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Health Condition(s) or Problem
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Alcohol and/or drug misuse/dependence
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Lay Summary
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Background and study aims
An extensive body of evidence-based literature may be found to support psychosocial intervention approaches which support Breaking Free Online?s treatment programme structure however, limited research has been conducted to date regarding with the use of Web-based interactive interventions to make alcohol and drug treatments more accessible to the affected populations. This study aims to find out whether Breaking Free Online, a web-based unique computerised treatment programme for people with alcohol and/or drug problem, will make changes to their lifestyle, health and social function and whether will be maintained following completion of the treatment.
The aim of Breaking Free Online is to enable 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 causing and maintaining their dependence. The programme includes personal progress checks and a personal toolbox of downloadable resources.
Who can participate?
The participant will need to:
1. Be 18 to 65 years and have a problem with alcohol and/or drugs use
2. Be willing and able to give informed consent for participation in the study
3. Have an e-mail account for the length of the study
4. Have a problem with alcohol and/or drug use for more than 6 months
5. Have been admitted onto the study via standard services, at point of referral
6. Not following standard treatment for alcohol and/or drug misuse at the moment of study recruitment
7. Be willing to follow a treatment for problem alcohol and drug use for 12 weeks
8. Be willing to provide follow-up information at 3, 6 and 12 months after treatment
What does the study involve?
This is a randomised controlled study, which means it will compare people who have used the programme and people who have not used it in a randomised manner that is, based on chance.
The participant will be randomly allocated to one of the following groups:
Standard Treatment (control group): also called ?treatment as usual? for alcohol and/or drugs and is delivered by the alcohol and drug services.
Breaking Free Online (investigational group): is the web-based computerised treatment programme. Aims to identify, understand and actively address the underlying psychological and lifestyle factors that are driving their dependence on alcohol or drugs.
This study will consist of a 12-week treatment for problem alcohol and drug use treatment, administered in addition to the standard treatment provided by the alcohol and drug misuse services. The treatment sessions will have a total duration range of 30-60 min. All participants will be asked to answer questions about alcohol and/or drug use and how this affects their lifestyle before and after receiving treatment and later on, at 3, 6 and 12 months. The total duration of the study is 15 months for all participants.
What are the possible benefits and risks of participating?
You will receive a web-based computerised treatment programme which aim to help people to understand their difficulties and to restore control by following a personalised model. However, as it may happen with the standard treatment, it is possible that you may, or may not, see any changes in your lifestyle, health and social function due to taking part in this study. The information we get from this study will be used to further understand and make recommendations that may help the alcohol and drug services improve the treatment for people with alcohol and drug problems, which will in return have potential benefits for the participants and families and the whole society.
There are no known risks or adverse effects expected to participating in this study. 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 (from ISRCTN)
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Who can enter the trial
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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
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Who cannot enter the trial
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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
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What will happen
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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).
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Primary aim
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Proportion of participants who have achieved a reduction from baseline in substance use consumption assessed by online self-administered psychosocial assessments
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Secondary Aim
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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
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Participant Information Sheet
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Not available in web format, please use the contact details below to request a patient information sheet
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Website
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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Manchester
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