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Trial registered on ANZCTR


Registration number
ACTRN12619001522101
Ethics application status
Approved
Date submitted
23/10/2019
Date registered
4/11/2019
Date last updated
22/04/2020
Date data sharing statement initially provided
4/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
INTEGRATE: An integrated treatment for young people with psychological distress.
Scientific title
INTEGRATE: An integrated treatment to decrease psychological distress and substance use in young people seeking help for emerging mental illness.
Secondary ID [1] 298707 0
None
Universal Trial Number (UTN)
Trial acronym
INTEGRATE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health 313613 0
Condition category
Condition code
Mental Health 312046 312046 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The INTEGRATE intervention is a novel, integrated, manualised psychological treatment delivered over up to 10 sessions over a period of up to 16 weeks. Per protocol treatment is defined as completion of at least 5 sessions of INTEGRATE psychotherapy. Sessions occur approximately every 1-2 weeks. Participants receiving INTEGRATE will receive 10 sessions unless they discontinue treatment earlier or reach 16 weeks without completing 10 sessions. The INTEGRATE manual has been designed specifically for this study.

Each treatment session will be delivered by a trained INTEGRATE allied health clinician, and will last approximately 45-50 minutes. The INTEGRATE intervention is based on a specifically designed manual, which comprises of a number of treatment modules. Treatment modules are targeted at psychological vulnerabilities that may increase risk for a range of mental health concerns, such as anxiety and depression, in addition to substance use disorders. The INTEGRATE intervention includes sessions targeting personality vulnerabilities, behavioural vulnerabilities, decision-making vulnerabilities, lifestyle vulnerabilities, and harm minimisation and psycho-education related to drug and alcohol use. In addition to these modules, the intervention provides for two flexible sessions, that can be used according to the clinician's judgement, and two Cognitive Behavioural Therapy (CBT) sessions in which standard evidence-based CBT methods such as psycho-education about the cognitive model, thought monitoring, cognitive restructuring, and behavioural interventions such as activity scheduling and structured exposure will be employed to address the young person’s primary presenting psychiatric symptoms.

After each treatment session the study clinicians will be required to complete a treatment fidelity record which will record length of session, content covered in the session and any other relevant session details. This information will be used to assess treatment fidelity in addition to treatment compliance. Treatment sessions will also be audio recorded in order to assess fidelity and compliance. A proportion of these sessions will be listened to and coded by the treatment trainer during the study, and at the conclusion of the study to assess for fidelity. All study treatment recordings will be saved on the secure Orygen server in the research database. Only authorised personnel will have access to these recordings.
Intervention code [1] 314977 0
Treatment: Other
Intervention code [2] 314978 0
Behaviour
Intervention code [3] 314980 0
Lifestyle
Comparator / control treatment
Participants Treatment as Usual (TAU), in which they will be allocated to a headspace Allied Health Professional (AHP) for up to 10 sessions of psychotherapy, funded by Medicare. For the purpose of this study, we will request treating AHPs to complete, at the end of each session, a single page checklist of the psychological interventions employed in that session.
Control group
Active

Outcomes
Primary outcome [1] 320689 0
Change in past month self reported days of alcohol or other drug (AOD) use at 16 weeks compared with baseline, using the Timeline Follow Back (TLFB).
Timepoint [1] 320689 0
16 weeks.
Secondary outcome [1] 372518 0
Change in past month TLFB days of AOD use at 6, 12, and 18 months compared with baseline
Timepoint [1] 372518 0
6, 12, and 18 months
Secondary outcome [2] 372519 0
Change in highest Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) risk score (i.e. problematic use of most problematic drug class) at 4, 6, 12, and 18 months compared with baseline
Timepoint [2] 372519 0
4, 6, 12, and 18 months
Secondary outcome [3] 372520 0
Change from baseline in past month average frequency of alcohol consumed (TLFB) at 4, 6, 12, and 18 months.
Timepoint [3] 372520 0
4, 6, 12, and 18 months.
Secondary outcome [4] 372521 0
Change from baseline in past month average frequency of cannabis consumed (TLFB) at 4, 6, 12, and 18 months;
Timepoint [4] 372521 0
4, 6, 12, and 18 months.
Secondary outcome [5] 372522 0
Per cent positive biochemical AOD tests (urine analysis) at 4, 6, 12, and 18 months.
Timepoint [5] 372522 0
4, 6, 12, and 18 months.
Secondary outcome [6] 372523 0
Treatment retention (number of sessions completed during 4 months and 12 months), determined from case notes.
Timepoint [6] 372523 0
4 months and 12 months.
Secondary outcome [7] 372524 0
New diagnoses of Substance Use Disorders at 6, 12, and 18 months, assessed using the SCID-V.
Timepoint [7] 372524 0
6, 12, and 18 months.
Secondary outcome [8] 372525 0
Change in self-reported depression symptoms at 4, 6, 12, and 18 months relative to baseline - self-rated Quick Inventory of Depression Symptomatology (QIDS).
Timepoint [8] 372525 0
4, 6, 12, and 18 months.
Secondary outcome [9] 372526 0
Change in suicidality between baseline and 4, 6, 12, and 18 months – using the Suicidal Ideation Screen (SIS).
Timepoint [9] 372526 0
4, 6, 12, and 18 months.
Secondary outcome [10] 372527 0
Change in psychological distress between baseline and 4, 6, 12, and 18 months – using the Kessler-10 Psychological Distress Scale (K-10).
Timepoint [10] 372527 0
4, 6, 12, and 18 months.
Secondary outcome [11] 372528 0
Change in anxiety between baseline and 4, 6, 12, and 18 months – using the Generalized Anxiety Disorder Scale (GAD-7).
Timepoint [11] 372528 0
4, 6, 12, and 18 months.
Secondary outcome [12] 372529 0
Researcher-rated response to treatment – defined as a Clinical Global Impression–Improvement (CGI-I) score of less than or equal to 2 (“much” or “very much” improved) at week 16.
Timepoint [12] 372529 0
16 weeks.
Secondary outcome [13] 372530 0
Participant-rated response to treatment – defined as a Patient Global Impression – Improvement (PGI-I) score of less than or equal to 2 (“much” or “very much” improved) at week 16.
Timepoint [13] 372530 0
16 weeks.
Secondary outcome [14] 372531 0
Change in quality of life between baseline and 4, 6, 12, and 18 months – using the Assessment of Quality of Life (AQoL-8D).
Timepoint [14] 372531 0
4, 6, 12, and 18 months
Secondary outcome [15] 372532 0
Change in social and occupational function between baseline and 4, 6, 12, and 18 months – using the Social and Occupational Functioning Scale (SOFAS)
Timepoint [15] 372532 0
4, 6, 12, and 18 months.
Secondary outcome [16] 376421 0
Change in anxiety between baseline and 4, 6, 12, and 18 months – using the Overall Anxiety Severity and Impairment Scale (OASIS);
Timepoint [16] 376421 0
4, 6, 12, and 18 months
Secondary outcome [17] 376422 0
Change from baseline in past month average quantity of alcohol consumed (TLFB) at 4, 6, 12, and 18 months.
Timepoint [17] 376422 0
4, 6, 12, and 18 months
Secondary outcome [18] 376423 0
Change from baseline in past month average quantity of cannabis consumed (TLFB) at 4, 6, 12, and 18 months;
Timepoint [18] 376423 0
4, 6, 12, and 18 months
Secondary outcome [19] 376424 0
Per cent positive biochemical AOD tests (breathalyser) at 4, 6, 12, and 18 months.
Timepoint [19] 376424 0
4, 6, 12, and 18 months.
Secondary outcome [20] 376425 0
Change in social and occupational function between baseline and 4, 6, 12, and 18 months – using the Global Functioning Social and Role Scale
Timepoint [20] 376425 0
4, 6, 12, and 18 months

Eligibility
Key inclusion criteria
Aged 12-25 years inclusive;
Stage 1a or 1b mental illness assessed using structured clinical interview (Structured Clinical Interview for DSM-V; SCID-5);
At screening, self-reported use during the past month of at least 4 occasions of use of cannabis or alcohol or at least one occasion of use of another illicit drug (e.g. methamphetamine, ecstasy, cocaine etc.), assessed using the Timeline Follow-back (TLFB; participants using alcohol only will be required to have consumed in excess of Australian National Guidelines for Alcohol Consumption of greater than 4 standard drinks on at least 1 occasion in the past month);
Treatment with either a stable dose of an antidepressant or no antidepressant for at least 2 weeks at screening;
Sufficient English fluency to complete treatment and participate in the study;
Ability to provide written informed consent.
Minimum age
12 Years
Maximum age
25 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Stage 2 and higher mental illness assessed via SCID-5 interview and SOFAs ratings.
Currently in AOD specific treatment, or open to referral to AOD treatment at headspace;
Current treatment with antipsychotic medication, mood stabiliser or ADHD medication;
Acute suicidality at screening, as indicated by a SIS raw score of at least 12.
Participation in another trial, which is likely to affect data for this study, determined by the Investigator.
Intellectual disability, as indicated by estimated or documented IQ of 70 or less.

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)
After the baseline assessment has been completed, the participant will be randomised to one of the two treatment groups. A randomisation list has been generated by an independent, blinded statistician and passed onto the electronic database technician/designer. Therefore, allocation concealment is performed via central randomisation by a computer, which will then be inputted into the eCRF by the technician. Upon randomisation, an email will be sent directly to the unblinded study Project Managers, specifying whether the participant should be allocated to the INTEGRATE treatment, or Treatment as Usual. Participants will be randomised sequentially on a 1:1 basis as they become eligible for randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomisation sequence with blocks will be implemented in a web-based system.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
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
Recruitment postcode(s) [1] 27198 0
3030 - Werribee
Recruitment postcode(s) [2] 27199 0
3020 - Sunshine
Recruitment postcode(s) [3] 27200 0
3046 - Glenroy
Recruitment postcode(s) [4] 27201 0
3064 - Craigieburn

Funding & Sponsors
Funding source category [1] 303260 0
Charities/Societies/Foundations
Name [1] 303260 0
Gandel Philanthropy
Address [1] 303260 0
Gandel Philanthropy
Level 9, Office Tower One, Chadstone Place
1341 Dandenong Road
PO Box 204
Chadstone Vic 3148
Country [1] 303260 0
Australia
Primary sponsor type
Other
Name
Orygen
Address
35 Poplar Rd
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 303268 0
None
Name [1] 303268 0
Address [1] 303268 0
Country [1] 303268 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303798 0
University of Melbourne Psychology Health & Applied Sciences HESC
Ethics committee address [1] 303798 0
Alan Gilbert Building,
Level 5, The University of Melbourne,
161 Barry Street,
Victoria 3010 Australia
Ethics committee country [1] 303798 0
Australia
Date submitted for ethics approval [1] 303798 0
28/03/2019
Approval date [1] 303798 0
25/06/2019
Ethics approval number [1] 303798 0
1953554

Summary
Brief summary
The aim of the study is to test whether a new integrated psychological treatment (INTEGRATE) improves mental health difficulties and decreases the risk of problematic substance use in young people, compared with usual treatment.

Young people between the ages of 12 and 25 (inclusive) will be randomised to receive either i) the INTEGRATE therapy, or ii) treatment as usual (TAU), for 16 weeks in a double-blind, randomised controlled trial (RCT), with followup to 18 months.

The primary hypothesis is that young people who are randomised to receive the INTEGRATE intervention will decrease their alcohol and other drug use compared to participants in the TAU group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94846 0
Dr Gillinder Bedi
Address 94846 0
Orygen
35 Poplar Road
Parkville VIC 3052
Country 94846 0
Australia
Phone 94846 0
+61 3 9966 9435
Fax 94846 0
Email 94846 0
gill.bedi@orygen.org.au
Contact person for public queries
Name 94847 0
Ms Shelley Baird
Address 94847 0
Orygen
35 Poplar Road
Parkville VIC 3052
Country 94847 0
Australia
Phone 94847 0
+61 1300 679 436
Fax 94847 0
Email 94847 0
Shelley.Baird@orygen.org.au
Contact person for scientific queries
Name 94848 0
Dr Gillinder Bedi
Address 94848 0
Orygen
35 Poplar Road
Parkville VIC 3052
Country 94848 0
Australia
Phone 94848 0
+61 1300 679 436
Fax 94848 0
Email 94848 0
gill.bedi@orygen.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data collected include sensitive information. For this reason, we do not have ethical approval to make IPD data available.
What supporting documents are/will be available?
No other documents available
Summary results
No Results