ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618001563257

Ethics application status

Approved

Date submitted

4/09/2018

Date registered

19/09/2018

Date last updated

10/06/2021

Date data sharing statement initially provided

10/06/2021

Date results information initially provided

10/06/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

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

Scientific title

A pilot randomised control trial to determine the efficacy of a telephone delivered transdiagnostic (Fullfix) intervention for comorbid substance and mental health problems in young people

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Alcohol use

Mental Health - Depression

Substance Use

Mental Health - Anxiety

Condition category

Condition code

Mental Health

Addiction

Mental Health

Depression

Mental Health

Anxiety

Mental Health

Studies of normal psychology, cognitive function and behaviour

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention will be the FullFix telehealth treatment. The FullFix telehealth treatment consists of four core sessions and four additional optional sessions tailored to the individual’s specific risk and protective factor profile using a case-formulation approach. The modules are delivered individually in 20-40 min telephone therapy calls for up to 8 weekly or fortnightly sessions. Sessions may be broken into two shorter calls per week if the participant prefers. As it is a telephone intervention, the location of the intervention will vary. The clinician will ensure the participant is in a safe and private location during the sessions. The clinician will be delivering the intervention from their office.
The intervention will be delivered by trained research psychologists, general registered psychologists, provisional psychologists, or trained LLW clinicians.
Core Modules:
In Session 1, participants are provided with motivational enhancement training and are provided with personalised assessment feedback and psychoeducation about their alcohol and other drug use and related problems, depression and anxiety symptoms, emotion regulation difficulties, and coping styles (e.g. avoidance, aggression, risky behaviors). A preliminary case formulation is developed and treatment goals are identified. Participants also receive psychoeducation around harm minimisation strategies for alcohol and other drug use, and develop a harm minimisation implementation intention plan.

In Session 2, participants first review how the implementation of their harm minimisation plan went over the previous week. They are then assessment feedback on their personality risk profile including impulsivity and sensation seeking proneness, positive and negative urgency, and anxiety and depression proneness. This information is then incorporated into the participant’s case formulation and they are provided with cognitive behavioural coping skills training targeting their top 1-2 personality risk profiles. Those predominantly with high in anxiety proneness are trained in mindful breathing and thought awareness and acceptance for anxious thoughts. Individuals high in depression proneness receive behavioural activation and thought awareness and acceptance training for depressive thoughts. Those high in sensation seeking receive training in savouring techniques to increase their awareness and ability to focus on and experience positive feelings from everyday activity (e.g. mindful eating) and are encouraged to identify and schedule natural highs from functional activities (e.g. exercise, skateboarding, rock climbing) and daily experiences (food, sex, music). Participants with high levels of impulsivity receive mindfulness training to increase awareness of their thoughts and emotions, are encouraged to apply the Stop-Think-Do rubric to help them slow down their decision-making processes sufficiently to consider likely outcomes of behavioural alternatives. Participants with high levels of positive or negative urgency will receive training to recognising and learning to observe emotions emotional responses (positive and negative), sitting with emotional responses (positive and negative) combined with either impulsivity or sensation seeking training depending on their personality risk profile. At the end of the session participants develop a coping skills implementation intention plan.

In Session 3, participants first review how the implementation of their coping skills plan went over the previous week. They then receive assessment feedback of their strengths, and identify which strengths they think they have, and what strengths they can draw on to help with their coping of skills identified in session 1 and 2. They are encouraged to incorporate their strengths into their coping skills plan at the end of their session.

In Session 4, participants review their goals, coping skills, and strengths. The session content then focuses on how to generalise the participants coping plan using a 5-step self-regulation framework. The session will focus on 1) teaching participants to become more aware of their surroundings, internal and external state; 2) acknowledging (rather than avoiding) the present moment; 3) redirecting their attention and focus; 4) appraising the situation and their coping strategies; and 5) choosing and taking the best course of action.
Additional Modules:
Physical Self-regulation Session: This session will focus on awareness and understanding of psychophysiological responses, ways to regulate physiological responses, specifically through diaphragmatic breathing and relaxation, and longer-term strategies for self-care (sleep hygiene, healthy eating, and physical activity).
Emotions Self-regulation Session: This session comprises of psychoeducation (what are emotions, function of emotions, thought-feeling-behaviour connection); recognising and learning to observe emotions/emotional responses (positive and negative), sitting with emotional responses (positive and negative); and emotion regulation strategies.
Cognitive Self-regulation Session: This session extends on skills taught in Session 2 to address maladaptive coping strategies (suppression, rumination, avoidance); improve positive coping (appraisal, problem solving, and acceptance).
Social Self-regulation Session, which focuses on gaining social support, making and keeping social connections and relationships, identifying barriers to social connectedness, and interpersonal skills training to help overcome barriers.

If necessary, case-management will be provided by Lives Lived Well staff in addition to FullFix. Frequency, duration, modality (phone or face-to-face) and type of case-management will be recorded for each participant.

To assess intervention adherence and fidelity, telephone treatment sessions will be audio-recorded, with the participant’s consent. Clinicians will also record a session component checklist for each session completed. Supervision meetings will be held fortnightly to monitor session delivery and treatment adherence. Additionally, the supervisor will review a randomly selected session audio segment, independently rating it and a Session Component Checklist, and discuss any departures from protocol. A random sample (20%) of session recordings will be independently rated for treatment fidelity to ensure core features of the allocated treatment are delivered.

Intervention code [1]

Treatment: Other

Intervention code [2]

Behaviour

Comparator / control treatment

Assessment Feedback and Information and usual care: Participants will receive usual care as delivered by their assigned Lives Lived Well (LLW) AOD clinician (typically an allied health professional with at least a bachelors degree). Treatment as usual typically consists of case management and AOD counselling, delivered via phone or face to face. A typical episode of care consists of 2-10 Sessions. Personalised assessment feedback on the participant's alcohol and other drug use and related physical, psychological and social consequences will also be sent to the usual care clinician via email. The clinician will also receive instructions from the research team on how to share this feedback with their client.

Usual care is not based upon specific guidelines, nor does it have a prescribed number of sessions, frequency or duration of sessions. There is no specified duration for which participants will receive usual care, as duration of care is provided for the duration of client’s needs, and determined on a case by case basis. Details of episodes of care and session case-notes will be recorded by LLW clinicians. Frequency of sessions, duration, modality (phone or face-to-face) and type of session (e.g. counselling, case management) will be measured for each participant. A file audit of all episodes of care will be conducted for a random sample of 20% of participants, assessed by an independent researcher.

Control group

Active

Outcomes

Primary outcome [1]

Level of substance use and related problems through a composite score on the Alcohol, Smoking and Substances Involvement Screening Test (WHO ASSIST)

Timepoint [1]

Baseline and 1, 2 (primary endpoint), 6, and 12 months post-baseline

Primary outcome [2]

Depression symptom severity, measured using the Patient Health Questionnaire (PHQ-9)

Timepoint [2]

Baseline and 1, 2 (primary endpoint), 6, and 12 months post-baseline

Primary outcome [3]

Anxiety severity, measured using the Generalized Anxiety Disorder scale (GAD-7)

Timepoint [3]

Baseline, and 1, 2 (primary endpoint), 6, and 12 months post baseline

Secondary outcome [1]

Mental health and wellbeing: Measured on the 14-item version of the Mental Health Continuum – Short Form (MHC-SF; Keyes, 2005)

Timepoint [1]

Baseline and 1, 2, 6, and 12 months post baseline

Secondary outcome [2]

Work and Social Adjustment: Measured using the Work and Social Adjustment Scale (WSAS; Mundt, Marks, Shear, & Greist, 2002)

Timepoint [2]

Baseline, and 1, 2, 6, and 12 months post baseline

Secondary outcome [3]

Quality of Life: 8 item EUROHIS-QOL (Schmidt, Mühlan, & Power, 2005)

Timepoint [3]

Baseline, and 1, 2, 6, and 12 months post baseline

Secondary outcome [4]

Self Efficacy: Controlled Drug Self-Efficacy Scale, adapted from the Controlled Drinking Self-Efficacy Scale (CDSE; Sitharthan, Soames, Kavanagh, Sitharthan, & Hough, 2003)

Timepoint [4]

Baseline, and 1, 2, 6, and 12 months post baseline

Secondary outcome [5]

Composite score of frequency/quantity for Use of Primary and Secondary Drug in the past month using the Opiod Treatment Index (OTI) - Primary outcome.

Timepoint [5]

Baseline, and 1, 2 (primary endpoint), 6, and 12 months post baseline

Eligibility

Key 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.

Minimum age

16 Years

Maximum age

35 Years

Sex

Both males and females

Can healthy volunteers participate?

Key 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

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Randomisation will be conducted using a computer-generated, random allocation sequence, by a person who is not involved in recruitment or data collection. The allocation will then be communicated to the case managers.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomisation will be conducted using a computer-generated, random allocation sequence. Randomisation sequence will be created using statistical software and stratified by centre and age (16 – 20, 21 – 25) with a 1:1 allocation using block sequences.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Sample size and power calculation: We found medium effect sizes in our pilot CBT study. With 50 participants in each group, we will have 95% power to detect medium effects with alpha (a) set at 0.05. We predict a 20-30% attrition rate at 12 months based on our pilot data and previous work and will therefore need to randomize 130 participants.

Measures:
Feasibility: is assessed via treatment engagement (e.g. number of sessions attended) and client satisfaction using the 5-item Patient Experiences Questionnaire.
Alcohol and Other Drug Use (Primary outcome): Alcohol and drug use will be assessed using The World Health Organization (WHO) Alcohol, Smoking and Substance Involvement Screening Test (ASSIST), which screens for all levels of problem substance use, covering tobacco, alcohol, cannabis, cocaine, amphetamine-type stimulants, inhalants, sedatives, hallucinogens, opiates and ‘other drugs’; The Opiate Treatment Index (OTI) will be used as a measure of the frequency/quantity of alcohol and illicit drug use in the past month.
Mental Health (Primary Outcomes): Depression and anxiety will be assessed using the Patient Health Questionnaire (PHQ-9]) and Generalised Anxiety Disorder 7-item (GAD-7) scale.
Additional Mental Health Measures: A 4-item PTSD screen and psychosis screen will also be included.
Wellbeing (Secondary Outcome): The 14-item version of the Mental Health Continuum (MHC) measures emotional, social and psychological wellbeing
Functioning (Secondary Outcome): The 5 item The Work and Social Adjustment Scale (WSAS) measures participants daily functioning and social impairment.
Mechanisms of change (Process outcomes)
Transdiagnostic Risk and Protective Factors: Impulsivity will be measured using the 20-item short form of the UPPS-P Impulsive Behavior Scale which assesses five sub-traits of impulsivity – negative urgency, positive urgency, lack of perseverance, lack of premeditation, and sensation seeking. The 18-item Difficulties in Emotion Regulation Scale (DERS) will be used to measure emotion regulation difficulties. The 32-item Coping Inventory for Stressful Situations (CISS) measures emotion and task orientated coping. Social Support will be measured using the 10-item short form of the social provisions scale. To assess social belonging, an adapted version of the the Exeter Identity Transition Scale (EXITS) measure of the number of important group memberships will be used [45]. Self-perceived strengths, are assessed using an adaptation of the 24-item Signature Strengths Survey. The 24-item Five-Facet Mindfulness Questionnaire (FFMQ-SF) will assess different aspects of mindfulness.
Cost effectiveness: Health related quality of life will be assessed using the 5 level version of EuroQoL [EQ-5D-5L].
Information on health care service use will also be collected.
Experience Sampling Methodology (ESM): will be used to evaluate the proposed transdiagnostic mechanisms of change (i.e. the treatment targets of intervention). The dynamic measurement of process variables at random time intervals has been shown to increase the construct, ecological, and external validity of assessments. ESM will involve the completion of a 16-item self-regulation momentary scale of emotion regulation, impulsivity, sensation seeking, mindfulness, as well as items assessing positive and negative mood and AOD use delivered via a mobile app. Participants will complete the measure 3 times per week each fortnight, over the duration of the intervention time-frame (at baseline, 2nd week of treatment, 4th week, 6th week, and 8th week) at random intervals once per day on Friday, Monday and a random Tuesday, Wednesday or Thursday. This approach will ensure we will sample across a range of situations, including typical high-risk periods (e.g. weekend).

Data analysis: The independent variable is treatment condition, with 2 levels: (i) Full Fix + TAU and (ii) TAU only. Preliminary one-way analyses of variance and Chi-squared analyses will be undertaken to check for baseline group differences on demographic, primary and secondary outcomes and process variables. Group differences on the primary and secondary outcome measures at 1, 2, 6, and 12 months will be examined using a series of mixed effects model repeated measures analyses of variance (MMRM). Intent to treat analysis is performed and effect sizes will be reported. The EMA analysis will use multilevel models to account for the correlated nature of the within-person repeated measure data and examine variables at both the day- and individual-level. To examine the process mechanisms, mediation and moderation analyses that examine multivariate change over time will be conducted (e.g. running mediated multivariate latent curve models or autoregressive latent trajectory model with appropriate covariates and moderators). The mediator and moderator variables will be the above described transdiagnostic risk and protective factors.

Cost-effectiveness: An analysis alongside the trial will display the costs of the FullFix + TAU (case-management) vs TAU (counselling and case-management) only against their health benefits in both natural units and as QALYs (EQ-5D-5L).
Cost-effectiveness will be assessed by determining whether the additional costs of FullFix will be offset by any cost savings that arise from a reduced use of health care services and productivity losses avoided under the intervention. Uncertainty in the assessment will be estimated using non-parametric bootstrapping.

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

20/09/2018

Actual

5/10/2018

Date of last participant enrolment

Anticipated

20/08/2019

Actual

27/07/2020

Date of last data collection

Anticipated

14/09/2021

Actual

Sample size

Target

130

Accrual to date

Final

150

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment postcode(s) [1]

4350 - Toowoomba

Recruitment postcode(s) [2]

4610 - Kingaroy

Recruitment postcode(s) [3]

4405 - Dalby

Recruitment postcode(s) [4]

4413 - Chinchilla

Recruitment postcode(s) [5]

4343 - Gatton

Recruitment postcode(s) [6]

4341 - Laidley

Recruitment postcode(s) [7]

4370 - Warwick

Recruitment postcode(s) [8]

4822 - Burleigh

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC)

Address [1]

GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

The University of Queensland

Address

School of Psychology
McElwain Building
The University of Queensland
St Lucia QLD 4072

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Queensland Human Research Ethics Committee A

Ethics committee address [1]

Level 3, Brian Wilson Chancellery
The University of Queensland
St Lucia QLD 4072

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/06/2018

Approval date [1]

11/07/2018

Ethics approval number [1]

2018001185

Summary

Brief summary

This pilot randomized controlled trial (RCT) aims to examine the feasibility, efficacy, and cost-effectiveness of a new risk-targeted transdiagnostic CBT telehealth program (FullFix) for comorbid alcohol and other drugs (AOD) and mental health problems in young people. The study aims to recruit 130 participants aged 16 - 25, who will be randomised to receive 4 core modules (and up to 4 additional modules) targeting transdiagnostic risk and protective factors for mental health and AOD use, or usual AOD care. Participants' AOD use, mental health, and functional outcomes will be assessed at baseline, and at 1 month, 2, 6, and 12 months post baseline.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Leanne Hides

Address

School of Psychology
McElwain Building
The University of Queensland
St Lucia QLD 4072

Country

Australia

Phone

+ 61 7 336 56398

Fax

+61 7 3365 4466

[email protected]

Contact person for public queries

Name

Prof Leanne Hides

Address

School of Psychology
McElwain Building
The University of Queensland
St Lucia QLD 4072

Country

Australia

Phone

+ 61 7 336 56398

Fax

+61 7 3365 4466

[email protected]

Contact person for scientific queries

Name

Dr Zoe Walter

Address

School of Psychology
McElwain Building
The University of Queensland
St Lucia QLD 4072

Country

Australia

Phone

+ 61 7 344 32569

Fax

+61 7 3365 4466

[email protected]

Data sharing statement

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

Yes

What data in particular will be shared?

All de-identified individual participant data collected during the trial will be available

When will data be available (start and end dates)?

Immediately following publication, no end date

Available to whom?

Individual researchers who provide a methodologically sound proposal with the approval of the chief investigators

Available for what types of analyses?

Only to achieve the aims in the approved proposal

How or where can data be obtained?

www.rdm.uq.edu.au

What supporting documents are/will be available?

Doc. No.	Type	Link	Email	Attachment
12001	Study protocol	https://rdm.uq.edu.au	[email protected]
12002	Informed consent form	https://rdm.uq.edu.au	[email protected]
12003	Ethical approval	https://rdm.uq.edu.au	[email protected]	375367-(Uploaded-22-07-2020-12-17-22)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	FullFix: A randomised controlled trial of a telephone delivered transdiagnostic intervention for comorbid substance and mental health problems in young people.	2021	https://dx.doi.org/10.1136/bmjopen-2020-045607

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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