Mindfulness, acceptance and reflection training by text message - an effectiveness trial investigating stress-reduction in the general population of Sweden
| ISRCTN | ISRCTN39222610 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39222610 |
- Submission date
- 29/05/2024
- Registration date
- 30/05/2024
- Last edited
- 06/08/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Psychosocial stress is a major public health concern, contributing to significant suffering and costs to society. There is a lack of effective intervention that could be offered at an early stage to those needing to reduce their stress in life. Recent advances in psychology have provided self-help exercises that are suitable to test as fully digital interventions. This study aims to test a 12-week digital course in mindfulness- and acceptance-based stress reduction and investigate its effectiveness.
Who can participate?
People above the age of 15 years who seek information online about stress and stress reduction
What does the study involve?
Participants will be randomly allocated to receive either daily exercises in mindfulness and acceptance or be directed to self-studies on a webpage with mental health information. Perceived stress and other measures of well-being will be measured before, after 12 weeks, as well as 6 and 12 months after the intervention.
What are the possible benefits and risks of participating?
A risk identified is that participants wait to seek professional help. To address this risk the digital platform will advise participants with symptoms of depression to seek additional help. Participation may, on the other hand, contribute to the acquisition of skills and perspectives that foster resilience and uncover a sense of strength and stability.
Where is the study run from?
H.K.H. Crown Princess Victoria Children's Hospital (Sweden)
When is the study starting and how long is it expected to run for?
February 2024 to November 2025
Who is funding the study?
Swedish Cancer Society
Who is the main contact?
Oskar Lundgren, oskar.lundgren@liu.se
Contact information
Public, Scientific, Principal Investigator
H.K.H. Crown Princess Victoria Children's Hospital
Linköping
58185
Sweden
 ORCID ID |
0000-0001-7883-3895 |
|---|---|
| Phone | +46 (0)101030226 |
| oskar.lundgren@liu.se |
Study information
| Study design | Semi-blinded interventional randomized controlled effectiveness trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Prevention, Treatment, Efficacy |
| Participant information sheet | Not available in web format, please use contact information to request a participation information sheet |
| Scientific title | Digital mindfulness, acceptance and reflection training for the general population - the Cultivating Resilience In Stressed People (CRISP) trial |
| Study acronym | CRISP |
| Study objectives | The 12-week digital course in daily mindfulness and acceptance exercises is effective in reducing perceived stress among stressed people from the general population. Furthermore, improvements in perceived stress are mediated through acquired increases in equanimity. |
| Ethics approval(s) |
Approved 07/05/2024, Swedish Ethical Review Authority (Etikprövningsmyndigheten Box 2110, Uppsala, 750 02, Sweden; +46 (0)10 475 08 00; registrator@etikprovning.se), ref: 2024-01974-01 |
| Health condition(s) or problem(s) studied | People above the age of 15 years from the general population, who self-identify a need for stress reduction |
| Intervention | 12 weeks of text message delivered mindfulness- and acceptance-based stress-reduction (AiM) vs 12 weeks of mental health self-study (control). The effectiveness of a 12-week, text message delivered, mindfulness- and acceptance-based stress-reduction course will be investigated in a semi-blinded randomized controlled trial, in which the 12-week course will be compared to self-studies of mental health information. The study population will be people aged above 15 years seeking help online for stress and have access to a mobile phone. Employing a Bayesian sequential design, the study will continuously monitor the primary outcome to calculate target criteria for when to stop recruiting, allowing for avoidance of both under- and over-recruitment. A measure of perceived stress (Cohen’s 10-item version) will be the primary outcome, and mediation analysis will reveal if improvements are mediated by acquired equanimity. Follow-up measures will be made at 3-, 6- and 12 months. Effectiveness will be analyzed with Bayesian regression models, and mediation will be analyzed by using a causal inference framework. Randomization will be fully automated and computerized and neither research personnel nor participants will be able to influence allocation. Stratified block randomization (with random block sizes of 2 and 4) will be done based on self-reported history of serious disease during childhood. |
| Intervention type | Behavioural |
| Primary outcome measure | Current primary outcome measure as of 06/08/2025: Perceived stress is measured using the 10-item version of Cohen's Perceived Stress Scale (PSS) at 3 months, 6 months and 1 year. Previous primary outcome measure: Perceived stress is measured using the 10-item version of Cohen's Perceived Stress Scale (PSS) at baseline, 1 month, 3 months, 6 months and 1 year |
| Secondary outcome measures | Current secondary outcome measures as of 06/08/2025: 1. Mental well-being is measured using the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) at 3 months, 6 months and 1 year. 2. Life satisfaction is measured using the 2-item Cantrils Ladder at 3 months, 6 months and 1 year. 3. Anxiety is measured using the General Anxiety Disorder-7 (GAD-7) scale at 3 months, 6 months and 1 year. 4. Depression is measured using the Patient Health Questionnaire-9 (PHQ-9) scale at 3 months, 6 months and 1 year. 5. Equanimity (mediator tested) is measured using the two-factor equanimity scale (EQUA-S) scale at 1 month, 3 months, 6 months and 1 year. Previous secondary outcome measures: 1. Mental well-being is measured using the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) at baseline, 1 month, 3 months, 6 months and 1 year 2. Life satisfaction is measured using the 2-item Cantrils Ladder at baseline, 1 month, 3 months, 6 months and 1 year 3. Anxiety is measured using the General Anxiety Disorder-7 (GAD-7) scale at baseline, 1 month, 3 months, 6 months and 1 year 4. Depression is measured using the Patient Health Questionnaire-9 (PHQ-9) scale at baseline, 1 month, 3 months, 6 months and 1 year 5. Equanimity (mediator tested) is measured using the two-factor equanimity scale (EQUA-S) scale at baseline, 1 month, 3 months, 6 months and 1 year |
| Overall study start date | 10/02/2024 |
| Completion date | 01/11/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Lower age limit | 15 Years |
| Upper age limit | 120 Years |
| Sex | Both |
| Target number of participants | An upper bound on the target number of participants has been simulated to be from 1250 to 1429 |
| Key inclusion criteria | 1. People from the general population 2. Above the age of 15 years 3. Access to a mobile phone 4. Language skills (Swedish) to comprehend study information and questionnaires |
| Key exclusion criteria | Does not meet the inclusion criteria |
| Date of first enrolment | 01/06/2024 |
| Date of final enrolment | 01/09/2025 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Linköping
58185
Sweden
Sponsor information
Hospital/treatment centre
University Hospital
Linköping
58185
Sweden
| Phone | +46 (0)1010300 |
|---|---|
| info@regionostergotland.se | |
| Website | https://www.regionostergotland.se/ |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Swedish Cancer Society
- Location
- Sweden
Results and Publications
| Intention to publish date | 01/04/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results will be reported in a peer-reviewed scientific journal during 2026, and presented during a conference organized by a behavioral medicine or public health society. If the study results in data interesting for the general public, the results will also be communicated through press-releases and interactions with traditional and digital media. |
| IPD sharing plan | The dataset generated during and/or analysed during the current study will be available upon reasonable request from the study PI Oskar Lundgren (oskar.lundgren@liu.se). |
Editorial Notes
06/08/2025: The following changes were made to the study record:
1. The primary and secondary outcome measures were updated.
2. The target number of participants was changed from '2000' to 'An upper bound on the target number of participants has been simulated to be from 1250 to 1429'.
29/05/2024: Study's existence confirmed by the Swedish Ethical Review Authority.
