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Trial registered on ANZCTR


Registration number
ACTRN12613000849796
Ethics application status
Approved
Date submitted
24/07/2013
Date registered
1/08/2013
Date last updated
2/11/2018
Date data sharing statement initially provided
2/11/2018
Date results information initially provided
2/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Test of a new, technology-assisted motivational intervention for substance misuse in early psychosis.
Scientific title
A pilot test of Functional Imagery Training (FIT) as a motivational intervention to reduce cannabis use in young people with early episode psychosis.
Secondary ID [1] 282898 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cannabis Use Disorder 289713 0
Schizophrenia Spectrum and Other Psychotic Disorders 289715 0
Condition category
Condition code
Mental Health 290035 290035 0 0
Addiction
Mental Health 290039 290039 0 0
Schizophrenia
Mental Health 290091 290091 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The current study aims to test the effectiveness of a newly developed, technology-assisted, motivational intervention in a sample of consumers with early psychosis (within first 3 episodes and first 3 years) and co-occuring cannabis use. The study objectives are to:

1. Deliver the Functional Imagery Training (FIT) intervention to 20 young adults aged 16-25 years who are experiencing early episode psychosis and using cannabis;
2. Qualitatively explore participants' experiences of the treatment and solicit suggestions for enhancement of the intervention.

Functional Imagery Training (FIT) implements theoretical and empirical advances in our understanding of motivation, and how it is maintained. It retains the spirit and typical elements of motivational interviewing, but employs imagery throughout face-to-face sessions, and uses a smartphone to cue both functional motivations and related behaviours in the natural environment. Personal pictorial libraries are stored on the phone to cue imagery and functional motivations ('What will get better'), plans for risk situations ('What I'll do') and personal achievements ('My successes'). Expected benefits of control focus on proximal, probable and highly valued outcomes - features that maximise impact and are easily imagined. Plans for risky situations include fun activities that are inconsistent with cannabis use, and activities that demand concentration (to reduce craving imagery). Consumers nominate risky times when they want to receive self-generated messages or pictorial icons to help maintain control. Ideas of the personal libraries at the initial session may not match what actually occurs, so consumers add images and short videos to remind them of actual positive changes, effective plans and relevant successes. Daily personal experiences are captured and tagged for use in the libraries. Consumers augment the affective impact of experienced benefits by projecting them into the future and develop alternate imaginal 'TV adds' to keep them fresh.

The FIT intervention comprises two face-to-face treatment sessions of 1 hour duration, held one week apart. Sessions combine motivational interviewing with use of imagery to identify reasons for cannabis reduction, possible goals and strategies, and build confidence. Imagery involves creation of multisensory mental pictures relating to the goal, reasons for change and success with similar goals in the past. Session 2 concludes with instruction in how their smartphone can be used to assist them to use the intervention techniques in their everyday life. Treatment support phone calls of 10-15 minutes occur in weeks 3, 4, 8 and 12. In view of difficulties with appointment-keeping in this group, after initial sessions, FIT is delivered by phone. Support calls reinforce goal comittment and problem-solve difficulties.

It is hypothesised that participants will report significantly fewer occcassions of cannabis use in the 3 months following treatment compared to the 3 months before treatment, as well as a reduction in psychotic symptom severity and improvement in overall quality of life.
Intervention code [1] 287598 0
Behaviour
Intervention code [2] 287599 0
Treatment: Other
Comparator / control treatment
Nil (Pilot Study)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290087 0
Significantly fewer occassions of cannabis use in the 3 months following treatment compared to the 3 months before treatment, as measured by a Timeline Follow-Back (TLFB). This is the most widely used calendar-based method for collecting estimates of drug use. The TLFB uses a calendar and other memory aids (e.g., birthdays, holidays, special events) to gather retrospective estimates of an individual's daily substance use over a specified period of time.
Timepoint [1] 290087 0
At baseline assessment, 13 weeks after baseline.
Primary outcome [2] 290088 0
Significantly lower score on the Severity of Dependence Scale (SDS). The SDS is a 5-item questionnaire that provides a total score indicating the severity of dependence on a particular substance. The higher the score, the higher the level of dependence.
Timepoint [2] 290088 0
At baseline assessment, 13 weeks after baseline.
Primary outcome [3] 290089 0
Significantly lower score on the DrugCheck Problem List. The DrugCheck Problem List is a 12-item screening instrument for substance-related comorbidity and impact of substance use on functioning (e.g., physical, psychosocial). The higher the score, the greater the level of dysfunction caused by the substance.
Timepoint [3] 290089 0
At baseline assessment, 13 weeks after baseline.
Secondary outcome [1] 303919 0
Reduced score on the Brief Psychiatric Rating Scale (BPRS). Persons having or suspected of having schizophrenia or other psychotic disorders manifest the disorder in multiple ways. The BPRS assesses the level of 18 symptom constructs such as hostility, suspiciousness, hallucination, and grandiosity. It is particularly useful in gauging the efficacy of treatment in consumers who have moderate to severe psychoses. It is based on the clinician's interview with the consumer and observations of the consumer's behaviour.
Timepoint [1] 303919 0
At baseline assessment, 13 weeks after baseline.
Secondary outcome [2] 303920 0
Higher score on the Assessment of Quality of Life - 8 Dimensions (AQoL-8D). The AQoL-8D consists of 8 separately scored dimensions that assess health-related quality of life. The AQoL-8D provides a global 'utility' score, and the higher the score the greater the quality of life.
Timepoint [2] 303920 0
At baseline assessment, 13 weeks after baseline.
Secondary outcome [3] 303921 0
Higher score on the Global Assessment of Functioning (GAF). The GAF is a numeric scale (0 through 100) used by mental health clinicians to rate subjectively the social, occupational and physiological functioning of adults.
Timepoint [3] 303921 0
At baseline assessment, 13 weeks after baseline.
Secondary outcome [4] 303922 0
Higher score on the Goal Motivation Scale (GMS). The GMS is designed to assess a person's level of motivation towards achieving a particular goal.
Timepoint [4] 303922 0
At baseline assessment, 4 weeks after baseline.

Eligibility
Key inclusion criteria
Key inclusion criteria are as follows:

1. Aged 16 to 25 years;
2. Current episode of a DSM-5 psychotic disorder;
3. No more than 2 prior episodes of psychosis, and within 3 years of initial episode;
4. At least 28 days of cannabis use in the previous 3 months as assessed by a Timeline Follow-Back;
5. Score of at least 1 on the DrugCheck Problem List for cannabis use;
6. Access to a smartphone capable of taking and storing photos, and of setting calendar tasks and reminders;
7. Sufficient English to give informed consent and to participate in the study without translation (assessed based on observation).
Minimum age
16 Years
Maximum age
25 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Key exclusion criteria are as follows:

1. Scoring greater than 0 on the DrugCheck Problem List for substances other than cannabis (excluding nicotine and caffeine);
2. Injected use of any drug in the previous 4 weeks (excluding prescribed anti-psychotic medication);
3. Presence of permanent cognitive impairment that would impair ability to give informed consent (such as brain injury or intellectual ability - assessement based on observation and knowledge of consumer).

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



Intervention assignment
Single group
Other design features
Nil.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)
QLD
Recruitment postcode(s) [1] 24573 0
4109 - Macgregor
Recruitment postcode(s) [2] 24574 0
4102 - Dutton Park

Funding & Sponsors
Funding source category [1] 287676 0
University
Name [1] 287676 0
Queensland University of Technology
Institute of Health and Biomedical Innovation
Centre for Youth Substance Abuse Research (CYSAR)
Address [1] 287676 0
CYSAR K Floor
Mental Health Centre
Royal Brisbane and Women's Hospital
Herston, QLD 4029
Country [1] 287676 0
Australia
Primary sponsor type
Individual
Name
Prof David Kavanagh
Address
Institute of Health and Biomedical Innovation
GPO Box 2434
Brisbane, QLD 4001
Country
Australia
Secondary sponsor category [1] 286411 0
Individual
Name [1] 286411 0
Dr Frances Dark
Address [1] 286411 0
Early Psychosis Team
Princess Alexandra Hospital
519 Kessels Road
Macgregor, QLD 4109
Country [1] 286411 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289639 0
Metro South Human Research Ethics Committee (EC00167)
Ethics committee address [1] 289639 0
Centres for Health Research
Level 7 TRI
37 Kent Street
Woollongabba, QLD 4102
Ethics committee country [1] 289639 0
Australia
Date submitted for ethics approval [1] 289639 0
15/07/2013
Approval date [1] 289639 0
18/09/2013
Ethics approval number [1] 289639 0
HREC/13/QPAH/418

Summary
Brief summary
A lifetime diagnosis of substance use disorder is seen in 40% of Australians with psychosis, and has substantial symptomatic and functional impacts. Both problems have detrimental effects on motivation, hindering treatment gains. A newly developed intervention, Functional Imagery Training (FIT), uses individually tailored imagery (multisensory mental 'pictures') to consolidate motivation, rehearse coping strategies and enhance confidence. Personal smartphones are used to assist in use of imagery and to set reminders, while the OnTrack Get Real Internet program supports self-management of psychotic symptoms. The current study aims to:

1. Examine the effectiveness of FIT with 20 young adults aged 16-25 years who are experiencing early episode psychosis and using cannabis;
2. Qualitatively explore participants' experiences of the treatment and solicit suggestions for enhancement of the intervention.

Participants are recruited from the Early Psychosis Team, Princess Alexandra Hospital. Case managers obtain verbal consent from the consumer to pass on their details to the research team. If the consumer is less than 18 years of age and has a parent/guardian involved in their care, staff also obtain consent from the parent/guardian. The research team contact the consumer to provide more information about the study, and to make an appointment for the baseline assessment.

The baseline assessment lasts up to 60 minutes and includes questions about cannabise use, psychiatric history and symptoms, and quality of life. The FIT intervention commences one week later and comprises two face-to-face treatment sessions of 1 hour duration, held one week apart. Sessions combine motivational interviewing with the use of imagery to identify reasons for cannabis reduction, possible goals and strategies, and to build confidence. Imagery involves creation of multisensory mental pictures relating to the goal, reasons for change and success with similar goals in the past. Session 2 concludes with instruction in how their smartphone can be used to assist them to use the intervention techniques in their everyday life. Treatment support phone calls of 10-15 minutes occur in weeks 3, 4, 8 and 12 after baseline. Support calls reinforce goal committment and problem-solve difficulties. Cannabis use and goal motivation are also assessed in the 4 week call. A follow-up interview of 60 minutes duration occurs 13 weeks post-baseline and assesses cannabis use, psychiatric symptoms, quality of life, and experiences of the treatment.

Throughout FIT, participants remain engaged with routine care and are encouraged to use the OnTrack Get Real Internet program for assistance with their psychiatric symptoms.
Trial website
Nil.
Trial related presentations / publications
Nil.
Public notes
Nil.

Contacts
Principal investigator
Name 41710 0
Prof David Kavanagh
Address 41710 0
Centre for Children's Health Research, Queensland University of Technology, 62 Graham St, South Brisbane, QLD, 4101
Country 41710 0
Australia
Phone 41710 0
+61 7 3069 7327
Fax 41710 0
Email 41710 0
david.kavanagh@qut.edu.au
Contact person for public queries
Name 41711 0
Prof David Kavanagh
Address 41711 0
Centre for Children's Health Research, Queensland University of Technology, 62 Graham St, South Brisbane, QLD, 4101
Country 41711 0
Australia
Phone 41711 0
+61 7 3069 7327
Fax 41711 0
Email 41711 0
david.kavanagh@qut.edu.au
Contact person for scientific queries
Name 41712 0
Prof David Kavanagh
Address 41712 0
Centre for Children's Health Research, Queensland University of Technology, 62 Graham St, South Brisbane, QLD, 4101
Country 41712 0
Australia
Phone 41712 0
+61 7 3069 7327
Fax 41712 0
Email 41712 0
david.kavanagh@qut.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The sample size was so small and the recruitment location so specific sharing of data could inadvertently reveal participant identities.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
Only 4 participants took part in the intervention and completed follow-up assessments. One reported no current cannabis use at any assessment. The remaining participants reported a decrease in standard cannabis units (.25gms cannabis) consumed from Baseline to Post (57% to 68% reduction across participants), which was maintained at Follow-up (67% to 69% reduction across participants). Cannabis-using days over the previous 2 weeks also decreased from Baseline to Post and Follow-up.