Trial Review

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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
2/02/2022
Date data sharing statement initially provided
2/02/2022
Date results provided
2/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Development and evaluation of a mindfulness and compassion based program: An intervention for youth with psychotic experiences.
Scientific title
Development and evaluation of a mindfulness and compassion based program for youth with psychotic experiences: A pilot study
Secondary ID [1] 291371 0
Nil Known
Universal Trial Number (UTN)
U1111-119308960
Trial acronym
The MAC-P Program
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
Psychosis 325118 0
Schizophrenia 325119 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 psychosis experiences. 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
No Control Treatment
Control group
Uncontrolled

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)
Secondary outcome [12] 405813 0
Attachment style assessed using Relationships Questionnaire by Bartholomew & Horowitz (1991).
Timepoint [12] 405813 0
Before the intervention begins, when the intervention ends and 6 weeks later (i.e. pre- post and 6 weeks later).

Secondary outcome [13] 405814 0
Brief Psychiatric Rating Scale (Lukoff et al., 1986)
Timepoint [13] 405814 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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Currently acutely suicidal
Organic brain syndrome
Severe cognitive impairment
Problematic substance abuse
Insufficient fluency in English language

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
There was no allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomised block allocation was not conducted
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Single group
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
Completed
Date of first participant enrolment
Anticipated
Actual
27/09/2016
Date of last participant enrolment
Anticipated
15/04/2018
Actual
5/03/2018
Date of last data collection
Anticipated
30/06/2018
Actual
23/06/2018
Sample size
Target
42
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 295843 0
University
Name [1] 295843 0
Monash University
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
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
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
[email protected]
Contact person for public queries
Name 73063 0
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
[email protected]
Contact person for scientific queries
Name 73064 0
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
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification, can be made available
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
Only researchers who provide a methodologically sound proposal on a case-by-case basis
Available for what types of analyses?
To achieve the aims in the approved proposal and for IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator

[email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.