Data

INTEGRATE: An integrated treatment to decrease psychological distress and substance use in young people seeking help for emerging mental illness.

Orygen

Dataset description

This dataset includes information from a randomized controlled trial evaluating the efficacy of the INTEGRATE intervention, a manualized psychological treatment aimed at reducing mental health difficulties and substance use in young people aged 12-25. The dataset captures details on treatment session attendance, content covered, session length, and treatment fidelity for participants receiving up to 10 sessions of INTEGRATE therapy over 16 weeks. It also includes data on the control group, who received treatment as usual (TAU), with psychological interventions recorded by clinicians. The primary outcomes measured are changes in alcohol and drug use between the INTEGRATE and TAU groups.
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Subjects

FOR: Mental Health |

Source Study

Trial acronym

INTEGRATE

Trial ID

ACTRN12619001522101

Purpose

Treatment

Phase

Not Applicable

Funding

Charities/Societies/Foundations,Gandel Philanthropy

Scientific enquiries

Dr Gillinder Bedi

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 ....
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Key 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 standar ....
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Key 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 ....
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Can healthy volunteers participate?

No

 

Population

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

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 ....
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Comparison

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.

Outcomes

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.

Study Protocol: Not Available
Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?

yes

What data in particular will be shared?

All data, anonymised.

When will data be available?

Data are currently embargoed. They will be available after the main results have been published for an indefinite time.

Available to whom?

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

Available for what types of analyses?

To any type of analyses. Assessed on a case-by-case basis

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au