None listed
Conditions
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 12 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.
Interventions
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
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.
Sponsors
Orygen
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
12 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
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 standard drinks on greater than or equal to 1 occasion in the past month); OR Self-reported, clinically-relevant binge alcohol use (i.e. at least 4 standard drinks on at least one occasion) in the past 3 months, which resulted in clear potential for harm or high-risk behaviour (i.e. blackouts, hospital attendance, driving while intoxicated); Treatment with either a stable dose of an antidepressant or no antidepressant greater than or equal to 2 weeks at screening; Sufficient English fluency to complete treatment and participate in the study; Ability to provide written informed consent – where the participant is under 18 years of age, a parent or guardian will also be required to provide written informed consent or the young person will consent as a mature minor.
Exclusion criteria
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 assessment; 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.
Outcome results
None listed