Plain English Summary
Background and study aims
Schizophrenia spectrum disorders are chronic and severe mental disorders that affects how a person thinks, feels, and behaves. Research has shown that cognitive limitations in schizophrenia spectrum disorders limit the effectiveness of the treatments delivered to patients. Therefore several therapies have been developed to deal with cognitive impairment. Recent years have witnessed how mindfulness has been receiving a lot of interest from the scientific community. Mindfulness through meditation helps people to learn to observe sensations, and one’s reactions to them, with clear, gentle and non-judgemental awareness, and in so doing to let go of self-defeating habitual reactions to difficult experience. Studies in healthy people have shown that mindfulness increases well-being and quality of life in disorders and medical conditions where symptoms persist in spite of usual treatment. The effects of mindfulness-based interventions over cognitive functions in general population have been examined with broadly positive findings. Studies have shown that mindfulness is safe and beneficial for people with distressing psychosis. The premise behind mindfulness interventions for any disorder is that even when symptoms persist, people can learn to respond to them differently and thus be less distressed and disabled by them. Therefore, when mindfulness is adapted to psychosis the primary outcome is well-being instead symptoms (although it has been reported that mindfulness reduces negative symptoms of schizophrenia). Even though the increasing number of studies reporting mindfulness benefits over quality of life of people diagnosed with schizophrenia, no study has looked at the effect of mindfulness over cognitive impairment. This is an important issue for practitioners due cognitive impairment usually implies a ceiling effect over the outcomes of rehabilitation treatment. The aim of this study is to explore the potential benefits of adding mindfulness to standard rehabilitation treatment delivered in a rehabilitation community centre.
Who can participate?
Adults aged 18 to 65 who are diagnosed with schizophrenia.
What does the study involve?
Participants enrolled in the study received the standard rehabilitation care recommended by clinical guide treatments: drug prescription (controlled by regular psychiatrist from the local hospital service) and rehabilitation treatment (psychological cognitive therapy and strategies for preventing relapse) delivered by routine clinical staff from the rehabilitation centre. Participants allocated to rehabilitation treatment enhanced with mindfulness received the same treatment than the other group, but they also received a week session of mindfulness. Participants were required to go to a venue lent by the city council each time a week for the 26 week program.
What are the possible benefits and risks of participating?
It is likely that participants allocated to mindfulness could increase their well-being and psychological quality of life. As pointed by recent studies, there is no risk derived from participate of mindfulness training when it is carried over following the recommendations to adapt it to psychotic patients. So we do not expect side effects above the standard rate communicated by clinical guides for both treatment arms.
Where is the study run from?
UCR "Son Serralta" Community Rehabilitation Centre (Spain)
When is the study starting and how long is it expected to run for?
February 2013 to January 2016
Who is funding the study?
1. Board of Innovation, Research and Tourism of the Balearic Islands (UK)
2. Spanish Ministry of Economy and Competitiveness (UK)
3. European Social Fund (UK)
Who is the main contact?
Professor Enric Munar
Mr Emilio Lopz-Navarro
Trial website
Contact information
Type
Public
Primary contact
Prof Enric Munar
ORCID ID
Contact details
University of Balearic Islands
Ctr. Valldemossa Km 7,5
Guillem Cifre Building
Palma de Mallorca
07122
Spain
Type
Scientific
Additional contact
Mr Emilio Lopez-Navarro
ORCID ID
http://orcid.org/0000-0002-0240-9278
Contact details
University of Balearic Islands
Ctr. Valldemossa Km 7,5
AMAS Building
Palma de Mallorca
07122
Spain
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1806/2015
Study information
Scientific title
Integrated Rehabilitation Treatment enhanced with mindfulness compared with Integrated Rehabilitation Treatment in people with schizophrenia spectrum disorders: Effects over executive functions and theory of mind skills
Acronym
Study hypothesis
Integrated Rehabilitation Treatment (IRT) enhanced with mindfulness is better than IRT alone enhancing executive functions and theory of mind skills.
Ethics approval
Bioethics Committee of the University of Balearic Islands, 17/07/2013, ref: Registry number: 6163
Study design
Interventional pilot single-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Community
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet: Dr. Enric Munar enric.munar@uib.cat
Condition
Schizophrenia disorder and schizophrenia-related disorders following DSM-IV criteria
Intervention
Participants contacted by their regular psychiatrist to perform an interview to be informed about mindfulness and what participation in the trial would involve as well to assess eligibility. At the end of the interview each patient, or his legal guardian, are invited to participate and sign informed consent. After sign informed consent, randomisation identification is assigned to each patient and recorded in the clinical record form. Participants are randomly allocated by software to Integrated Rehabilitation Treatment (IRT) or IRT plus mindfulness group, with a group size for mindfulness of 10-12. Cohorts are randomised once numbers are sufficient to begin a mindfulness group.
Participants are randomly allocated to one of two groups:
Active Control: Participants receive Integrated Rehabilitation Treatment (IRT) consisting in pharmacothreapy combined with 26 one hour weekly sessions of cognitive behaviour therapy techniques for symptom management as well strategies for preventing relapse and conflict management. Drug prescription is delivered by local hospital psychiatric service, so research staff was not involved on it. Cognitive behaviour therapy techniques and strategies for preventing rellapse and conflict management were delivered by routine staff members from the community centre where the study took place. IRT contains no mindfulness training.
IRT enhanced with mindfulness-based therapy: Participants run throughout the 26 week rehabilitation treatment program, and in addition one mindfulness session each week. Mindfulness sessions last for 60 minutes and are run in group format.
Participants are followed up during clinical trial was carried by participants’ regular psychiatrist from the local hospital service. Regular psychiatrists were informed by a research team member about patient enrolment in the study.
No follow up assessment was planned after end of the trial.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
1. Executive Functions are measured using the Trail Making Test, Stroop Test, Digits from WAIS-III, and the Controlled Oral Word Association Test at baseline and 26 weeks.
2. Theory of Mind is measured using the Hinting Test and the Reading the Mind in the Eyes Test at baseline and 26 weeks
3. General mindfulness awareness in daily life as a consequence of treatment are assessed by Mindfulness Attention Awareness Scale (MAAS) at baseline and 26 weeks
Secondary outcome measures
1. Symptoms are measured using videotapped Positive and Negative Syndrome Scale at baseline and 26 weeks
2. Demographic information is measured using clinical record form at baseline
Overall trial start date
01/02/2013
Overall trial end date
31/01/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age between 18-65
2. Diagnosis of schizophrenia or schizoaffective disorder
3. No changes in psychiatric medication or hospitalization in last month
4. Have signed informed consent
5. Be able to understand and read Spanish language
6. Any gender
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Significant cognitive impairment
2. Inability to attend mindfulness sessions
3. Posed a risk of violence to the researchers
4. Refused to participate or to sign informed consent
Recruitment start date
01/08/2013
Recruitment end date
31/01/2015
Locations
Countries of recruitment
Spain
Trial participating centre
UCR "Son Serralta" Community Rehabilitation Centre
C/ de Femenies, 33
Palma de Mallorca
07013
Spain
Sponsor information
Organisation
University of Balearic Islands
Sponsor details
Ctra. de Valldemossa
km 7,5.
Palma de Mallorca
07122
Spain
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Board of Innovation, Research and Tourism of the Balearic Islands
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Spanish Ministry of Economy and Competitiveness
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
European Social Fund
Alternative name(s)
Fondo Social Europeo, Fonds Social Européen, Europäische Sozialfonds, ESF
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Results and Publications
Publication and dissemination plan
Data will be published in a scientific peer-reviewed journal from the category of Clinical Psychology or Psychiatry.
IPD sharing statement:
The datasets generated during and/or analysed during the current study is not expected to be made available due to Spanish Organic Law 15/1999 on Personal Data Protection (Articles 8 and 11), data about health-related outcomes cannot be distributed to third-parties without specific consent of the participant or court decision. Data will be held in an external encrypted hard disk.
Intention to publish date
01/03/2018
Participant level data
Not expected to be available
Results - basic reporting
Publication summary