Alcohol and/or drug misuse/dependence in prisoners Mental and Behavioural Disorders Drug and alcohol rehabilitation
Conditions
Interventions
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
Sponsors
Breaking Free Online (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 18/09/2020: Substance consumption assessed by online self-administered psychosocial assessments at baseline, 4 weeks, 3 months and 6 months post-treatment _____ Previous primary outcome measure as of 30/08/2019: Proportion of participants who have achieved a reduction from baseline in substance use consumption assessed by online self-administered psychosocial assessments _____ Previous primary outcome measure from 21/08/2014 to 30/08/2019: Proportion of participants who have achieved a reduction from baseline in substance use consumption assessed by urinalysis _____ Original primary outcome measure: Proportion of participants who have achieved a reduction from baseline in substance use consumption assessed by online self-administered psychosocial assessments | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 18/09/2020: All measures assessed at baseline, 4 weeks, 3 months and 6 months post-treatment 1. Mental health sequelae assessed using the Patient Health Questionnaire (PHQ-4), which has been built into the 'progress check' function of the Breaking Free Online digital platform, which is completed by participants assigned to the Breaking Free treatment arm at 4-weeks post treatment-engagement, and into paper questionnaires for all other participants and timepoints 2. Re-offending. Participants are asked at each follow-up whether they have exhibited any behaviour that has seen them get 'in trouble' with the authorities. 3. Treatment engagement and treatment completion rates assessed using the Breaking Free digital platform 4. Perceived ability to reduce or abstain from using alcohol or drugs assessed using the Severity of Dependence Scale (SDS), which has been built into the 'progress check' function of the Breaking Free Online digital platform and is completed by participants assigned to the Breaking Free treatment arm at 4-weeks post treatment-engagement, and into paper questionnaires for all other participants and timepoints 5. Total amount of time spent engaged with each of the three treatments assessed using the Breaking Free digital platform _____ Previous 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 substan | — |
Countries
United Kingdom
Outcome results
None listed