Condition category
Mental and Behavioural Disorders
Date applied
10/10/2017
Date assigned
16/10/2017
Last edited
16/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://osr.uib.cat/

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

Publication citations

Additional files

Editorial Notes