Psychotic DisordersNCT03143907
Mindfulness Group-based Intervention for Early Psychosis
A study testing Mindfulness Ambassador Council for Early Psychosis (MAC-EP) in people with Psychotic Disorders and Schizophrenia, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 5 sites in Canada.
Trial summary
Recent research has suggested that mindfulness-based interventions (MBI) for psychosis may be effective in reducing the negative symptoms of schizophrenia (e.g., social withdrawal, lack of motivation) and the distress associated with psychotic symptoms (e.g., hearing voices) and could lead to improvements in… Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- Psychotic Disorders, Schizophrenia
- What is being tested?
- Mindfulness Ambassador Council for Early Psychosis (MAC-EP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 5 sitesCanada
- Study dates
- 22 Feb 2018to 31 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants must currently be in treatment for psychosis at one of the five Early Psychosis Intervention (EPI) study sites. In addition, participants must have been involved in the program for a period of less than 3 years, due to the focus of this study being on the treatment of early psychosis. Participants must be fluent in English, as determined by referring clinicians or researchers (in the case of advertisement referred participants) in order to meaningfully participate in the MAC intervention and complete the assessment tools.
Who cannot join
- Potential participants that show high levels of disorganized or disruptive behaviour (as determined by a cut off score of 4 or 5 on the Positive Formal Thought Disorder or Bizarre Behaviour items of the Scale for the Assessment of Positive Symptoms [SAPS]) such that they will not be able to meaningfully participate in the MAC intervention will be excluded from the study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Canadian Mental Health Association Chatham-Kent Health Alliance
Chatham, Ontario, N7L 1C1
Canadian Mental Health Association Wellington-Waterloo
Guelph, Ontario, N1H 0A1
Cleghorn Early Psychosis Intervention Clinic
Hamilton, Ontario, L9C 0E3
Prevention and Early Intervention Program for Psychoses
London, Ontario, N6A 5W9
Canadian Mental Health Association Lambton-Kent
Sarnia, Ontario, N7T 4C7
About this study
Official title: Mindfulness Group-based Intervention for Early Psychosis: A Multi-Site Randomized Control Trial
Recent research has suggested that mindfulness-based interventions (MBI) for psychosis may be effective in reducing the negative symptoms of schizophrenia (e.g., social withdrawal, lack of motivation) and the distress associated with psychotic symptoms (e.g., hearing voices) and could lead to improvements in functioning and quality of life. MBI research to date has primarily focused on studies of patients with chronic psychotic illness, yet relatively little is known about the use of MBIs for youth recovering from their first episode of psychosis. Results from recently published pilot studies appear promising in terms of the feasibility, acceptability, and potential clinical utility (e.g., improved psychological symptoms) of MBIs for the early psychosis population (Ashcroft et al., 2012; van der Valk et al., 2013; Khoury et al., 2015). The current project team has completed a pilot study at the Prevention and Early Intervention Program for Psychoses (PEPP) at London Health Sciences Centre (LHSC), wherein the "Mindfulness Ambassador Council" (MAC), a 12-week facilitated group intervention promoting mindfulness skills and the development of emotional and social competencies, was shown to be an effective, feasible, and acceptable means of treating youth in the early stages of psychotic illnesses. In follow up to the initial pilot study, the purpose of this study is to perform a multi-site Randomized Control Trial to determine the effectiveness of the MAC group intervention on reducing psychotic disorder symptomatology for transitional aged youth experiencing early psychosis. The main hypothesis, based on previous findings on the use of MBIs in psychotic disorders, including results from our initial pilot study at PEPP, is that people with early psychosis who participate in the MAC group intervention will experience improvement in mindfulness skills and affective symptoms compared to those receiving treatment as usual (TAU). Furthermore, we expect that people experiencing early psychosis who participate in MAC will have an improvement in their negative symptoms, quality of life, recovery (self-esteem, perceived recovery), perceived coping, assertiveness, social functioning, and cognitive skills, and a reduction in healthcare service utilization (e.g., emergency room visits, inpatient admissions/length of hospitalization).
Read the detailed description
The purpose of this multi-site RCT is to determine the effectiveness of the MAC group intervention on reducing psychotic disorder symptomatology (primary outcome) as well as promoting quality of life, critical skills for recovery and decreasing mental health service utilization (secondary outcomes) for transitional aged youth (16-25 years old) experiencing early psychosis. This study is being run at five southern Ontario Early Psychosis Intervention (EPI) sites with Prevention and Early Intervention Program for Psychoses (PEPP) at London Health Sciences Centre (LHSC) being the lead site. Three of the larger sites (located in London, Kitchener-Waterloo, and Hamilton Ontario) are following the RCT design, while the two smaller sites (located in Chatham-Kent and Sarnia, Ontario) are participating in a pre-post design.
For the three RCT sites we aim to recruit 20-24 participants, and for the pre-post sites we aim to recruit 10 participants (total n=92 participants). Participants at the RCT sites will be randomized into Group-A (n = 12; immediate treatment intervention group) or Group-B (n = 12; delayed treatment intervention group). Group-A will receive the MAC intervention at the onset of the study, while Group-B will receive treatment as usual (TAU). Group-B will have the option of receiving the MAC intervention approximately 6 months after the onset of the study. At all times during this study, participants who are receiving the MAC intervention will also be able to continue receiving TAU. Both groups will be assessed with a battery of quantitative measures at baseline (T1), three months later (i.e., immediately post-MAC intervention) (T2), and again three months post-MAC intervention (T3). The measures include interview assessments of psychotic disorder symptoms, and self-report measures of affect, self-esteem, quality of life, coping strategies, assertiveness, social functioning, mindfulness and cognitive skills. In addition, healthcare utilization records for the 6 months preceding MAC intervention onset and for the 6 month duration of the study (3 month MAC intervention + 3 month post-MAC intervention follow-up period) will be collected. Researchers conducting symptom assessment interviews and data analysis will be blinded to the group membership of participants. For the two pre-post sites, all 10 participants will receive the MAC intervention immediately. All 10 participants will complete T1, T2, and T3 assessments and their healthcare utilization records will also be collected.
Based on the pilot study at PEPP-LHSC, and based on previous findings of Mindfulness Based Interventions for psychoses in the literature, we are expecting that participation in the MAC intervention will result in improvement in the following areas: psychotic symptomology (including affective symptoms), mindfulness skills, quality of life, measures of recovery (self-esteem, perceived recovery), perceived coping, assertiveness, social functioning, cognitive skills, and a reduction in healthcare service utilization (e.g., emergency room visits, inpatient admissions/length of hospitalization).
- Conditions
- Psychotic Disorders, Schizophrenia
- Being tested
- Mindfulness Ambassador Council for Early Psychosis (MAC-EP)
- Keywords
- Mindfulness, Group Therapy
- Medical subject headings
- Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Ambassador Council for Early Psychosis (MAC-EP)Behavioural
MAC is a 12-week facilitated group mindfulness intervention promoting the development of social-emotional competence in youth created by Mindfulness Without Borders (MWB; www.mwb.org). A meditative practice, mindfulness focuses one's awareness on the present, acknowledging and accepting without judging one's feelings, thoughts, or bodily sensations. Each session has a unique focus (e.g., paying attention, practicing gratitude) and consists of facilitated group learning, discussion and mindfulness skills practice. Home assignments to help reinforce specific lesson are also assigned. MAC has demonstrated acceptability, feasibility, and promising beneficial effects in schools, and in the pilot study conducted at the Early Psychosis Program at London Health Sciences Centre in London, Ontario. Its youth-focus and emphasis on building social and emotional competencies through mindfulness make it a promising intervention for youth recovering from their first episode of psychosis.
| Study group | Role | What they receive |
|---|---|---|
| Group-A - Immediate Intervention | Other | Immediate Mindfulness Ambassador Council for Early Psychosis (MAC-EP) Receives: Behavioral: Mindfulness Ambassador Council for Early Psychosis (MAC-EP) |
| Group-B - Delayed Intervention | Other | 6 month treatment as usual waitlist followed by Mindfulness Ambassador Council for Early Psychosis (MAC-EP) Receives: Behavioral: Mindfulness Ambassador Council for Early Psychosis (MAC-EP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Evaluation of Negative Symptoms (SNS)
Self-report measure for the assessment of negative symptoms
Measured: Baseline, change from Baseline in SNS at 3 months, change from Baseline in SNS at 6 months
Kentucky Inventory of Mindfulness Skills
Self-report measure of mindfulness skills
Measured: Baseline, change from Baseline in KIMS at 3 months, change from Baseline in KIMS at 6 months
Secondary outcomes (10)
Rosenberg Self-Esteem Scale (RSES)
self-report measure of self-esteem
Measured: Baseline, change from Baseline in RSES at 3 months, change from Baseline in RSES at 6 months
Profile of Mood States - Short Form (POMS-SF)
self-report measure of mood
Measured: Baseline, change from Baseline in POMS-SF at 3 months, change from Baseline in POMS-SF at 6 months
World Health Organization Quality of Life Scale - Brief version (WHOQOL-BREF)
self-report measure of quality of life
Measured: Baseline, change from Baseline in WHOQOL at 3 months, change from Baseline in WHOQOL at 6 months
Ways of Coping Questionnaire (WCQ)
self-report measure of ways to cope
Measured: Baseline, change from Baseline in WCQ at 3 months, change from Baseline in WCQ at 6 months
Cognitive Failures Questionnaire (CFQ)
self-report measure of cognitive failures
Measured: Baseline, change from Baseline in CFQ at 3 months, change from Baseline in CFQ at 6 months
Rathus Assertiveness Scale (RAS)
self-report measure of assertiveness
Measured: Baseline, change from Baseline in RAS at 3 months, change from Baseline in RAS at 6 months
Health Care Utilization Records Post-Intervention
form to document participant health care utilization
Measured: Utilization at Baseline and during the 6 months following the mindfulness intervention
Kentucky Inventory of Mindfulness Skills (KIMS)
self-report measure of mindfulness skills
Measured: Baseline, change from Baseline in KIMS at 3 months, change from Baseline in KIMS at 6 months
Maryland Assessment of Recovery in People With Serious Mental Illness (MAR)
self-report measure of perceived self-recovery
Measured: Baseline, change from Baseline in MAR at 3 months, change from Baseline in MAR at 6 months
First-Episode Social Functioning Scale (FESFS)
self-report measure of social functioning
Measured: Baseline, change from Baseline in FESFS at 3 months, change from Baseline in FESFS at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start22 Feb 2018
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Five sites in total are participating. Three of the five sites are following a RCT design (randomized group allocation; treatment and control group). Two of the five sites are following a pre-post design (no randomized allocation and no control group).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- University of Western Ontario, Canada, London Health Sciences Centre, Mindfulness Without Borders
- Responsible party
- Sponsor
- Investigators
- Arlene MacDougall, M.Sc. M.D., Principal investigator, University of Western Ontario/London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143907
- Sponsor's protocol ID
- 108941
- Status last verified
- Sep 2020
- First submitted
- 4 May 2017
- Last updated
- 24 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Khoury B, Lecomte T, Fortin G, Masse M, Therien P, Bouchard V, Chapleau MA, Paquin K, Hofmann SG. Mindfulness-based therapy: a comprehensive meta-analysis. Clin Psychol Rev. 2013 Aug;33(6):763-71. doi: 10.1016/j.cpr.2013.05.005. Epub 2013 Jun 7.
PubMed 23796855Khoury B, Sharma M, Rush SE, Fournier C. Mindfulness-based stress reduction for healthy individuals: A meta-analysis. J Psychosom Res. 2015 Jun;78(6):519-28. doi: 10.1016/j.jpsychores.2015.03.009. Epub 2015 Mar 20.
PubMed 25818837Bell MD, Corbera S, Johannesen JK, Fiszdon JM, Wexler BE. Social cognitive impairments and negative symptoms in schizophrenia: are there subtypes with distinct functional correlates? Schizophr Bull. 2013 Jan;39(1):186-96. doi: 10.1093/schbul/sbr125. Epub 2011 Oct 5.
PubMed 21976710Birchwood M, Todd P, Jackson C. Early intervention in psychosis. The critical period hypothesis. Br J Psychiatry Suppl. 1998;172(33):53-9.
PubMed 9764127Shonin E, Van Gordon W, Griffiths MD. Mindfulness-based interventions: towards mindful clinical integration. Front Psychol. 2013 Apr 18;4:194. doi: 10.3389/fpsyg.2013.00194. eCollection 2013. No abstract available.
PubMed 23616779Shonin E, Van Gordon W, Griffiths MD. Do mindfulness-based therapies have a role in the treatment of psychosis? Aust N Z J Psychiatry. 2014 Feb;48(2):124-7. doi: 10.1177/0004867413512688. Epub 2013 Nov 12. No abstract available.
PubMed 24220133Norman RM, Manchanda R, Malla AK, Windell D, Harricharan R, Northcott S. Symptom and functional outcomes for a 5 year early intervention program for psychoses. Schizophr Res. 2011 Jul;129(2-3):111-5. doi: 10.1016/j.schres.2011.04.006. Epub 2011 May 5.
PubMed 21549566Chambers R, Lo BCY, Allen NB. The impact of intensive mindfulness training on attentional control, cognitive style and affect. Cognitive Therapy & Research 32: 303-322, 2008.
Buchanan RW. Persistent negative symptoms in schizophrenia: an overview. Schizophr Bull. 2007 Jul;33(4):1013-22. doi: 10.1093/schbul/sbl057. Epub 2006 Nov 10.
PubMed 17099070Tan LB, Lo BC, Macrae CN. Brief mindfulness meditation improves mental state attribution and empathizing. PLoS One. 2014 Oct 17;9(10):e110510. doi: 10.1371/journal.pone.0110510. eCollection 2014.
PubMed 25329321Wenk-Sormaz H. Meditation can reduce habitual responding. Altern Ther Health Med. 2005 Mar-Apr;11(2):42-58.
PubMed 15819448Zeidan F, Johnson SK, Diamond BJ, David Z, Goolkasian P. Mindfulness meditation improves cognition: evidence of brief mental training. Conscious Cogn. 2010 Jun;19(2):597-605. doi: 10.1016/j.concog.2010.03.014. Epub 2010 Apr 3.
PubMed 20363650Chadwick P, Hughes S, Russell D, Russell I, Dagnan D. Mindfulness groups for distressing voices and paranoia: a replication and randomized feasibility trial. Behav Cogn Psychother. 2009 Jul;37(4):403-12. doi: 10.1017/S1352465809990166. Epub 2009 Jun 23.
PubMed 19545481Chadwick P, Strauss C, Jones AM, Kingdon D, Ellett L, Dannahy L, Hayward M. Group mindfulness-based intervention for distressing voices: A pragmatic randomised controlled trial. Schizophr Res. 2016 Aug;175(1-3):168-173. doi: 10.1016/j.schres.2016.04.001. Epub 2016 Apr 14.
PubMed 27146475
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Group-based Intervention for Early Psychosis: A Multi-Site Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03143907
- Acronym / sponsor ID
- 108941
- Conditions
- Psychotic Disorders, Schizophrenia
- Keywords
- Mindfulness, Group Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- University of Western Ontario, Canada, London Health Sciences Centre, Mindfulness Without Borders
- Study start
- 22 Feb 2018 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 8 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recent research has suggested that mindfulness-based interventions (MBI) for psychosis may be effective in reducing the negative symptoms of schizophrenia (e.g., social withdrawal, lack of motivation) and the distress associated with psychotic symptoms (e.g., hearing voices) and could lead to improvements in functioning and quality of life. MBI research to date has primarily focused on studies of patients with chronic psychotic illness, yet relatively little is known about the use of MBIs for youth recovering from their first episode of psychosis. Results from recently published pilot studies appear promising in terms of the feasibility, acceptability, and potential clinical utility (e.g., improved psychological symptoms) of MBIs for the early psychosis population (Ashcroft et al., 2012; van der Valk et al., 2013; Khoury et al., 2015). The current project team has completed a pilot study at the Prevention and Early Intervention Program for Psychoses (PEPP) at London Health Sciences Centre (LHSC), wherein the "Mindfulness Ambassador Council" (MAC), a 12-week facilitated group intervention promoting mindfulness skills and the development of emotional and social competencies, was shown to be an effective, feasible, and acceptable means of treating youth in the early stages of psychotic illnesses. In follow up to the initial pilot study, the purpose of this study is to perform a multi-site Randomized Control Trial to determine the effectiveness of the MAC group intervention on reducing psychotic disorder symptomatology for transitional aged youth experiencing early psychosis. The main hypothesis, based on previous findings on the use of MBIs in psychotic disorders, including results from our initial pilot study at PEPP, is that people with early psychosis who participate in the MAC group intervention will experience improvement in mindfulness skills and affective symptoms compared to those receiving treatment as usual (TAU). Furthermore, we expect that people experiencing early psychosis who participate in MAC will have an improvement in their negative symptoms, quality of life, recovery (self-esteem, perceived recovery), perceived coping, assertiveness, social functioning, and cognitive skills, and a reduction in healthcare service utilization (e.g., emergency room visits, inpatient admissions/length of hospitalization).
Detailed description
The purpose of this multi-site RCT is to determine the effectiveness of the MAC group intervention on reducing psychotic disorder symptomatology (primary outcome) as well as promoting quality of life, critical skills for recovery and decreasing mental health service utilization (secondary outcomes) for transitional aged youth (16-25 years old) experiencing early psychosis. This study is being run at five southern Ontario Early Psychosis Intervention (EPI) sites with Prevention and Early Intervention Program for Psychoses (PEPP) at London Health Sciences Centre (LHSC) being the lead site. Three of the larger sites (located in London, Kitchener-Waterloo, and Hamilton Ontario) are following the RCT design, while the two smaller sites (located in Chatham-Kent and Sarnia, Ontario) are participating in a pre-post design.
For the three RCT sites we aim to recruit 20-24 participants, and for the pre-post sites we aim to recruit 10 participants (total n=92 participants). Participants at the RCT sites will be randomized into Group-A (n = 12; immediate treatment intervention group) or Group-B (n = 12; delayed treatment intervention group). Group-A will receive the MAC intervention at the onset of the study, while Group-B will receive treatment as usual (TAU). Group-B will have the option of receiving the MAC intervention approximately 6 months after the onset of the study. At all times during this study, participants who are receiving the MAC intervention will also be able to continue receiving TAU. Both groups will be assessed with a battery of quantitative measures at baseline (T1), three months later (i.e., immediately post-MAC intervention) (T2), and again three months post-MAC intervention (T3). The measures include interview assessments of psychotic disorder symptoms, and self-report measures of affect, self-esteem, quality of life, coping strategies, assertiveness, social functioning, mindfulness and cognitive skills. In addition, healthcare utilization records for the 6 months preceding MAC intervention onset and for the 6 month duration of the study (3 month MAC intervention + 3 month post-MAC intervention follow-up period) will be collected. Researchers conducting symptom assessment interviews and data analysis will be blinded to the group membership of participants. For the two pre-post sites, all 10 participants will receive the MAC intervention immediately. All 10 participants will complete T1, T2, and T3 assessments and their healthcare utilization records will also be collected.
Based on the pilot study at PEPP-LHSC, and based on previous findings of Mindfulness Based Interventions for psychoses in the literature, we are expecting that participation in the MAC intervention will result in improvement in the following areas: psychotic symptomology (including affective symptoms), mindfulness skills, quality of life, measures of recovery (self-esteem, perceived recovery), perceived coping, assertiveness, social functioning, cognitive skills, and a reduction in healthcare service utilization (e.g., emergency room visits, inpatient admissions/length of hospitalization).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Five sites in total are participating. Three of the five sites are following a RCT design (randomized group allocation; treatment and control group). Two of the five sites are following a pre-post design (no randomized allocation and no control group).
| Arm | Type | Receives |
|---|---|---|
| Group-A - Immediate Intervention | Other | Behavioral: Mindfulness Ambassador Council for Early Psychosis (MAC-EP)Immediate Mindfulness Ambassador Council for Early Psychosis (MAC-EP) |
| Group-B - Delayed Intervention | Other | Behavioral: Mindfulness Ambassador Council for Early Psychosis (MAC-EP)6 month treatment as usual waitlist followed by Mindfulness Ambassador Council for Early Psychosis (MAC-EP) |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Participants must currently be in treatment for psychosis at one of the five Early Psychosis Intervention (EPI) study sites. In addition, participants must have been involved in the program for a period of less than 3 years, due to the focus of this study being on the treatment of early psychosis. Participants must be fluent in English, as determined by referring clinicians or researchers (in the case of advertisement referred participants) in order to meaningfully participate in the MAC intervention and complete the assessment tools.
Key exclusion criteria (1 listed)
- Potential participants that show high levels of disorganized or disruptive behaviour (as determined by a cut off score of 4 or 5 on the Positive Formal Thought Disorder or Bizarre Behaviour items of the Scale for the Assessment of Positive Symptoms [SAPS]) such that they will not be able to meaningfully participate in the MAC intervention will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Ambassador Council for Early Psychosis (MAC-EP)MAC is a 12-week facilitated group mindfulness intervention promoting the development of social-emotional competence in youth created by Mindfulness Without Borders (MWB; www.mwb.org). A meditative practice, mindfulness focuses one's awareness on the present, acknowledging and accepting without judging one's feelings, thoughts, or bodily sensations. Each session has a unique focus (e.g., paying attention, practicing gratitude) and consists of facilitated group learning, discussion and mindfulness skills practice. Home assignments to help reinforce specific lesson are also assigned. MAC has demonstrated acceptability, feasibility, and promising beneficial effects in schools, and in the pilot study conducted at the Early Psychosis Program at London Health Sciences Centre in London, Ontario. Its youth-focus and emphasis on building social and emotional competencies through mindfulness make it a promising intervention for youth recovering from their first episode of psychosis. | Behavioural | Group-A - Immediate Intervention, Group-B - Delayed Intervention |
Primary outcome
Self-Evaluation of Negative Symptoms (SNS)
Time frame: Baseline, change from Baseline in SNS at 3 months, change from Baseline in SNS at 6 months
Self-report measure for the assessment of negative symptoms
Kentucky Inventory of Mindfulness Skills
Time frame: Baseline, change from Baseline in KIMS at 3 months, change from Baseline in KIMS at 6 months
Self-report measure of mindfulness skills
10 secondary outcomes
Rosenberg Self-Esteem Scale (RSES)
Time frame: Baseline, change from Baseline in RSES at 3 months, change from Baseline in RSES at 6 months
Profile of Mood States - Short Form (POMS-SF)
Time frame: Baseline, change from Baseline in POMS-SF at 3 months, change from Baseline in POMS-SF at 6 months
World Health Organization Quality of Life Scale - Brief version (WHOQOL-BREF)
Time frame: Baseline, change from Baseline in WHOQOL at 3 months, change from Baseline in WHOQOL at 6 months
Ways of Coping Questionnaire (WCQ)
Time frame: Baseline, change from Baseline in WCQ at 3 months, change from Baseline in WCQ at 6 months
Cognitive Failures Questionnaire (CFQ)
Time frame: Baseline, change from Baseline in CFQ at 3 months, change from Baseline in CFQ at 6 months
Rathus Assertiveness Scale (RAS)
Time frame: Baseline, change from Baseline in RAS at 3 months, change from Baseline in RAS at 6 months
Health Care Utilization Records Post-Intervention
Time frame: Utilization at Baseline and during the 6 months following the mindfulness intervention
Kentucky Inventory of Mindfulness Skills (KIMS)
Time frame: Baseline, change from Baseline in KIMS at 3 months, change from Baseline in KIMS at 6 months
Maryland Assessment of Recovery in People With Serious Mental Illness (MAR)
Time frame: Baseline, change from Baseline in MAR at 3 months, change from Baseline in MAR at 6 months
First-Episode Social Functioning Scale (FESFS)
Time frame: Baseline, change from Baseline in FESFS at 3 months, change from Baseline in FESFS at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- Background: PubMed 23796855Khoury B, Lecomte T, Fortin G, Masse M, Therien P, Bouchard V, Chapleau MA, Paquin K, Hofmann SG. Mindfulness-based therapy: a comprehensive meta-analysis. Clin Psychol Rev. 2013 Aug;33(6):763-71. doi: 10.1016/j.cpr.2013.05.005. Epub 2013 Jun 7.
- Background: PubMed 25818837Khoury B, Sharma M, Rush SE, Fournier C. Mindfulness-based stress reduction for healthy individuals: A meta-analysis. J Psychosom Res. 2015 Jun;78(6):519-28. doi: 10.1016/j.jpsychores.2015.03.009. Epub 2015 Mar 20.
- Background: PubMed 21976710Bell MD, Corbera S, Johannesen JK, Fiszdon JM, Wexler BE. Social cognitive impairments and negative symptoms in schizophrenia: are there subtypes with distinct functional correlates? Schizophr Bull. 2013 Jan;39(1):186-96. doi: 10.1093/schbul/sbr125. Epub 2011 Oct 5.
- Background: PubMed 9764127Birchwood M, Todd P, Jackson C. Early intervention in psychosis. The critical period hypothesis. Br J Psychiatry Suppl. 1998;172(33):53-9.
- Background: PubMed 23616779Shonin E, Van Gordon W, Griffiths MD. Mindfulness-based interventions: towards mindful clinical integration. Front Psychol. 2013 Apr 18;4:194. doi: 10.3389/fpsyg.2013.00194. eCollection 2013. No abstract available.
- Background: PubMed 24220133Shonin E, Van Gordon W, Griffiths MD. Do mindfulness-based therapies have a role in the treatment of psychosis? Aust N Z J Psychiatry. 2014 Feb;48(2):124-7. doi: 10.1177/0004867413512688. Epub 2013 Nov 12. No abstract available.
- Background: PubMed 21549566Norman RM, Manchanda R, Malla AK, Windell D, Harricharan R, Northcott S. Symptom and functional outcomes for a 5 year early intervention program for psychoses. Schizophr Res. 2011 Jul;129(2-3):111-5. doi: 10.1016/j.schres.2011.04.006. Epub 2011 May 5.
- BackgroundChambers R, Lo BCY, Allen NB. The impact of intensive mindfulness training on attentional control, cognitive style and affect. Cognitive Therapy & Research 32: 303-322, 2008.
- Background: PubMed 17099070Buchanan RW. Persistent negative symptoms in schizophrenia: an overview. Schizophr Bull. 2007 Jul;33(4):1013-22. doi: 10.1093/schbul/sbl057. Epub 2006 Nov 10.
- Background: PubMed 25329321Tan LB, Lo BC, Macrae CN. Brief mindfulness meditation improves mental state attribution and empathizing. PLoS One. 2014 Oct 17;9(10):e110510. doi: 10.1371/journal.pone.0110510. eCollection 2014.
- Background: PubMed 15819448Wenk-Sormaz H. Meditation can reduce habitual responding. Altern Ther Health Med. 2005 Mar-Apr;11(2):42-58.
- Background: PubMed 20363650Zeidan F, Johnson SK, Diamond BJ, David Z, Goolkasian P. Mindfulness meditation improves cognition: evidence of brief mental training. Conscious Cogn. 2010 Jun;19(2):597-605. doi: 10.1016/j.concog.2010.03.014. Epub 2010 Apr 3.
- Heinssen, R.K., Goldstein, A.B., \& Azrin, S.T. (2014). Evidence-Based Treatments for First Episode Psychosis: Components of Coordinated Specialty Care. Recovery After An Initial Schizophrenia Episode (RA1SE).Link provided by the sponsor.
- Mindfulness Without BordersLink provided by the sponsor.
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Cognitive Neurocomputational Task Reliability and Clinical Applications Consortium: Study 2
SCHIZOPHRENIA 1 (Disorder), Schizo Affective Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arlene MacDougall, M.Sc. M.D. principal investigator
University of Western Ontario/London Health Sciences Centre
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Ambassador Council for Early Psychosis (MAC-EP) in people with Psychotic Disorders and Schizophrenia, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Evaluation of Negative Symptoms (SNS) (time frame: Baseline, change from Baseline in SNS at 3 months, change from Baseline in SNS at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03143907, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2020.