Substance Use DisordersTSF_NorwayNCT00708890
Twelve Step Based Self-help Groups for Substance Related Disorders
A study testing Brief motivation to participate in TSG in people with Substance Use Disorders, run by Sorlandet Hospital HF at 1 site in Norway.
Trial summary
The Twelve Step groups are the most available and widespread self-help groups for patients with alcohol or drug related disorders. In a public health perspective, self-help groups (SHGs) may be considered as a supplement to professional treatment and provide aftercare soon as professional treatment has ended. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Brief motivation to participate in TSG
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2008to Feb 2011
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with alcohol and substance use disorders treated on a detox ward
Who cannot join
- Severe psychiatric comorbidity
- Patients on opioid replacement therapy
- Those who have appointment with other inpatient treatment at intake (and will be transferred to such treatment)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Twelve Step Based Self-help Groups for Substance Related Disorders - A Randomized Controlled Trial on a Detoxification Center
The Twelve Step groups are the most available and widespread self-help groups for patients with alcohol or drug related disorders. In a public health perspective, self-help groups (SHGs) may be considered as a supplement to professional treatment and provide aftercare soon as professional treatment has ended.
There is a need to investigate if U.S. findings and procedures concerning referrals from the health services to Twelve Step Groups (TSGs) can be replicated and accommodated to a cultural setting which is unfamiliar with these groups. There is also a particular need in the Norwegian treatment system to develop alternative treatment strategies for patients undergoing detoxification to improve their chances of long-term recovery, due to deficient formal follow-up alternatives.
Read more
We plan to carry out a RCT-study. One hundred and sixty patients entering a detoxification treatment center (Addiction Unit, Sørlandet Hospital, Kristiansand, Norway) will be assigned to two different groups: One given standard information about TSGs (brief advice) and one given intensive referral (motivational sessions and contact with TSG volunteers). A follow up assessment is planned at 6 months to determine whether intensive referral results in more TSG attendance, and if this mediates less substance use and better functioning outcomes.
This study introduces a new concept in the Norwegian health care system and relies on a systematic cooperation with user organizations (SHGs) and user volunteers. Thus the study focuses strongly on user resources.
- Conditions
- Substance Use Disorders
- Being tested
- Brief motivation to participate in TSG
- Keywords
- Substance use disorders, Self-help groups, Twelve Step groups
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief motivation to participate in TSGBehavioural
The intensive intervention will consist of a boost motivational session on follow-up alternatives and particularly on attending TSGs. Efforts will be made to connect the patients with TSG volunteers via the AA/NA contact telephone. The patients are encouraged to invite AA/NA contact persons to visit them on the ward. The patient will then have the possibility to be followed to a meeting after treatment. The patients in the intensive referral group will get a phone call four weeks after discharge. The focus of this call will be on continued motivation to attend TSGs.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Behavioral: Brief motivation to participate in TSG |
| Control group | No intervention | Will only get a standard information about TSG group (information about meeting etc.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-help groups attendance and involvement during 6 months observation period.
Measured: Six months after detox treatment
Secondary outcomes (1)
1)Substance use outcomes measured by Europ-ASI 2) Quality of Life
Measured: 6 months after detox treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2008 (estimated)
- Study startSep 2008
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00708890
- Sponsor's protocol ID
- SSHF_815357
- Acronym
- TSF_Norway
- Status last verified
- Apr 2014
- First submitted
- 27 Jun 2008
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Vederhus JK, Timko C, Kristensen O, Clausen T. The courage to change: patient perceptions of 12-Step fellowships. BMC Health Serv Res. 2011 Dec 15;11:339. doi: 10.1186/1472-6963-11-339.
PubMed 22171827Vederhus JK, Timko C, Kristensen O, Hjemdahl B, Clausen T. Motivational intervention to enhance post-detoxification 12-Step group affiliation: a randomized controlled trial. Addiction. 2014 May;109(5):766-73. doi: 10.1111/add.12471. Epub 2014 Feb 16.
PubMed 24400937
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Twelve Step Based Self-help Groups for Substance Related Disorders - A Randomized Controlled Trial on a Detoxification Center
- ClinicalTrials.gov ID
- NCT00708890
- Acronym / sponsor ID
- TSF_Norway / SSHF_815357
- Conditions
- Substance Use Disorders
- Keywords
- Substance use disorders, Self-help groups, Twelve Step groups
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Study start
- Sep 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 2 Jul 2008 (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.
The Twelve Step groups are the most available and widespread self-help groups for patients with alcohol or drug related disorders. In a public health perspective, self-help groups (SHGs) may be considered as a supplement to professional treatment and provide aftercare soon as professional treatment has ended.
There is a need to investigate if U.S. findings and procedures concerning referrals from the health services to Twelve Step Groups (TSGs) can be replicated and accommodated to a cultural setting which is unfamiliar with these groups. There is also a particular need in the Norwegian treatment system to develop alternative treatment strategies for patients undergoing detoxification to improve their chances of long-term recovery, due to deficient formal follow-up alternatives.
We plan to carry out a RCT-study. One hundred and sixty patients entering a detoxification treatment center (Addiction Unit, Sørlandet Hospital, Kristiansand, Norway) will be assigned to two different groups: One given standard information about TSGs (brief advice) and one given intensive referral (motivational sessions and contact with TSG volunteers). A follow up assessment is planned at 6 months to determine whether intensive referral results in more TSG attendance, and if this mediates less substance use and better functioning outcomes.
This study introduces a new concept in the Norwegian health care system and relies on a systematic cooperation with user organizations (SHGs) and user volunteers. Thus the study focuses strongly on user resources.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Brief motivation to participate in TSG |
| Control group | No intervention | –Will only get a standard information about TSG group (information about meeting etc.) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with alcohol and substance use disorders treated on a detox ward
Key exclusion criteria (3 listed)
- Severe psychiatric comorbidity
- Patients on opioid replacement therapy
- Those who have appointment with other inpatient treatment at intake (and will be transferred to such treatment)
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 |
|---|---|---|
| Brief motivation to participate in TSGThe intensive intervention will consist of a boost motivational session on follow-up alternatives and particularly on attending TSGs. Efforts will be made to connect the patients with TSG volunteers via the AA/NA contact telephone. The patients are encouraged to invite AA/NA contact persons to visit them on the ward. The patient will then have the possibility to be followed to a meeting after treatment. The patients in the intensive referral group will get a phone call four weeks after discharge. The focus of this call will be on continued motivation to attend TSGs. | Behavioural | Intervention group |
Primary outcome
Self-help groups attendance and involvement during 6 months observation period.
Time frame: Six months after detox treatment
1 secondary outcome
1)Substance use outcomes measured by Europ-ASI 2) Quality of Life
Time frame: 6 months after detox treatment
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 8 Feb 2023.
- Results publication: PubMed 22171827Vederhus JK, Timko C, Kristensen O, Clausen T. The courage to change: patient perceptions of 12-Step fellowships. BMC Health Serv Res. 2011 Dec 15;11:339. doi: 10.1186/1472-6963-11-339.
- Results publication: PubMed 24400937Vederhus JK, Timko C, Kristensen O, Hjemdahl B, Clausen T. Motivational intervention to enhance post-detoxification 12-Step group affiliation: a randomized controlled trial. Addiction. 2014 May;109(5):766-73. doi: 10.1111/add.12471. Epub 2014 Feb 16.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief motivation to participate in TSG in people with Substance Use Disorders, run by Sorlandet Hospital HF at 1 site in Norway.
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 1 inclusion and 3 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 8 Feb 2023. 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 Norway. 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.
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?
Self-help groups attendance and involvement during 6 months observation period. (time frame: Six months after detox treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00708890, which also lists 2 linked publications.
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 8 Feb 2023; AzTrials last refreshed its copy on 29 Oct 2026.