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

Trial Source

Health Conditions
  • Alcohol and/or drug misuse/dependence
Recruiting
Recruitment Status
ISRCTN09846981
Primary Trial ID Number
Summary
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
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
Research Question
  • 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
Design Type
Sorry, this information is not available
Ethics Approval
Research Ethics Committee (UK) and R&D Offices (UK)
Publications
Sorry, this information is not available
Countries of Recruitment
United Kingdom
Participant Sex
Both
Participant Age Range
Adult
Participant Type
Patient
Trial Sample Size
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
Interventions
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).
Design Details
Sorry, this information is not available
Study Design
Multi-centre randomised controlled trial
Results Reporting
Sorry, this information is not available
Acronym
Sorry, this information is not available
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
Secondary Trial Identifying Number
N/A
Website
Sorry, this information is not available
Study Funded By
Breaking Free Online Ltd (UK)
Funder Type
Sorry, this information is not available
Study Sponsored By
Breaking Free Online (UK)
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment

01 Jan 2014

Recruitment End Date

01 Jan 2017

Trial End Date

01 Jan 2017

Date added to Registry

01 Aug 2011

Last Updated

21 Aug 2014