µg) or a placebo, under double-blind conditions. Outcomes include feasibility, acceptability, safety, and psychological measures at baseline, during treatment, and at one- and six-month follow-ups. The study aims to determine whether a full-scale trial is possible and to provide initial evidence on whether microdosing may enhance psychological care in this population.
Pilot and feasibility studies
April 29, 2025
Shirley Harris, Jennifer Jordan, Amanda Wilkinson et al.
1 citation
Anxiety and depression are common in people with COPD, worsening disability and reducing quality of life. The anxiety-breathlessness cycle and low self-efficacy hinder self-management. Standard mindfulness programs help but require travel and time. This mixed-method pre-post study with 3-month follow-up tests the feasibility of a portable, self-delivered mindful breathing intervention for up to 30 adults with COPD in New Zealand. Primary aims are uptake, retention, adherence, and acceptability; secondary aims include preliminary change in self-efficacy. Data collection is ongoing. If feasible, the intervention could reduce barriers to treatment and support a larger trial.
Pilot and feasibility studies
June 21, 2025
Sine Skovbjerg, Michelle Kolls, Anette Kjærbye-Thygesen et al.
A feasibility trial of prenatal mindfulness-based stress reduction (MBSR) for pregnant women with psychosocial vulnerabilities found the intervention feasible in a clinical setting, supporting a future randomized controlled trial. Of 123 eligible women, 73 (59.3%) consented; 37 were assigned to MBSR and 36 to a waitlist. Only 54.1% of the intervention group completed the program, and loss to follow-up was high (56.8% intervention, 50% control). Secondary outcomes—mental well-being, perceived stress, anxiety, depression, decentering, mindfulness, and self-compassion—trended in expected directions except for reflective functioning. Strategies to improve adherence and reduce missing data are recommended.
Pilot and feasibility studies
March 15, 2025
Anita B Amorim, Trudy Rebbeck, Nicholas T Van Dam et al.
A pilot randomized controlled trial will test the feasibility and acceptability of an online mindfulness-based stress reduction (MBSR) program for people with chronic musculoskeletal pain who are on waitlists for multidisciplinary pain clinics in Australia's public healthcare system. Thirty-two participants from two clinics in Sydney will be randomly assigned to either the online MBSR group or usual care. The study will assess feasibility, patient-reported outcomes, adherence to mindfulness practice, and adverse events using validated questionnaires, along with qualitative interviews to explore participants' experiences. Results will guide the design of larger future trials.