NCT00708890

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 2, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

February 8, 2023

Status Verified

April 1, 2014

Enrollment Period

2.4 years

First QC Date

June 27, 2008

Last Update Submit

February 3, 2023

Conditions

Keywords

Substance use disordersSelf-help groupsTwelve Step groups

Outcome Measures

Primary Outcomes (1)

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

    Six months after detox treatment

Secondary Outcomes (1)

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

    6 months after detox treatment

Study Arms (2)

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.)

Interventions

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.

Intervention group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with alcohol and substance use disorders treated on a detox ward

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sørlandet Sykehus

Kristiansand, VA, 4604, Norway

Location

Related Publications (2)

  • 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.

Related Links

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2008

First Posted

July 2, 2008

Study Start

September 1, 2008

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

February 8, 2023

Record last verified: 2014-04

Locations