INTEGRATE
ACTRN12619001522101
Treatment
Not Applicable
Charities/Societies/Foundations,Gandel Philanthropy
Dr Gillinder Bedi
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 12 months. The primary hypothesis is .... Read more
Aged 12-25 years inclusive; Seeking treatment at headspace for mental ill-health; At screening, either: Self-reported use during the past month of greater than or equal to 4x use of cannabis or alcohol, greater than or equal to 1x 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 >4 standar .... Read more
Lifetime DSM-V diagnosis of a psychotic or bipolar disorder (assessed using structured clinical interview; SCID-5) OR current DSM-V diagnosis of either post-traumatic stress disorder, obsessive compulsive disorder, or an eating disorder for which the young person is seeking treatment; Currently in AOD specific treatment, or open to referral to AOD treatment at headspace; Current treatment with antipsychotic medication or mood stabiliser Acute suicidality at screening, determined by clinical risk .... Read more
No
Sample Size 71
Min. age 12 Years
Max. age 25 Years
Sex Both males and females
Condition category Mental Health
Condition code Mental Health
Intervention code Behaviour , Lifestyle , Treatment: Other
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 f .... Read more
Control group Active
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.
Outcome: 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: 16 weeks.
yes
All data, anonymised.
Data are currently embargoed. They will be available after the main results have been published for an indefinite time.
Data will potentially be available to researchers from not-for profit organisations, commercial organisations or other based in any location. All data requests will be considered by the data custodian and the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. For further information, see Orygen data management policy
To any type of analyses. Assessed on a case-by-case basis