INTEGRATE: An integrated treatment for young people with psychological distress.

INTERVENTION: 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 CONDITION: Mental Health ‐ Other mental health disorders Mental Health; ; Mental Health PRIMARY 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).[16 weeks.] 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. SECONDARY OUTCOME: Change from baseline in past month average frequency of alcohol consumed (TLFB) at 4, 6, 12, and 18 months.[4, 6, 12, and 18 months.] Change from baseline in past month average frequency of cannabis consumed (TLFB) at 4, 6, 12, and 18 months; [4, 6, 12, and 18 months.] Change from baseline in past month average quantity of alcohol consumed (TLFB) at 4, 6, 12, and 18 months.[4, 6, 12, and 18 months] Change from baseline in past month average quantity of cannabis consumed (TLFB) at 4, 6, 12, and 18 months; [4, 6, 12, and 18 months] Change in anxiety between baseline and 4, 6, 12, and 18 months – using the Generalized Anxiety Disorder Scale (GAD‐7).[4, 6, 12, and 18 months.] Change in anxiety between baseline and 4, 6, 12, and 18 months – using the Overall Anxiety Severity and Impairment Scale (OASIS);[4, 6, 12, and 18 months] 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[4, 6, 12, and 18 months] Change in past month TLFB days of AOD use at 6, 12, and 18 months compared with baseline[6, 12, and 18 months] Change in psychological distress between baseline and 4, 6, 12, and 18 months – using the Kessler‐10 Psychological Distress Scale (K‐10).[4, 6, 12, and 18 months.] Change in quality of life between baseline and 4, 6, 12, and 18 months – using the Assessment of Quality of Life (AQoL‐8D).[4, 6, 12, and 18 months] Change in self‐reported depression symptoms at 4, 6, 12, and 18 months relative to baseline ‐ self‐rated Quick Inventory of Depression Symptomatology (QIDS).[4, 6, 12, and 18 months.] Change in social and occupational function between baseline and 4, 6, 12, and 18 months – using the Global Functioning Social and Role Scale[4, 6, 12, and 18 months] Change in social and occupational function between baseline and 4, 6, 12, and 18 months – using the Social and Occupational Functioning Scale (SOFAS) [4, 6, 12, and 18 months.] Change in suicidality between baseline and 4, 6, 12, and 18 months – using the Suicidal Ideation Screen (SIS).[ 4, 6, 12, and 18 months.] New diagnoses of Substance Use Disorders at 6, 12, and 18 months, assessed using the SCID‐V.[6, 12, and 18 months.] Participant‐rated response to treatment – defined as a Patient Global Impression – Improvement (PGI‐I) score of less than or equal to 2 (“muchâ€? or “very muchâ€? improved) at week 16.[16 weeks.] Per cent positive biochemical AOD tests (breathalyser) at 4, 6, 12, and 18 months.[4, 6, 12, and 18 months.] Per cent positive biochemical AOD tests (urine analysis) at 4, 6, 12, and 18 months.[4, 6, 12, and 18 months.] Researcher‐rated response to treatment – defined as a Clinical Global Impression–Improvement (CGI‐I) score of less than or equal to 2 (“muchâ€? or “very muchâ€? improved) at week 16.[16 weeks.] Treatment retention (number of sessions completed during 4 months and 12 months), determined from case notes.[4 months and 12 months.]