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

This study has been completed.
Sponsor:
Information provided by:
Sorlandet Hospital HF
ClinicalTrials.gov Identifier:
NCT00708890
First received: June 27, 2008
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Substance Use Disorders
Behavioral: Brief motivation to participate in TSG

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Twelve Step Based Self-help Groups for Substance Related Disorders - A Randomized Controlled Trial on a Detoxification Center

Resource links provided by NLM:


Further study details as provided by Sorlandet Hospital HF:

Primary Outcome Measures:
  • Self-help groups attendance and involvement during 6 months observation period. [ Time Frame: Six months after detox treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1)Substance use outcomes measured by Europ-ASI 2) Quality of Life [ Time Frame: 6 months after detox treatment ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: September 2008
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention group Behavioral: Brief motivation to participate in TSG
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.)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00708890

Locations
Norway
Sørlandet Sykehus
Kristiansand, VA, Norway, 4604
Sponsors and Collaborators
Sorlandet Hospital HF
  More Information

Additional Information:
Publications:
Responsible Party: Svein Gunnar Gundersen, Sørlandet Hospital HF
ClinicalTrials.gov Identifier: NCT00708890     History of Changes
Other Study ID Numbers: SSHF_815357
Study First Received: June 27, 2008
Last Updated: April 15, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Sorlandet Hospital HF:
Substance use disorders
Self-help groups
Twelve Step groups

Additional relevant MeSH terms:
Disease
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 22, 2014