Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615001279516
Ethics application status
Approved
Date submitted
18/11/2015
Date registered
24/11/2015
Date last updated
7/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the feasibility of a Mindfulness Based Cognitive Therapy text package for
young adults who have experienced psychosis symptoms.
Scientific title
Feasibility and utility of a Mindfulness-Based Cognitive Therapy text messaging programme (MINT) for young adults who have experienced psychosis symptoms who are engaged with Early Intervention Teams.
Secondary ID [1] 287912 0
Auckland District Health Board registration 6990
Universal Trial Number (UTN)
UTN: U111111720224
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clients engaged with Early Intervention Psychosis 296794 0
Depression 296810 0
Anxiety 296811 0
Condition category
Condition code
Mental Health 297024 297024 0 0
Psychosis and personality disorders
Mental Health 297076 297076 0 0
Depression
Mental Health 297077 297077 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A text message package (called MINT) based on Mindfulness Based Cognitive Therapy (Segal et al., 2002), was developed. MINT is an adjunct to treatment as usual by the Early Intervention Psychosis team. Participants will received two text messages a day to encourage them to practice the mindfulness skills learnt in therapy at home. MINT lasts for 8 weeks. Weekly measures will be collected at baseline, during the intervention, and post-intervention. Home-based mindfulness practice is supported by the text message package (MINT), short mindfulness practices are suggested in-line with the TAU mindfulness skills learnt in existing therapy. Examples of these text messages are: "Placing your hand on your stomach, feeling it rise and fall with your breath. ", "Placing a flower by your bed so you can see it when you wake up. Next time you see the flower, smile and breathe deeply 3 times.", "Taking 3 minutes, focusing on the breath, sit or lie comfortably. Breathing in... breathing out. "
Intervention code [1] 293267 0
Treatment: Other
Intervention code [2] 293268 0
Lifestyle
Intervention code [3] 293269 0
Behaviour
Comparator / control treatment
Within subjects design. Participants provide their own baseline measures, which act as a control comparison, in a single case design ABA, multiple baseline approach.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296619 0
Change in number of days a week of home-based mindfulness practice. As assessed by weekly self-report question.
Timepoint [1] 296619 0
At the end of the intervention there is a primary time point to assess the intervention compared to baseline, another time point is 3 weeks post-intervention to see if gains are maintained.
Primary outcome [2] 296620 0
Change in levels of mindfulness skills, as assessed by the Cognitive and Affective Mindfulness Scale - Revised (10-item) (Feldman et al., 2007).
Timepoint [2] 296620 0
At the end of the intervention there is a primary time point to assess the intervention compared to baseline, another time point is 3 weeks post-intervention to see if gains are maintained.
Secondary outcome [1] 318942 0
Changes in symptoms of depression and anxiety as measure by the Patient Health Questionnaire - 4 (Kroenke et al., 2009) as a composite.
Timepoint [1] 318942 0
At the end of the intervention there is a primary time point to assess the intervention compared to baseline, another time point is 3 weeks post-intervention to see if gains are maintained.
Secondary outcome [2] 318988 0
Changes in symptoms of depression measure by the first two items on the Patient Health Questionnaire - 4 (Kroenke et al., 2009).
Timepoint [2] 318988 0
At the end of the intervention there is a primary time point to assess the intervention compared to baseline, another time point is 3 weeks post-intervention to see if gains are maintained.
Secondary outcome [3] 318989 0
Changes in symptoms of anxiety as measure by the last two items on the Patient Health Questionnaire - 4 (Kroenke et al., 2009).
Timepoint [3] 318989 0
At the end of the intervention there is a primary time point to assess the intervention compared to baseline, another time point is 3 weeks post-intervention to see if gains are maintained.

Eligibility
Key inclusion criteria
Participants must be actively receiving therapy from an Early Intervention Psychosis Clinical Psychologist. Potential participants were approached in the first instance by their Clinical Psychologist. To be eligible, the participants must have had a New Zealand based mobile phone capable of sending and receiving text messages.
Minimum age
18 Years
Maximum age
34 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
If participants are deemed unsuitable for the intervention by their Clinical Psychologist. Any disclosure of high risk would result in termination of the intervention.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
A single case design approach, with ABA and multiplebaseline
features will be used to evaluate the intervention.
The single case approach is useful in real life settings, as it can monitor changes in participants’ behavior (Engel &
Schutt, 2013). This type of approach seeks to demonstrate that the intervention has an effect on behavior compared
to functioning before the intervention was administered (Mitchell & Jolley, 2001).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In ABA design, the baseline is measured to establish the level of behavior (A), then the intervention is given and the behavior measured (B) and then the intervention is withdrawn and behavior measured again (A) (Mitchell & Jolley, 2001). Using a nonconcurrent
multiple baseline approach is suitable for comparing more than three participants and if consistent results are found the likelihood that change is due to an external event is reduced (Engel & Schutt, 2013). By exploring small numbers of individuals in a real life setting, rich data can be gathered that may be lost in larger group trials (Engel & Schutt, 2013). This exploratory research in a clinical setting is likely to obtain between 12 and 20 participants and
therefore the ABA approach is suitable. No statistical assumptions or sample size calculations were undertaken as this is no appropriate for a single case design, where the mode of analysis is visual analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/01/2016
Actual
23/02/2016
Date of last participant enrolment
Anticipated
29/07/2016
Actual
21/06/2016
Date of last data collection
Anticipated
Actual
3/10/2016
Sample size
Target
12
Accrual to date
Final
9
Recruitment outside Australia
Country [1] 7335 0
New Zealand
State/province [1] 7335 0
Auckland

Funding & Sponsors
Funding source category [1] 292398 0
University
Name [1] 292398 0
Massey University, Albany
Country [1] 292398 0
New Zealand
Primary sponsor type
University
Name
Massey University Auckland
Address
Private Bag 102904
North Shore Mail Centre
Auckland
0745
New Zealand
Country
New Zealand
Secondary sponsor category [1] 291080 0
None
Name [1] 291080 0
Address [1] 291080 0
Country [1] 291080 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293866 0
Health and Disabilities Ethics Committee
Ethics committee address [1] 293866 0
Health and Disability Ethics Committees
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 293866 0
New Zealand
Date submitted for ethics approval [1] 293866 0
14/10/2015
Approval date [1] 293866 0
11/11/2015
Ethics approval number [1] 293866 0
15/NTB/201

Summary
Brief summary
This study aims to evaluate whether a mindfulness-based text message package, delivered as an adjunct to existing therapy, can help to improve levels of home-based mindfulness practice and increase mindfulness skills for patients involved in Early Intervention Teams. A text message package, called MINT, based on Mindfulness Based Cognitive Therapy (MBCT) has been developed by the researcher. Clinical participants will be recruited from
the Early Intervention Teams’ (EIT) clinical psychologists in Auckland, New Zealand, based on their clinical evaluation of their patients’ suitability for inclusion. The EIT intensive treatment consists of long periods of rapport building, followed by MBCT based skills, with therapy typically lasting for 2 to 3 years. The EIT provides its own crisis management, and monitors the risk of their patients on a weekly basis. It thus provides an excellent opportunity to
evaluate the effect of MINT, in addition to treatment as usual (TAU), with the lowest possible risks. The intervention will consist of 8 weeks, where participants will be receiving two text messages daily, containing focus mindfulness information and suggesting mindfulness practices. The research design will follow a single case method structure with a multiple baseline ABA approach. The EIT clinicians will be collecting a range of quantitative measures during baseline, intervention and postintervention periods. These will include a question about the number of days of Mindfulness practice in the previous week, the Cognitive and Affective Mindfulness Scale – Revised (CAMSR; Feldman, Hayes, Kumar, Greeson, & Laurenceau, 2007), and the Patient Health Questionnaire – 4 (PHQ4; Kroenke, Spitzer, Williams, & Lowe, 2009). At the end of the trial, participants’ and clinical psychologists’
experiences of using the text message package will be explored using a questionnaire specifically designed for this purpose.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61582 0
Mrs Mary Miller
Address 61582 0
Massey University Auckland
Private Bag 102904
North Shore Mail Centre
Auckland
0745
New Zealand
Country 61582 0
New Zealand
Phone 61582 0
+6421783283
Fax 61582 0
Email 61582 0
[email protected]
Contact person for public queries
Name 61583 0
Mrs Mary Miller
Address 61583 0
Centre for Psychology
Massey University Auckland
Private Bag 102904
North Shore Mail Centre
Auckland
0745
New Zealand
Country 61583 0
New Zealand
Phone 61583 0
+64 9 4418175
Fax 61583 0
Email 61583 0
[email protected]
Contact person for scientific queries
Name 61584 0
Mrs Mary Miller
Address 61584 0
Centre for Psychology
Massey University Auckland
Private Bag 102904
North Shore Mail Centre
Auckland
0745
New Zealand
Country 61584 0
New Zealand
Phone 61584 0
+64 9 4418175
Fax 61584 0
Email 61584 0
[email protected]

No information has been provided regarding IPD availability


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.