Alcohol AbusePhase 3NCT01184612
Effects of Motivational Interviewing in Prison
A Phase 3 study testing Motivational Interviewing; MI in people with Alcohol Abuse, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Motivational Interviewing (MI) is a communication style demonstrated to decrease drug and alcohol use. A five session MI intervention (BSF) was implemented in the Swedish correctional system. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alcohol Abuse
- What is being tested?
- Motivational Interviewing; MI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2004to Jul 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Born between 01-01-1954 and 31-12-1984;
- Conditional release no later than 30-06-2005 (this was extended to 19-09-2005 and again to 31-03-2006);
- Swedish or Norwegian speaker;
- Not having previously received BSF in remand or any other prison;
- Heavy use of alcohol or drugs, measured by the standard prison and probation system: 1= occasional use; 2= heavy use;
- ASI interview at intake;
- No order for deportation after release from prison
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Motivational Interviewing Delivered by Existing Prison Staff: A Randomized Controlled Study of Effectiveness on Substance Use After Release
Motivational Interviewing (MI) is a communication style demonstrated to decrease drug and alcohol use. A five session MI intervention (BSF) was implemented in the Swedish correctional system. The intervention was delivered by counsellors with workshop only MI training (BSF) or by counsellors with workshop MI training followed by peer group supervision based on audio taped feedback (BSF+).
Aim was to examine whether BSF in prisons reduces drug and alcohol use more effectively than interviews conducted according to the usual planning interview routine (UPI).
- Conditions
- Alcohol Abuse
- Being tested
- Motivational Interviewing; MI
- Keywords
- Inmates with heavy use of alcohol or drugs
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing; MIBehavioural
MI is a communication style defined as a collaborative, person-centred form of guiding to elicit and strengthen motivation to change. The method is based on four principles: showing empathy; developing discrepancy between the subject's current behaviour and an alternate, more desired, behaviour; reinforcing self-efficacy; and "rolling" with resistance to change. Client arguments for change are elicited and reinforced in an atmosphere that is empathic, collaborative and supportive of autonomy. The choice to change and the responsibility for change remain with the client.
| Study group | Role | What they receive |
|---|---|---|
| (BSF) MI sessions | Active comparator | 5 semi-structured manualised MI sessions was conducted by existing prison staff having undergone 3 days of Motivational Interviewing workshop training and 2 days of training with the BSF manual. Receives: Behavioral: Motivational Interviewing; MI |
| (BSF+) MI sessions with supervision | Active comparator | 5 semi-structured manualised MI sessions was conducted by ordinary prison staff having undergone 3 days of Motivational Interviewing workshop training and 2 days of training with the BSF manual, followed by ongoing Motivational Interviewing training with feedback based on audio taped sessions in peer supervision groups. Receives: Behavioral: Motivational Interviewing; MI |
| (UPI) Usual Planning Interview | Active comparator | 5 sessions was conducted by prison staff according to usual working practices, with the exception that content was structured into 5 sessions and audio recorded. The provision of a government decree served as a basis for the intervention, covering planning of prison activities and post release arrangements including strategies for drug use cessation. Receives: Behavioral: Motivational Interviewing; MI |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of days with substance use
alcohol- or drug use as measured by the Addiction Severity Index (ASI) at intake and at 10 months after release
Measured: of the last 30 days
Secondary outcomes (2)
reported days of illegal activity
as measured by Addiction Severity Index at intake and 10 months after release
Measured: during the preceding 30 days
number of days working
as measured by the Addiction Severity Index at intake and 10 months after release
Measured: during the last 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startApr 2004
- Primary completionMar 2007
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- the research committee of the National Prison and Probation Administration
- Investigators
- Lars G Forsberg, Ph D, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184612
- Sponsor's protocol ID
- 30225613
- Status last verified
- Oct 2003
- First submitted
- 18 Aug 2010
- Last updated
- 19 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Interviewing Delivered by Existing Prison Staff: A Randomized Controlled Study of Effectiveness on Substance Use After Release
- ClinicalTrials.gov ID
- NCT01184612
- Acronym / sponsor ID
- 30225613
- Conditions
- Alcohol Abuse
- Keywords
- Inmates with heavy use of alcohol or drugs
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- the research committee of the National Prison and Probation Administration
- Study start
- Apr 2004
- Primary completion
- Mar 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 19 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Motivational Interviewing (MI) is a communication style demonstrated to decrease drug and alcohol use. A five session MI intervention (BSF) was implemented in the Swedish correctional system. The intervention was delivered by counsellors with workshop only MI training (BSF) or by counsellors with workshop MI training followed by peer group supervision based on audio taped feedback (BSF+).
Aim was to examine whether BSF in prisons reduces drug and alcohol use more effectively than interviews conducted according to the usual planning interview routine (UPI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| (BSF) MI sessions | Active comparator | Behavioral: Motivational Interviewing; MI5 semi-structured manualised MI sessions was conducted by existing prison staff having undergone 3 days of Motivational Interviewing workshop training and 2 days of training with the BSF manual. |
| (BSF+) MI sessions with supervision | Active comparator | Behavioral: Motivational Interviewing; MI5 semi-structured manualised MI sessions was conducted by ordinary prison staff having undergone 3 days of Motivational Interviewing workshop training and 2 days of training with the BSF manual, followed by ongoing Motivational Interviewing training with feedback based on audio taped sessions in peer supervision groups. |
| (UPI) Usual Planning Interview | Active comparator | Behavioral: Motivational Interviewing; MI5 sessions was conducted by prison staff according to usual working practices, with the exception that content was structured into 5 sessions and audio recorded. The provision of a government decree served as a basis for the intervention, covering planning of prison activities and post release arrangements including strategies for drug use cessation. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Born between 01-01-1954 and 31-12-1984;
- Conditional release no later than 30-06-2005 (this was extended to 19-09-2005 and again to 31-03-2006);
- Swedish or Norwegian speaker;
- Not having previously received BSF in remand or any other prison;
- Heavy use of alcohol or drugs, measured by the standard prison and probation system: 1= occasional use; 2= heavy use;
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Interviewing; MIMI is a communication style defined as a collaborative, person-centred form of guiding to elicit and strengthen motivation to change. The method is based on four principles: showing empathy; developing discrepancy between the subject's current behaviour and an alternate, more desired, behaviour; reinforcing self-efficacy; and "rolling" with resistance to change. Client arguments for change are elicited and reinforced in an atmosphere that is empathic, collaborative and supportive of autonomy. The choice to change and the responsibility for change remain with the client. | Behavioural | (BSF) MI sessions, (BSF+) MI sessions with supervision, (UPI) Usual Planning Interview |
Primary outcome
number of days with substance use
Time frame: of the last 30 days
alcohol- or drug use as measured by the Addiction Severity Index (ASI) at intake and at 10 months after release
2 secondary outcomes
reported days of illegal activity
Time frame: during the preceding 30 days
number of days working
Time frame: during the last 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars G Forsberg, Ph D principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Motivational Interviewing; MI in people with Alcohol Abuse, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of days with substance use (time frame: of the last 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2010.