FullFix: A pilot trial of a telephone delivered transdiagnostic intervention for comorbid substance and mental health problems in young people

Not Applicable

Active, not recruiting

• Conditions: Alcohol use; Mental Health - Depression; Substance Use; Mental Health - Anxiety; Mental Health - Addiction; Mental Health - Studies of normal psychology, cognitive function and behaviour

• Registration Number: ACTRN12618001563257
• Lead Sponsor: The University of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-19
• Last Update Posted: 14 June 2021

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Aged 16-25 years;
- Participants seeking help for their AOD use from participating Lives Lived Well Services;
- Alcohol, Smoking and Substance Involvement Screening Test (ASSIST): above moderate severity for alcohol use or illicit drug use, and screening measures score above moderate severity for depression (Patient Health Questionnaire – 9 [PHQ9]) or anxiety (Generalized Anxiety Disorder 7-item);
- Access to phone technology.

Exclusion Criteria

- Current serious medical problem or traumatic injury;
- Not fluent in spoken or written English;
- Unmodified hearing impairment;
- Current high suicide risk (current intent and plan);
- Current or history of psychosis in past 12 months;
- History of traumatic brain injury or organic brain disease;
- Currently in acute alcohol or drug withdrawal

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
evel of substance use and related problems through a composite score on the Alcohol, Smoking and Substances Involvement Screening Test (WHO ASSIST)[Baseline and 1, 2 (primary endpoint), 6, and 12 months post-baseline];Depression symptom severity, measured using the Patient Health Questionnaire (PHQ-9)[Baseline and 1, 2 (primary endpoint), 6, and 12 months post-baseline];Anxiety severity, measured using the Generalized Anxiety Disorder scale (GAD-7)[Baseline, and 1, 2 (primary endpoint), 6, and 12 months post baseline]

Secondary Outcome Measures

Name	Time	Method
Work and Social Adjustment: Measured using the Work and Social Adjustment Scale (WSAS; Mundt, Marks, Shear, & Greist, 2002)[Baseline, and 1, 2, 6, and 12 months post baseline];Quality of Life: 8 item EUROHIS-QOL (Schmidt, Mühlan, & Power, 2005)[Baseline, and 1, 2, 6, and 12 months post baseline];Self Efficacy: Controlled Drug Self-Efficacy Scale, adapted from the Controlled Drinking Self-Efficacy Scale (CDSE; Sitharthan, Soames, Kavanagh, Sitharthan, & Hough, 2003)[Baseline, and 1, 2, 6, and 12 months post baseline];Composite score of frequency/quantity for Use of Primary and Secondary Drug in the past month using the Opiod Treatment Index (OTI) - Primary outcome.[Baseline, and 1, 2 (primary endpoint), 6, and 12 months post baseline];Mental health and wellbeing: Measured on the 14-item version of the Mental Health Continuum – Short Form (MHC-SF; Keyes, 2005)[Baseline and 1, 2, 6, and 12 months post baseline]