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Trial registered on ANZCTR


Registration number
ACTRN12617000397314
Ethics application status
Approved
Date submitted
13/03/2017
Date registered
17/03/2017
Date last updated
17/03/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Development of a mindfulness and compassion based program for young people: An intervention for sub-threshold and brief psychotic symptoms.
Scientific title
Development and evaluation of a mindfulness and compassion based program for young people with an at risk mental state: a randomized control trial.
Secondary ID [1] 291371 0
Nil Known
Universal Trial Number (UTN)
U1111-119308960
Trial acronym
MAC-ARMS
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
At Risk Mental State
302367 0
Depression 302521 0
Anxiety 302522 0
Stress 302523 0
Condition category
Condition code
Mental Health 301952 301952 0 0
Other mental health disorders
Mental Health 301953 301953 0 0
Depression
Mental Health 301954 301954 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This Mindfulness with Compassion intervention is an 8-week group program with sessions delivered face to face for 1.5 hours once a week. The program will be delivered by two facilitators. The first facilitator has over 10 years experience working with youth with an ARMS. and has been a trained mindfulness teacher for the past 6 years. The second facilitator will may change from program to program. However, each co-facilitator will be a mental health professional who at a minimum will have sat an evidence-based mindfulness program as a participant and has a mindfulness practice. The program will be delivered in urban clinics.

The first half of the program introduces participants to mindfulness primarily through experiential exercises. It involves a variety of meditations and informal practices for use in daily life that are specifically tailored to the needs of the at risk mental state group. The fourth session takes a more didactic approach exploring the core difficulties associated with the at risk mental state and mapping these onto the three emotional regulation systems used in Compassion Focused Therapy. The remaining sessions continue to build participants’ mindfulness skills with an explicit focus on developing compassion.
Intervention code [1] 297409 0
Treatment: Other
Intervention code [2] 297523 0
Behaviour
Comparator / control treatment
Control group will be receiving treatment as usual (TAU). By TAU we mean the treatment participants would normally receive in the clinic they are attending regardless of the intervention study.
Control group
Active

Outcomes
Primary outcome [1] 301372 0
Self-Compassion assessed using the Self-Compassion Questionnaire by Neff (2003)
Timepoint [1] 301372 0
There are three assessment points in this study; before the intervention begins, when the intervention ends and 6 weeks later (i.e. pre-post and 6 weeks follow-up)


Secondary outcome [1] 332469 0
Mindfulness

Assessed using the Five Facet Mindfulness Questionnaire by Baer et al. (2006)
Timepoint [1] 332469 0
Before the intervention begins, when the intervention ends and 6 weeks later (i.e. pre-post and 6 weeks follow-up)
Secondary outcome [2] 332470 0
Frequency of attenuated or brief psychotic symptoms assessed using the Comprehensive Assessment of the At Risk Mental Sate (CAARMS) by Yung et al. (2005).
Timepoint [2] 332470 0
Before the intervention begins, when the intervention ends and 6 weeks later (i.e. pre-post and 6 weeks follow-up)
Secondary outcome [3] 332471 0
Depression assessed using Depression Anxiety Stress Scale-21 (DASS-21) by Anthony et al. (2008)
Timepoint [3] 332471 0
Before the intervention begins, when the intervention ends and 6 weeks later (i.e. pre-post and 6 weeks follow-up)
Secondary outcome [4] 332472 0
Anxiety assessed using Depression Anxiety Stress Scale-21 (DASS-21) by Anthony et al. (2008)
Timepoint [4] 332472 0
Before the intervention begins, when the intervention ends and 6 weeks later (i.e. pre-post and 6 weeks follow-up)
Secondary outcome [5] 332473 0
Stress assessed using Depression Anxiety Stress Scale-21 (DASS-21) by Anthony et al. (2008)
Timepoint [5] 332473 0
Before the intervention begins, when the intervention ends and 6 weeks later (i.e. pre-post and 6 weeks follow-up)
Secondary outcome [6] 332474 0
Fear of Compassion as assessed using the Fear of Compassion Scale by Gilbert et al. (2011)
Timepoint [6] 332474 0
Before the intervention begins, when the intervention ends and 6 weeks later (i.e. pre-post and 6 weeks follow-up)
Secondary outcome [7] 332475 0
Self-Criticism and Reassurance assessed using Forms of Self-Criticizing/Attacking and Self-Reassuring Scale (FRCRS) by Gilbert et al. (2004)
Timepoint [7] 332475 0
Before the intervention begins, when the intervention ends and 6 weeks later (i.e. pre-post and 6 weeks follow-up)
Secondary outcome [8] 332477 0
Self-Connectedness assessed using Social Connectedness Scale by Lee and Robins (1995)
Timepoint [8] 332477 0
Before the intervention begins, when the intervention ends and 6 weeks later (i.e. pre-post and 6 weeks follow-up)
Secondary outcome [9] 332478 0
Social Functioning assessed using Global Functioning: Social and Role scales by Cornblatt et al. (2007)
Timepoint [9] 332478 0
Before the intervention begins, when the intervention ends and 6 weeks later (i.e. pre-post and 6 weeks follow-up)
Secondary outcome [10] 332841 0
Role Functioning assessed using the Global Functioning: Social and Role scales by Cornblatt et al. (2007)
Timepoint [10] 332841 0
Before the intervention begins, when the intervention ends and 6 weeks later (i.e. pre-post and 6 weeks follow-up)
Secondary outcome [11] 332842 0
Distress of attenuated or brief psychotic symptoms assessed using the Comprehensive Assessment of the At Risk Mental Sate (CAARMS) by Yung et al. (2005).
Timepoint [11] 332842 0
Before the intervention begins, when the intervention ends and 6 weeks later (i.e. pre-post and 6 weeks follow-up)

Eligibility
Key inclusion criteria
Meets criteria for the at risk mental state for psychosis as measured by the Comprehensive Assessment of At Risk Mental Statement (CAARMS)
Minimum age
15 Years
Maximum age
25 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Currently acutely suicidal
Organic brain syndrome
Severe cognitive impairment
Psychosis or schizophrenia
Problematic substance abuse
Insufficient fluency in English language

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization by an independent researcher using computer software
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent researcher will perform a randomized block allocation. Stratification will also be used based on (i) gender, (ii) life-time depression and (iii) duration of sub-threshold or brief psychotic symptoms.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Descriptive statistics will be conducted and data will be examined to ensure that it meets the assumptions required for ANOVA tests. If all the assumptions are met, or solutions are found for assumptions that are not met, repeated measures ANOVA will be carried out. Significant overall effects will be followed-up with appropriate post-hoc tests.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 295843 0
University
Name [1] 295843 0
Monash University
Address [1] 295843 0
Southern Synergy, Faculty of Medicine, Nursing and Health Sciences
Monash University, ART Building
Dandenong Hospital
126-128 Cleeland Street
Dandenong
VIC 3175
Country [1] 295843 0
Australia
Primary sponsor type
Individual
Name
Professor Graham Meadows
Address
Southern Synergy, Faculty of Medicine, Nursing and Health Sciences
Monash University, ART Building
Dandenong Hospital
126-128 Cleeland Street
Dandenong
VIC 3175
Country
Australia
Secondary sponsor category [1] 294695 0
Individual
Name [1] 294695 0
Assistant Professor Barnaby Nelson
Address [1] 294695 0
The National Centre of Excellence in Youth Mental Health
35 Poplar Road
Parkville
VIC 3052
Country [1] 294695 0
Australia
Other collaborator category [1] 279466 0
Individual
Name [1] 279466 0
Dr David Moseley
Address [1] 279466 0
Early in Life Mental Health Service
Monash Medical Centre
246 Clayton Rd
Clayton
VIC 3168
Country [1] 279466 0
Australia
Other collaborator category [2] 279467 0
Individual
Name [2] 279467 0
Dr Liz Hopkins
Address [2] 279467 0
Headspace
973 Nepean Highway
Bentleigh
VIC
3204
Country [2] 279467 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297125 0
Monash Health HREC
Ethics committee address [1] 297125 0
Level 2, i Block
Monash Medical Centre
246 Clayton Road
CLAYTON VIC 3168
Ethics committee country [1] 297125 0
Australia
Date submitted for ethics approval [1] 297125 0
17/02/2016
Approval date [1] 297125 0
06/05/2016
Ethics approval number [1] 297125 0
HREC/16/MonH/43

Summary
Brief summary
The aim of the study is to develop and pilot a mindfulness and compassion based group intervention for youth who meet the ‘at risk for psychosis’ criteria. The program has been designed as an conjunct to treatment as usual. It specifically focuses on developing mindfulness and compassion skills in relation to attenuated psychotic symptoms, depression, anxiety, stress, self-criticism, social and daily functioning.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73062 0
Dr Tara Hickey
Address 73062 0
Southern Synergy
ART Building, Dandenong Hospital
126-128 Cleeland Street
Dandenong
VIC 3175
Country 73062 0
Australia
Phone 73062 0
+61 3 9902 9696
Fax 73062 0
Email 73062 0
tara.hickey@monash.edu
Contact person for public queries
Name 73063 0
Dr Tara Hickey
Address 73063 0
Southern Synergy
ART Building, Dandenong Hospital
126-128 Cleeland Street
Dandenong
VIC 3175
Country 73063 0
Australia
Phone 73063 0
+61 3 9902 9696
Fax 73063 0
Email 73063 0
tara.hickey@monash.edu
Contact person for scientific queries
Name 73064 0
Dr Tara Hickey
Address 73064 0
Southern Synergy
ART Building, Dandenong Hospital
126-128 Cleeland Street
Dandenong
VIC 3175
Country 73064 0
Australia
Phone 73064 0
+61 3 9902 9696
Fax 73064 0
Email 73064 0
tara.hickey@monash.edu

No information has been provided regarding IPD availability
Summary results
No Results