Condition category
Mental and Behavioural Disorders
Date applied
08/07/2011
Date assigned
01/08/2011
Last edited
22/01/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
An extensive body of evidence-based literature may be found to support psychosocial intervention approaches for drug and alcohol difficulties within criminal justice populations. However, limited research has been conducted to date regarding with the use of online interventions in this population. This study therefore aims to find out whether Breaking Free Online Health and Justice, a web-based computerised treatment programme for people with alcohol and/or drug problems, can support services users in UK prisons to stop using drugs and alcohol and make changes to their lifestyle, health and whether these changes will be maintained following completion of the treatment. The aims of the Breaking Free programme is to enable people to understand what might be driving their drugs and alcohol use, and provide them with skills and resources to help them gain control by following a personalised Lifestyle Balance Model that helps them prioritise the areas on which they need to focus to resolve the issues that are causing their difficulties.

Who can participate?
1. Male or female participants with problem alcohol and/or drug use aged 18 to 65 years
2. Participant is willing and able to give informed consent for participation in the study
3. Is serving a prison sentence of at least 4 months
4. Problem alcohol and/or drug use present for more than 12 months
5. Participant is not following standard treatment for alcohol and/or drug misuse at the time of recruitment into the study
6. Willing to follow a treatment for problem alcohol and/or drug use for 8 weeks
7. Willing to provide outcome measures at 6-months follow-up
8. Concomitant alcohol and drug/s use permitted, as well as any prescribed medication

What does the study involve?
This is a randomised controlled study, which means it will compare people who have used the Breaking Free programmes with people who have not used them in a randomised manner, that is, based on chance.
The participants will be randomly allocated to one of the following groups:
1. Breaking Free Online Health and Justice treatment programme assisted by a trained service worker (investigational group) plus ‘standard treatment’.
2. Standard treatment (control group).

This study will consist of an 8-week treatment period for problem alcohol and drug use, via the Breaking Free programme which will be provided in addition to the standard treatment provided by prison alcohol and drug misuse services. The treatment sessions will have a total duration range of 8 weekly 30-60 minutes. All participants will be asked to provide urine samples to test for drug use and also answer questions about their alcohol or drug use and how this affects their lifestyle before and after receiving treatment and later on, at 3 and 6 months. The total duration of the study is 9 months for all participants.

What are the possible benefits and risks of participating?
Participants will receive a treatment programme which will aim to help them to understand their difficulties and to gain control by following a personalised model. However, as may happen with the standard treatment, it is possible that they may, or may not, see any changes in their drug or alcohol use, lifestyle or health due to taking part in this study. The information from this study will be used to further understand and make recommendations that may help the alcohol and drug services improve the treatment they provide for people with alcohol and drug problems, which will in return have potential benefits for the participants and families and the whole of society.
There are no known risks or adverse effects expected. Any information you provide will be used only for the purposes for which it is collected, and not in any other way without your consent.

Where is the study run from?
The study will take place in participating alcohol and drug services within UK prisons, these will be the main contact point for future participants.

When is the study starting and how long is it expected to run for?
The study will start in March 2015 and is expected to run until March 2019.

Who is funding the study?
Breaking Free Online Ltd (UK)

Who is the main contact?
Dr Sarah Elison-Davies (Research Director)
selison@breakingfreegroup.com

Trial website

http://www.breakingfreeonline.com

Contact information

Type

Scientific

Primary contact

Dr Sarah Elison-Davies

ORCID ID

Contact details

Breaking Free Online Limited
274 Deansgate
Manchester
M3 4JB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A parallel-group comparison of 8-week Breaking Free Online Health and Justice programme as an adjunct to standard treatment for substance misuse, in criminal justice settings

Acronym

Study hypothesis

Current hypothesis as of 19/01/2018:
This multi-centre randomised controlled study aims to measure the changes that the Breaking Free Online Health and Justice programme, together with the standard treatment for alcohol or drugs, may be able to make on the lifestyle, health and social function of people with alcohol or drug problems and whether these changes will be maintained after 6 months of completion of the treatment.

Current hypothesis as of 21/08/2014:
This multi-centre randomised controlled study aims to measure the changes that the Breaking Free Online Health and Justice, and Breaking Free Pillars of Recovery group and key working programmes, together with the standard treatment for alcohol or drugs, may be able to make on the lifestyle, health and social function of people with alcohol or drug problems and whether these changes will be maintained after 6 months of completion of the treatment.

Previous hypothesis:
This multi-centre randomised controlled study aims to measure the changes that Breaking Free Online, together with the standard treatment for alcohol or drugs, may be able to make on the lifestyle, health and social function of people with alcohol or drug problem and whether these changes will be maintained after 12 months of completion of the treatment.

Ethics approval

Research Ethics Committee (UK) and R&D Offices (UK)

Study design

Multi-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Alcohol and/or drug misuse/dependence

Intervention

Current interventions as of 19/01/2018:
1. Standard treatment - prior to performing the standard treatment, assessments/questionnaires are carried out as routine by the key workers in the alcohol and drug misuse services. The most used of these assessments is the Treatment Outcome Profile (TOP). The main components of the standard low-intensity interventions, defined as motivational and treatment engagement tools to reduce substance misuse, are delivered by the key workers in the alcohol and drug misuse services and include techniques such as Motivational Interviewing and Contingency Management. Some participants will be required to follow high-intensity interventions for drug-specific and/or common mental health problems, delivered by a specialist psychological therapist through CBT-based interventions. The treatment may also require delivering Detoxification and prescriptive basic ITEP (International Treatment Effectiveness Programme)

2. Intervention group: the Breaking Free treatment programme is administered
2.1. Breaking Free Online Health and Justice (online programme)

This treatment programme aims to help people to understand the difficulties driving their drug and alcohol use and to gain control by following a personalised Lifestyle Balance Model that helps them prioritise the areas on which they need to focus to resolve their difficulties. Psychometric assessments will be performed which comprise standardised validated questionnaires.

Previous interventions as of 21/08/2014:
1. Standard treatment - prior to performing the standard treatment, assessments/questionnaires are carried out as routine by the key workers in the alcohol and drug misuse services. The most used of these assessments is the Treatment Outcome Profile (TOP). The main components of the standard low-intensity interventions, defined as motivational and treatment engagement tools to reduce substance misuse, are delivered by the key workers in the alcohol and drug misuse services and include techniques such as Motivational Interviewing and Contingency Management. Some participants will be required to follow high-intensity interventions for drug-specific and/or common mental health problems, delivered by a specialist psychological therapist through CBT-based interventions. The treatment may also require delivering Detoxification and prescriptive basic ITEP (International Treatment Effectiveness Programme)

2. Intervention group: the Breaking Free treatment programmes will be administered:
2.1. Breaking Free Online Health and Justice (online programme)
2.2. Breaking Free Pillars of Recovery (group and key working programme)

This treatment programme aims to help people to understand the difficulties driving their drug and alcohol use and to gain control by following a personalised Lifestyle Balance Model that helps them prioritise the areas on which they need to focus to resolve their difficulties. Urinalysis and psychometric assessments will be performed which comprise standardised validated questionnaires.

Previous interventions:
1. Standard treatment - prior to performing the standard treatment, assessments/questionnaires are carried out as routine by the key workers in the alcohol and drug misuse services. The most used of these assessments is the Treatment Outcome Profile (TOP). The main components of the standard low-intensity interventions, defined as motivational and treatment engagement tools to reduce substance misuse, are delivered by the key workers in the alcohol and drug misuse services and include techniques such as Motivational Interviewing and Contingency Management. Some participants will be required to follow high-intensity interventions for drug-specific and/or common mental health problems, delivered by a specialist psychological therapist through CBT-based interventions. The treatment may also require delivering Detoxification and prescriptive basic ITEP (International Treatment Effectiveness Programme)

2. Intervention group: the Breaking Free Online treatment programme will be administered. This web-based computerised treatment programme aims to help people to understand their difficulties and to restore control by following a personalised Lifestyle Balance Model that helps them prioritise the areas on which they need to focus to resolve the issues that are the cause of and maintain alcohol or drug dependence. A psycho-social assessment will be performed which comprises standardised validated questionnaires. The programme includes features like the personal progress check during the treatment and a personal toolbox of resources that can be downloadable (print, email or MP3 audio).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measure

Current primary outcome measures as of 21/08/2014:
Proportion of participants who have achieved a reduction from baseline in substance use consumption assessed by urinalysis

Previous primary outcome measures:
Proportion of participants who have achieved a reduction from baseline in substance use consumption assessed by online self-administered psychosocial assessments

Secondary outcome measures

Current secondary outcome measures as of 19/01/2018:
1. Self-reported substance dependence
2. Mental health sequelae
3. Re-offending
4. Treatment engagement and treatment completion rates
5. Perceived ability to reduce or abstain from using alcohol or drugs
Total amount of time spent engaged with each of the three treatments

Previous secondary outcome measures as of 21/08/2014:
1. Self-reported substance use
2. Mental health sequelae
3. Re-offending
4. Treatment engagement and treatment completion rates
5. Perceived ability to reduce or abstain from using alcohol or drugs
Total amount of time spent engaged with each of the three treatments

Previous secondary outcome measures:
1. Change of health outcomes from baseline compared to standard treatment assessed by online self-administered psychosocial assessments:
1.1. Treatment engaging and treatment completion rates
1.2. Perceived ability to manage risk in using alcohol or drugs (including injecting risk behaviour)
1.3. Perceived emotional well-being
1.4. Perceived physical health, mental health and lifestyle
2. Change of social function outcomes from baseline compared to standard treatment assessed by online self-administered psychosocial assessments (only applicable to the relevant investigational populations):
2.1. Reoffending
2.2. Perceived ability to engage with education/employment

Overall trial start date

01/01/2014

Overall trial end date

01/03/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 19/01/2018:
1. Male or female participants with problem alcohol and/or drug use aged 18 to 65 years
2. Participant is willing and able to give informed consent for participation in the study
3. Is serving a prison sentence of at least 4 months
4. Problem alcohol and/or drug use present for more than 12 months
5. Participant is not following standard treatment for alcohol and/or drug misuse at the time of recruitment into the study
6. Willing to follow a treatment for problem alcohol and/or drug use for 8 weeks
7. Willing to provide outcome measures at 6-months follow-up
8. Concomitant alcohol and drug/s use permitted, as well as any prescribed medication

Previous inclusion criteria as of 21/08/2014:
1. Male or female participants with problem alcohol and/or drug use aged 18 to 65 years
2. Participant is willing and able to give informed consent for participation in the study
3. Is serving a prison sentence of at least 4 months
4. Problem alcohol and/or drug use present for more than 12 months
5. Participant is not following standard treatment for alcohol and/or drug misuse at the time of recruitment into the study
6. Willing to follow a treatment for problem alcohol and/or drug use for 12 weeks
7. Willing to provide outcome measures at 6-months follow-up
8. Concomitant alcohol and drug/s use permitted, as well as any prescribed medication

Previous inclusion criteria:
1. Male or female participants with problem alcohol and drug use aged 18 to 65 years
2. Participant is willing and able to give informed consent for participation in the study
3. E-mail account user for the length of the study
4. Problem alcohol and drug use present for more than 6 months
5. Admitted at point of referral via standard services
6. Not following standard treatment for alcohol and drug misuse at the moment of study recruitment
7. Willing to follow a treatment for problem alcohol and drug use for 12 weeks
8. Willing to provide outcome measures at follow-up time points (3, 6 and 12 months after treatment)
9. Concomitant alcohol and drug/s use permitted, as well as any prescribed medication

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

128

Participant exclusion criteria

Current exclusion criteria as of 19/01/2018:
1. Male or female participants with problem alcohol and/or drug use aged under 18 or over 65 years
2. Participation in any other alcohol and/or drug-related clinical studies*
3. Is serving a prison sentence of less than 4 months
4. Participants detained under the Mental Health Act
5. Participants with a known and diagnosed intellectual or developmental disability which may impair their ability to engage with the Breaking Free Online Health and Justice treatment programme and complete the necessary assessment measures included in the methodology
6. Participants who report they are pregnant
7. Non-English-speaking participants (study information material and programme only produced in English)

Previous exclusion criteria as of 21/08/2014:
1. Male or female participants with problem alcohol and/or drug use aged under 18 or over 65 years
2. Participation in any other alcohol and/or drug-related clinical studies*
3. Is serving a prison sentence of less than 4 months
4. Participants detained under the Mental Health Act
5. Participants with a known and diagnosed intellectual or developmental disability which may impair their ability to engage with the Breaking Free Online Health and Justice and Breaking Free Pillars of Recovery treatment programmes and complete the necessary assessment measures included in the methodology
6. Participants who report they are pregnant
7. Non-English-speaking participants (study information material and programme only produced in English)

Previous exclusion criteria:
1. Participants with problem alcohol and drug use aged under 18 or over 65 years
2. Participation in any other alcohol and drug related clinical studies*
3. Detained under the Mental Health Act
4. Presence of permanent cognitive impairment or psychotic symptoms
5. Participants who are known to be pregnant
6. Non-English speaking participants (as study information material and programme only produced in English)
* = With the exception of the Integrated Drug Treatment System (IDTS) Evaluation

Recruitment start date

01/03/2018

Recruitment end date

01/03/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

274 Deansgate
Manchester
M3 4JB
United Kingdom

Sponsor information

Organisation

Breaking Free Online (UK)

Sponsor details

3rd Floor
274 Deansgate
Manchester
M3 4JB
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.breakingfreeonline.com

Funders

Funder type

Hospital/treatment centre

Funder name

Breaking Free Online Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results from data analyses will be published in high-impact peer reviewed journals when all data have been collected and analysed.

IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

01/08/2019

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

22/01/2018: The publication and dissemination sharing plans have been added as well as the participant level sharing statement. 19/01/2017: The following changes have been made to the study: 1. The scientific title has been updated from "A parallel-group comparison of 12-week Breaking Free Online Health and Justice and Breaking Free Pillars of Recovery treatment programmes, as adjuncts to standard treatment for substance misuse, in criminal justice settings" to 2. The target number of participants has been updated from 560 to 128. 3. The interventions has been updated. 4. The secondary outcome measures have been updated. 5. The inclusion and exclusion criteria has been updated. 6. The hypothesis has been updated. 7. The recruitment dates have been updated from 01/01/2014-01/01/2017 to 01/03/2018-01/03/2019. 8. The overall trial end date has been updated from 01/01/2017 to 01/03/2020. 9. The trial website has been added 10 .The study contact has been amended from Dr Sarah Elison to Dr Sarah Elison-Davies 11. The plain English summary has been update according to the changes in the study 21/08/2014: The following changes were made to the trial record: 1. The public title was changed from 'Breaking Free Online comparison to alcohol/drug standard treatment' to 'Breaking Free Online Health and Justice Outcomes in Prisons' 2. The scientific title was changed from 'A randomised, parallel-group comparison of 12-week Breaking Free Online treatment programme and standard intervention for problem alcohol and drug use' to 'A parallel-group comparison of 12-week Breaking Free Online Health and Justice and Breaking Free Pillars of Recovery treatment programmes, as adjuncts to standard treatment for substance misuse, in criminal justice settings' 3. The anticipated start date was changed from 01/02/2012 to 01/01/2014 4. The anticipated end date was changed from 01/06/2014 to 01/01/2017 5. The target number of participants was changed from 560 to 180