Digital mindfulness- and acceptance-based stress reduction intervention for individuals looking online for help: protocol for the CRISP randomised controlled trial.
Lovisa Af Ekenstam, Per Nyman, Olov Änghagen, Ulrika Åhdén, Marcus Bendtsen, Oskar Lundgren
BMJ Open December 3, 2025 DOI: 10.1136/bmjopen-2024-089707 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Peer reviewed |
|---|---|
| Population | Individuals 15 years or older seeking help online for stress who have access to a mobile phone |
| Intervention | referrals to self-studies on mental health information found online |
| Duration | 12-week digital course; follow-up at 3, 6, and 12 months |
| Measures | Cohen's 10-item version of the Perceived Stress Scale |
| Topics | Meditation |
| Keywords | Humans Bayes theorem Stress, psychological Research design Adolescent Adult Female Chronic disease Self care |
| Key findings | The protocol describes a planned trial to estimate whether a 12-week digital mindfulness- and acceptance-based stress reduction course reduces perceived stress compared with online self-study referrals, with outcomes assessed at 3, 6, and 12 months and mediation by acquired equanimity. |
Abstract
Introduction: Psychosocial stress is a major public health concern, contributing to significant suffering and costs to society. There is a lack of effective interventions that could be offered at an early stage to people who need to reduce their stress in life. Recent advances in psychology have provided evidence-based exercises suitable for testing in an entirely digital intervention. This study aims to estimate the effectiveness of a 12-week digital course in mindfulness- and acceptance-based stress reduction. Methods and analysis: The effectiveness of the 12-week digital course will be estimated in a parallel-groups randomised controlled trial, in which the control group will receive referrals to self-studies on mental health information found online. The study population will be individuals 15 or older, seeking help online for stress and who have access to a mobile phone. Employing a Bayesian sequential design, the primary outcome will be monitored monthly, after the 6-month follow-up, to calculate target criteria for when to stop recruiting. Perceived stress (Cohen's 10-item version) will be the primary outcome, with estimands of interest being differences between groups at 3 (immediate), 6 (prolonged) and 12 months (maintained). Mediation analysis will reveal if differences between groups are mediated by acquired equanimity. Effectiveness will be analysed with Bayesian regression models, and mediation will be analysed by using a causal inference framework. Ethics and dissemination: The research was approved by the Swedish Ethical Review Authority on 2024-05-07 (2024-01974-01). The study will reach out to a vulnerable population, and participation may displace efforts to seek professional help. We have built-in automatic advice to seek additional help for participants scoring high on the depression scale at baseline, before allocation to study groups. The findings from this study will be submitted to peer-reviewed journals and presented at relevant national and international meetings. Trial registration number: ISRCTN39222610.
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 6
- How Does Mindfulness Meditation Work? Proposing Mechanisms of Action From a Conceptual and Neural Perspective Perspectives on Psychological Science October 14, 2011
- Effectiveness of online mindfulness-based interventions in improving mental health during the COVID-19 pandemic: A systematic review and meta-analysis of randomized controlled trials. PLoS One September 21, 2022
- PROMISE: A Model of Insight and Equanimity as the Key Effects of Mindfulness Meditation Frontiers in Psychology October 22, 2019
- Reliability and validity of an equanimity questionnaire: the two-factor equanimity scale (EQUA-S) PeerJ July 18, 2019
- A pilot study and randomized controlled trial of the mindful self-compassion program. Journal of Clinical Psychology October 15, 2012
and 1 more in the library