MedPath

Breaking Free Online Health and Justice outcomes in prisons

Not Applicable
Suspended
Conditions
Alcohol and/or drug misuse/dependence in prisoners
Mental and Behavioural Disorders
Drug and alcohol rehabilitation
Registration Number
ISRCTN09846981
Lead Sponsor
Breaking Free Online (UK)
Brief Summary

2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/30392125

Detailed Description

Not available

Recruitment & Eligibility

Status
Suspended
Sex
All
Target Recruitment
128
Inclusion Criteria

Current inclusion criteria as of 30/08/2019:
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 4 weeks
7. Willing to provide outcome measures at 3- and 6-months follow-up
8. Concomitant alcohol and drug/s use permitted, as well as any prescribed medication

Previous inclusion criteria from 19/01/2018 to 30/08/2019:
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 from 21/08/2014 to 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 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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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