A definitive randomised controlled trial of a group mindfulness-based psychological therapy for people with psychosis: the MIND-P study.
Lyn Ellett, Laura Dannahy, Kate Bennett, Maria Chorozoglou, Beth Ford, Zachary Howarth, Joshua Phillip Waterman, Adedamola Falana, Katherine Berry
BMC Psychiatry November 26, 2025 DOI: 10.1186/s12888-025-07470-3 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Peer reviewed |
|---|---|
| Sample size | 144 |
| Population | Adults with a schizophrenia spectrum diagnosis with current persecutory delusions or attending an early intervention in psychosis service |
| Interventions | Group mindfulness therapy Treatment as usual |
| Duration | Approximately 8 months (4-month therapy period plus 4-month follow-up) |
| Topics | Meditation |
| Keywords | Group therapy Psychosis Randomised controlled trial Schizophrenia |
| Key findings | The trial will test whether group mindfulness therapy plus treatment as usual is more effective than treatment as usual alone for reducing depression in people with schizophrenia and persecutory delusions. |
Abstract
Schizophrenia is a severe mental illness with a significant disease, economic and social burden. Persecutory delusions (beliefs that one will be harmed or mistreated) are a common symptom of schizophrenia with associated high levels of depression. International clinical guidelines recommend individual cognitive behaviour therapy for schizophrenia, but there are currently no group psychological therapies recommended in NICE guidelines. We conducted a pilot randomised controlled trial, comparing group mindfulness therapy (GMT) to treatment as usual (TAU) for people with schizophrenia and persecutory delusions where we demonstrated feasibility and acceptability. It is now timely to progress to conduct a definitive randomised controlled trial (RCT). A parallel group RCT with single blind assessment comparing GMT + TAU (intervention condition) with TAU alone (control condition). The PHQ-9 and additional patient-reported psychometric measures will be collected at three time points: at baseline (prior to randomisation), end of therapy (approx 4 months post randomisation), and follow up (approx 8 months post-randomisation). Participants will be 144 adults with a schizophrenia spectrum diagnosis with current persecutory delusions or attending an early intervention in psychosis service, recruited across 3 NHS sites (Hampshire and Isle of Wight Healthcare NHS Foundation Trust, Greater Manchester Mental Health NHS Foundation Trust, and Pennine Care NHS Foundation Trust), randomised 1:1 to intervention or control groups. The therapy will be delivered according to our published manualised protocol. We will also monitor and evaluate a range of safety indices throughout the trial, conduct mediation and moderation analyses to understand how, and for whom, the therapy is most effective and assess cost effectiveness. If shown to be effective and cost-effective, GMT will positively impact the lives of people with schizophrenia, by providing an evidence-based group therapy. This is particularly important as there are no group psychological therapies for schizophrenia in the NICE guidelines and group therapies offer the potential for cost savings for service providers. The findings will be disseminated to a range of stakeholders, including service users/carers, academic researchers, clinicians, research participants and the general public, via academic publications, conferences, plain English summary (written and video versions) and public engagement events. ISRCTN: ISRCTN16318074, registered on 07/02/2025.
Comparable studies
Other randomized controlled trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment | 2003 | Randomized controlled trial | n = 41 |
| Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients | 2000 | Randomized controlled trial | n = 145 |
| Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults | 2008 | Randomized controlled trial | n = 139 |
| Short-term meditation training improves attention and self-regulation Undergraduate Chinese students | 2007 | Randomized controlled trial | n = 40 |
| Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients | 2004 | Randomized controlled trial | n = 73 |
Citations in the library
Cites 3
- Mindfulness for psychosis: Current evidence, unanswered questions and future directions Psychology and Psychotherapy Theory Research and Practice June 30, 2023
- Examining the Occurrence and Clinical Impact of Difficult Experiences that Emerge during a Mindfulness-Based Intervention among Individuals at High-Risk of Suicide. Mindfulness June 18, 2024
- Mindfulness for paranoid beliefs: evidence from two case studies. Behavioural and Cognitive Psychotherapy September 14, 2012