3M Study - Maria Malmö Mobile Telephone Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Region Skane
Sponsor:
Information provided by (Responsible Party):
Anders C Håkansson, Region Skane
ClinicalTrials.gov Identifier:
NCT01706380
First received: October 8, 2012
Last updated: October 11, 2012
Last verified: October 2012
  Purpose

The present study, in an out-patient setting for substance use treatment in adolescents, examines the effect on treatment retention of a mobile telephone follow-up technique (interactive voice response), with or without personal feedback. Subjects in treatment for substance use disorders will be followed by automated mobile telephone contact with questions about psychiatric symptoms and substance use, and the investigators hypothesize that this technique, including a personal feedback reporting back to the client whether his or her status is changing in one way or another, may increase the treatment retention, possibly by means of an intensified treatment contact.


Condition Intervention
Substance Use Disorders
Behavioral: Interactive voice response with personal feedback
Behavioral: Interactive voice response without personal feedback

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Interactive Voice Response With and Without Personal Feedback in the Treatment of Adolescents With Substance Use Disorders

Further study details as provided by Region Skane:

Primary Outcome Measures:
  • Retention in substance use disorder treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Duration of retention in treatment and whether the client remains in treatment at 3 months or not.


Secondary Outcome Measures:
  • Improvement in substance use [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Do patients in the intervention group improve more than in the control group, with respect to substance use (alcohol/drug use), during the duration of the interactive voice response intervention?

  • Improvements in psychiatric symptoms [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Do patients in the intervention group improve more than in the control group, with respect to psychiatric symptoms, during the duration of the interactive voice response intervention?


Other Outcome Measures:
  • Clinical course with respect to emergency visits [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Clinical course with respect to hospitalizations [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Clinical course with respect to repeated treatment episodes [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: October 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interactive voice response with personal feedback
Interactive voice response follows the client twice weekly for 3 months with respect to symptoms and substance use, in both arms. This intervention group also receives a personalized and automated feedback describing whether the symptom status of the patient is better, worse or equal, compared to the preceding follow-up.
Behavioral: Interactive voice response with personal feedback
Personal feedback is given at the end of each automated telephone follow-up call, and reports back to the patient whether his och her symptom status is better, worse or equal, compared to the previous telephone call.
Active Comparator: Interactive voice response without personal feedback
This control group is also followed with identical interactive voice response follow-up, addressing symptoms and substance use, but without the personal feedback.
Behavioral: Interactive voice response without personal feedback
Control condition. Identical follow-up but without personal feedback.

  Eligibility

Ages Eligible for Study:   up to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient applying for substance use disorder treatment at out-patient facility Maria Malmö, Malmö, Sweden, who are less than 25 years old and who provide written informed consent to participate in the study.

Exclusion Criteria:

  • Patients who do not provide written informed consent to the study, or whose psychiatric condition or language difficulties make it impossible for them to understand patient information and give informed consent to the study.
  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: NCT01706380

Locations
Sweden
Maria Malmö, Dept of Psychiatry Skane and City of Malmö, Sweden Recruiting
Malmö, Skane, Sweden, 205 02
Contact: Anders Hakansson, MD, PhD    + 46 703 135677    anders_c.hakansson@med.lu.se   
Contact: Martin Olsson, MD, PhD student    + 46 46 171000    martin.o.olsson@skane.se   
Principal Investigator: Anders Hakansson, MD, PhD         
Sponsors and Collaborators
Region Skane
  More Information

No publications provided

Responsible Party: Anders C Håkansson, MD, PhD, Region Skane
ClinicalTrials.gov Identifier: NCT01706380     History of Changes
Other Study ID Numbers: 3M Study
Study First Received: October 8, 2012
Last Updated: October 11, 2012
Health Authority: Sweden: Ethics Committee, Lund University, Sweden
Sweden: Dept of Psychiatry Skane, Sweden

Keywords provided by Region Skane:
Substance use disorders
Adolescents
Retention
Mobile telephone
Follow-up
Interactive voice response

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

ClinicalTrials.gov processed this record on August 27, 2014