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Trial registered on ANZCTR


Registration number
ACTRN12619000559112
Ethics application status
Approved
Date submitted
13/08/2018
Date registered
10/04/2019
Date last updated
12/03/2020
Date data sharing statement initially provided
10/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of a brief versus extended telephone delivered intervention for hazardous alcohol use among young people living with severe mental ill-health
Scientific title
Pilot randomised controlled trial of two telephone delivered interventions for hazardous alcohol use among young people living with severe mental ill-health
Secondary ID [1] 295792 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hazardous alcohol use
 309223 0
psychosis 309225 0
schizophrenia 309226 0
alcohol use in young people with severe mental ill-health 309235 0
Condition category
Condition code
Mental Health 308097 308097 0 0
Addiction
Mental Health 308098 308098 0 0
Schizophrenia
Mental Health 308099 308099 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This pilot randomised controlled trial (RCT) will compare a 10 session telephone delivered Transdiagnostic CBT (TrCBT) intervention for hazardous alcohol use among young people with SMI with a 2 session telephone brief intervention (QuikFix) comparator treatment. The intervention will be delivered by endorsed clinical psychologists and provisionally registered psychologists.

Transdiagnostic CBT (TrCBT): Participants will receive the same first two sessions as those in the QuikFix condition (see comparator treatment). In addition, participants will be offered the opportunity to continue to have up to six further telephone sessions. These sessions will be weekly and approximately 30 minutes in duration. Session material is based on principles of metacognitive therapy for emotional disorder (Wells, 2000) and metacognitive formulation of problem drinking (Spada, Caselli & Wells, 2013). Email summaries of specific skills learnt in session will be sent to participants at the completion of a session. A brief text message will be sent between the participant’s sessions to promote skills rehearsal, monitoring of health behaviours and maintain contact with the participant.

Participants in the TrCBT condition are also offered the opportunity for a significant other or family member to access two phone sessions of support which involve orienting the person to coping skills and referral to potential helpful resources. These sessions will be provided by a different psychologist to the one allocated to provide treatment to the associated young person. The first family support session will be 60 mins in duration and the second approximately 30 minutes. Sessions will be conducted a week apart and based on the 5-step method (Copello et al, 2010) which aims to assist family members supporting those with substance misuse issues and help them identify and access appropriate coping strategies and personal support mechanisms.
Intervention code [1] 312123 0
Behaviour
Intervention code [2] 312124 0
Treatment: Other
Comparator / control treatment
Brief Risk-Targeted QuikFix Intervention (Hides, Wilson, Quinn & Sanders, 2016) : The Brief Risk-Targeted QuikFix Intervention incorporates psychological risk-targeted assessment and feedback, motivational interviewing, and cognitive-behavioural coping skills training components.
In Session 1, the participant is given personalised assessment feedback, which not only includes a focus on alcohol or other drug (AOD) use, but also includes psychoeducation about their dominant psychological risk factor (anxiety proneness, depression proneness, impulsivity, or sensation seeking), associated problematic coping behaviors (e.g. avoidance, aggression, risky behaviours), and how this may affect their AOD use. Participants are given information on AOD harm minimization strategies. The intervention encourages them to develop implementation intentions, a technique based on the Theory of Planned Behaviour. For homework, they are encouraged to implement their AOD use plan, and are emailed a session summary and a brief SMS message as a reminder.

In Session 2, the young person’s success in implementing their AOD use plan is reviewed and if necessary, the plan is revised. They then receive risk-targeted training in two cognitive behavioural coping skills. Session 2 concludes with participants developing an implementation intention for future AOD-related situations, which incorporates their specific coping skills. They are encouraged to rehearse this plan in session, and identify and address potential impediments. A session summary of their alcohol use plan is subsequently sent via email. Finally, the clinician then makes two brief phone calls (maximum 30 minutes) at 2 months post-baseline to check in with the young person and remind them of session content. The two check-in sessions are designed to be delivered over a period of two weeks, however, the sessions can be delivered over a maximum of four weeks.
Control group
Active

Outcomes
Primary outcome [1] 307076 0
Acceptability of intervention will be measured by semi-structured interviews and the Client Satisfaction Questionnaire - 8 (CSQ-8)
Timepoint [1] 307076 0
All participants will complete the CSQ-8 at the completion of the intervention. Interviews will be held with a sub-sample of participants in the four weeks following a participant's completion of the intervention.
Primary outcome [2] 307077 0
Feasibility of treatment will be measured by recruitment rate and rate of attrition
Timepoint [2] 307077 0
Data will be collected on number of participants recruited in the recruitment phase and number of participants who completed treatment in each condition.
Secondary outcome [1] 350565 0
Change in the Alcohol Use Disorders Identification Test (AUDIT) score
Timepoint [1] 350565 0
-Baseline (recruitment)
-3 months post-baseline
-6 months post-baseline
-12 months post-baseline
Secondary outcome [2] 350566 0
Change in level of psychological distress as measured by the Kessler Psychological Distress Scale (K6)
Timepoint [2] 350566 0
-Baseline (recruitment)
-3 months post-baseline
-6 months post-baseline
-12 months post-baseline
Secondary outcome [3] 350639 0
Current risk of depression will be assessed using the Patient Health Questionnaire (PHQ-9)
Timepoint [3] 350639 0
-Baseline (recruitment)
-3 months post-baseline
-6 months post-baseline
-12 months post-baseline
Secondary outcome [4] 350640 0
Anxiety will be measured by the GAD7, a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder (GAD).
Timepoint [4] 350640 0
-Baseline (recruitment)
-3 months post-baseline
-6 months post-baseline
-12 months post-baseline
Secondary outcome [5] 350642 0
Levels of use of substances other than alcohol will be measured by the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Timepoint [5] 350642 0
-Baseline (recruitment)
-3 months post-baseline
-6 months post-baseline
-12 months post-baseline
Secondary outcome [6] 368907 0
Levels and intensity of physical activity in daily living will be measured by the International Physical Activity Questionnaire (IPAQ)
Timepoint [6] 368907 0
-Baseline (recruitment)
-3 months post-baseline
-6 months post-baseline
-12 months post-baseline
Secondary outcome [7] 368908 0
Quality of life with be assessed by the EUROHIS-QOL-8
Timepoint [7] 368908 0
-Baseline (recruitment)
-3 months post-baseline
-6 months post-baseline
-12 months post-baseline
Secondary outcome [8] 368909 0
Metacognitions about the positive and negative effects of alcohol use will be measured by the Positive Alcohol Metacognitions Scale/Negative Alcohol Metacognitions Scales (PAMS/NAMS)
Timepoint [8] 368909 0
-Baseline (recruitment)
-3 months post-baseline
-6 months post-baseline
-12 months post-baseline
Secondary outcome [9] 368910 0
Metacognitive beliefs will be assessed by the Metacognitions Questionnaire -30 (MCQ 30)
Timepoint [9] 368910 0
-Baseline (recruitment)
-3 months post-baseline
-6 months post-baseline
-12 months post-baseline
Secondary outcome [10] 368912 0
Reasons for drinking alcohol will measured by the Drinking Motives Questionnaire-Short Form-Revised (DMQ-SF-R). Three additional questions have been added to this measure to assess motivations to use alcohol to moderate specific symptoms of severe mental ill-health
Timepoint [10] 368912 0
-Baseline (recruitment)
Secondary outcome [11] 368914 0
The Short Questionnaire for Family Members (Affected by Addiction) (SQFM(AA)) will be used to measure the extent and type of harmful impact that a family member perceives the relative's substance use has on the family
Timepoint [11] 368914 0
- First session with family member (family baseline)
- Six months post family baseline

Eligibility
Key inclusion criteria
Inclusion criteria: Consumers of Hunter New England and non-government mental health services ; AUDIT score greater than or equal to 4.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Homelessness; hearing impairment sufficient to prohibit a telephone interview; acute suicidality; and an acquired brain injury severe enough to interfere with understanding of the program. Severely dependent drinkers will be delayed entry to the study until they have undergone formal detoxification.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Staff at participating mental health and support services will identify clients who they believe meet study criteria and ask them if they are interested in participating in the study. If a client expresses interest, they will be provided with brief information about the study and a copy of the Participant Information and Consent Form to review. Verbal consent to be contacted will be obtained by service staff and the potential participant’s first name, mobile phone and email contact details will be recorded on a contact form. A Research therapist independent of the participating mental health and support services will contact these recruitment sites services weekly to support recruitment and contact those listed on the contact form for a brief screening of approximately 20 minutes duration (to provide further study information, confirm consent, and screen for eligibility). If eligible and consenting to participate, the participant will assigned a participant identification number which is sequential in order of recruitment. The participant can then continue to the baseline assessment, or an appointment will be made for the participant to complete this assessment at a later time. Following completion of baseline assessment, participants will then be randomly assigned to either the Quikfix or TrCBT. The randomisation schedule has been created via computerised random number generation by an independent biostatistician and is stored securely by an independent research team member. The treating psychologist will contact the independent research team member by email or telephone before the first session of therapy commences to receive the participant's randomised allocation. The participant is notified from the outset that all participants will receive two sessions of therapy and that they will be advised at the first session if they have been randomised into the condition to received more than two treatment sessions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised random number generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Intention-to-treat analyses will be applied. Percentage recruitment rates, program retention, and client satisfaction will be used to determine feasibility and acceptability of the intervention. A sample of 40 participants will allow estimation of the standard deviation for the AUDIT score to be within 15% of their true values with 80% confidence.

Qualitative data will be collected and analysed using Interpretative Phenomenological Analysis (IPA). Interviews will be semi-structured with the research psychologist working from an interview guide of relevant topics. These interviews will be transcribed verbatim and systematically analysed by two coders who independently review transcripts searching for the primary themes identified by participants. Coders will consult about any disagreements in rating and these will be resolved via discussion

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/05/2019
Actual
19/08/2019
Date of last participant enrolment
Anticipated
7/12/2020
Actual
Date of last data collection
Anticipated
14/12/2021
Actual
Sample size
Target
40
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 16111 0
James Fletcher - Newcastle
Recruitment postcode(s) [1] 29627 0
2300 - Newcastle

Funding & Sponsors
Funding source category [1] 300385 0
Charities/Societies/Foundations
Name [1] 300385 0
Australian Rotary Health
Country [1] 300385 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive,
Callaghan,
NSW 2308
Country
Australia
Secondary sponsor category [1] 299838 0
None
Name [1] 299838 0
Address [1] 299838 0
Country [1] 299838 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301194 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 301194 0
Ethics committee country [1] 301194 0
Australia
Date submitted for ethics approval [1] 301194 0
31/08/2018
Approval date [1] 301194 0
04/10/2018
Ethics approval number [1] 301194 0
18/09/19/4.04

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86178 0
Prof Amanda Baker
Address 86178 0
School of Medicine and Public Health
The University of Newcastle
PO Box 833
Newcastle NSW 2300
Country 86178 0
Australia
Phone 86178 0
+61 412 267 164
Fax 86178 0
Email 86178 0
Amanda.Baker@newcastle.edu.au
Contact person for public queries
Name 86179 0
Sonja Pohlman
Address 86179 0
School of Psychology
The University of Newcastle
University Drive
Callaghan NSW 2308
Country 86179 0
Australia
Phone 86179 0
+61 418 871 088
Fax 86179 0
Email 86179 0
Sonja.Pohlman@newcastle.edu.au
Contact person for scientific queries
Name 86180 0
Amanda Baker
Address 86180 0
School of Medicine and Public Health
The University of Newcastle
PO Box 833
Newcastle NSW 2300
Country 86180 0
Australia
Phone 86180 0
+61 412 267 164
Fax 86180 0
Email 86180 0
Amanda.Baker@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Trial participants are ensured confidentiality and only group de-identified data will be shared


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.