Breaking Free Online Health and Justice Outcomes in Prisons | Recruiting
Breaking Free Online Health and Justice Outcomes in Prisons

Trial Source

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Health Conditions
  • Alcohol and/or drug misuse/dependence
Primary Contact Details
Recruiting
Recruitment Status
ISRCTN09846981
Primary Trial ID Number
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. In addition, a traditional group and key working programme, Breaking Free Pillars of Recovery, is also included in the study as an adjunct to standard treatment, in order to examine how this may help service users in prisons make similar changes. The aims of the Breaking Free programmes (both the online programme and group/key working programme) are 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 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 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. Breaking Free Pillars of Recovery group and key-working treatment programme facilitated by a trained service worker (investigational group) plus ‘standard treatment’. 3. Standard treatment (control group). This study will consist of a 12-week treatment period for problem alcohol and drug use, via the Breaking Free programmes 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 12 weekly 30-60 min for the Breaking Free Online Health and Justice group, and 12 weekly 120 min group sessions plus 12 weekly 30 min key working sessions for the Breaking Free Pillars of Recovery group. 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 January 2015 and is expected to run until January 2017. Who is funding the study? Breaking Free Online Ltd (UK). Who is the main contact? Dr Sarah Elison (Head of Research) selison@breakingfreegroup.com
Research Details
  • 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. On 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
Phase
Not Applicable
Study Design
Multi-centre randomised controlled trial
Study Type
Interventional
Intervention

Current 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
Primary Outcome Measures
  • 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 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
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
560
Participant Inclusion Criteria
  • Current 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 Exclusion Criteria
  • Current 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
Trial Location(s)
Manchester
M3 4JB
Trial Contact(s)
Primary Trial Contact
Dr Sarah Elison
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
Scientific Title
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
EudraCT Number
Sorry, this information is not available
Funder(s)
  • Breaking Free Online Ltd (UK)
Other Study ID Numbers
N/A
Sponsor(s)
Breaking Free Online (UK)
Key Dates

Recruitment Start Date

01 Jan 2014

Recruitment End Date

01 Jan 2017

Trial Start Date

01 Jan 2014

Trial End Date

01 Jan 2017

Date Assigned

01 Aug 2011

Last Updated

21 Aug 2014