- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00708890
Twelve Step Based Self-help Groups for Substance Related Disorders (TSF_Norway)
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
VA
-
Kristiansand, VA, Norway, 4604
- Sørlandet Sykehus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with alcohol and substance use disorders treated on a detox ward
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Intervention group
|
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.
|
|
NO_INTERVENTION: Control group
Will only get a standard information about TSG group (information about meeting etc.)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Self-help groups attendance and involvement during 6 months observation period.
Time Frame: Six months after detox treatment
|
Six months after detox treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
1)Substance use outcomes measured by Europ-ASI 2) Quality of Life
Time Frame: 6 months after detox treatment
|
6 months after detox treatment
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Vederhus 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SSHF_815357
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