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
January 24, 2023
Steven D. Pratscher, Kimberly T. Sibille, Roger B. Fillingim
9 citations
Chronic low back pain is common and disabling, and self-management strategies that can be done at home are needed. Breathing practices may help because breathing is linked to stress, emotion, and pain. This pilot study will test the feasibility and acceptability of a 5-day conscious connected breathing with breath retention intervention compared to a deep breathing sham control in 24 adults with chronic low back pain. Both interventions are delivered via standardized audio recordings and described as Breathing and Attention Training to reduce expectancy effects. Feasibility will be assessed through recruitment, adherence, retention, and completion rates, and acceptability through participant satisfaction and helpfulness ratings.
Pilot and Feasibility Studies
October 28, 2025
Candice Richardson, Cindy Chan, Emily Macgregor et al.
1 citation
A new therapy combining psilocybin with evidence-based psychotherapies for people with advanced cancer, called PEARL therapy, will be tested in an open-label trial with 15 participants. The study will assess whether the therapy is acceptable, feasible, and safe by tracking recruitment, retention, adherence, and serious adverse events, and by collecting self-report questionnaires and qualitative interviews. This research aims to inform policy, training, and clinical guidelines for psychedelic-assisted therapies, which may improve quality of life for those with advanced disease.
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.
Pilot and Feasibility Studies
August 20, 2025
Chung Jung Mun, Estrella Contreras, Yushu Xiao et al.
This paper describes the protocol for a feasibility randomized controlled trial that will compare mindfulness-based stress reduction (MBSR) alone, open-label placebo (OLP) alone, and a combined MBSR+OLP intervention for chronic pain. The authors note that MBSR has modest effect sizes and does not engage the endogenous opioid system, while OLP may activate that system. The trial will include an 8-week intervention period with four in-person sessions and a 3-month follow-up. The goal is to assess feasibility and acceptability to inform a future multi-site efficacy trial.
Pilot and Feasibility Studies
September 3, 2021
Stacey Hatch, Dorothy Kessler, Marcia Finlayson et al.
Anxiety affects 6.4% of Canadian adults aged 65 and older, impairing memory and daily activities. Emotion-focused mindfulness therapy (EFMT), a meditation-based intervention that reduces anxiety in general populations, will be tested for feasibility with older adults via telehealth. This pilot randomized controlled trial will enroll 48 participants, randomly assigned to immediate EFMT or a wait-list control. Data will be collected at baseline, 8 weeks, and 16 weeks. Primary outcomes are recruitment, retention, and adherence; secondary outcomes track anxiety changes. Results will determine if a larger trial is warranted.
Pilot and Feasibility Studies
September 20, 2020
Ira Kantrowitz-Gordon, Susan M. McCurry, Carol A. Landis et al.
This ongoing randomized controlled trial tests the feasibility and estimates the efficacy of a 6-week online mindfulness meditation intervention, combined with cognitive-behavioral therapy for insomnia (CBT-I), to help pregnant women in remission from depression self-manage insomnia. Fifty pregnant women between 12 and 28 weeks gestation will be randomly assigned to a mindfulness or education-only control group. Feasibility outcomes include recruitment, retention, adherence, and acceptability; the primary clinical outcome is sleep quality measured by the Pittsburgh Sleep Quality Index. Secondary outcomes include actigraphy and diary-based sleep measures, mood, and self-management factors. Results will inform a larger efficacy trial.
Pilot and Feasibility Studies
August 14, 2018
Elisa Aguirre, Josh Stott, Georgina Charlesworth et al.
Depression and dementia are major public health problems, and depression in early-stage dementia is common, reducing quality of life and speeding cognitive decline. Mindfulness-Based Cognitive Therapy (MBCT) is an effective depression prevention programme, and emerging evidence suggests adapted mindfulness interventions may benefit people with dementia by reducing depressive symptoms and slowing deterioration in cognitive functions such as sustained attention and task switching. This single-blind randomised controlled feasibility trial will recruit participants with mild to moderate depression and early-stage dementia from memory services, giving them immediate or delayed access to an 8-week MBCT programme. The study will test trial design, recruitment, retention, acceptability, and adherence, and provide preliminary efficacy data to inform a future full RCT.