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Twelve Step Based Self-help Groups for Substance Related Disorders (TSF_Norway)

Primary Purpose

Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Brief motivation to participate in TSG
Sponsored by
Sorlandet Hospital HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders focused on measuring Substance use disorders, Self-help groups, Twelve Step groups

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Sørlandet Sykehus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Will only get a standard information about TSG group (information about meeting etc.)

Outcomes

Primary Outcome Measures

Self-help groups attendance and involvement during 6 months observation period.

Secondary Outcome Measures

1)Substance use outcomes measured by Europ-ASI 2) Quality of Life

Full Information

First Posted
June 27, 2008
Last Updated
February 3, 2023
Sponsor
Sorlandet Hospital HF
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1. Study Identification

Unique Protocol Identification Number
NCT00708890
Brief Title
Twelve Step Based Self-help Groups for Substance Related Disorders
Acronym
TSF_Norway
Official Title
Twelve Step Based Self-help Groups for Substance Related Disorders - A Randomized Controlled Trial on a Detoxification Center
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorlandet Hospital HF

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders
Keywords
Substance use disorders, Self-help groups, Twelve Step groups

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Will only get a standard information about TSG group (information about meeting etc.)
Intervention Type
Behavioral
Intervention Name(s)
Brief motivation to participate in TSG
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-help groups attendance and involvement during 6 months observation period.
Time Frame
Six months after detox treatment
Secondary Outcome Measure Information:
Title
1)Substance use outcomes measured by Europ-ASI 2) Quality of Life
Time Frame
6 months after detox treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Sørlandet Sykehus
City
Kristiansand
State/Province
VA
ZIP/Postal Code
4604
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
22171827
Citation
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.
Results Reference
result
PubMed Identifier
24400937
Citation
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.
Results Reference
result
Links:
URL
http://www.seraf.uio.no/forskning/Interaktivt%20forum/Registrerte%20forskningsprosjekter/gruppe3/Vederhus.pdf
Description
The Norwegian Centre for Addiction Research web site

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Twelve Step Based Self-help Groups for Substance Related Disorders

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